睿学教育Wisdome Education

Jacqueline Schwartz, PharmD

• Assistant Professor, School of Pharmacy, Pacific University, Hillsboro, Oregon

https://www.pacificu.edu/about/directory/people/jacqueline-schwartz-pharmd-rph

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At 1 year of follow-up menstruation migraines purchase on line fluoxetine, there was no difference between groups in the occurrence of major coronary events pregnancy 5 months purchase fluoxetine with paypal. Despite greater lowering of low-density lipoprotein in the early intensive group menstrual cramps 6 weeks postpartum order fluoxetine 20 mg without a prescription, there were no differences between the early intensive and less aggressive groups on the primary endpoint (cardiovascular death, myocardial infarction, readmission for acute coronary syndrome, or stroke), or on any individual component of the primary outcome. Nine patients in the simvastatin only group developed myopathy (creatine kinase level greater than 10 times the upper limit of normal with associated muscle symptoms) while taking 80 mg compared with 1 patient in the placebo first group (P=0. Three of the 9 in the simvastatin group had creatine kinase levels higher than 10 000 units/L and met the definition for rhabdomyolysis. The rate of myopathy was high, despite the exclusion of patients at increased risk of myopathy due to renal impairment or concomitant therapy with agents known to enhance Statins Page 51 of 128 Final Report Update 5 Drug Effectiveness Review Project myopathy risk, or for having a prior history of nonexercise-related elevations in creatine kinase level or nontraumatic rhabdomyolysis. The lack of effect of more intensive treatment in this trial may have been due to several factors. The “early intensive” group started with only 40 mg of simvastatin, and did not increase to 80 mg for 30 days. Patients who were taking statin therapy at the time of their myocardial infarction (at randomization) were excluded. The study authors reported that the trial had less statistical power than originally planned due to a lower than expected number of end points and a higher than expected rate of study drug discontinuation. The large randomized trials summarized above provided strong evidence about the balance of benefits and harms from statin therapy. Because they were analyzed on an intention- to-treat basis, the benefits (reductions in coronary events, strokes, and, in some studies, mortality) in subjects who tolerated and complied with medication were diluted by the lack of benefit in subjects who discontinued medication because of side effects or did not complete the study for other reasons. Moreover, the mortality results of the trials indicated clearly that for the enrolled subjects and the duration of the trials, statins are beneficial. The balance of benefits and harms of statin drugs over a longer time than the trial durations remains unclear. Studies of the progression of atherosclerosis with secondary or incidental coronary heart disease endpoints Twelve studies of the effects of statins on progression of atherosclerosis also reported rates of 147-158 187 coronary or cardiovascular events. A head-to-head trial of the effect of atorvastatin 80 mg compared with pravastatin 40 mg on progression of atherosclerosis did not meet inclusion criteria because it did not report health outcomes. However, this study did meet inclusion criteria for Key Question 1 (see Evidence Table 1). In these studies, the primary endpoint was progression of atherosclerosis, and all of the patients had known coronary heart disease. To answer the question of whether treatment with a statin is associated with a reduction in clinical cardiovascular outcomes in patients with coronary heart disease, these studies were considered fair or fair-to-poor quality. In 6 of the 12 trials clinical outcomes were not a preplanned endpoint (they were "spontaneously reported"), and sample sizes were relatively small. Table 12 and Evidence Table 5 summarize the results of these studies. The number of trials and patients studied for each statin are as follows: fluvastatin (1 trial; N=429), lovastatin (3 trials; N=1520), pravastatin (5 trials; N=2220), and simvastatin (3 trials; N=1118). The information about fluvastatin was inconclusive and the other 3 statins were already known to be effective from better studies. In general, most trials in which coronary heart disease events were not a prespecified endpoint found a trend towards a reduction in clinical events in favor of a statin. In the trials in which coronary heart disease events were a secondary endpoint, there was usually a significant reduction in 1 of the components of coronary heart disease events. While consistent, the results of these studies are difficult to interpret because of possible reporting bias. That is, these trials may have been more likely to report a result if it was statistically significant or indicated a trend favoring treatment. Similar trials of progression of atherosclerosis that found no trend probably did not report coronary events. For this reason, we did not conduct a meta-analysis to pool the results of these studies. Statins Page 52 of 128 Final Report Update 5 Drug Effectiveness Review Project Table 12.

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Triptans Page 2 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1 menstrual relief hormone balance discount generic fluoxetine canada. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Bomhof Multicenter single-dose RCT Not stated 618 39 years I H S criteria 6-month history of migraine; 1-8 1999 conducted in Europe of 84% female 18-65 men and reports per month; no evidence naratriptan vs women's health center of oregon discount fluoxetine master card. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Bomhof H women's health clinic tweed heads buy fluoxetine without prescription. O cva, cardiovascular disease, Merck, co-investigator Permitted NR 1999 significant ecg abnormality, history or (maker of rizatriptan) drug or alcohol use, past use of study drugs Carpay 1997 Known narcotic/alcohol abuse Glaxo NR 142/124/124 ergotamine abuse pregnancy, breast-feeding history of ECG evidence of ischaemic heart disease significant concomitant disease significant psychiatric illness known hypersensitivity to/intolerance of sumatriptan current use of fluarizine Triptans Page 4 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Bomhof 96 (did not take study 1999 medication) Carpay 1997 NR/NR Triptans Page 5 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Charlesworth Multicentre, DB, Double- 42 centers in 1547 Mean age=19. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Charlesworth History of basilar, ophthalmoplegic AstraZeneca NR 1547/1383/1372 2003 migraine reported non-migraine > 10 days/month 6 months before study pregnancy, lactation, inadequate conception in women ischaemic heart disease, arrhythmias/cardiac accessory uncontrolled hypertension, use of monoamine oxidase-A inhibitors, methylergometrine within 2 weeks of study clinically significant abnormal laboratory result recent history of drug/alcohol abuse known hypersensitivity/adverse reaction to study treatments/triptans existing serious medical condition participation in another clinical study at same time of this study risk of transmitting Hep B/HIV Colman, 2001 Subjects could not have uncontrolled Pharmacia Rescue medications NR/NR/1255 Spierings, hypertension, defined as a diastolic allowed at 2 hours 2001 blood pressure higher than 95 mm Hg or a systolic blood pressure higher than 160 mm Hg, or clinically significant disease affecting any system but especially the cardiovascular or gastrointestinal tract Triptans Page 7 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Charlesworth 66/8 2003 Colman, 2001 NR/NR Spierings, 2001 Triptans Page 8 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Diez Multicenter, randomized, open, NR 436 Mean age: 36. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Diez Complex forms of migraine, pregnancy, Almirall Prodesfarma Rescue medication NR/436/372 2007 lactation, hypersensitivity to any permitted (NSAIDs) component of the study medications, history signs or symptoms of ischemic heart disease, cerebrovascular accidents, transient ischemic attack or peripheral vascular disease. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Diez 54/10 2007 DowsonDowson 32(14. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Gallagher Multicenter, multiple-dose Not stated 1212 39 years IHS criteria; 1 For women, use of reliable 1999, 2000 analysis of DB RCT, 6 month 85% female year history of contraception. Patients who had study; conducted in Europe of race/ethnicity migraine 2 or more migraines included in zolmitriptan vs. Garcia-Ramos Multicenter, single-attack, DB Not stated 548 Mean age=36. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Gallagher H/o ischemic heart disease, arrhythmia, Zeneca, co-investigator Some permitted NR 1999, 2000 hypertension, some types of migraine; drug or alcohol abuse, abnormal lab tests Garcia-Ramos 1) Coronary artery disease, heart failure, Pfizer Rescue medication 563 screened/548 2003 uncontrolled hypertension or abnormal allowed by 4 hours post- randomized/483 treated an UK/Latin ECG; dose (excluding any other attack America 2) frequent migraine or concommitant triptan, ergotamine, or nonmigrainous headache (<6 per month), ergotamine-like substance) Fair quality migraine variants (e. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Gallagher 233 who had only 1 1999, 2000 headache Garcia-Ramos 65 not treated/4 2003 withdrawn/1 (0. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Geraud Multicenter, single-dose DB Outpatient 1311 38 years IHS criteria; 1 Average of 1-6 attacks per 2000 RCT conducted in Europe and 85% female year history of month for the 6 months Australia of zolmitriptan vs. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Geraud H/o ischemic heart disease, arrhythmias, Maker of zolmitriptan, co- Permitted NR 2000 uncontrolled hypertension, use of investigator psychoactive drugs, history of drug or alcohol abuse; certain types of migraine; any condition that could interfere with efficacy assessments, pregnant or breastfeeding Goadsby Hemiplegic or basilar migraine, tension- Almirall Prodesfarma Rescue medication (other NR/NR/1298 2007 type headache >4 days/month, inability than triptans) was to distinguish between tension-type and permitted migraine headache, history of ischaemic heart disease, severe or uncontrolled hypertension, cerebrovascular disease, peripheral artery disease, moderate to severe renal or hepatic disease, pregnancy, lactation, history of abuse of analgesics or ergot derivatives or triptans, allergy or sensitivity to sulfonamides or triptans Goadsby, 2000 >6 migraine attacks per month, frequent Pfizer, Ltd. Rescue medication NR/NR/857 Jackson, 1998 tension-type headaches, recent history allowed after 2 hours of alcohol or other substance misuse, serious allergic reactions to drugs, use of any experimental drug within the past month, pregnant or breastfeeding women, severely limited gastrointestinal absorption, any medical condition that might interfere with the interpretations of the study results, coronary artery disease, heart failure, uncontrolled hypertension, and receiving medication specifically contraindicated with sumatriptan Triptans Page 16 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Geraud 253; 225 did not take 2000 medication, 28 were lost to follow-up Goadsby 122/NR 2007 Goadsby, 2000 157/849 (18. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Gruffyd-JonesGruffydd-Jones Multicentre, randomized, open, NRMulticenter, double-dummy Not stated 1787401 Age range=18-42 years IHS criteriaMale or female Average of 1-6 attacks perHistory of migraine for at least 2001 RCT conducted in 21 countries 86% female 18-65 men and month for 2 months preceding of zolmitriptan vs. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Gruffyd-JonesGruffydd-Jones Pregnancy, lactating, inadequateNR Astra-Zeneca, funderNR Most prohibitedRescue medication: 414/401/388NR 2001 contraception in females, ischemic heart disease, arrhythmias, cardiac accessory pathway disorders, hypertension, use of MAO inhibitors, recent history of alcohol or drug abuse, abnormal clinical lab result, STDs, hepatitis B. Havanka History suggestive of cardiovascular or Glaxo, co-investigator Prophylactic medications NR 2000 cerebrovascular disease; hypertension; stopped 1 week before the pregnant or lactating; history of drug or study; rescue drugs not alcohol or ergotamine abuse; use of permitted MAO inhibitors, SSRIs, lithium, or flunarizine. Triptans Page 19 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Gruffydd-JonesGruffyd-Jones 620, many because109/30% 2001 they did not have 6 attacks Havanka NR 2000 Triptans Page 20 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Age Author Number Gender Year Design Setting randomized Ethnicity Patients Inclusion criteria Kolodny 2004 Multicenter, randomized, NR 1288 mean age: 40 Male or female At least 6 month history of (b) placebo, crossover, DB years, adults, aged migraine White: 87% over 18 years good health standing Female: 86% that met IHS criteria for migraine Kolodny Multicenter, randomized, NR 1447 Mean age: 40 Male or female At least 6 month history of 2004(a) placebo, crossover, DB years, adults, aged migraine White: 87% over 18 years good health standing Female: 86% that met IHS criteria for migraine Lainez Randomized, open, crossover NR 439 Adults aged 18 Be in good health, 1 to 8 2006 to 65 years who migraines/month met IHS criteria for migraine Lines Multicenter single-dose DB Not stated 792 40 years I H S criteria 6-month history of migraine; 1-8 1997 RCT conducted in Sweden, 80% women 18-65 men and attacks per month Lines Norway, the United Kingdom ethnicity NR women. Characteristics of head-to-head trials Number screened/ Author Funding sources eligible/ Year Exclusion criteria and role of funder Other medications enrolled Kolodny 2004 Use of monoamine oxidase inhibitors, Merck Standard antimigraine 1287/1287/1287 (b) methysergide/propranolol, participation prophylactic (with in study 1 exception of non-steroidal anti-inflammatory drugs, daily analgesics, or propranolol) Kolodny Use of monoamine oxidase inhibitors, Merck Standard antimigraine 1447/1447/1447 2004(a) methysergide/propranolol prophylactic (with exception of non-steroidal anti-inflammatory drugs, daily analgesics, or propranolol) Lainez Preponderance of mild attacks, baslar or NR Rescue medication 509/506/439 2006 hemiplegic migraines, difficutly permitted (NSAIDs) distinguishing migraine from tension or other interval headache, cardiovascular disease, ECG abnormality, uncontrolled hypertension, renal, hepati or other systemic disease Lines NR Merck, co-investigator Escape medications, NR 1997 consisting of standard Lines analgesics or anti-emetics, 2001 were allowed from 2 hours onwards. Triptans Page 22 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1. Characteristics of head-to-head trials Number Author withdrawn/ Year lost to follow-up Kolodny 2004 NR/NR (b) Kolodny 13/18 2004(a) Lainez 67/0 2006 Lines 141 (did not take study 1997 medication) Lines 2001 Triptans Page 23 of 184 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 1.

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Mixed populations: Relapsing-remitting and secondary progressive multiple sclerosis Beta interferons ® • Quality of life improved with interferon beta-1b SC (Betaseron )-treated patients when compared with untreated controls breast cancer 49ers cheap 20 mg fluoxetine fast delivery, however the effect diminished based on higher baseline disability scores 6272 menopause fluoxetine 10 mg order amex. Natalizumab • Based on limited data from 4 trials menstrual discomfort buy genuine fluoxetine online, there was no statistically significant difference ® between natalizumab (Tysabri ) and placebo in change in Expanded Disability Status Scale, although 1 of the trials did find that natalizumab significantly impacted relapse rate. These findings must be interpreted with extreme caution as these trials were of relatively Disease-modifying drugs for multiple sclerosis Page 24 of 120 Final Report Update 1 Drug Effectiveness Review Project short durations and this finding was markedly different from that of the 2 larger natalizumab trials in relapsing-remitting multiple sclerosis patients alone. Mitoxantrone ® • Pooled data from 4 trials provided evidence that mitoxantrone (Novantrone ) was superior to placebo for relapse-related outcomes and disease progression. Primary progressive multiple sclerosis • One systematic review of 2 small trials comparing interferon to placebo (1 interferon beta- ® ® 1a IM [Avonex ] and 1 interferon beta-1a SC [Betaseron ]) found no difference in relapse related and disease progression outcomes when the data was pooled. The pooling did not allow for comparative effectiveness and results were limited by the small number (N=143). Mixed populations: Primary and secondary progressive multiple sclerosis Glatiramer acetate 2 • In a -site study conducted in a “chronic progressive” patient population, glatiramer ® acetate (Copaxone ) was found to be superior to placebo for disease progression and Expanded Disability Status Scale change at 24 months at 1 of 2 centers. There were no other significant differences between the glatiramer acetate and placebo groups in effectiveness outcomes. No studies of beta interferons, natalizumab, or mitoxantrone in a mixed primary and secondary progressive multiple sclerosis population were found. Progressive relapsing multiple sclerosis • No studies were identified that assessed the use of 1 of the included drugs in patients with progressive relapsing multiple sclerosis. Mixed populations: Clinically isolated syndrome + relapsing-remitting multiple sclerosis ® • One small fair-quality study compared interferon beta-1b SC (Betaseron ) to glatiramer acetate and found no difference on relapse related outcomes. Disease-modifying drugs for multiple sclerosis Page 25 of 120 Final Report Update 1 Drug Effectiveness Review Project Detailed Assessment Previously conducted systematic reviews of disease-modifying drugs for multiple sclerosis We found 6 systematic reviews that assessed multiple drugs for the treatment of multiple 31-37 sclerosis. One of these reviews was updated in 2009 but without new evidence of the 38 outcomes of interest this review was not analyzed further. One review focused on treatment of 33 symptoms rather than disease modification and will not be discussed here. Another focused on the association of depression with beta interferon and glatiramer acetate treatment and is 34 discussed under Key Question 3 below. The 4 remaining reviews included beta interferons, glatiramer acetate, and mitoxantrone. The best quality review was the one conducted for the National Institute for Clinical Excellence by Clegg and Bryant and a related article that updated 31, 32 that review. This review assessed the general effectiveness of the interventions compared with placebo. No attempts were made to compare the drugs to one another; however the review will be used in the appropriate sections below. Additional systematic reviews of individual drugs are considered as appropriate below. Relapsing-remitting multiple sclerosis Beta interferons 37 While we found 1 systematic review that directly compared the interferons, 2 additional studies directly comparing beta interferons have since been published, limiting the usefulness of that review for our purposes. Direct evidence Five trials directly compared one beta interferon to another, ranging from 16 to 24 months in 39-43 duration in patients with relapsing-remitting multiple sclerosis. While these were all fair- quality trials, there was variation in their features and risk of bias. However, none met all criteria for good quality, and none presented sets of flaws that appeared to indicate high risk for bias. The EVIDENCE trial compared 2 44 the beta-1a interferons to each other and original data was published in 2002. A crossover phase followed in which all patients were either switched to or continued on interferon beta-1a ® SC (Rebif ). Given the lack of comparative data on this crossover phase, it will only be included 45 in the discussion of harms that follows. The 2 Etemadifar trials compared all 3 beta interferons to another, and in the most recent trial, also to azathioprine. This later study did not report 43 relapse related outcomes.

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Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Schuster et al women's health of illinois purchase fluoxetine 20 mg without prescription. Patients aged >=18 years pregnancy weeks order 10 mg fluoxetine overnight delivery, with Pregnant and lactating women menstruation tumblr purchase fluoxetine with a mastercard, women not using reliable 6 week dietary lead-in phase, then 2004 CHD or other atherosclerotic contraception, patients with a history of homozygous familial randomization to 5 arm trial system R,OL,MC,ITT disease, type 2 diabetes, a CHD hypercholesterolemia or known type III hyperlipoproteinemia, with (drug a for 8 weeks then drug b or c for risk >20% over 10 years, with LDL- active arterial disease (e. Statins Page 165 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Schuster et al. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Schuster et al. Sponsored by Astra 2004 Zeneca R,OL,MC,ITT 5-arm trial that included statin switching (to rosuvastatin) at 8 weeks 3140 patients randomized 16 weeks of treatment Statins Page 167 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Schwartz et al, 2004 Patients aged >18 years, with LDL- Pregnant women, patients currently taking concomitant drugs known After a 6 week dietary lead-in, treatment C levels >=160 and< 250 mg/dL, to affect the lipid profile or to present a potential safety concern, a for the first 12 weeks: R, DB, MC and trig levels <=400 mg/dL, and history of active arterial disease (e. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Schwartz et al, 2004 Efficacy analysis for 382 patients: "Although adverse events were frequently reported in these high-risk patients, % LDL-C change from baseline they were generally mild and not attributed to trial medication. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Schwartz et al, 2004 Sponsored by Astra Zeneca R, DB, MC 382 patients randomized 24 week treatment period Statins Page 170 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Stalenhoef et al. Also >3X ULN; and use of prohibited concomitant medications. Statins Page 171 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Stalenhoef et al. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Stalenhoef et al. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Strandberg et al, 2004 Men and women >=18 years with A history of serious adverse events or hypersensitivity to an hMG-CoA rosuv 10 mg/d LDL-c level >135 mg/dL for statin- reductase inhibitor other than the study drugs; active hepatic disease; atorv 10 mg PO OD R (2:1), OL, MC, 2-arm naïve patients or >120 mg/dL in homozygous or heterozygous familial hypercholesterolemia (FH); study, ITT patients using the starting dose of unstable angina; elevated serum creatinine concentration (>220 optional extension period for rosuv pts who another lipid-lowering drug. Statins Page 174 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Strandberg et al, 2004 Efficacy analysis for 911 patients (rosuv 10mg/d, n= 627; atorv 10mg/d, n= Patients experiencing any AE (estimated from graph): 284) Rosuv ~38% (n=261) R (2:1), OL, MC, 2-arm Atorv ~37% (n=125). Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Strandberg et al, 2004 Supported by a grant from AstraZeneca R (2:1), OL, MC, 2-arm study, ITT 1024 patients randomized (n=686 to rosuv 10 mg/d, n=338 to atorv 10 mg/d) 12 weeks Statins Page 176 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Wolffenbuttel et al. Men and women with type 2 use of lipid-lowering drugs after visit 1, or a history of serious or After a 6-week dietary lead-in, treatment 2005 diabetes who had received hypersensitivity reactions to statins. Concomitant treatment with erythromycin, clarithromycin, azole antifungal agents, cyclosporin, antiviral agents, phenytoin, carbamazepine, phenobarbital, or nefazodone. Statins Page 177 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Wolffenbuttel et al. One aorta patient developed abnormality in ALT % of patients achieving LDL-c goals at 6, 12, and 18 weeks (p vs aorta): (>3X ULN) Patients reaching LDL-c <100. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Wolffenbuttel et al. Supported by 2005 AstraZeneca R, Open-label, MC 263 patients randomized (N=263) 18 week treatment period Statins Page 179 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Rosuvastatin vs Simvastatin Laks, 2008 Men and women aged 18 or older Familial hypercholesterolemia, secondary dysliidemia of any cause, Rosuvastatin 10 mg vs simvastatin 20 mg Open-label, multicenter with primary hypercholesterolemia history of serious adverse effect or hypersensitivity to othe statins, for 12 weeks and a 10-year CV risk >20% or a pregnancy, breastfeeding, and women of childbearing potential not history of CHD or other established using contraception, malignancy, use of disallowed concomitant atherosclerotic disease and fasting medications, history of alcohol or drug dependence, active liver triglycrides <=4. All were statin-naïve (not diabetes, unstable angina, uncontrolled hypertension, unexplained received a statin in the past 6 serum creatine kinase >3 times ULN, serious or unstable medical or months) or subjects on a start dose psychological conditin that compromises safety or participation in the or other lipid lowering therapy, trial. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Results (mean changes in lipoprotein levels) Harms/Comments Laks, 2008 Least squares mean percent change (SE) from baseline, rosuvastatin vs rosuvastatin vs simvastatin: Open-label, multicenter simvastatin: Overall withdrawals: 9. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Clinical Trial Funding Source Laks, 2008 AstraZeneca Open-label, multicenter Statins Page 182 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1. Trials comparing LDL-c lowering/HDL-c raising abilities of 2 or more statins Inclusion Criteria/ Patient Clinical Trial Population Exclusion criteria Intervention Switching statins Kai T et al, 2008 Men and women aged 41–87 years Familial hypercholesterolemia, severe liver dysfunction (transaminase > Switching from simvastatin 10mg/day to Open-label, single-center with mild hypertension and 100 IU/l), severe renal failure (creatinine > 2. Statins Page 183 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 1.

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Nonsteroidal antiinflammatory drugs (NSAIDs) 50 of 72 Final Report Update 4 Drug Effectiveness Review Project 150 women's health group columbia tn order discount fluoxetine on line. Toward an Understanding of NSAID-Related Adverse Events: The Contribution of Longitudinal Data menopause young age purchase fluoxetine online from canada. Calin A womens health eugene oregon order cheap fluoxetine online, Cawley MI, Pal B, Rosenberg JN, Silas AM, Williams PI. Multicentre double- blind comparison of sustained action formulations of tiaprofenic acid and indomethacin in osteoarthritis. Comparative double-blind study of tiaprofenic acid versus piroxicam in the treatment of osteoarthritis of the knee. Buchbinder R, Forbes A, Kobben F, Boyd I, Snow RM, McNeil JJ. Clinical features of tiaprofenic acid (surgam) associated cystitis and a study of risk factors for its development. Adverse reactions to tiaprofenic acid mimicking interstitial cystitis. How does cystitis affect a comparative risk profile of tiaprofenic acid with other non-steroidal antiinflammatory drugs? An international study based on spontaneous reports and drug usage data. Lisse J, Espinoza L, Zhao SZ, Dedhiya SD, Osterhaus JT. Functional status and health- related quality of life of elderly osteoarthritic patients treated with celecoxib. The Journals of Gerontology Series A, Biological Sciences and Medical Sciences. A randomized, multicentre, double-blind, parallel-group study to assess the adverse event-related discontinuation rate with celecoxib and diclofenac in elderly patients with osteoarthritis. Cyclo-oxygenase-2 inhibitors versus non- selective non-steroidal anti-inflammatory drugs and congestive heart failure outcomes in elderly patients: a population-based cohort study. Subgroup analyses to determine cardiovascular risk associated with nonsteroidal antiinflammatory drugs and coxibs in specific patient groups. Effects of COX inhibition on blood pressure and kidney function in ACE inhibitor-treated blacks and hispanics. Does celecoxib potentiate the anticoagulant effect of warfarin? Battistella M, Mamdami MM, Juurlink DN, Rabeneck L, Laupacis A. Risk of upper gastrointestinal hemorrhage in warfarin users treated with nonselective NSAIDs or COX-2 inhibitors. Concomitant coumarin-NSAID therapy and risk for bleeding. Effect of ibuprofen on cardioprotective effect of aspirin. Nonsteroidal antiinflammatory drugs (NSAIDs) 51 of 72 Final Report Update 4 Drug Effectiveness Review Project 165. Garcia Rodriguez LA, Varas-Lorenzo C, Maguire A, Gonzalez-Perez A. Nonsteroidal antiinflammatory drugs and the risk of myocardial infarction in the general population. COX-2-selective inhibitors and the risk of upper gastrointestinal bleeding in high-risk patients with previous gastrointestinal diseases: a population-based case-control study. Differences in outcomes of patients with congestive heart failure prescribed celecoxib, rofecoxib, or non-steroidal anti-inflammatory drugs: population based study. Nonsteroidal antiinflammatory drugs (NSAIDs) 52 of 72 Final Report Update 4 Drug Effectiveness Review Project Appendix A. NSAIDs with a ratio of <1 indicate selectivity for cyclooxygenase-2.

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Genomewide association studies and assessment of germline genetic variation associated with treatment re- of the risk of disease menstrual cycle 9 days fluoxetine 10 mg buy amex. The management of elderly patients with CLL is more complex than that of younger patients due to the greater frequency of comorbidities and functional impairment as well as reduced organ function women's health issues who order fluoxetine pills in toronto. Many of the recent advances in the care of CLL patients (prognostication women's health center lebanon tennessee order on line fluoxetine, more intense combination therapy regimens) are of unclear relevance for elderly patients. This review addresses 5 key questions in the management of elderly patients with CLL: (1) why is classifying the “fitness” of CLL patients necessary; (2) what criteria should be used to classify patient fitness; (3) when should elderly patients be treated; (4) how should therapy be selected for elderly patients; and (5) which therapy is best (for this patient)? Introduction advanced age, efficacious treatment is needed for these individuals The last 2 decades have been a time of tremendous progress in because a majority of patients beginning treatment for CLL will die as a direct result of the disease or its complications. Most patients are diagnosed with early-stage disease before developing symptoms after they are incidentally found to have This review addresses 5 key questions in the management of elderly lymphocytosis. Insights into the molecular biology and genetics patients with CLL: (1) why is classifying the “fitness” of CLL of the leukemic CLL B cell have not only led to a better patients necessary; (2) what criteria should be used to classify understanding of disease biology,1-3 but have also enhanced the patient fitness; (3) when should elderly patients be treated; (4) how accuracy of prognostication4,5 and identified potential new should therapy be selected for elderly patients; and (5) which therapeutic targets. There are several purposes for classifying fitness level in patients With such CIT approaches, a high proportion of patients achieve with CLL. The first is to accurately categorize the patient’s life a minimal residual disease–negative disease state, a depth of 9,10 expectancy unrelated to CLL (eg, due to other health problems). This information can then be used for patient counseling and to help define the importance of durable disease control when Unfortunately, these advances do not benefit all patients uni- selecting treatment. CLL is a disease of the elderly, with a median age of CLL patient is acceptable for an individual with a life expectancy onset of 70 years. According to the Surveillance Epidemiol- of 24 months due to other health problems, whereas it would be ogy and End Results (SEER) registry, 75% of patients are considered inadequate for an individual with a 10-year life more than 65 years of age at the time of diagnosis. These data illustrate the limitations of using chronologic age alone to estimate survival in patients with CLL. Because most patients have early-stage disease at diagnosis and are observed for several years before starting treatment, the median age The second reason to classify fitness is to help determine the at the time therapy is initiated is closer to 75 years. Elderly patients patient’s ability to tolerate aggressive therapy. A 70-year-old have been underrepresented in previous clinical trials, which has woman with CLL in need of treatment may have an average life resulted in uncertainty regarding the optimal treatment approaches expectancy unrelated to CLL of greater than 15 years. Rather than chrono- conditions and begin treatment after the age of 70. Life expectancy in the United States17 The number and severity of comorbid health conditions also provides Life expectancy, y important information regarding patient fitness. A Mayo Clinic study of 373 unselected CLL patients found that 89% of newly diagnosed Current age, y Men Women patients had at least one comorbid condition and 46% had at least one 65 18. Although the presence of a major comorbidity affected OS on univariate analysis, it was not a significant predictor on the multivariate analysis adjusting for CLL-specific characteristics (eg, and the pharmacokinetics (absorption, metabolism, excretion) of the 20 stage). This finding underscores that CLL-related characteristics are drugs to be used become key considerations in evaluating the suitability of a given treatment approach. This principle is well often the major factor influencing survival even when substantial illustrated by the Cancer and Leukemia Group B (CALGB) 9011 comorbidities are present. Although it enrolled only fit older patients trial, which found that creatinine clearance rather than age was the (performance status 0-2, no severe organ disfunction), the presence of 2 primary predictor of higher toxicity with fludarabine-based therapy or more comorbid health conditions was still associated with shorter 18 PFS and shorter OS in the German CLL5 trial. Historically, trials have primarily used an exclusionary (rather than a stratification) approach declaring patients above an age cutoff Organ function is a third factor in assessing patients’ suitability for or with any decrease in organ function or performance status aggressive treatment. It is well recognized that renal function decreases 19 with age. These criteria have excluded those with the characteristics typical of real-world CLL patients from participating. A consistent approach Renal Disease (MDRD) equation. For the patient they are evaluating and facilitate more rapid translation of example, a study of 100 000 individuals from Japan found that trial results into routine clinical practice. Although patients were traditionally classified based on age alone, it is now well recognized that chronologic age is not a reliable surrogate for physiologic age or fitness.

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This deletion appears to protect homozygous individuals from sexual transmission of HIV-1 menstrual tea fluoxetine 20 mg purchase with visa. If infected women's health center fishersville va cheap 10 mg fluoxetine mastercard, these individuals have a slower decrease in their CD4 T cell count and a longer AIDS-free survival than individuals with the wild type gene (Dean 1996 menstrual cycle 7 days late purchase fluoxetine 10 mg overnight delivery, Liu 1996, Samson 1996). In healthy individuals, there is no strong evidence for any illness associated with the deletion. Thus, targeting the inter- action between HIV-1 and the CCR-5 receptor appears to be an attractive therapeu- tic goal to prevent or slow disease progression. In 2008 the case of a person (the “Berlin” patient) with acute myeloid leukemia and HIV-1 infection was published. This patient underwent stem cell transplantation from a donor who was homozygous for the CCR5 32 deletion. The patient has remained without viral rebound for more than five years after transplantation and discontinuation of ART. This outcome demonstrates the critical role CCR5 plays in maintaining HIV-1 infection (Hütter 2009, Allers 2011). In treatment-naïve patients, R5 strains are found in 80–90%, compared to only 50– 55% in patients with antiretroviral exposure (Hoffmann 2007). The most important predictor of R5 tropism seems to be a higher CD4 T cell count in both naïve and antiretrovirally-pretreated patients. A low HIV plasma viremia seems to be associ- ated with R5 tropism only in untreated patients (Moyle 2005, Brumme 2005). In contrast, X4 viruses are almost exclusively found in advanced stages of the disease. When the CD4 T cell count is >500/µl, they are only found in 6%; at <25 CD4 T cells/µl, in more than 50% of patients (Brumme 2005). CCR5 antagonists probably need be given earlier in the course of disease. In the salvage situation, patients often harbor X4 viruses. The role of CCR5 antagonists might lie rather in the substitution of other antiretroviral agents in case of toxicity. Testing for co-receptor usage (Tropism testing) Since CCR5 blockers are effective only when a predominant R5 virus is present in the patient and co-receptor switch is not systematic, a baseline determination of the co-receptor usage of the virus is mandatory. Tropism testing prior to treatment avoids unnecessary costs and additional risks for the patient. Non-effectivity of CCR5 antag- onists may cause regimen frailty and lead to resistance. This is why the development of CCR5 antagonists has brought along a completely new laboratory branch which focuses on predicting the co-receptors mainly or exclusively used by viral popula- tion (see the chapter on Resistance). Several commercial assays have been developed to determine HIV tropism pheno- typically, such as Trofile (Monogram Biosciences). These assays are complex, time- consuming and require a viral load of at least 500–1,000 copies. A new version of the assay, Trofile-ES, can detect smaller numbers of X4 virus (ES, enhanced sensi- tivity), resistant to CCR5 inhibitors, when they constitute a minor subpopulation. Several studies have illustrated the potential benefit of the use of the newer, more sensitive tests (Saag 2008, Su 2008). Overview of antiretroviral agents 109 Determing tropisms with genotypic testing is more easier, less time consuming and less expensive. Genotypic tropism testing has been validated by several studies and has now substituted the more complex and expensive phenotypic assay (Sierra 2007, Poveda 2009, Swenson 2011). Presently the focus of research is on the V3 loop of the envelope protein gp120, as this is the region where HIV binds to the co-recep- tor (Jensen 2003, Briz 2006). However, tropism does not only seem to be defined by the V3 loop sequence – viral isolates with identical V3 loops can differ in tropism (Huang 2006, Low 2007). With genotypic testing, CCR5 antagonists may be suitable for many patients who have side effects on other agents, as long as the viral load is well suppressed.

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Progress in clinical neurosciences: A systematic review of the use of triptans in acute migraine women's health and fitness tips cheapest generic fluoxetine uk. Pharmacological treatments for acute migraine: quantitative systematic review women's health clinic northfield 10 mg fluoxetine buy amex. Triptans Page 49 of 80 Final Report Update 4 Drug Effectiveness Review Project 53 women's health initiative generic 10 mg fluoxetine otc. Wilding IR, Clark D, Wray H, Alderman J, Muirhead N, Sikes CR. In vivo disintegration profiles of encapsulated and nonencapsulated sumatriptan: gamma scintigraphy in healthy volunteers. The bioequivalence of standard sumatriptan tablets and two encapsulated forms of sumatriptan. Effect of encapsulation on absorption of sumatriptan tablets: data from healthy volunteers and patients during a migraine. Therapeutic benefit of eletriptan compared to sumatriptan for the acute relief of migraine pain--results of a model-based meta-analysis that accounts for encapsulation. Brandes JL, Kudrow D, Cady R, Tiseo PJ, Sun W, Sikes CR. Eletriptan in the early treatment of acute migraine: influence of pain intensity and time of dosing. Silberstein SD, Cady RK, Sheftell FD, Almas M, Parsons B, Albert KS. Efficacy of eletriptan in migraine-related functional impairment: functional and work productivity outcomes. Effectiveness of eletriptan in reducing time loss caused by migraine attacks. Unpublished Protocol 39 Supplemental Dossier on Maxalt compiled October 2008 for the Drug Effectiveness Review Project. A placebo-controlled crossover study of rizatriptan in the treatment of multiple migraine attacks. Efficacy of Rizatriptan 10 mg administered early in a migraine attack. Efficacy and safety of rizatriptan wafer for the acute treatment of migraine. Meta-analysis of the efficacy and safety of zolmitriptan in the acute treatment of migraine. Comparison of zolmitriptan and sumatriptan for the acute treatment of migraine. Klapper J, Lucas C, Rosjo O, Charlesworth B, group Zs. Benefits of treating highly disabled migraine patients with zolmitriptan while pain is mild. Spierings ELH, Gomez-Mancilla B, Grosz DE, Rowland CR, Whaley FS, Jirgens KJ. Oral almotriptan vs oral sumatriptan in the abortive treatment of migraine: A double- blind, randomized, parallel-group, optimum-dose comparison. Meta-analysis examining the efficacy and safety of almotriptan in the acute treatment of migraine. Triptans Page 50 of 80 Final Report Update 4 Drug Effectiveness Review Project 71. Consistent efficacy and tolerability of almotriptan in the acute treatment of multiple migraine attacks: results of a large, randomized, double-blind, placebo-controlled study. Effect of early intervention with almotriptan vs placebo on migraine-associated functional disability: results from the AEGIS Trial. A double-blind, placebo-controlled trial of almotriptan. Early intervention with almotriptan: results of the AEGIS trial (AXERT Early Migraine Intervention Study). Oral almotriptan in the treatment of migraine: a dose finding study. Equivalent efficacy of oral almotriptan, a new 5- HT1B/1D agonist, compared with sumatriptan 100mg. Paper presented at: 40th Annual Scientific Meeting of the American Association for the Study of Headache1998; San Francisco, CA.

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Therefore menstrual hygiene discount 10 mg fluoxetine fast delivery, especially in these patients menstruation kits 20 mg fluoxetine purchase overnight delivery, if eligible breast cancer care generic fluoxetine 10 mg without prescription, alloge- therapeutic alternatives will continue to be a major challenge in neic HCT should be planned as early as possible. In the setting of treatment-naive patients, first-line therapies with HMAs such as AZA are considered standard of care in older patients ( 60 years of age). Therefore, the ties, including cases with an additional TP53 mutation9,22 are value of prior induction chemotherapy (IC) is still not clear in the associated with lower survival rates compared with other cytoge- absence of randomized trials. Further poor prognostic variables include the with a considerable toxicity mainly in the absence of response. Two presence of peripheral blasts and severe RBC-TD,21 thus potentially recent retrospective studies have demonstrated that pre-HCT therapy allowing a prediction of outcome before the start of AZA (Figure 1). Considerations for choosing the optimal treatment before allogeneic HCT in patients with MDS. In general, there are 3 potential treatment options for transplantation-eligible patients before allogeneic HCT. The figure provides some rationale for choosing the optimal therapy before a planned transplantation. The recommendation above is based on the fact that patients with a poor-risk karyotype have a lower chance to respond to IC than patients with normal cytogenetics ( 40% vs 70%). In patients with poor-risk karyotype and no identified donor, a soft “bridging” (although with a lower chance of response than with IC) that avoids the immediate toxicities of IC might be a reasonable alternative. Alternatively, patients with a good-risk karyotype have a good chance of responding to IC, which might therefore be considered as an option even in the immediate absence of a compatible donor. An stances, mainly in younger and medically fit MDS patients (Figure important prerequisite before the initiation of IC may be the 2). A recent study by our group in AML patients 60 years of age availability of a suitable donor, mainly to be able rescuing nonre- in remission demonstrated less toxicity with RIC compared with sponding patients. In addition, several predictive factors for A large body of evidence exists from retrospective studies long-term outcome with HMAs have been determined (Figure 1) showing that systemic iron overload (SIO) in MDS patients and might therefore guide treatment decisions regarding when to (mainly as a result of RBC-TD before HCT) is associated with finally proceed to transplantation. Given the limitation of serum ferritin measurement, including its association with variables important for transplanta- better than MAC? In fact, we and others36,37 have recently presented data demonstrat- patients. Because the intensity of transplantation conditioning is linked to NRM, the development of RIC regimens and the use of ing that MRI-based liver iron concentration rather than ferritin is alternative donor sources have allowed the successful application of of prognostic significance after allogeneic HCT. Labile plasma HCT in older and comorbid patients with MDS as well. Conversely, iron is released as a result of pretransplantation conditioning; RIC transplantations rely on the GVL effect and have been however, so far, the direct consequences of this observation in associated with a higher risk of disease relapse compared with vivo and on the posttransplantation period are largely unknown. It is recommended to use iron irradiation or busulfan and treosulfan, but no regimen has been chelation before HCT in selected patients with SIO, although no formally shown to be superior compared with others. The results of definitive cutoff for ferritin or liver iron has been systematically these studies have been summarized in several recent reviews. Alternatively, allogeneic HCT should be performed Nevertheless, MAC regimens are still considered in certain circum- earlier, before SIO becomes clinically evident. Hematology 2013 525 Relapse after allogeneic HCT: who is at risk and how MRD-guided therapy, which offers treatment to patients with to prevent it detectable MRD only after HCT. Until recently, the majority of Relapse still remains a major challenge in the care of patients after patients with MDS often lacked a disease-specific molecular marker allogeneic HCT, also due to the wide application of RIC transplanta- for MRD detection. Our group has recently reported the first trial evaluating the factors influencing relapse risks after transplantation are disease efficacy of a preemptive treatment with AZA for MRD defined by a decreasing CD34 donor chimerism to prevent or delay hemato- burden before HCT (reflected by blast count and RBC-TD) and logic relapse in patients with CD34 MDS or AML after allogeneic cytogenetic risk group. In fact, in a recent publication by the Seattle 8 HSCT. Therefore, these patients need to be carefully evaluated for their curative potential with an allogeneic HCT to determine whether they should be exposed to the immediate hazards Summary of the procedure or if alternative treatment options exist. Should allogeneic HCT be a potential curative option in older patients with MDS? Yes, but the risks of the underlying disease Generally, the prognosis of MDS patients relapsing after allogeneic have to be balanced against comorbidities, hazards of the allogeneic HCT is poor, especially in the case of an early relapse within the first procedure, patient’s preferences, and therapeutic alternatives. If 6 months after HCT because patients are still recovering from the possible, these patients should be treated within prospective trials sequelae of the overall approach.

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Placebo-controlled trials in patients with PAR……………………………… menopause foods to eat fluoxetine 10 mg without prescription. Quality assessment of head-to-head trials in patients with PAR……………………241 Evidence Table 6a breast cancer north face jacket 10 mg fluoxetine purchase with amex. Quality assessment of placebo-controlled trials in patients with PAR…… menstrual diary buy fluoxetine on line.. Placebo-controlled trials in children with PAR………………………………………... Quality assessment of placebo-controlled trials in children with PAR……………... Trials in patients with non-allergic rhinitis…………………………………... Quality assessment of trials in patients with non-allergic rhinitis………. Quality assessment of placebo-controlled trials of harms outcomes…. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Allow e dothe r Trial Nam e S tudy De sign m e dications/ (Quality S core ) S e tting Eligibility crite ria Inte rve ntions Run-in/w ashoutpe riod inte rve ntions Be rge r P aralle l-group,single - Adult and adole sce ntsw ith spring TAAAQ 220m cg daily W ash-out pe riod x5days N R 2003 blind,R CT S AR forat le ast 24m os. F P 200m cg daily involving discontinuation U S A M ultice nte r P ositive e picutane ousorintrade rm al of allrhinitism e dications (F air) te st toone orm ore of grassortre e S tudyduration:3w e e ks R un-in:none ------------- polle nand/oroutdoorm olds K aise r TN S S (the sum of discharge , 2004 stuffine ss,itching,and sne e zing U S A score sre corde d the m orning of random izationvisit plusscore sfrom 3 of the 4pre viousdaysw e re re quire d toe qualat le ast 42(of a possible 84) pointsforpatie ntstocontinue inthe study. NCS Page 3 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Num be r Country Age Num be rscre e ne d/ w ithdraw n/ Trial Nam e Me thodof outcom e asse ssm e nt Ge nde r Othe rpopulation e ligible / lostto (Quality S core ) andtim ingof asse ssm e nt Ethnicity characte ristics e nrolle d fu/analy z e d Be rge r P atie nt re porte d se ve rity(0=abse nt to M e anage (ye ars):31. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Trial Nam e (Quality S core ) Outcom e s Be rge r TNS S TAAAQ =F P (data N R ) 2003 TN S S m ode rate :TAAAQ (n=69)=39% im prove m e nt from base line vsF P (n=76)=36% im prove m e nt from base line (p=N S ) U S A TN S S se ve re :TAAAQ (n=79)=38% im prove m e nt from base line vsF P (n=71)=41% im prove m e nt from base line (p=N S ) (F air) IN S S m ode rate and se ve re diffe re nce inm e anchange from base line w asstatisticallysignificant TAAAQ =F P (p=N S ) ------------- INS S (m e ane stim ate d from graph): K aise r N asal discharge :-0. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Total w ithdraw als; Trial Nam e Me thodof adve rse e ffe cts w ithdraw als due to adve rse (Quality S core ) asse ssm e nt Adve rse Effe cts Re porte d e ve nts Com m e nts Be rge r R e porte d bypatie nt TAAAQ (n=148)vsF P (n=147)(any W ithdraw als(ove rall):8 K aise rre -analyze d Be rge re t 2003 R e sponse sto2S AQ ite m s causality,(%);possiblyre late d,(%)) W ithdraw als(adve rse e ve nts):aldata toe xam ine the e ffe cts U S A prospe ctive lyde fine d as He adache :10(6. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Allow e dothe r Trial Nam e S tudy De sign m e dications/ (Quality S core ) S e tting Eligibility crite ria Inte rve ntions Run-in/w ashoutpe riod inte rve ntions Gross P aralle l-group,single - Adult and adole sce ntsw ith fall TAAAQ 220m cg daily F P W ash-out pe riod x5days N o 2002 blind,R CT (ragw e e d)AR forat le ast 24m onths. NCS Page 7 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Num be r Country Age Num be rscre e ne d/ w ithdraw n/ Trial Nam e Me thodof outcom e asse ssm e nt Ge nde r Othe rpopulation e ligible / lostto (Quality S core ) andtim ingof asse ssm e nt Ethnicity characte ristics e nrolle d fu/analy z e d Gross P atie nt re porte d nasalsym ptom M e anage (ye ars):38. R Q L Q n=349 (F air) itching/te aring/re dne ss)tw ice daily Black4. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Trial Nam e (Quality S core ) Outcom e s Gross TAAAQ vsF P 2002 TNS S :49. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Total w ithdraw als; Trial Nam e Me thodof adve rse e ffe cts w ithdraw als due to adve rse (Quality S core ) asse ssm e nt Adve rse Effe cts Re porte d e ve nts Com m e nts Gross R e porte d bypatie nt via daily TAAAQ (n=172)vsF P (n=180)(possibly W ithdraw als(ove rall):10 Applicationre actioninclude d 2002 que stionnaire s re late d,(%);probablyre late d,(%)): W ithdraw als(adve rse e ve nts):post-dose burning,stinging, U S A Bodyasa w hole :2(1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Allow e dothe r Trial Nam e S tudy De sign m e dications/ (Quality S core ) S e tting Eligibility crite ria Inte rve ntions Run-in/w ashoutpe riod inte rve ntions R atne r P lace bo-controlle d Adult patie ntsw ith m ode rate to F P 200m cg inthe m orning + R un-inpe riod 4-14days Chlorphe niram ine 4m g 1992 D ouble -blind se ve re S AR forat le ast 24m onths place bointhe e ve ning W ash-out:none table ts U S A R CT P ositive skinte st toM ountainCe dar, BD P 168m cg tw ice daily (F air) M ultice nte r Juniperusashei P lace botw ice daily N orm aladre nalfunction W om e nof non-childbe aring pote ntial S tudyduration:2w e e ks At le ast 200/400pointsonIN S S onat le ast 4out of 7daysof run-inpe riod NCS Page 11 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Num be r Country Age Num be rscre e ne d/ w ithdraw n/ Trial Nam e Me thodof outcom e asse ssm e nt Ge nde r Othe rpopulation e ligible / lostto (Quality S core ) andtim ingof asse ssm e nt Ethnicity characte ristics e nrolle d fu/analy z e d R atne r N asale xam days1,8,and 15and M e anage (ye ars):37. NCS Page 12 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Trial Nam e (Quality S core ) Outcom e s R atne r F P vsBD P vsP L 1992 INS S (clinician-rate d,patie nt-rate d): U S A F orallIN S S F P =BD P >P L (P <0. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Total w ithdraw als; Trial Nam e Me thodof adve rse e ffe cts w ithdraw als due to adve rse (Quality S core ) asse ssm e nt Adve rse Effe cts Re porte d e ve nts Com m e nts R atne r Elicite d byinve stigatorat F P (n=106)vsBD P (103)vsP L (n=104) W ithdraw als(ove rall):4 Authorsonlyliste d adve rse 1992 e ach clinic visit S ore throat:2(2%)vs2(2%)vs1(1%) W ithdraw als(adve rse e ve nts):e ve ntsif re porte d by3orm ore U S A Blood innasalm ucus:6(6%)vs1(1%)vs 2(place bogroup for patie ntsacrosstre atm e nt (F air) 2(%) insom nia,obje ctionable odor groups N asalburning:5(5%)vs2(2%)vs4(4%) of studydrug) Epistaxis:3(3%)vs2(2%)vs0 Allce nte rsw e re inTe xasw ith He adache :0vs1(1%)vs3(3%) analle rge nspe cific tothat Anye ve nt:19(18%)vs10(10%)vs19(18%) re gion. NCS Page 14 of 357 Final Report Update 1 Drug Effectiveness Review Project Evide nce Table 1. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Country Allow e dothe r Trial Nam e S tudy De sign m e dications/ (Quality S core ) S e tting Eligibility crite ria Inte rve ntions Run-in/w ashoutpe riod inte rve ntions Graft P lace bo-controlle d Adult and adole sce nt (at le ast 12 M F 200m cg inthe m orning +R un-inpe riod:none N o 1996 D ouble -blind ye arsold)ptsw ith S AR forat le ast 24place bointhe e ve ning W ash-out pe riod:1dayto U S A P aralle lgroup m onths BD P 168m cg tw ice daily stop nasal,oral,orocular (F air) R CT P ositive skinprickte st toragw e e d P lace botw ice daily de conge stants. O ral M ultice nte r W om e nof non-childbe aring statusor antihistam ine sfora using acce ptable form of birth control S tudyduration:8w e e ks variable am ount of tim e F re e of nasaland non-nasal de pe nding ondurationof sym ptom s(score le ssthanore qual action to1)and TN S S le ssthanore qualto S yste m ic corticoste roids 2at scre e ning and base line. He ad-to-he adtrials inpatie nts w ithS AR Author Ye ar Num be r Country Age Num be rscre e ne d/ w ithdraw n/ Trial Nam e Me thodof outcom e asse ssm e nt Ge nde r Othe rpopulation e ligible / lostto (Quality S core ) andtim ingof asse ssm e nt Ethnicity characte ristics e nrolle d fu/analy z e d Graft IN S S :4nasalsym ptom s M e anage (ye ars):34. GlobalEvaluationbypatie nt and M D at e ach visit Com pliance e valuate d w ith phone callday15and 43 Adve rse e ve nts(safe ty)re vie w e d w ith M D at e ach visit.

Nafalem, 61 years: Summary of the evidence by key question Strength of Key question Comparison evidence Conclusion 1. The treatment of multiple sclerosis involves acute relapse treatment with corticosteroids, symptom management with appropriate agents, and disease modification with disease-modifying drugs. Higher dose most likely produces larger population size during the initial viremia, increasing the time and the number of pathogens available to make a particular mutant.

Campa, 58 years: Detailed assessment General efficacy and effectiveness We did not find any studies on the general efficacy and effectiveness of any included drugs that met our eligibility criteria. The authors noted an odds ratio for myocardial infarction of 1. Romagne et al generated a human to NSG mice after 250 cGy radiation with or without 6 doses of IL-2 monoclonal antibody called 1-7F9 that recognizes the inhibitory or IL-15 intraperitoneally.

Aidan, 60 years: Her mother was excessively fond of her; and her grandmother doted on her still more. The main conclusion is that cerebral silent cerebral ischemia (“acute silent stroke”) by diffusion- ischemia occurs far more frequently than previously recognized in weighted MRI. Anthracyclines Doxorubicin Liposomal doxorubicin These options include combinations such as CyBorD (cyclophospha- Immunomodulatory drugs (IMiDs) mide, bortezomib, dexamethasone), VRD (bortezomib, lenalidomide, Thalidomide dexamethasone), KRD (carfilzomib, lenalidomide, dexamethasone), Lenalidomide PVD (pomalidomide, bortezomib, dexamethasone), KPD (carfil- Pomalidomide zomib, pomalidomide, dexamethasone), or traditional combinations Proteasome inhibitors Bortezomib such as DT-PACE (dexamethasone, thalidomide, cisplatin, adriamy- Carfilzomib cin, cyclophosphamide, etoposide) or DCEP (dexamethasone, cyclo- phosphamide, etoposide, cisplatin).

Marus, 23 years: Atomoxetine treatment has been assessed in a 12-week placebo-controlled trial of 398 147 adults with ADHD and comorbid alcohol use disorders. Almotriptan Direct comparisons We included 4 head-to-head trials of almotriptan 12. HbA1c at 1-year Incidence of follow-up Tan M 2004 treatment- Hispanic NR Pio: −0.

Lars, 21 years: Forest plots for both weighted mean difference and risk ratio were created to visually inspect the 7 2 data. Although it is known that these agents, first developed in the in MDS and AML. Hypertriglyceridemia and/or hypofibrinogenemia Fasting triglycerides 3 mmol/L Increased awareness has emerged that patients with acquired Fibrinogen 1.

Potros, 26 years: MPs Cells that are activated or undergo apoptosis release procoagulant Interestingly, when we evaluated the association between platelet MPs (also referred to as microvesicles or extracellular vesicles) into numbers and occurrence of VTE more closely for different cancer the circulation. Overall withdrawals were nonsignificantly lower for lisinopril compared with candesartan. Therefore, retreatment with BV provides a reasonable palliative option for patients with RR HL that BV after allo-SCT responded to a first course and requires careful monitoring for the Relapse after an allo-SCT for RR HL occurs in up to 50% of patients development or exacerbation of peripheral neuropathy.

Keldron, 35 years: The term exercise-induced asthma sometimes refers to persons who have exacerbation of their chronic asthma during exercise. Hence it might be speculated, that mankind shares a long coevolution together with HPgV and retroviruses, which could explain why HIV – in contrast to SIV in other primates – until recently was not able to establish a stable endemic. Mönkemeyer M, Schmidt RE, Wedemeyer H, Tillmann HL, Heiken H.

Hamlar, 41 years: Proton pump inhibitors Page 260 of 304 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 13. Clin Infect Dis 2009, 48:1138-51 Berenguer J, Miralles P, Arrizabalaga J, et al. R esults ofplacebo-controlled trials ofnewerinsom niadrugs A uth or,year O utcom e M easure R esults PSG wake aftersleeponset(W A SO ),min R amelteon4mg:48.

Sugut, 38 years: It contains 10 items only, and is known as the Hyperactivity Index. Several JAK kinase family long-term outcome for patients with detectable BCR-ABL1 cells members, including JAK2, are activated in BCR-ABL1–expressing who do not resume TKI treatment is unknown, but the situation cells. Asthma control days were not different among groups for the first 14 days of treatment; however, from day 14 to 21, levalbuterol 0.

Kaffu, 37 years: Virological success is more appropriate for judging the efficacy of specific regimens. We included one recent, good-quality systematic review and meta-analysis of all four targeted immune modulators approved by the US Food and Drug Administration for Crohn’s 190 disease. Persistent low-level HIV-1 RNA between 20 and 50 copies/mL in antiretroviral-treated patients: associated factors and virological outcome.

Akascha, 43 years: Paroxetine reduces social anxiety in individuals with a co-occurring alcohol use disorder. Impact of lamivudine on the risk of liver-related death in 2,041 HBsAg- and HIV-positive individuals: results from an inter-cohort analysis. Included system aticreviews and m eta-analyses ofskeletalm uscle relaxants inpatients with m usculoskeletal conditions Tim e period covered and F unding A uth or sources used inliterature source and M eth od of C h aracteristics of Y ear A im s search Eligibility criteria Exclusioncriteria role appraisal identified articles VanTulder Systematicreview of th rough O ctober2001 R andomiz ed Studies of U niversity of Independently 27 studies excluded 48, 49 effectiveness of (M EDL IN E,EM BA SE)or controlled trials and ch lormez anone Toronto and assessed by two 2003 skeletalmuscle 2002 (C och rane L ibrary) double-blind and botulinum VU U niversity reviewers using 30 trials of2884 patients relaxants inth e controlled clinical toxin M edical criteria (11-item included (14 ofth ese treatmentofback M EDL IN E,C och rane L ibrary, trials ofpatients with C enter instrument) studies did notmeetour pain EM BA SE nonspecificlow back A msterdam recommended by inclusioncriteria because painreceiving th e C och rane Back th ey were non-English or skeletalmuscle R eview G roup.

Lukjan, 34 years: Whole parasites provide the most realistic aggregate measure of differentia- tion. Anticonvulsant trials measuring 50% response rate in pain reduction Relative risk Study, year N Duration (95% confidence interval) Divalproex Kochar, 2005 40 8 weeks 4. Withdrawals due to AEs controlled, 34% BDP DPI (%): 8 vs.

Tom, 49 years: This systematic review did not rate the quality of included trials for adverse event assessment. P value: The probability (ranging from zero to one) that the results observed in a study could have occurred by chance if the null hypothesis was true. Pashankar FD, Carbonella J, Bazzy-Asaad A, Friedman A.

Asam, 47 years: If untreated, there is a high level of replication of HIV in the macrophages and microglial cells of the brain. It has the medial surface for articulation with the talus. There was also less Insomnia Page 34 of 86 Final Report Update 2 Drug Effectiveness Review Project 50 rebound insomnia with zolpidem 5 mg than triazolam 0.

Rendell, 29 years: Silvery-shining, spiral treponema are noticeable due to their typical rotating and bending movements when applying large-scale dark-field microscopy obtained from the stimulus secretion from the ulcus durum. They found 26 trials comparing salmeterol to placebo, and eight trials comparing salmeterol to salbutamol (albuterol). In half of the patients, there may be a not rule out the suspected disease.

Sancho, 42 years: One of the nonresponders revealed an impor- still requires large volumes of donor blood. The principle of cell therapies and the risk factors for toxicity antigen-specific T cell therapy was realized with first-generation CARs, which link an antibody-derived single-chain variable frag- ment (scFv) to the CD3 intracellular signaling domain of the TCR Introduction complex (Figure 1). Alcohol intolerance and facial flushing in patients treated with topical tacrolimus.

Boss, 56 years: Two independent reviewers achieved consensus on all included and excluded articles. This chapter reviews novel strategies that maximize the GVL effect of DLI by enhancing activity while limiting toxicity. Because of this, systematic reviews that fail to include unpublished studies may overestimate the true effect of an intervention.

Norris, 63 years: It is nevertheless especially important to do gen- Mammography is the gold standard for screening eral examination for patients with advanced disease and assessment for breast cancer in developed coun- as they are more likely to have metastasis. For example, Enterocytozoon bieneusi is often resistant to albendazole. Including a taxane may even (cyclophosphamide, methotrexate and 5-fluor- add further benefit.

Jaffar, 31 years: In general, for questions about the relative benefit of a drug, the results of well- executed randomized controlled trials are considered better evidence than results of cohort, case- control, and cross-sectional studies. However, in recent years, the role of acutely ruptured atherosclerotic plaques in mice,36 suggesting that the contact system in thrombosis has regained new interest due to factor XII-induced coagulation plays a role in atherothrombosis in a several observations in animal studies in knockout mice, other similar fashion as factor XI. In contrast, IKAROS gene family tors) and histone modifiers (eg, histone demethylase inhibitors and alterations are selectively associated with different subtypes of histone deacetylase inhibitors) are in clinical trials and have been high-risk ALL.

Dawson, 33 years: ACE inhibition and ANG II receptor blockade improve glomerular size-selectivity in IgA nephropathy. Nevirapine versus atazanavir/ritonavir, each combined with tenofovir diso- proxil fumarate/emtricitabine, in antiretroviral-naive HIV-1 patients: the ARTEN Trial. Detailed Assessment of TZDs: Harms Restricted access for rosiglitazone In September 2010, the US Food and Drug Administration announced that GlaxoSmithKline must develop a restricted access program for its drug, rosiglitazone (Avandia ) and combination products that contain rosiglitazone (Avandaryl , and Avandamet ).

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