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Barrios V buy 150mg effexor xr with mastercard, et al 2005 Men and women 18 years with Congestive heart failure; MI effexor xr 150 mg amex, coronary artery bypass surgery or R (1:1) buy 75 mg effexor xr overnight delivery, DB generic effexor xr 37.5 mg, MC, AC, documented hypercholesterolemia and angioplasty within the past 3 months; poorly controlled or newly modified ITT atherosclerotic or CHD; serum LDL-C diagnosed (within 3 months) Type I or II diabetes; uncontrolled between 2. Statins Page 263 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 5. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Intervention Results (mean changes in lipoprotein levels) Ballantyne C, et al, 2005 10 weeks, with 4-week placebo/diet run-in Efficacy analysis for 1850 patients. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Safety/Comments Funding Source Ballantyne C, et al, 2005 ALT >3 ULN, presumed consecutive all atorva 10 (1. All ez/simva 0 Merck/Schering Plough (Vyva study) (0. Statins Page 265 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 5. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Inclusion Criteria/ Patient Population Exclusion criteria Constance C, et al 2007 Men and women >18 years of age, Congestive heart failure defined by NYA class III or IV; myocardial diagnosed with T2D, HBA1C < 10%, infarction, coronary artery bypass surgery or angioplasty within 3 R (1:1:1), DB, MC, AC, alanine aminotransferase (ALT) and/or months; uncontrolled hypertension (systolic >160 mm Hg or diastolic modified ITT aspartate aminotransferase (AST) levels >100 mm Hg); uncontrolled endocrine or metabolic disease known to 1. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Intervention Results (mean changes in lipoprotein levels) Constance C, et al 2007 4-week baseline period while continuing to LDL-C % change from baseline receive open label eze/simva 10/20 -26. EZE/SIMVA 10/20 mg, HDL-C % change from baseline EZE/SIMVA 10/40 mg eze/simva 10/20 2. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Safety/Comments Funding Source Constance C, et al 2007 Eze/simva 10/20 vs. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Inclusion Criteria/ Patient Population Exclusion criteria Ezetimibe/Simvastatin (Vytorin) vs. Simvastatin Bays H, et al 2004 men and women aged 18 to 80 years; <50% of ideal body weight according to the R(1:1:1:1:1:1:1:1::1:1) , DB, primary hypercholesterolemia 1983 Metropolitan Height and Weight tables (or MC, PC, ITT defined as LDL-C concentrations >145 body weight <100 lb), hypersensitivity to statins, or mg/dL but <150 mg/dL and triglycerides alcohol consumption >14 drinks per week; pregnant 1,528 patients randomized (TG) <350 mg/dL at visit 2; alanine or lactating females. Ose L, et al 2007 See Bays 2004 See Bays 2004 R(1:1:1:1:1:1) , DB, MC, AC, ITT 2959 patients randomized- 2855 MITT (n= 1427 eze/simva and 1428 rosuvastatin) 14 weeks Shankar, et al 2007 Male and female 18 years or more; LDL-C Unstable angina w/in 3 months; uncontrolled diabetes; hypertension, R(1:1) , DB, MC, AC, ITT > 135 for naïve and >120 otherwise. Rosuvastatin Statins Page 269 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 5. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Intervention Results (mean changes in lipoprotein levels) Bays H, et al 2004 6- to 8 week washout period; 4-week, LDL-c reduction % from baseline at week 12: R(1:1:1:1:1:1:1:1::1:1) , DB, single-blind, placebo run in, randomized eze/simva 10/10 44. Ose L, et al 2007 Protocol-compliant patients who completed LDL-c reduction % from baseline at week 14: R(1:1:1:1:1:1) , DB, MC, AC, the 12-week base study were eligible to simva 10 31. HDL-c increase % from baseline at week 14: 1428 rosuvastatin) simva 10 4. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Safety/Comments Funding Source Bays H, et al 2004 placebo vs. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Inclusion Criteria/ Patient Population Exclusion criteria Catapano A, et al 2006 Men and women 18–81 years with LDL‑C None reported ≥ 145 mg/dL (3. Statins Page 272 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 5. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Intervention Results (mean changes in lipoprotein levels) Catapano A, et al 2006 10 weeks, 4 weeks placebo/diet run-in LDL-C % change from baseline followed by 6 weeks active treatment of ros 10 -45. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Safety/Comments Funding Source Catapano A, et al 2006 Pooled eze/simva vs. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Inclusion Criteria/ Patient Population Exclusion criteria Ezetimibe/Simvastatin (Vytorin) vs. Doubling of Statin dose Reckless J, 2008 Men and women (>18 years) hospitalized Congestive heart failure defined by NYA Class III or IV; poorly (INFORCE) for investigation of a coronary event and controlled (HBA1c > 9. Roeters van Lennep H, Men and women > 18 years of age with Cholesterol-lowering medication regime changed in the previous 4 2008 (EASEGO) controlled stable DM2 (> 3 months) and/or weeks; any other investigational drug within 3 months; pregnant or R(1:1) , open-label, MC, AC, established CHD. Misc Farnier M, et al 2007 Men and women 18 through 79 years of homozygous familial hypercholesterolemia; type I or V hyperlipidemia; R (3:3:3:1), DB, MC, P/AC, age with mixed hyperlipidemia and no treatment with LDL apheresis; congestive heart failure ; uncontrolled ITT coronary heart disease (CHD) or CHD-risk cardiac arrhythmia; unstable hypertension; pancreatitis; inadequately equivalent disease (except for type 2 controlled diabetes (HbA1c >8. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Intervention Results (mean changes in lipoprotein levels) Reckless J, 2008 Doubling of the statin dose (n = 211) or LDL-c reduction % from baseline at week 12: (INFORCE) Eze ⁄ Simva 10 ⁄ 40 mg (n = 213) for 12 eze/simva 27% vs.. R(1:1) , open-label, MC, AC, tablet in CHD/DM2 patients on the doubling 11. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Safety/Comments Funding Source Reckless J, 2008 Eze/simva vs. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Inclusion Criteria/ Patient Population Exclusion criteria Guyton J, et al 2008 Men and women aged 18 years to 79 NR R(2:2:5) , DB, MC, AC, ITT years with LDL-C levels (130 to 190 mg/dl), triglyceride levels ( 500 mg/dl), and 1220 patients randomized- metabolic and clinical stability. Statin Bays H, et al 2003 Women and men, 18 to 70 years old, with Known prior allergy or intolerability to any of the study drugs, history 2 consecutive baseline low-density of substance abuse or dependence within 12 months, >14 alcoholic R (1:1:1:1), Open label, MC, lipoprotein (LDL) cholesterol blood levels drinks/week, uncontrolled psychiatric disease, participation in another AC, modified ITT >160 mg/dl without coronary artery investigational study within 30 days , or probucol administration within disease, or >130 mg/dl if coronary artery the previous year history of; active gallbladder disease; uncontrolled 315 patients randomized disease was present. Other lipid inclusion hypertension; renal insufficiency (serum creatinine 1. Statins Page 278 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 5. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Intervention Results (mean changes in lipoprotein levels) Guyton J, et al 2008 eze/simva (10/20 mg) or niacin (titrated to LDL-c reduction % from baseline at week 24: R(2:2:5) , DB, MC, AC, ITT 2 g), eze/simva (10/20 mg) + niacin eze/simva -53. Niacin ER/Lovastatin 1000/40 39 R (1:1:1:1), Open label, MC, Atorvastatin (10-40) or simvastatin (10-40) Niacin ER/Lovastatin 2000/40 42 AC, modified ITT. Niacin ER/Lovastatin 2000/40 32 atorvastatin (n=82) or atorvastatin 6 simvastatin (n=76)) simvastatin 7 Niacin ER/lovastatin vs. Atorvastatin or simvastatin at all compared doses (p <0. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Safety/Comments Funding Source Guyton J, et al 2008 Eze/simva vs. Otherwise, no R (1:1:1:1), Open label, MC, significant differences were seen in the incidence of rash, hyperglycemia, AC, modified ITT hyperuricemia, or gastrointestinal complaints between treatment groups. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Inclusion Criteria/ Patient Population Exclusion criteria Lin, et al 2006 ≥ 20 years of age; failure to control LDL-C TG > 500 mg/dL; breast feeding in female subject; pregnancy or not R (1:1), DB, SC (Taiwan), level under the 4-week therapeutic lifestyle exercising appropriate birth control during course of study; type I AC, modified ITT changes (TLC); hyperlipidemia, CHD and diabetes; uncontrolled type II diabetes requiring insulin treatment; CHD risk equivalents, receiving uncontrolled hypertension (systolic blood pressure > 180 mmHg or 70 patients randomized concomitant treatment other than lipid- diastolic blood pressure > 110 mmHg); uncontrolled hypothyroidism; (modified ITT 61) (niacin control treatment that was known to affect acute myocardial infarction within the proceeding 3 months; extended-release/lovastatin lipid level and dose maintained unchanged insufficient renal function (serum creatinine > 2. Statins Page 281 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 5. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Intervention Results (mean changes in lipoprotein levels) Lin, et al 2006 5-week wash out, 16-week drug treatment, LDL-c reduction % from baseline at week 16: R (1:1), DB, SC (Taiwan), and 4-week Niacin ER/Lovastatin 30. AC, modified ITT follow-up period simvastatin 36 (p=0. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Safety/Comments Funding Source Lin, et al 2006 Niacin ER/Lovastatin 30 vs. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Inclusion Criteria/ Patient Population Exclusion criteria Simvastatin/Niacin-ER (Simcor) vs. Statin Ballantyne C, et a l 2008 Increased ATP III risk-adjusted non–HDL Aspartate aminotransferase or alanine aminotransferase >1. Patients had to comply reasonably with a 319 patients randomized standard cholesterol-lowering diet for at Simvastatin (20 mg/d) (n least 4 weeks and be willing to comply with =121) vs.. NER/S (1,000/20 this diet for the duration of the study. NER/S (2,000/20 mg/d) (n = 66) 6 weeks Statins Page 284 of 395 Final Report Update 5 Drug Effectiveness Review Project Evidence Table 5. Trials comparing LDL-c lowering and HDL-c raising abilities of fixed-dose combination products Clinical Trial Intervention Results (mean changes in lipoprotein levels) Ballantyne C, et a l 2008 A screening phase, an Median % change in Non-HDL Cholesterol (SEACOAST I study) open-label simvastatin run-in phase, a lipid Simvastatin -7.

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The FDA has approved fluoxetine effexor xr 150 mg on line, sertraline buy effexor xr 75mg free shipping, and paroxetine CR for the treatment of premenstrual dysphoric disorder (PMDD) and late luteal phase dysphoric disorder (LLPDD) purchase effexor xr 75mg amex. We did not find any head-to-head studies comparing SSRIs or other second-generation 220 cheap effexor xr 150mg on line, 221 222, 223 antidepressants to each other. Two systematic reviews and two RCTs compared second-generation antidepressants to placebo. Studies were conducted over two to six menstrual cycles. Some studies included in the 220, 221 meta-analyses compared intermittent luteal phase therapy with continuous treatment and with placebo. Included studies were conducted in women of reproductive age (18 to 49 years) 220 with a clinical diagnosis of PMDD or LLPDD or in women of any age who met the diagnostic 221 criteria for PMS, PMDD and LLDD. Women were required to meet DSM criteria in all two trials. The more recent meta-analysis included studies which used Self-Rating scales, confirmation by psychiatric evaluation or predefined diagnostic criteria for PMDD or LLPDD 220 according to DSM-III or DSM-IV. The detailed interviews required to determine a diagnosis of PMDD in these studies may limit the generalizability of the findings to patients in others settings such a primary care or gynecological offices where a diagnosis of PMDD is often made on less strict criteria. Most studies excluded women with depression or other psychiatric illness, those with irregular menstrual cycles, and those taking hormones (including oral contraceptives). Both placebo-controlled trials used a patient-assessed daily symptom rating or report in addition 222, 223 to the CGI. Patients monitored their symptoms through the use of diaries, calendars, or visual analog scales. In addition to patient reports of symptoms, one trial used the 21-item HAM- 222 D. Studies included in the meta-analyses used similar efficacy outcome measures. SSRIs compared to placebo in adult outpatients with premenstrual dysphoric disorder or late luteal phase dysphoric disorder SSRIs compared with placebo 220 The updated Cochrane Collaboration Report reported on efficacy outcomes of FDA-approved and non-FDA-approved SSRIs. This good-quality meta-analysis pooled data from 22 trials comparing various SSRIs to placebo, including citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline. Citalopram was more effective than placebo with a SMD of -1. This RCT did not fulfill our inclusion criteria due to the small sample size. Second-generation antidepressants 71 of 190 Final Update 5 Report Drug Effectiveness Review Project 2. Other second-generation antidepressants compared to placebo in adult outpatients with premenstrual dysphoric disorder or late luteal phase dysphoric disorder Venlafaxine compared with placebo One fair RCT compared an SNRI, specifically a continuous daily dose of venlafaxine (50-200 222 mg/d), to placebo over four menstrual cycles. It reported 36 percent of subjects as lost to follow-up. Venlafaxine-treated subjects had significantly lower premenstrual daily symptom report scores and 21-item HAM-D scores than placebo subjects. Sixty percent of venlafaxine- treated subjects were considered responders (e. Nefazodone compared with placebo One fair RCT compared a second-generation antidepressant, specifically both a continuous and 223 intermittent daily dose of nefazodone (100-400 mg/d), to placebo over two menstrual cycles. This trial did not, however, compare intermittent and continuous therapy to each other. Twenty- two percent of subjects were reported as lost to follow-up in this trial. For both dosing methods, no significant differences were seen between nefazodone and placebo in either patient self-rated global improvement or any of the individual symptoms assessed (irritability, depressed mood, affect lability, tension, breast tenderness, bloating, and food craving). Continuous therapy as compared to intermittent therapy A subgroup analysis in a good meta-analysis reported premenstrual dosing did not differ in 220, 224 efficacy from continuous dosing. Summary of the evidence We identified no head-to-head trials. Significant differences in study characteristics make this evidence insufficient to identify differences among treatments. Effectiveness We did not identify any study with a high degree of generalizability. Efficacy Two meta-analyses provided good evidence that citalopram has a significantly greater efficacy 220, 221 than placebo in the treatment of PMDD and LLPDD. One fair RCT provides evidence that 222 the efficacy is significantly greater for venlafaxine than for placebo. Lastly, evidence from one fair RCT indicates that nefazodone does not have greater efficacy than placebo in the treatment 223 of PMDD or LLPDD. There is FDA-approved evidence of the efficacy of fluoxetine, paroxetine, and sertraline in the treatment of PMDD and LLPDD. We could not identify sufficient evidence on the efficacy of escitalopram, mirtazapine, and bupropion for treating either PMDD or LLPDD. Second-generation antidepressants 72 of 190 Final Update 5 Report Drug Effectiveness Review Project Table 19. Interventions, numbers of patients, and quality ratings of studies in adults with premenstrual dysphoric disorder or late luteal phase dysphoric disorder Quality Author, Year Interventions N Results rating SSRIs compared with placebo 220 5 SSRIs compared with Significantly greater Brown et al. For outpatients with depressive, anxiety, and/or premenstrual dysphoric disorder, do second-generation antidepressants differ in safety, tolerability, or adverse events? Most of the studies that examined the efficacy of one drug relative to another also determined differences in tolerability. Methods of adverse events assessment differed greatly. Few studies used objective scales such as the UKU-SES (Utvalg for Kliniske Undersogelser Side Effect Scale) or the adverse reaction terminology from the World Health Organization (WHO). Most studies combined patient- reported adverse events with a regular clinical examination by an investigator. Often it was hard to determine whether assessment methods were unbiased and adequate. Rarely were adverse events prespecified and defined. Short study durations and small sample sizes additionally limited the validity of adverse events assessment in many trials. Few RCTs were designed to assess adverse events as primary outcomes. Most published studies were post hoc analyses or retrospective reviews of databases. We included observational studies if the sample size was larger than 100 and the study duration was at least 1 year (Table 21). Tolerability and Discontinuation Rates Nausea, headache, diarrhea, fatigue, dizziness, sweating, sexual side effects, tremor, dry mouth, and weight gain were commonly reported adverse events.

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JAMA : the journal of the American Medical Association purchase effexor xr 75 mg. Resnick SM cheap effexor xr 75mg visa, Coker LH buy generic effexor xr 150mg line, Maki PM buy effexor xr 150 mg line, Rapp SR, Espeland MA, Shumaker SA. Postmenopausal hormone use and cholecystectomy in a large prospective study. Hormone replacement therapy and endometrial cancer risk: a meta-analysis. Menopausal hormone replacement therapy and risk of ovarian cancer. Estrogen replacement therapy and ovarian cancer mortality in a large prospective study of U. Cancer incidence and mortality tin women receiving estrogen and estrogen-progestin replacement therapy - long term followup of a Swedish cohort. Long term hormone therapy for perimenopausal and postmenopausal women [Systematic Review]. Hormone therapy Page 73 of 110 Final Report Update 3 Drug Effectiveness Review Project Appendix A. Literature search strategies Menopausal Symptoms 1 DIENESTROL/ or dienestrol. Abbreviations and acronyms BMC=Bone mineral content BMD = Bone mineral density Ca = Calcium CCT = Combined continuous treatment regimen CEE = Conjugated equine estrogen Cyclic = Cyclic regimen DB = Double blind E2 = Estradiol E2V=Estradiol valerate EE= Esterified estrogen IU = International Unit MPA = Medroxyprogesterone acetate NETA = Norethindrone acetate NR = Not reported P = Placebo group RCT = Randomized controlled trial Rx = Treatment group SD = Standard deviation TAHBSOO = Total abdominal hysterectomy with bilateral salpingo-oophorectomy Hormone therapy Page 76 of 110 Final Report Update 3 Drug Effectiveness Review Project Appendix C. Quality criteria For Controlled Trials Assessment of Internal Validity To assess the internal validity of individual studies, the EPC adopted criteria for assessing the internal validity of individual studies from the US Preventive Services Task Force and the NHS Centre for Reviews and Dissemination. Was the assignment to the treatment groups really random? Adequate approaches to sequence generation: Computer-generated random numbers Random numbers tables Inferior approaches to sequence generation: Use of alternation, case record numbers, birth dates or week days Not reported 2. Adequate approaches to concealment of randomization: Centralized or pharmacy-controlled randomization Serially-numbered identical containers On-site computer based system with a randomization sequence that is not readable until allocation Other approaches sequence to clinicians and patients Inferior approaches to concealment of randomization: Use of alternation, case record numbers, birth dates or week days Open random numbers lists Serially numbered envelopes (even sealed opaque envelopes can be subject to manipulation) Not reported 3. Were the groups similar at baseline in terms of prognostic factors? Were outcome assessors blinded to the treatment allocation? Was the patient kept unaware of the treatment received? Did the article include an intention-to-treat analysis, or provide the data needed to calculate it (i. Hormone therapy Page 77 of 110 Final Report Update 3 Drug Effectiveness Review Project 10. Did the article report attrition, crossovers, adherence, and contamination? Is there important differential loss to follow-up or overall high loss to follow-up? How similar is the population to the population to whom the intervention would be applied? What was the funding source and role of funder in the study? Hormone therapy Page 78 of 110 Final Report Update 3 Drug Effectiveness Review Project Appendix D. Quality scores for trials in Cochrane review of hot flashes/flushes Treatment Outcome Baseline Losses to Analysis Study/Year Allocation Blinding Assessment Equality Follow-up Basis Archer 1992 B A A B C C Baerug 1998 A A A A A C Baumgardner 1978 A A A A A B Bech 1998 B A A C C C Blumel 1994 A A A A A C Campbell 1976 B B A B C C Chung 1996 A A A A C C Conard 1995 A B A A C C Coope 1975 A A A A C C Coope 1981 A A A A C C Davidsen 1974 B B A B B C Dennerstein 1978 B A A B C C Derman 1995 A A A A C A Hagen 1982 B B A A C C Jensen J 1983 B A A A C C Jensen P 1987 B B A A C C Marslew 1992 A A A A C C Martin 1971 B A A A C C PEPI 1998 A A A C A A Paterson 1982a A A A A C C Viklylaeva 1997 A A A A A B Hormone therapy Page 79 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix D. Q uality scores fortrials in C och rane review ofh otflash es/flush es (continued) C och rane Q uality A ssessm entC riteria A ssessm ent A B C Allocationconcealm ent Adequatee. Treatm entblinding Statem entthatcontainerswereidentical,drugs N otreported/unclear HR T andplacebonot identical wereidenticalinappearance,etc. O utcom eassessm ent Blinded,standardizedassessm ent Assessm entprocedures Assessm entnotblindedor standardized notstated Baselineequalityof treatm entgroups Groupsbalancedinterm sof age,m enopause Balancenotreported Groupsnotbalanced status,andm enopausesym ptom s L ossestofollow-up (notincluding early L ossesof 10% orless N otreported/unclear L ossesof m orethan10% cessationof therapy,followedup) Basisforanalysis Intention-to-treatanalysis U nclear N otintention-to-treat Hormone therapy Page 80 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix E. Q uality scores ofreviewed h otflash /flush trials Eligibility B linding:outcom e M aintenance of Study A llocation criteria assessors,care Intention-to-treat com parable Y ear R andom assignm ent? Al-Az z awi, Yes Yes M oreoophorectom y invaginal Yes Yes Yes Yes 2003 ring group (25% vs21%) Buckler,2003 G elfand2003 Yes N otreported M oresm okersinPrefestgroup Yes Yes N otclear-num ber N otclear (10. Saure,2000 Yes;m ethodsN R N R Yes Yes D ouble-blind N R U nclear G ood,1999 Yes;m ethodsN R N R Yes Yes D ouble-blind N R U nclear Hormone therapy Page 81 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix E. Q uality scores ofreviewed h otflash /flush trials Study R eporting ofattrition, Differentialloss to followupor Y ear contam ination,etc? Q uality Score F unding source Externalvalidity Al-Az z awi,2003 Attritiony es 34/159(21%)withdrew (by 12 G ood Sponsoredby G alen F air Buckler,2003 weeks):20. F air reportedby group group notgiven Speroff,2003 Attritiony es 16% withdrew:12. Saure,2000 Som e 15% E 2;16% E 2V F air N R F air G ood,1999 Som e 15% overall F air TheraTech Inc. F air Hormone therapy Page 82 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix E. Q uality scores ofreviewed h otflash /flush trials Eligibility B linding:outcom e M aintenance of Study A llocation criteria assessors,care Intention-to-treat com parable Y ear R andom assignm ent? G ordon,1995 Yes;m ethodsN R N R Yes Yes D ouble-blind U nclear U nclear Studd,1995 Yes;m ethodsN R N R Yes Yes D ouble-blind Yes U nclear F reedm an, Yes;m ethodsN R N R Yes Yes D ouble-blind N R U nclear 2002 J irapiny oet Yes;m ethodsN R M ethodN R M eanG reenescoreslightly Yes D ouble-blind;m ethods N o; U nclear al,2003 higherinE 2thanplacebo N R PP analy sisex cludes (20. Q uality scores ofreviewed h otflash /flush trials Study R eporting ofattrition, Differentialloss to followupor Y ear contam ination,etc? Q uality Score F unding source Externalvalidity G ordon,1995 Som e 13-26% R x ;30% placebo F air 3M F air Studd,1995 Som e 16% overall F air N R F air F reedm an,2002 N R N R F air N IH F air J irapiny oetal, Attritiony es 16. HR T-naïvewom en only N otelovitz ,2000a Som e R x groups11-21%;placebo17% F air N ovoN ordisk F air N otelovitz ,2000b Som e 16% overall F air N R F air U tian,2001 Som e 19% overall;23% placebo;30% F air W y eth-Ay erst F air 0. Hormone therapy Page 84 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix E. Q uality scores ofreviewed h otflash /flush trials Eligibility B linding:outcom e M aintenance of Study A llocation criteria assessors,care Intention-to-treat com parable Y ear R andom assignm ent? Bacchi- Yes;m ethodsN R N R Yes Yes D ouble-blind Yes U nclear M odena, 1997 D eAloy sio, Yes;m ethodsN R N R Slightvariation Yes D ouble-blind Yes U nclear 2000 deVrijer, Yes;m ethodsN R N R Yes Yes D ouble-blind Yes U nclear 1999 N otelovitz , Yes;m ethodsN R N R Yes Yes D ouble-blind Yes U nclear 2000c Shulm an, Yes Yes Yesex ceptforsm oking Yes Yes Yes U nclear 2002 Speroff,1996 Yes;m ethodsN R Yes D escribed,dataN R Yes Yes U nclear U nclear vanHolst, Yes;m ethodsN R N R D escribed,dataN R Yes D ouble-blind Yes U nclear 2000 vanHolst, Yes;m ethodsN R N R Slightvariation Yes D ouble-blind Yes U nclear 2002 U tian,1999 Yes;m ethodsN R Yes Slightvariation Yes D ouble-blind Yes,dataN R U nclear W iklund, Yes;m ethodsN R N R Yes Yes U nclearif double-blind Yes Yes,dataN R 1993 Hormone therapy Page 85 of 110 Final Report Update 3 Drug Effectiveness Review Project A ppendix E. Q uality scores ofreviewed h otflash /flush trials Study R eporting ofattrition, Differentialloss to followupor Y ear contam ination,etc? Q uality Score F unding source Externalvalidity Bacchi-M odena, Som e 6% R x ;15% placebo F air N R F air 1997 D eAloy sio,2000 Som e 7% R x ;25% placebo F air N R F air deVrijer,1999 Som e 11% overall F air N R F air N otelovitz ,2000c Som e 5% overall(11R x ,1placebo) F air R hone-Poulenc R orer F air Shulm an,2002 Som e 3% overall F air Berlex L abs F air Speroff,1996 Som e <20% R x ;31% placebo F air ParkD avis F air vanHolst,2000 Som e 7% overall F air N R F air vanHolst,2002 Som e 17% overall F air N R F air U tian,1999 Som e 10% overall(12R X ;8placebo) F air L ab F ournierSA F air W iklund,1993 Som e 4% R x ;8% placebo F air N R F air Hormone therapy Page 86 of 110 Final Report Update 3 Drug Effectiveness Review Project AppendixF. Qualityscoresof reviewedbonedensityandfracturetrials Blinding:outcome Maintenanceof Study Random Allocation G roupssimilarat Eligibilitycriteria assessors,care Intention-to-treat comparable Year assignment? R ubinacci, M ethodnot N otreported M eanF SH values Yes Yes N o N otclear 2003 reported slightly higherinE 2 group;duem ainly to very high valueinone participant. N otelovitz , M ethodnot N otreported Yes Yes Yes Yes N otclear 2002 reported Civitelli,2002 M ethodnot N otreported W om eninHR T arm 2 Yes Yes N otclear N otclear reported y earsolderthanplacebo; num berof y earssince m enopausesim ilar.

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Comparison of nebulized ipratropium bromide with salbutamol vs salbutamol alone in acute asthma exacerbation in children buy 37.5 mg effexor xr with visa. Ralston ME cheap 37.5 mg effexor xr overnight delivery, Euwema MS generic effexor xr 150mg fast delivery, Knecht KR 75 mg effexor xr amex, Ziolkowski TJ, Coakley TA, Cline SM. Comparison of levalbuterol and racemic albuterol combined with ipratropium bromide in acute pediatric asthma: a randomized controlled trial. Lack of evidence for beta-2 receptor selectivity: a study of metaproterenol, fenoterol, isoproterenol, and epinephrine in patients with asthma. Comparison of fenoterol and terbutaline administered by intermittent positive pressure breathing. A comparative double-blind study of the bronchodilator effects and side effects of inhaled fenoterol and terbutaline administered in equipotent doses. Fenoterol is as effective as terbutaline in the pear- shaped spacer. A comparison of terbutaline and fenoterol unit dose vials in treating children with acute asthmatic attacks. Comparison of Bricanyl Turbuhaler and Berotec dry powder inhaler. The efficacy of terbutaline and fenoterol aerosols on adult exercise- induced asthma. Comparative effects of pirbuterol acetate, metaproterenol, and placebo aerosols on pulmonary function and incidence of cardiac ectopy. Comparison of safety and efficacy of inhaled pirbuterol with metaproterenol. Chester EH, Doggett WE, Montenegro HD, Schwartz HJ, Jones PK. Quick-relief medications for asthma Page 63 of 113 Final Report Update 1 Drug Effectiveness Review Project 101. A comparative study of the aerosolized bronchodilators, isoproterenol, metaproterenol and terbutaline in asthma. A comparison of levalbuterol with racemic albuterol in the treatment of acute severe asthma exacerbations in adults. Wraight JM, Smith AD, Cowan JO, Flannery EM, Herbison GP, Taylor DR. Adverse effects of short-acting beta-agonists: potential impact when anti-inflammatory therapy is inadequate. Long-term effect of ipratropium bromide and fenoterol on the bronchial hyperresponsiveness to histamine in children with asthma. Therapy with fenoterol and ipratropium bromide powder]. Pharmacological similarities and differences between beta -agonists. Case-control study of severe life threatening asthma (SLTA) in a developing community. Quick-relief medications for asthma Page 64 of 113 Final Report Update 1 Drug Effectiveness Review Project Appendix A. Search strategies Original Search Database: EBM Reviews - Cochrane Central Register of Controlled Trials <1st Quarter 2006> Search Strategy: -------------------------------------------------------------------------------- 1 Salmeterol. Quality assessment methods for drug class reviews for the Drug Effectiveness Review Project This appendix outlines the methods used by the Oregon Evidence-based Practice Center, based at Oregon Health & Science University, and any subcontracting Evidence-based Practice Centers in producing drug class reviews for the Drug Effectiveness Review Project. The procedure outlined in this appendix ensures that the reviews created by using these methods are scientifically defensible, reproducible, and well documented. These methods were adapted from the Procedure Manual developed by the Methods Work Group of the United States Preventive Services Task Force (version 1. All included studies and systematic reviews are assessed for quality and assigned a rating of “good,” “fair,” or “poor”. Studies that have a fatal flaw in 1 or more criteria are rated poor quality. Studies that meet all criteria are rated good quality. As the “fair-quality” category is broad, studies with this rating vary in their strengths and weaknesses: The results of some fair quality studies are likely to be valid, while others are only probably valid. A poor-quality trial is not valid: Its results are at least as likely to reflect flaws in the study design as a true difference between the compared drugs. Controlled Trials Assessment of Internal Validity 1. Was the assignment to treatment groups really random? Adequate approaches to sequence generation: Computer-generated random numbers Random numbers tables Inferior approaches to sequence generation: Useofalternation,caserecordnumber, date of birth, or day of week Not reported 2. Adequateapproachestoconcealmentofrandomization: Centralized or pharmacy-controlled randomization Serially-numbered identical containers On-site computer based system with a randomization sequence that is not readable until allocation Other approaches sequence to clinicians and patients Inferior approaches to concealment of randomization: Useofalternation,caserecordnumber, date of birth, or day of week Open random numbers lists Quick-relief medications for asthma Page 72 of 113 Final Report Update 1 Drug Effectiveness Review Project Serially numbered envelopes (even sealed opaque envelopes can be subject to manipulation) Not reported 3. Were the groups similar at baseline in terms of prognostic factors? Were outcome assessors blinded to the treatment allocation? Was the patient kept unaware of the treatment received? Did the article include an intention-to-treat analysis or provide the data needed to calculate it (that is, number assigned to each group, number of subjects who finished in each group, and their results)? Did the article report attrition, crossovers, adherence, and contamination? Is there important differential loss to follow-up or overall high loss to follow-up? How similar is the population to the population to whom the intervention would be applied? What was the funding source and role of funder in the study? Was the selection of patients for inclusion non-biased; that is, was any group of patients systematically excluded? Is there important differential loss to follow-up or overall high loss to follow-up? Was there a clear description of the techniques used to identify the events? Was there unbiased and accurate ascertainment of events (independent ascertainers, validation of ascertainment technique)?

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