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Reductions in overactive bladder-related incontinence from pooled analysis of phase III trials evaluating treatment with solifenacin cheap imitrex 25 mg online back spasms 32 weeks pregnant. Solifenacin is effective for the treatment of OAB dry patients: a pooled analysis trusted imitrex 25mg muscle relaxant rotator cuff. Dmochowski RR, Nitti V, Staskin D, Luber K, Appell R, Davila GW. Transdermal oxybutynin in the treatment of adults with overactive bladder: combined results of two randomized clinical trials. Rovner ES, Rackley R, Nitti VW, Wang JT, Guan Z, Study G. Tolterodine extended release is efficacious in continent and incontinent subjects with overactive bladder. Treatment of overactive bladder: the Antimuscarinic Clinical Effectiveness Trial. Efficacy and tolerability of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), compared with oxybutynin in the treatment of patients with overactive bladder. Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. Anderson RU, MacDiarmid S, Kell S, Barada JH, Serels S, Goldberg RP. Effectiveness and tolerability of extended-release oxybutynin vs extended-release tolterodine in women with or without prior anticholinergic treatment for overactive bladder. Overactive bladder Page 50 of 73 Final Report Update 4 Drug Effectiveness Review Project 108. Immediate-release oxybutynin versus tolterodine in detrusor overactivity: a population analysis. Persistence with overactive bladder pharmacotherapy in a Medicaid population. Varadharajan S, Jumadilova Z, Girase P, Ollendorf DA. Economic impact of extended- release tolterodine versus immediate- and extended-release oxybutynin among commercially insured persons with overactive bladder. A multicenter, prospective, open-label study of tolterodine extended-release 4 mg for overactive bladder: The Speed of Onset of Therapeutic Assessment Trial (STAT). Evidence for the efficacy and safety of tolterodine in the treatment of overactive bladder. Abrams P, Malone-Lee J, Jacquetin B, Wyndaele JJ, Wein A, et al. Twelve month treatment of overactive bladder: efficacy and tolerability of tolterodine. Long-term safety, tolerability and efficacy of extended- release tolterodine in the treatment of overactive bladder. Safety profile of tolterodine as used in general practice in England: results of prescription-event monitoring. Does gender or age affect the efficacy and safety of tolterodine? Ouslander JG, Maloney C, Grasela TH, Rogers L, Walawander CA. Implementation of a nursing home urinary incontinence management program with and without tolterodine. Journal of the American Medical Directors Association. Evaluation of a new once-daily formulation of oxbutynin for the treatment of urinary urge incontinence. Haab F, Cardozo L, Chapple C, Ridder AM, Solifenacin Study Group.
On the basis of these results buy imitrex 50 mg amex back spasms 40 weeks pregnant, the authors concluded that in older people the benefit of sleep agents may not outweigh their risks purchase imitrex 25mg mastercard muscle relaxant cyclobenzaprine high. Pregnancy A prospective cohort study in Canada evaluated pregnancy outcomes after first-trimester 133 exposure to zopiclone in 40 women. The sample consisted of women who had initiated contact with a program that provides counseling for pregnant women, thus it is not representative of the total population of women who were exposed to zopiclone during pregnancy. Newborns in the zopiclone group had a significantly lower mean birth weight than newborns never exposed to the drug (3249 ± 676 grams compared with 3624 ± 536 grams; P=0. Once birth weight was adjusted for gestational age, the differences were no longer significant. There was no difference in outcome of pregnancy, delivery method, assisted deliveries, fetal distress, presence of meconium at birth, preterm deliveries, or neonatal intensive care admissions between zopiclone and control groups. A 1998 report of prescription-event monitoring studies of newly marketed drugs, conducted in general practices in the UK, includes information on pregnancy outcome in 23 146 women exposed to zolpidem and 18 exposed to zopiclone during pregnancy. In women who had taken zolpidem, there were 2 spontaneous and 6 legal abortions. In women who had taken Insomnia Page 40 of 86 Final Report Update 2 Drug Effectiveness Review Project zopiclone, there were 3 spontaneous and 3 legal abortions, and in one the outcome is unknown. There were no congenital anomalies among the 18 live births in women exposed to either drug. Comorbid conditions Active-control trials show that zopiclone is similar to benzodiazepines for sleep outcomes and 23 adverse effects in patients withdrawing from alcohol, patients with generalized anxiety 34 41 disorder, and in patients with stroke living in a residential care facility. Zolpidem 5 mg, but not 10 mg, was more effective than triazolam 0. Zaleplon has been studied in placebo-controlled trials in patients undergoing 109 kidney dialysis. Zopiclone has been compared with placebo in trials of patients with 76 75, 82 97 rheumatoid arthritis or fibromyalgia and in patients who are shiftworkers. Eszopiclone 112 was more effective than placebo for insomnia in patients with rheumatoid arthritis, in patients 78 with depression who were also taking fluoxetine, in patients with generalized anxiety disorder 214 114 who were also taking escitalopram, and in peri- and postmenopausal women. In a single- dose study, ramelteon 16 mg improved polysomnographic sleep duration, total sleep time, and WASO in patients with mild to moderate chronic obstructive pulmonary disease; there was no difference between ramelteon and placebo on subjective sleep measures or on objective sleep 215 latency. While these studies provide evidence that these drugs are effective for some sleep outcomes in patients with particular comorbid conditions, they do not provide evidence about the comparative efficacy of newer insomnia drugs in these subgroups. Three studies evaluated newer insomnia drugs in patients with obstructive sleep apnea 104 86 and continuing symptoms of inadequate sleep: Eszopiclone and ramelteon were studied in patients with mild to moderate sleep apnea; zolpidem was studied in patients with severe sleep 69 92 apnea; and zopiclone was studied in patients with upper airway resistance syndrome. These were all small (N = 8 to 26), short-term crossover studies conducted in sleep laboratories. Patients enrolled were predominantly male and 45 to 55 years old. Three studies enrolled patients whose body mass index was in the obese or severely obese range 69, 86, 104 (mean body mass indexes 30, 32, and 36), and one study’s patient population had a mean 92 body mass index in the “overweight” category (26. These studies were conducted with 1 to 7 nights of treatment. In the studies of mild to moderate sleep apnea, sleep lab outcomes were better with eszopiclone than placebo, but ramelteon was no better than placebo. Latency to persistent sleep time and number of awakenings were similar for eszopiclone and placebo nights, but WASO, sleep efficiency, total sleep time, and wake time during sleep were statistically significantly 104 better during the eszopiclone nights. Total sleep time was 15 minutes longer with eszopiclone. With ramelteon, sleep lab measures of latency to persistent sleep, number of awakenings, total sleep time, and WASO were similar during drug and placebo 86 nights. In addition, patient assessment of sleep (number of awakenings, total sleep time, sleep quality, sleep latency, level of alertness, awake time, and ability to concentrate) were also not different between the 2 sessions. However, the very small size of this study could have led to a type II error. For example, differences seen in total sleep time (14.
Placebo controlled trials of beta blockers for heart failure Author Year Mean EF Country NYHA Class Eligibility criteria Anonymous 28 order 25mg imitrex fast delivery spasms on left side of abdomen. Placebo controlled trials of beta blockers for heart failure Author Year Interventions (drug purchase 25 mg imitrex mastercard spasms meaning in telugu, regimen, Country Exclusion criteria duration) Anonymous NR Stage 1: 2000 Candesartan: 4-16 mg daily Enalapril: 20 mg daily The Randomized Candesartan 48 mg and enalapril 20 Evaluation of mg Strategies for Left Ventricular Stage 2: Dysfunction Pilot Addition of Metoprolol CR (met CR) Study (RESOLVD) 25-200 mg daily or placebo Fair quality Beta blockers Page 236 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Age Other population Year Allowed other Method of outcome assessment Gender characteristics Country medications/interventions and timing of assessment Ethnicity (diagnosis, etc) Anonymous Stage I medications Primary: Mean age=61. Placebo controlled trials of beta blockers for heart failure Author Method of Year Number screened/ Number withdrawn/ adverse effects Country eligible/enrolled lost to fu/analyzed Outcomes assessment? Anonymous nr/468/426 nr/nr/426 6-minute walk distance change (meters): met NR 2000 CR=(-1); pla=(-3) Quality of life: met CR=pla (data NR) The Randomized NYHA functional class: met CR=pla (data NR) Evaluation of All-cause deaths: met CR=8(3. Placebo controlled trials of beta blockers for heart failure Author Year Withdrawals due to adverse events (%, adverse Country Adverse effects reported n/enrolled n) Comments Anonymous NR Overall discontinuation due to intolerability: met 2000 CR=11%; pla=12% Permanent discontinuation due to: The Randomized Symptomatic hypotension: met CR=4(1. Placebo controlled trials of beta blockers for heart failure Author Year Mean EF Country NYHA Class Eligibility criteria Waagstein 28. Patients were prospectively stratified into Europe NYHA Class an ischemic heart disease (IHD) group and a dilated cardiomyopathy I=0 (DCM) group. DCM was diagnosed based on the presence of LV Fair quality IIa=13. Placebo controlled trials of beta blockers for heart failure Author Year Interventions (drug, regimen, Country Exclusion criteria duration) Waagstein Coronary artery bypass grafting (CABG) or percutaneous transluminal Metoprolol 150 mg daily 2003 coronary angioplasty (PTCA) within the previous 6 months or who were Placebo x 6 months Europe scheduled for or expected to require these treatments during the 6- month study; patients who had a major ischemic event (acute MI or Fair quality unstable angina) within the previous 6 months and those with large anterior aneurysms, acute myocarditis, primary valvular heart disease, exercise-limiting angina pectoris or severe systemic disease; excessive consumption of alcohol (≥ 100 g of pure alcohol/day or ≥ 700 gram/week), resting systolic blood pressure > 190 mmHg or diastolic > 100 mmHg, systolic blood pressure <95 mmHg (unless considered occasional), heart rate < 50 beats/min, second- or third-degree atrioventricular (AV) block, sick sinus syndrome, sinoatrial block or atrial fibrillation (which makes equilibrium radionuclide angiography difficult to perform; pacemaker for third-degree AV block or a ventricular inhibited (VVI) pacemaker programmed with a fixed heart rate above the spontaneous heart rate Beta blockers Page 241 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Age Other population Year Allowed other Method of outcome assessment Gender characteristics Country medications/interventions and timing of assessment Ethnicity (diagnosis, etc) Waagstein ACE inhibitors, diuretics and Maximal exercise capacity (bicycle Mean age=56. Placebo controlled trials of beta blockers for heart failure Author Method of Year Number screened/ Number withdrawn/ adverse effects Country eligible/enrolled lost to fu/analyzed Outcomes assessment? Placebo controlled trials of beta blockers for heart failure Author Year Withdrawals due to adverse events (%, adverse Country Adverse effects reported n/enrolled n) Comments Waagstein NR 11. Placebo controlled trials of beta blockers for heart failure Author Year Mean EF Country NYHA Class Eligibility criteria Nebivolol Edes 2005 (ENECA) neb. Hospitalized patients or outpatients aged < 65; NYHA class II, III, IV placebo CHF; a stable clinical course; an LVEF <35%; and stable basic LVEF mean medication for CHF with ACE inhibitors and/or ARBs, diuretics, 25. Placebo controlled trials of beta blockers for heart failure Author Year Interventions (drug, regimen, Country Exclusion criteria duration) Nebivolol Edes 2005 (ENECA) Acute corinary syndrome; a MI within the last 3 months; PTCA or nebivolol: maximum tolerated dose coronary artery bypass surgery within the last month; obstructive or or maximum of 10 mg/day. Patients were also excluded if they received beta-blocker 8 months therapy in the 4 weeks prior to the beginining of the trial or known intolerance or hypersensitivity to nebibolol. Beta blockers Page 246 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Age Other population Year Allowed other Method of outcome assessment Gender characteristics Country medications/interventions and timing of assessment Ethnicity (diagnosis, etc) Nebivolol Edes 2005 (ENECA) intervention as add on therapy. Placebo controlled trials of beta blockers for heart failure Author Method of Year Number screened/ Number withdrawn/ adverse effects Country eligible/enrolled lost to fu/analyzed Outcomes assessment? Nebivolol Edes 2005 (ENECA) 354/NR/260 24/1/260 neb. Placebo controlled trials of beta blockers for heart failure Author Year Withdrawals due to adverse events (%, adverse Country Adverse effects reported n/enrolled n) Comments Nebivolol Edes 2005 (ENECA) 159/260 patients (360 total events neb. Placebo controlled trials of beta blockers for heart failure Author Year Mean EF Country NYHA Class Eligibility criteria Flather 2005 neb. Patients > 70 years old, clinical history with CHF with at least one of (SENIORS) placebo the following: documented hospital admission within previous 12 NYHA class I months with discharge diagnosis of CHF, documented left ventricular 3%, 2. Placebo controlled trials of beta blockers for heart failure Author Year Interventions (drug, regimen, Country Exclusion criteria duration) Flather 2005 New drug therapy for heart failure 6 weeks prior to randomization, any Nabivolol titrated to 10 mg once (SENIORS) change in cardiovascular drug therapy 2 weeks prior to randomization, daily. Beta blockers Page 251 of 494 Final Report Update 4 Drug Effectiveness Review Project Evidence Table 9. Placebo controlled trials of beta blockers for heart failure Author Age Other population Year Allowed other Method of outcome assessment Gender characteristics Country medications/interventions and timing of assessment Ethnicity (diagnosis, etc) Flather 2005 Angiotensin converting enzyme Primary: Mean neb. Placebo controlled trials of beta blockers for heart failure Author Method of Year Number screened/ Number withdrawn/ adverse effects Country eligible/enrolled lost to fu/analyzed Outcomes assessment? Flather 2005 nr/nr/2135 7/nr/2128 # events nebivolol vs. Placebo controlled trials of beta blockers for heart failure Author Year Withdrawals due to adverse events (%, adverse Country Adverse effects reported n/enrolled n) Comments Flather 2005 First 15 advers categories by incidence neb 1. Quality assessments of placebo-controlled trials of beta blockers for heart failure Author Year Randomization Allocation Similarity to target Country described? Quality assessments of placebo-controlled trials of beta blockers for heart failure Author Eligibility Outcome Patient Year criteria assessors Care provider unaware of Country Exclusion criteria for recruitment specified blinded blinded treatment Anonymous CHF due to hypertrophic or restrictvie cardiomyopathy with Yes Yes, blinded Yes, allocation Yes 1994 predominant left ventricular diastolic dysfunction; or secondary independent centrally to mitral or aortic valve disease surgically repaired <6 months, committee controlled; The Cardiac or not repaired.