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U. Esiel. Unity College.

Symbol use: Drug X > Drug Y = statistically significant difference in outcomes favoring Drug X; Drug X > Drug Y trend = point estimate favors Drug X viagra extra dosage 150mg online erectile dysfunction doctors in orange county, but the difference is not statistically significant or tests of statistical significance were NR; No difference = no statistically significant difference or tests of statistical significance were not reported and outcomes are similar discount viagra extra dosage 150mg mastercard muse erectile dysfunction wiki. Growth 31 Four head-to-head RCTs comparing fluticasone to beclomethasone viagra extra dosage 150 mg discount erectile dysfunction medication free samples, , fluticasone to 44, 249 62 budesonide, , or ciclesonide to budesonide assessed differences in growth. A fair 1-year multinational head-to-head trial determined differences in growth velocity comparing a medium dose of fluticasone (400 mcg/day) to a medium dose of beclomethasone (400 mcg/day) in 343 31 pre-pubertal children with asthma. ITT analysis revealed that adjusted mean growth velocity was significantly greater in fluticasone than in beclomethasone-treated patients (+0. Another fair RCT compared growth velocity in 60 children treated with either a low dose of fluticasone (200 mcg/day) or a low dose of budesonide (400 249 mcg/day) over one year. Fluticasone-treated children had less reduction in growth velocity than the budesonide-treated group (height standard deviation score: 0. The third RCT compared differences in growth velocity in 333 children treated with a medium dose of fluticasone (400 mcg/day) or a medium dose of budesonide (800 mcg/day) over 20 44 weeks. Linear growth velocity was greater for fluticasone-treated children compared to those treated with budesonide (adjusted mean increase in height: 2. The forth RCT compared growth in 621 children (age 6-11) treated with either a low dose of ciclesonide (160 mcg/day) or a low dose of budesonide (400 mgc/day) over 12 weeks. Ciclesonide-treated subjects had a greater mean body height increase (1. Four additional studies provide general evidence of growth retardation for ICSs (Table 246, 247 124, 254-256 26). A good quality meta- analysis assessed differences in short-term growth velocity in 273 children with mild to moderate 246 asthma treated with either beclomethasone (mean 400 mcg/day) or placebo for 7 to 12 months. The meta-analysis reported a statistically significant decrease in linear growth velocity of children treated with beclomethasone (-1. Another good-quality meta-analysis assessed short-term growth velocity in 855 children treated with beclomethasone or fluticasone compared to placebo. Growth velocity was statistically significantly reduced in those treated with beclomethasone (1. The best longer-term evidence of linear growth delay comes from the Childhood Asthma Management Program (CAMP) study, a good quality RCT with median follow-up of 4. The mean Controller medications for asthma 148 of 369 Final Update 1 Report Drug Effectiveness Review Project increase in height was significantly less in budesonide-treated patients than in placebo-treated patients (-1. This analysis was performed on an intent-to-treat basis, providing a more conservative result than an “as treated” analysis. The differences in growth occurred, however, primarily during the first year of treatment. After two years of treatment growth velocity was approximately the same between groups. Another placebo controlled trial assessing growth velocity under low-dose fluticasone treatment (100 mcg/day; 200 mcg/d) did not find any significant differences in linear 254, 270 growth compared to placebo after one year of treatment. One additional fair quality RCT (N = 360) compared linear growth rates in prepubertal children treated with montelukast, beclomethasone, or placebo over 56 weeks and found that the mean growth rate of subjects treated with beclomethasone was 0. Summary of studies on growth retardation Author Quality Year N Design Population Duration Results rating Head-to-head comparisons of ICS compared with ICS Pre- 31 pubertal Greater growth De Benedictis et al. Controller medications for asthma 149 of 369 Final Update 1 Report Drug Effectiveness Review Project III. Acute adrenal crisis The use of ICSs includes the risk of altered hypothalamic-pituitary axis (HPA axis) functioning and the rare possibility of resultant adrenal suppression. We did not find any studies meeting our inclusion/exclusion criteria reporting on the comparative frequency of clinical adrenal insufficiency in patients treated with ICSs. However, multiple studies report on adrenal suppression during ICS therapy using urinary or serum cortisol levels and results of stimulation tests as intermediate outcomes. It is unclear to what extent results from sensitive studies of HPA axis suppression can be extrapolated to assess differences in risks for clinically significant adrenal suppression. Various case reports indicate that acute adrenal crisis is an extremely rare but potentially 271-273 fatal adverse event of ICS treatment. However, in most cases dosing was likely outside approved labeling. These case reports did not meet eligibility criteria for this report. Cataracts Systemic corticosteroid-induced cataracts typically are located on the posterior side of the lens and are referred to as posterior subcapsular cataracts (PSC); we reviewed studies that compared the risk of PSC in ICS-treated populations to non-ICS-treated populations (Table 27). No study compared the risk of developing PSC between one ICS and another. One head- 257 to-head RCT evaluated the effect of ciclesonide and beclomethasone on eye lens opacity. One 255, 256 263-267 placebo-controlled trial and five observational studies evaluated the risk of 255, 256 developing cataracts between ICS- and non-ICS-treated patients. One RCT and one 263 observational study compared budesonide to placebo; the other studies all compared 255, 256, nonspecific ICS use to no ICS use. Two studies were conducted in pediatric populations, 263 266 one in a mixed population of children and adults, and four evaluated adult populations (≥ 257, 264, 265, 267 40 years). Both treatments were found to have minimal impact on lenticular opacities development and/or progression. Both trials conducted in children reported no significant differences in the development of PSC between budesonide- 255, 256, 263 treated patients and placebo or matched controls. One of these was the CAMP study, a good quality RCT with median follow-up of 4. The single study that included a mixed population of adults and children reported no increase in the risk of developing cataracts between ICS-treated patients and controls in persons younger than 40 years; a dose-, duration-, and age-related 266 increase in risk was observed for persons older than 40 years of age. Both case-control studies found the risk of cataracts increased at higher ICS doses and longer duration of treatment; one study reported a higher relative risk for ICS 267 doses greater than 1,600 mcg/day and one study reported a higher relative risk for budesonide 265 or beclomethasone doses greater than 1,000 mcg/day. Most studies did not control for or did not report previous exposure to systemic corticosteroids, a known cause of cataracts. Only one observational study controlled for previous exposure to systemic corticosteroids; controlling for systemic corticosteroid use and other 264 potential confounders had little effect on the magnitude of the associations in this study. Controller medications for asthma 150 of 369 Final Update 1 Report Drug Effectiveness Review Project Table 27.

Compared to aspirin alone order viagra extra dosage 120mg with mastercard erectile dysfunction unable to ejaculate, therapy with clopidogrel plus aspirin did not significantly reduce risk of death from any cause (6 purchase 150mg viagra extra dosage with mastercard erectile dysfunction protocol hoax. However viagra extra dosage 120 mg amex erectile dysfunction protocol list, due to the inherent limitations of post-hoc analyses, these results should be interpreted with caution until confirmed in an appropriately designed prospective trial. The fair-quality CASPAR trial evaluated clopidogrel 75 mg plus aspirin (range, 75 mg to 100 mg) as compared to aspirin alone (range, 75 mg to 100 mg) for 364 days (median) in 851 patients undergoing unilateral, below-knee bypass graft for atherosclerotic peripheral arterial 52 disease. Sex was predominantly male (76%) and mean age was 66 years. Type of graft used was venous in 70% of patients and prosthetic in the other 30%. The primary combined endpoint was defined as the first occurrence of index graft occlusion, a surgical or endovascular revascularization procedure on the index bypass graft or para-anastomotic region, an amputation above the ankle of the index limb, or death. In the overall study population, compared with aspirin alone, dual therapy with clopidogrel plus aspirin did not significantly reduce risk of any of the secondary endpoints of all-cause mortality (5. Nor did dual therapy with clopidogrel plus aspirin significantly reduce the combined primary endpoint in the overall study population (35% compared with 35%; hazard ratio, 0. However, for the primary endpoint, a significant interaction was detected between treatment effect and type of graft used. Although there was no significant difference between dual therapy with clopidogrel and aspirin as compared to aspirin alone in the subgroup of patients with venous grafts (34% compared with 28%; hazard ratio, 1. The benefit of clopidogrel plus aspirin in the prosthetic graft subgroup appeared to be primarily due to significant reductions in frequency of graft occlusions (32% compared with 47%; hazard ratio, 0. Results of subgroup analyses were not reported for the outcomes of cardiovascular mortality or revascularization. Newer antiplatelet agents 30 of 98 Final Update 2 Report Drug Effectiveness Review Project Key Question 2. For adults with acute coronary syndromes or coronary revascularization via stenting or bypass grafting, prior ischemic stroke or transient ischemic attack, or symptomatic peripheral vascular disease do antiplatelet agents differ in harms? Summary of Findings Direct evidence • We found no direct evidence of the comparative harms of different newer antiplatelet agents in patients with acute coronary syndrome managed medically or with peripheral vascular disease. Acute coronary syndrome managed with coronary revascularization via stenting or bypass grafting • TRITON-TIMI 38, a good-quality randomized controlled trial that evaluated prasugrel compared with clopidogrel provided moderate-strength evidence of increased risk of major bleeding with prasugrel and no difference in withdrawal due to adverse events at 15 months. It also provided low-strength evidence of increased withdrawals due to adverse events with ticlopidine. No significant differences between ticlopidine and clopidogrel were found after 30 days in a fair-quality observational study or after 6 months in a fair-quality randomized controlled trial. Stroke or transient ischemic attack • The PRoFESS trial provided moderate-strength evidence of a higher risk of major bleeding with the fixed-dose combination of extended-release dipyridamole plus aspirin than clopidogrel and high-strength evidence of increased withdrawals due to adverse events with the fixed-dose combination of extended-release dipyridamole plus aspirin. Rate of major bleeding was not significant in the clopidogrel and ticlopidine groups (1. Indirect evidence Acute coronary syndrome managed medically • One good-quality randomized controlled trial (CURE) provided moderate strength evidence of increased risk of major bleeding at 12 months with clopidogrel plus aspirin compared with aspirin alone. Newer antiplatelet agents 31 of 98 Final Update 2 Report Drug Effectiveness Review Project Stroke or transient ischemic attack • Two published trials (ESPS-2, ESPRIT) and 1 unpublished trial (JASAP) consistently found no significant difference between extended-release dipyridamole plus aspirin and aspirin alone in frequency of major bleeding. However, withdrawal due to adverse events with the combination of extended-release dipyridamole plus aspirin was significantly greater in 2 of 3 trials. Overall, major bleeding and withdrawals due to adverse events were not reported. When compared to 650 mg of aspirin daily over 24 months in black patients, the differences with ticlopidine on those same harms were smaller and not significant. Peripheral vascular disease • Compared with aspirin alone, major bleeding risk was not significantly increased during dual therapy with clopidogrel plus aspirin. Incidence of withdrawals due to adverse events was not reported. Detailed Assessment Acute coronary syndrome Direct evidence 21 In the CURE trial, adding clopidogrel to aspirin provided benefit regardless of the aspirin dose but with a higher incidence of bleeding. For patients with acute coronary syndrome, a statistically significant higher incidence of major bleeding occurred in the clopidogrel and aspirin group compared with the placebo plus aspirin group (3. A nonsignificant higher incidence of life-threatening bleeding occurred in the clopidogrel group (2. Minor bleeding episodes were twice as common with clopidogrel than with placebo. Though not 22 powered to detect differences in bleeding rates by aspirin dose, a post-hoc analysis from the CURE trial suggested that lower aspirin doses (75-100 mg) with clopidogrel have more favorable safety profiles in terms of bleeding rates compared to when clopidogrel was combined 21 with higher doses of aspirin. The discontinuation rates due to adverse events were comparable between clopidogrel and placebo. The rate for moderate bleeding in the symptomatic group was significant and was reported as 2. In CHARISMA trial, treatment was permanently Newer antiplatelet agents 32 of 98 Final Update 2 Report Drug Effectiveness Review Project discontinued by 20. Reasons for permanently discontinuing therapy were not provided in the main publication. The most common reason for adverse event-related early permanent discontinuations was a gastrointestinal event (3. Acute coronary syndrome managed with coronary revascularization via stenting or bypass grafting Direct evidence Prasugrel compared with clopidogrel 25 The 15-month TRITON-TIMI 38 trial reported noncoronary artery bypass graft surgery-related TIMI major bleeding for prasugrel (2. Life- threatening bleeding was reported for prasugrel (1. Total withdrawals due to adverse events for prasugrel compared with clopidogrel were 7. Clopidogrel compared with ticlopidine 29 In the 28-day CLASSICS trial, clopidogrel was better tolerated than ticlopidine in the primary endpoint (major peripheral bleeding complications, neutropenia or thrombocytopenia, or early discontinuation of study drug as the result of a noncardiac adverse event during the study-drug treatment period) (4. The most frequent reason for early discontinuation of study drug as the result of a noncardiac adverse event during the study-drug treatment period was skin disorders, primarily rash. The rates of major peripheral or bleeding complication were similar in all treatment groups: ticlopidine (1. The corresponding bleeding risk for ticlopidine compared with clopidogrel 75 mg was relative risk, 0. It reported no difference in major bleeding between ticlopidine compared with clopidogrel (relative risk, 1; 95% CI, 0. The retrospective analysis included 311 Japanese patients who had stent implantation between Newer antiplatelet agents 33 of 98 Final Update 2 Report Drug Effectiveness Review Project January 2007 and April 2009.

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Thiazolidinedione plus metformin compared with a second-generation sulfonylurea plus metformin (2 randomized controlled trials) did not show a consistent effect favoring 1 of the combinations quality 200mg viagra extra dosage erectile dysfunction causes mayo, nor did 2 randomized controlled trials comparing thiazolidinediones compared with repaglinide discount 150 mg viagra extra dosage visa depression and erectile dysfunction causes. One trial comparing pioglitazone to acarbose favored pioglitazone for HbA1c reduction purchase viagra extra dosage 120 mg fast delivery erectile dysfunction after vasectomy. In the sections below, we include the active-control good- and fair-quality TZD studies included in the 2008 Drug Effectiveness Review Project drug class review on TZDs (searches through Nov 2007), as well as new good- and fair-quality studies identified since that time (searches through July 28, 2010). Pioglitazone compared with an active control Characteristics of studies 125-140 We included 16 trials comparing pioglitazone with an active control (Tables 28 and 29). Seven monotherapy trials 126, 130, 133, 135 135, 137, 139, 140 compared pioglitazone to a sulfonylurea or to metformin. Trials examining combination therapy compared pioglitazone to a sulfonylurea with both groups 125, 127-129, 131 134 receiving various oral hypoglycemic agents or insulin or metformin. Pioglitazone 132, 136, 138 was compared to metformin as add-on to other diabetic therapy in 3 trials. Drug dosing across studies was fairly consistent, with most study populations 50-60 years of age. Studies 127, 128, 130, 135, 137 ranged between 3 and 18 months; 5 trials had follow-up of greater than 6 months. Characteristics of pioglitazone active-control trials with sulfonylureas in adults with type 2 diabetes a Age (years) (SD) a % Female a Sample size % White a (N) % Hispanic Author, year Follow-up Other population Combination Quality (weeks) characteristics Intervention therapy 67 (8. Characteristics of pioglitazone active-control trials with metformin in adults with type 2 diabetes a Age (years) (SD) a % Female a Sample % White a size (N) % Hispanic Author, year Follow-up Other population Combination Quality (weeks) characteristics Intervention therapy 51. Efficacy results HbA1c results for active-control trials of pioglitazone are presented in Tables 30 and 31. Effects on HbA1c were similar between treatment groups, with no statistically significant difference noted between groups in 13 of the 16 trials. The 3 trials reporting a statistically significant difference compared pioglitazone to a sulfonylurea and reported small between-group 127, 128, 133 differences in HbA1c (0. None of the trials comparing pioglitazone to metformin reported a statistically significant difference. In a small (N=92), monotherapy study in 133 Japan, HbA1c decreased more with glibenclamide (change in HbA1c −1. In an 18-month trial of glibenclamide compared with pioglitazone in newly-diagnosed diabetic 127 subjects taking a variety of concurrent hypoglycemic agents including insulin, HbA1c improved in both groups to a similar degree to week 32, then the improvement was maintained with pioglitazone but not with glimepiride. At the final follow-up (week 72), the between-group difference (in favor of pioglitazone) was −0. In the PERISCOPE trial (N=543), greater improvement in HbA1c was reported for subjects treated with pioglitazone (−0. Change in HbA1c for pioglitazone compared with sulfonylureas in adults with type 2 diabetes HbA1c (%) HbA1c (%) change from P value change from baseline of baseline (mean, SD) between- Author, year (mean, SD) for for active group Quality Intervention pioglitazone control difference Glipizide: start 5 mg daily; mean 125 Agarwal 2005 maximal dosage 41 mg daily −0. Change in HbA1c for pioglitazone compared with metformin in adults with type 2 diabetes HbA1c (%) change from HbA1c change P value of baseline (mean, from baseline between- Author, year SD) for (mean, SD) for group Quality Intervention pioglitazone active control difference 140 Pio 15 mg daily Kato 2009 -1. Rosiglitazone compared with an active control Characteristics of studies We included 14 active-control trials comparing rosiglitazone with an active control (Tables 32 141-154 144, 148, 149, 152-154 and 33). Six of these are new to this section in this report. There were 4 147, 148 monotherapy trials comparing rosiglitazone to metformin or rosiglitazone to a 145, 147, 149 sulfonylurea. The combined therapy trials compared rosiglitazone to a sulfonylurea 141-144, 152, 154 with both groups receiving metformin or insulin or compared rosiglitazone to 151 146 metformin with both groups receiving sulfonylureas or various hypoglycemic agents. Kadoglou and colleagues compared the addition of rosiglitazone with increasing the dose of metformin for people with inadequately controlled diabetes while taking metformin 850mg daily. Across active-control studies, rosiglitazone dosing was either 4 or 8 mg daily. Follow-up 147 142, intervals ranged from 24 weeks to 4 years, with 7 trials having follow-up of 1 year or more. Characteristics of rosiglitazone active-control trials with sulfonylurea in adults with type 2 diabetes a Age (years) (SD) a % Female a % White a Author, Sample size (N) % Hispanic year Follow-up Other population Combination Quality (weeks) characteristics Intervention therapy 58. Data shown are mean (SD) unless otherwise indicated. Characteristics of rosiglitazone active-control trials with metformin or other in adults with type 2 diabetes a Age (years) (SD) a % Female a % White a Sample size (N) % Hispanic Author, year Follow-up Other population Combination Quality (weeks) characteristics Intervention therapy 146b 58. Data shown are mean (SD) unless otherwise indicated. Efficacy results HbA1c results for active-control trials of rosiglitazone are presented in Tables 34 and 35. One of 147 the 14 trials, A Diabetes Outcomes Progression Trial (ADOPT), reported a statistically significantly greater improvement in HbA1c for subjects treated with rosiglitazone than those 143 treated with active controls and one reported greater improvement for the active control than for rosiglitazone. The other 12 trials reported no statistically significant difference between groups. ADOPT was a large (N=4360), multicenter, double-blind, randomized controlled trial designed to evaluate monotherapy with rosiglitazone, metformin, or glyburide. The trial reported greater improvement in HbA1c at 4 years for subjects treated with rosiglitazone than for those treated with metformin (treatment difference −0. Garber and colleagues reported greater improvement in glycemic control for subjects treated with a combination of glibenclamide 5 mg/metformin 1000 mg (once or twice daily) than for those treated with rosiglitazone 4-8 mg daily combined with metformin 1500-2000 mg daily (between-group 143 difference in HbA1c 0. Among the monotherapy trials, ADOPT (N=4360) was designed to evaluate monotherapy with rosiglitazone, metformin, or glyburide among subjects recently diagnosed (within 3 years) with type 2 diabetes and who had failed lifestyle therapy but had not started on 147 oral hypoglycemic agents. The primary outcome was monotherapy failure defined as fasting plasma glucose level of >180 mg/dL. Median duration of treatment with rosiglitazone was 4 years. The cumulative incidence of monotherapy failure at 5 years was 15% with rosiglitazone, 21% with metformin, and 34% with glyburide (P<0. The results of 2 smaller rosiglitazone monotherapy trials were similar to the results from ADOPT when the appropriate follow-up intervals were compared. Hanefeld and colleagues 145 found no significant difference between glibenclamide and rosiglitazone at 52-week follow-up and Pop-Busui and colleagues found no significant difference between glyburide and 149 rosiglitazone at 26 weeks.

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Subjects with a currentmedicalillness ora h istory ofserious psych iatricdisease or wh o were takingmedicationknown to affectsleeporvigilance were excluded buy viagra extra dosage 130mg erectile dysfunction age 40. Patients were also required to h ave a h abitual consumptionofmore th anfour caffeine-containingbeverages per day and to h ave no h istory of alcoh olabuse buy 200 mg viagra extra dosage with visa erectile dysfunction doctors in nj. Beverages containingalcoh olorcaffeine were proh ibited duringth e days ofstudy purchase viagra extra dosage 120 mg on-line erectile dysfunction icd 9 code. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M cC all2006 Patients aged 64-86 years wh o Patients were excluded ifth ey h ad M eanage (SD): 782/ 9/ 2 weeks Esz opiclone; (F air) metDSM -IV criteria for secondary insomnia orany 71. A mean severe C O PDoradvanced sleep W A SO of20 mins ormore, ph ase syndrome,orifth ey used with no nigh t<15 mins,a mean drugs knownto affectsleepwith in3 L PS of20 mins ormore with nodays,melatoninorany h erbal nigh t< 15 mins. Patients with supplements with alleged C N S comorbid conditions th atwere effects with in14 days orST. M edical were allowed ifth eirdisease abnormalities orunstable ch ronic was stable. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M oldofsky, Diagnosis ofF M was based on Patients were excluded ifth ey h ad M eanage (SD):42 N R / 3/ 4 days Z olpidem 5mg; 1996 (F air) th e A mericanC ollege of a serious medicalorpsych iatric (2); R h eumatology criteria to disorderoreith ersleepapnea or diffuse myalgia,atleast11 to sleeprelated periodicinvoluntary 18 tenderpoints inspecific limbmovementdisorderon anatomicregions,ch ronic polysomnograph y. O th erwise,allpatients were determined to be ingood h ealth based ona medicalh istory, examination,electrocardiogram, and laboratory analyses ofblood and urine samples. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M onch esky, A dults patients were enrolled Pregnancy and breast-feeding; M eanage (SD):N R N R / 0/ 7 days Z olpidem; 1986 (F air) wh o h ad suffered from concomitantuse ofneuroleptics, (N R ); insomnia foratleastth ree sedatives,analgesics,or month s and metatleasttwo ofantidepressants;a h istory ofdrug th e followingcriteria:(1)sleep abuse oraddiction;a h istory of latency of45 minutes ormore, serious psych iatric,h epatic,renal, (2)more th anth ree nigh tly ormetabolicdisorders;epilepsy;a awakenings with difficulty in knownh ypersensitivity to h ypnotic fallingasleepagain,(3)early drugs;abnormalliverorrenal finalmorningawakening,and function;abnormalh emogram (4)totalsleeptime ofusually values;and anestablish ed 0% female; N R / 2/ Placebo; less th anfive h ours and always diagnosis ofsleepapnea R ace/eth nicity:N R 99 91 ; less th ansixh ours. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M onch esky, M ale and female sh iftworkers Subjects previously receiving M eanage (SD): N R / N R / 12 days Z opiclone; 1989 (F air) betweenth e ages of22 and 55 h ypnoticmedicationwere eligible to 34. To be excluded ifth ey were pregnant, included inth e study, lactatingorwere notusinga participants h ad to alternate medically recogniz ed contraceptive betweena two-week day sh ift meth od. Subjects wh ose sleep (07:00 to 15:30 h )and a two- performance was disrupted by week nigh tsh ifts (18:00 to externalfactors and th ose taking 02:30 h )foratleastone year. During ofh ypersensitivity to one ormore each sh ift,two 10-minbreaks, h ypnoticdrugs were excluded. Sh ift psych iatricormedicaldisorderwere workers h ad to presenta also excluded as were th ose with a h istory ofinsomnia ofth ree or h istory ofalcoh olism,drugabuse or more consecutive day ornigh t caffeine overuse. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M onti,1996 A llpatients were sufferingfrom Pregnantwomen,womenofch ild- M eanage (SD): N R / N R / 27 days Z olpidem; (F air) atleast2 ofth e followingsleep bearingage with inadequate 44. A lcoh olabuse orintake ofh ypnotics oranxiolytics and/orantidepressants inth e seven days priorto th e baseline period 83% female; N R / N R / Placebo; also led to exclusion. R ace/eth nicity:N R 12 12 ; ; Insomnia 44 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed M onti,2000 Patients aged between27 and Patients with poorh ealth ,acute or M eanage (SD): N R / N R / 15 days Z olpidem; (Poor) 59 years,with ch ronicprimary ch ronicpain,decompensated 51. Patients with poorh ealth ;acute orch ronic pain;h epatic,renal,respiratory, cardiac,orneuropsych iatric diseases [subjects with a score of H A M D> 18,ora score ofH A M A (14 items)>16 were notincluded]; knowndrugallergy orabuse; periodiclegmovements during sleep;restless legs;orsleepapnea were excluded from th e study,as also were pregnancy women, breast-feedingmoth ers,subjects deemed insufficiently compliant,or th ose with clinically significant deviations inth eirlaboratory tests. A lcoh olabuse,intake ofh ypnotics oranxiolytics inth e sevendays priorto baseline period,ora positive benz odiaz epine urine screeningalso led to exclusion. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed Parrino (F air) H ypnoticnaïve subjects and h istory ofanxiety disorders,major M eanage (SD): N R / 4/ 6 days Z olpidem; metallcriteria fordiagnosis of depressioncriticalmedical 32. Sleepapnea, periodiclimbmovementand oth er 50% female; N R / 0/ Placebo; sleepdisorders R ace/eth nicity:N R 12 8 Z olpidem; Placebo; Perlis,2004 Patients aged 18 to 64 years Exclusioncriteria included M eanage (SD): 322/ 10/ 84 days Z olpidem; (F air) were eligible forth e study presence ofany significant 40. A dditionally,female patients were ineligible ifth ey were breastfeeding,pregnant,ornot usingdouble-barriercontraceptive meth ods. A 2-nigh t medicationwith in1 and 2 weeks (screening)meanPSG W A SO priorto screening,respectively. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed >= 40 minutes (not<30 R ace/eth nicity: 205 N R ; minutes oneith ernigh t),and 95. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed R oth () A dults 18-64 years ofage with DSM =IV axis I psych iatric M eanage (SD): N R / 20/ 21 days Z olpidem; primary insomnia,DSM -IV disorderorany sleepdisorder, 44. Two nigh tmean wk priorto screeningh aving W A SO ofatleast30 mins and received any substance with C N S TST between3 and 7 h our effects 58% female; N R / 1/ Placebo; each screeningnigh t R ace/eth nicity: 212 212 ; C aucasian90% ; A tscreening:65 years orolder Significantpsych iatricormedical M eanage (SD): N R / 0/ 9 weeks R amelteon ,diagnosis ofch ronicprimary illness as determined by th e 70. A t ramelteon)includingsleepaids and randomiz ation:meanL PS =20 h erbalpreparations with C N S mins on2 nigh ts with neith er effects,with in3 weeks ofbaseline nigh t<15 mins and a mean orwh o h ad flownacross more th an W A SO =60 mins with a wake 3 time z ones with in7 days of time =45 mins oneach ofth e 2 screening. A trandomiz ation: 63% female; N R / 0/ R amelteon8 nigh ts. A H I>15 orperiodiclegmovements mg; with arousalindex>20 onPSG. R ace/eth nicity: 100 100 Placebo; C aucasian:95% A sian:1% H ispanic:4% Black, N ative A merican, O th er:0% ; Insomnia 48 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed R amelteon 4mg; R amelteon 8mg; Placebo; ; R oth 2006 A ge 65 years orolderwith a Patients could noth ave h ad any M eanage (SD): N R / 128/ 5 weeks R amelteon4 (F air) diagnosis ofprimary insomnia significantmedicalorpsych iatric 72. Body mass indexmust h ave beenbetween18 and 34, inclusive,and h abitualbedtime musth ave beenbetween8:30 pm and 12:00 am. F orsubset ofpatients with severe sleep onsetdifficulties (sSL =60) 0% female; N R / N R / R amelteon8 receiving8 mgorplacebo were mg; included inposth ocanalysis R ace/eth nicity:N ot 829 N R Placebo; reported ; Sch arf,2005 M enand womenbetweenth e Patients with a priorh istory of M eanage (SD): 353/ 21/ 14 days Esz opiclone (F air) ages of65 and 85 years wh o allergies to z opiclone orany 72. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed excluded. R ace/eth nicity:N R 119 119 Placebo; ; Insomnia 50 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup Enrolled A nalyz ed Soares 2006 W omenaged 40-60 yrs wh o obstructive sleepapnea,h istory of M eanage (SD):49 642/ 51/ 4 weeks Esz opiclone; metDSM -IV criteria for substance abuse ordependence, (); insomnia inth e contextof consumptionofmore th an2 menopausaltransition,peri alcoh olicbeverages perday or14 menopausalorearly post perweek,use ofprescription menopausalwith variable cycle medications knownto affectsleep, length ;late menopausal and th e use ofoverth e counter transitionwith two ormore medicationaffectingsleepormood. Sleeplatency >= 45 minand sleepduration <= 6h ,>= 3x/wk for1 month ; insomnia symptoms post-date 100% female; N R / N R / ; onsetofperi-menopausal R ace/eth nicity: 410 410 ; symptoms,with no oth ercause C aucasian:77% ofsecondary insomnia Black:15% H ispanic:8% ; Soubrane DSM -IV-defined primary A ny DSM -IV A xis I psych iatric M eanage (SD): N R / 20/ 3 weeks Z olpidem M R ; (poster)(F air) insomnia,W A SO 1 h ourper disorder,sleepdisorder,h istory of 44. C h aracteristics ofPlacebo-controlled trials ofnewerinsom niadrugs A uth or,year InclusionC riteria ExclusionC riteria Dem ograph ics N um ber N um ber Study Interventions (Q uality) Screened W ith drawn Duration Eligible L ostto followup h ours pernigh tduringth e 2 counterorprescriptionsleep Enrolled A nalyz ed weeks priorto enrollment. C aucasian,10% oth er ; Terz ano, patients metth e criteria forth e patients h ad nocturnalmyoclonus M eanage (SD): N R / N R / 1 days Z olpidem; 1992 (Poor) diagnosis ofpersistent orsleepapnea syndrome 49. W A SO ofatleast30 circadianrh yth m disorder, mins oneach nigh twith a parasomnia,and dyssomnia), meanW A SO ofatleast40 h istory ofepilpesy,parasomnia and mins,a totalsleeptime of dissomnia),h istory ofepilepsy, between3 and 7 h ours on myasth enia gravis,evidence ofany each nigh t clinically significant,severe or unstable progressive,progressive, medicalorsurgicaldisorder,h isotry ofsubstance abuse,lifestyle th at precludes diagnosis ofprimary insomnia,use ofsleepmedication inth e previous 2 weeks, concommitantuse ofany psych otropicdrugoroth er substance knownto affectsleep with inth e previous week. Insomnia 52 of 309 Final Report Update 2 Drug Effectiveness Review Project Evidence Table 3.

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