Imitrex

By A. Grubuz. Thomas Aquinas College, Santa Paula CA.

Treatm entofestablish ed postoperative nauseaand vom iting:System aticreviews C h aracteristics of A uth or Tim e period N um berof identified articles: Y ear A im s covered Eligibility criteria patients study designs Tramer order imitrex 50 mg overnight delivery muscle relaxer 800 mg,1997 To testth e evidence fora M edline (1991- R andomiz ed controlled trials th at 1 buy imitrex 25mg with visa muscle relaxant drugs z,252 Sevenrandomiz ed dose-response with January 22,1996) evaluated th e effectofondansetron controlled trials (4 ondansetronfortreatmentof compared with a control(placebo, ondansetronvs placebo,2 PO N V and establish wh eth er no treatment,oranoth erantiemetic) ondansetronvs IV differences inefficacy onestablish ed PO N V and reported droperidol,1 ondansetron betweendoses are ofclinical th e outcome indich otomous form. Treatm entofestablish ed postoperative nauseaand vom iting:System aticreviews C h aracteristics of A uth or identified articles: Y ear populations C h aracteristics ofidentified articles:interventions Tramer,1997 F ourtrials in1043 F ourtrials ofa single ivdose ofondansetron1 mg,4 mg,or adults (82% female) 8 mgwith placebo; wh o complained of O ne trialofivondansetron8 mgvs ivdroperidol1. Antiemetics Page 451 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 13. Treatm entofestablish ed postoperative nauseaand vom iting:System aticreviews A uth or Y ear M ainresults early efficacy (with in6 h ours) M ainresults late efficacy (with in24 h ours) Tramer,1997 O dds R atio (95% C I);N N T (95% C I) O dds R atio (95% C I);N N T (95% C I) C omplete controloffurth ernausea orvomiting,orboth C omplete controloffurth ernausea orvomiting,orboth O ndansetronvs Placebo O ndansetronvs Placebo O ndansetron1 mg:3. Treatm entofestablish ed postoperative nauseaand vom iting:System aticreviews A uth or Y ear Subgroups A dverse events Tramer,1997 N o information. Antiemetics Page 453 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Design O th erpopulation Setting Trialtype Type ofSurgery ch aracteristics Inclusioncriteria A ctive-controlled trials C andiotti R C T N onemergency surgery,nototh erwise H istory ofPO N V:40% A dultfemales between18 and 64 years 2007 Parallel specified H istory ofmotionsickness:35% with anA SA I-III status,sch eduled to Single C enter A ctive N o ETO H use:86% undergo nonemergency surgery,requiring N o Smoking:86% generalanesth esia ofatleast30 minutes A verage BM I:26. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting Exclusioncriteria Intervention A llowed oth erm edication A ctive-controlled trials C andiotti Patients with knownh ypersensitivity to 5H T3 drugs, a)ondansetron4mg A llpatients received midaz olam 1-2mg, 2007 BM I>35,significantsystemicdisease patients wh o b)granisetron1mg th iopental(3-5mg/kg)was used forinduction Single C enter h ad nausea orvomiting24 h ours before study,any c)granisetron0. O rvecuronium antich olinergics,antih istamines,butyroph enones, (0. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or M eanA ge Screened/ W ith drawn/ Y ear R un-in/W ash G ender Eligible/ L ostto fu/ Setting out Eth nicity Enrolled A nalyz ed A ctive-controlled trials C andiotti no/no 43. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting R esults A dverse events A ctive-controlled trials C andiotti O ndansetronvs G ranisetron0. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Design O th erpopulation Setting Trialtype Type ofSurgery ch aracteristics Inclusioncriteria C oloma DB R C T L aparoscopicch olecystectomy 68 (76% ) H istory ofPO N V 22(24% ) H ealth y outpatients sch eduled for 2002 Parallel G ynecologiclaparoscopy 22 (24% ) H istory ofmotionsickness laparoscopicsurgery with general Single C enter A ctive 15(17% ) anesth esia;patients were enrolled ifth ey H istory ofdiz z iness 18(20% ) complained ofnausea orvomitinginth e postanesth esia care unitorinth e step- down(ph ase II)recovery unit. Dabbous DB R C T L aparoscopicch olecystectomy:55% H istory ofPO N V 46 (27% ) A SA C lass I and II patients undergoing 2001 Parallel L aparoscopich erniorrh aph y:7% H istory ofmotionsickness 9 laparoscopicsurgery wh o developed Single C enter A ctive L aparoscopicA ppendectomy:10% (5% ) PO N V. DiagnosticL aparoscopy 48:28% Antiemetics Page 458 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting Exclusioncriteria Intervention A llowed oth erm edication C oloma Patients were excluded ifth ey h ad takenan a)ondansetron4mg Proph ylacticantiemetic(e. Dabbous Patients receivingpre-orintraoperative a)ondansetron4 mg A llpatients were premedicated with 2001 antiemetics;postoperative painscores >5,patients b)droperidol1. Antiemetics Page 459 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or M eanA ge Screened/ W ith drawn/ Y ear R un-in/W ash G ender Eligible/ L ostto fu/ Setting out Eth nicity Enrolled A nalyz ed C oloma no/no 40 268/ N R / 2002 92% women 90/ 7/ Single C enter N otreported 90 90 Dabbous no/no 44 N R / N R / 2001 77% women N R / N R / Single C enter N otreported 173 173 Antiemetics Page 460 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting R esults A dverse events C oloma O ndansetronvs A custimulationvs C ombination ondansetronvs acustimulation 2002 C omplete response at2 h ours pruritus:3% vs 0% (N S) Single C enter C omplete response at2 h ours N umber(% ):17(57)vs 12 (40)vs 22 (73) difficulty voiding:3% vs 3% (N S) O ndansetronvs acustimulation,p:N S h eadach es:0 vs 0 (N S) C ombinationvs acustimulation,p:<0. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Design O th erpopulation Setting Trialtype Type ofSurgery ch aracteristics Inclusioncriteria F ujii DB R C T A bdominalh ysterectomy:76% N one h ad a h istory ofmotion W omenundergoingmajorgynecological 2000 Parallel Vaginalh ysterectomy:5% sickness orprevious PO N V. Antiemetics Page 462 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting Exclusioncriteria Intervention A llowed oth erm edication F ujii Patients with gastrointestinaldisease,th ose wh o a)granisetron40mcg/kg N one reported 2000 h ad a h istory ofmotionsickness,previous b)droperidol20mcg/kg Single center postoperative nausea and vomiting,orboth ;and c)metoclopramide 0. Antiemetics Page 463 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or M eanA ge Screened/ W ith drawn/ Y ear R un-in/W ash G ender Eligible/ L ostto fu/ Setting out Eth nicity Enrolled A nalyz ed F ujii no/no 44 N R / 0/ 2000 100% women N R / 0/ Single center N R 120 120 Antiemetics Page 464 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 14. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Setting R esults A dverse events F ujii G ranisetronvs droperidolvs metoclopramide Incidence ofadverse events (states "such 2000 C omplete controlofPO N V (no emesis and no rescue medication)for24 h ours as h eadach e and diz z iness): Single center 88% vs 55% vs 50% (p=0. Treatm entofestablish ed postoperative nauseaand vom iting:C om parative clinicaltrials A uth or Y ear Design O th erpopulation Setting Trialtype Type ofSurgery ch aracteristics Inclusioncriteria F ujii DB R C T Partialmastectomy:12% H istory ofPO N V:4% W omenwith A SA ph ysicalstatus I (no 2003 Parallel Partialmastectomy w/axillary dissection:9% H istory ofmotionsickness:9% organic,ph ysiologic,bioch emical,or Single C enter A ctive M odified radicalmastectomy:9% psych iatricdisturbance)wh o were M odified R adicalmastectomy w/axillary experiencingnausea and/oremesis after dissection:69% recovery from generalanaesth esia for breastsurgery. U nlugenc R C T A bdominal:88 (73% ) N o patients with a h istory of M enand women,A SA C lass I and II,ages 2003 Parallel G ynecological:32 (27% ) motionsickness orprevious 18 to 65,wh o were sch eduled forelective Single C enter A ctive postoperative vomiting. Patients were included ifnausea orvomitingoccurred duringth e first2 h ours inth e Postanesth esia R ecovery U nit.

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Overall trusted 25 mg imitrex muscle relaxant vitamin, complete response rates were not significantly different between drugs but varied widely across the trials imitrex 50 mg otc spasms hiccups, from a low of 17% with dolasetron in a study of women undergoing gynecologic surgery to a high of 98% in a study of “superficial surgical procedures” with 37% men. In addition to differences in surgical procedures and proportions of women, these studies also varied in dose of antiemetic. While ondansetron 4 mg was used in every trial, the dolasetron dose varied more. The 50 mg dose was superior to the 25 mg dose on total response rate at 24 Antiemetics Page 32 of 136 Final Report Update 1 Drug Effectiveness Review Project hours (no emesis plus no rescue medication plus no nausea), and both dolasetron 50 mg and ondansetron 4 mg were superior to dolasetron 25 mg on complete response (no emesis plus no 111 rescue medication use) at 24 hours. Aprepitant compared with ondansetron Two fair-quality trials (N=1727) compared oral aprepitant 40 mg and 125 mg with intravenous 116, 117 ondansetron 4 mg in primarily females undergoing open abdominal surgeries. Both trials were originally designed to test the superiority of aprepitant over ondansetron on the primary efficacy endpoint of complete response, defined as no emesis and no use of rescue medication for the first 24 hours after surgery. In the first trial, no significant difference was seen between aprepitant 40 mg or 125 mg and ondansetron (45% compared with 43% compared with 42%), but both doses of aprepitant were significantly better than ondansetron on the secondary endpoint 117 of no vomiting. The odds ratio of no vomiting for aprepitant compared with ondansetron was 3. Before the second trial was completed, its plan for statistical analysis was adjusted to accommodate dual primary endpoints: (1) noninferiority of aprepitant for complete response and (2) superiority of aprepitant for no vomiting during the first 24 hours after surgery. For the complete response endpoint, noninferiority was defined as a lower bound of a 1-sided 95% CI of 0. In this trial, complete response rates were 64%, 63%, and 55%, respectively, for aprepitant 40 mg, aprepitant 125 mg, and ondansetron 4 mg. Noninferiority was confirmed based on the following odds ratios and lower bounds of the associated 1-sided 95% CI (in parentheses): aprepitant 40 mg to ondansetron 1. Additionally, as in the first trial, significantly more patients had no vomiting during the first 24 hours in the aprepitant 40 mg group (84%; odds ratio 2. Ondansetron: orally disintegrating tablet compared with intravenous We included 2 trials that compared the oral disintegrating tablet and intravenous forms of ondansetron. Both trials were conducted in Turkey and both found no significant differences in 118, 119 postoperative nausea and vomiting outcomes. In the first trial, oral disintegrating tablet ondansetron 8 mg, intravenous ondansetron 4 mg, and placebo were compared in 150 young men 119 undergoing minor elective surgeries. In this trial, neither oral disintegrating tablet nor intravenous ondansetron was found to be significantly better than placebo in reducing incidence of postoperative nausea and vomiting, vomiting, or use of rescue medication during the first 24 hours after surgery. In the second trial, oral disintegrating tablet ondansetron 8 mg, intravenous ondansetron 8 mg, and placebo were compared in 90 women undergoing major gynecologic 118 surgery (mean age = 47 years). In this trial, both oral disintegrating tablet and intravenous forms of ondansetron were found to be better than placebo in reducing incidence of nausea and vomiting during the first 6 hours after surgery. There were no significant differences between the 2 forms of ondansetron. Dolasetron compared with granisetron Two trials compared dolasetron 12. In the trial of mostly women (84%) undergoing a variety of surgical procedures, a complete response was significantly more frequent with Antiemetics Page 33 of 136 Final Report Update 1 Drug Effectiveness Review Project 120 granisetron 1 mg intravenous (54. However, in a trial of women undergoing gynecological and breast surgeries, rate of total treatment failure did not differ significantly between low-dose granisetron intravenous (0. In both trials, patient satisfaction was not significantly different between the granisetron and dolasetron groups. One trial reported time to first intake of fluids or solids and quality of first postoperative 120 night sleep. There was no significant difference between granisetron and dolasetron in these outcomes. Placebo-controlled trials Head-to-head trials rarely reported patient satisfaction, quality of life, functional capacity, or hospital stays. Therefore, we included placebo-controlled trials to address these gaps (Evidence 121-159 Tables 11 and 12). Dolasetron was the only 5-HT3 antagonist that consistently showed significantly 121, 128, 148, 152 improved patient satisfaction compared with placebo across 4 trials.

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The overall hazard ratio for prasugrel compared with clopidogrel was 0 imitrex 50mg cheap muscle relaxant drugs cyclobenzaprine. The reduction in risk was significantly greater for prasugrel in patients younger than 65 years old (hazard ratio cheap 50 mg imitrex free shipping muscle relaxant without aspirin, 0. The authors performed a series of post-hoc exploratory analyses to identify subgroups of patients who did not have a favorable net clinical benefit. This was defined as the rate of death from any cause, nonfatal myocardial infarction, nonfatal stroke, or noncoronary artery bypass graft-related nonfatal major bleeding. Patients 75 years of age or older had no net benefit from prasugrel (hazard ratio, 0. In 20 332 patients with recent ischemic stroke who participated in the good-quality 42 PRoFESS trial, the finding of noninferiority of the fixed-dose combination of extended-release dipyridamole plus aspirin over clopidogrel for the primary outcome of recurrent stroke was consistent in subgroups of patients who were less than 65 years of age (7. Results of the hazard ratio analysis were displayed in graphical form, but the actual hazard ratios and 95% confidence intervals were not reported. Indirect evidence 21 In a subset analysis of CURE, compared with placebo plus aspirin, clopidogrel plus aspirin showed benefit in the rates of the first primary outcome in patients more than 65 years old (13. In that analysis, extended-release dipyridamole/aspirin was superior to either agent used alone in the secondary prevention of ischemic stroke, irrespective of age. While these data refer to adults, the product contains aspirin and thus should be avoided in children and teenagers with viral infection due to the risk of Reye’s syndrome. These patients, on various antiplatelet and anticoagulant agents for secondary stroke prevention, were predominantly female (68. The study was designated as poor quality due to its Newer antiplatelet agents 43 of 98 Final Update 2 Report Drug Effectiveness Review Project methodological limitations, but it suggested that patients aged 75 to 84 years and those who were more than 85 years old were more likely to have a bleed than were younger patients. After adjusting for various factors (including age, gender, physical impairment, and gastrointestinal bleeding risks when using gastrointestinal protectants, NSAIDS, or corticosteroids), users of ticlopidine showed an increased risk of hospitalization for bleeding episodes compared to nonusers of ticlopidine (odds ratio, 1. For comparison, the adjusted rate of hospitalizations for aspirin users due to bleeding was an odds ratio of 1. Racial groups Direct evidence In the PRoFESS trial, the finding of noninferiority of the fixed-dose combination of extended- release dipyridamole plus aspirin over clopidogrel for the primary outcome of recurrent stroke did not differ significantly across subgroups based on ethnicity in patients with recent ischemic 42 stroke (African, Chinese, South Asian, Other Asian, white/European, Native Latin). No other head-to-head trials of newer antiplatelet agents in other included populations reported subgroup analyses based on race. Indirect evidence There was little evidence to suggest that the newer antiplatelet agents differ in effect or tolerance 45 across ethnic groups. One study of African American stroke patients evaluated ticlopidine monotherapy to aspirin monotherapy and reported a similar benefit in each group in the prevention of recurrent stroke, myocardial infarction, or vascular death and a similar frequency of adverse effects compared to other studies. One of the 902 ticlopidine treated patients appeared to develop thrombocytopenia, with a possible diagnosis of thrombotic thrombocytopenic purpura. Gender Direct evidence TRITON-TIMI 38 reported Kaplan-Meier estimated hazard ratios for selected subgroups of patients for the primary composite endpoint (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke). No statistically significant interaction was found between sex and the relative effect of prasugrel compared with clopidogrel. The overall hazard ratio for prasugrel compared with clopidogrel was 0. In the PRoFESS trial, the finding of noninferiority of the fixed-dose combination of extended-release dipyridamole plus aspirin over clopidogrel for the primary outcome of recurrent stroke did not differ significantly in subgroups of men (9. Newer antiplatelet agents 44 of 98 Final Update 2 Report Drug Effectiveness Review Project Indirect evidence No studies yet indicate that men and women have different outcomes in primary events when using the newer antiplatelet agents. The majority of the studies included mostly male populations. A good-quality meta-analysis of blinded randomized controlled trials evaluated the relative effectiveness of clopidogrel plus aspirin to aspirin alone in subgroups of men and women 70 using a random effects model. This meta-analysis pooled data from 5 trials, including CREDO, CURE, CLARITY, COMMIT, and CHARISMA. However, because our review did not include CLARITY or COMMIT, we pooled the event data provided by Berger, et al. As can be seen in Table 5, clopidogrel significantly increased risk of major bleeding in both men and women and did not significantly reduce risk of all-cause mortality in either subgroup.