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The most comprehensive and highest-quality systematic review of serious infections associated with targeted immune modulators was a Cochrane review of 209 trials and extension 282 studies published up to January 2010 buy generic erectafil 20mg online. The authors conducted a network meta-analysis (mixed- effects logistic regression using an arm-based random-effects model within an empirical Beyes framework and Poisson distribution) on the incidence of serious infections with all of the targeted immune modulators using data from published systematic reviews with meta-analyses purchase erectafil 20 mg visa, including data from 119 studies and 41 036 patients erectafil 20 mg on-line. No reviews of natalizumab or alefacept were available at the time so the two drugs were not included discount erectafil 20mg otc. Serious infections were included based on individual study definitions order erectafil 20 mg mastercard, typically deaths, hospitalizations, and use of intravenous antibiotics associated with infection. The overall quality of the bodies of evidence (using the GRADE rating system) was high for abatacept and certolizumab and moderate for all others except rituximab, which was rated low quality. Relative to control groups, only certolizumab was associated with a statistically significant increase in risk of serious infection (odds ratio, 3. As a group, the targeted immune modulators did not result in increased odds of a serious infection compared with control groups (pooled odds ratio, 1. In indirect comparisons (network analysis adjusted for dose), abatacept resulted in statistically significantly lower odds of a serious infection compared with certolizumab, infliximab, and tocilizumab while certolizumab was associated with greater odds than adalimumab, anakinra, etanercept, golimumab, infliximab, rituximab, and placebo (Table 17). Statistically significant indirect comparisons: Serious Infection Drug Comparator drug Odds ratio 95% confidence interval Abatacept Certolizumab 0. The studies were similar to those included in the meta-analysis, and their results did not conflict with the network analysis results. For example, at 52 weeks, patients taking 100 mg of golimumab had the highest rate of serious infections (3. A small fair-quality trial of patients with rheumatoid arthritis who had failed at least one course of antitumor necrosis factor drugs received one course of open-label rituximab and then were randomized to placebo or 300 rituximab for a second course. There was no difference between groups in the rate of serious infection at week 48 (2% in each group). A pooled analysis of only abatacept trials and extension studies made comparisons of rates of hospitalization due to infection and pneumonia between 302 trial rates and estimates from epidemiological studies. Neither analysis showed a statistically significant increase in risk with abatacept. A similar pooled analysis of rituximab data found the rate of serious infection to be 4. A pooled analysis of certolizumab studies in patients with Crohn’s disease found that continued treatment following remission resulted in a rate of 7. Direct evidence from observational studies of targeted immune modulators included a good-quality prospective cohort study of registry data on patients with rheumatoid arthritis in 270 Britain. A total of 15 396 patients were included in this analysis. As a group antitumor necrosis factor drugs (adalimumab, etanercept and infliximab) resulted in statistically significant increase in risk for serious infections compared with disease-modifying antirheumatic drugs (adjusted hazard ratio, 1. Mortality within 30 days of serious infection, however, was statistically significantly lower with antitumor necrosis factor drugs (hazard ratio, 0. There were no statistically significant differences in risk of serious infection found between drugs, no difference in hospital stay, and no difference in risk in older patients. A fair quality retrospective cohort study of administrative medical and pharmacy data on 6992 patients with rheumatoid arthritis identified hospitalizations with ICD-9 codes for 283 infection and who were treated with a targeted immune modulator. In contrast to the study above, across all patients, regardless of whether they were using a targeted immune modulator drug for the first time or were switching from another such drug, abatacept (adjusted hazard ratio, 0. Rituximab was not found statistically significantly different. The study found also that the patients underlying risk for infection was a significant confounder. Progressive multifocal leukoencephalopathy In June 2009, the manufacturer of efalizumab voluntarily withdrew the drug from the United States market because of an increased risk of progressive multifocal leukoencephalopathy. Progressive multifocal leukoencephalopathy is a rapidly progressive, viral infection of the central nervous system that leads to death or severe disability. A case series of more than 3000 patients treated with natalizumab for various indications did not meet our formal inclusion criteria. This Targeted immune modulators 87 of 195 Final Update 3 Report Drug Effectiveness Review Project study, however, estimated the risk of progressive multifocal leukoencephalopathy of roughly one 304 in 1000 patients treated with natalizumab for a mean of 17. A descriptive report of 52 cases occurring in patients receiving rituximab revealed that the majority of patients were 305 taking other immunosuppressive treatments concomitantly. No evidence eligible for this review was available about the risk for progressive multifocal leukoencephalopathy for any of the other targeted immune modulators.

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Prepared by the Oregon Evidence-based Practice Center for the Drug Effectiveness Review Project generic erectafil 20mg free shipping. Dailey discount erectafil 20mg online, PharmD Peter Glassman purchase 20mg erectafil visa, MBBS purchase erectafil 20mg on line, MSc Marika Suttorp discount erectafil 20 mg visa, MS Susan Chen, BA Southern California Evidence-based Practice Center, RAND Original Report authors Janet H. Dailey, PharmD Peter Glassman, MBBS, MSc Marika Suttorp, MS Cony Rolón, BA Southern California Evidence-based Practice Center, RAND Funding The Drug Effectiveness Review Project, composed of 12 organizations including 11 state Medicaid agencies, and the Canadian Agency for Drugs and Technology in Health commissioned and funded for this report. These organizations selected the topic of the report and had input into its Key Questions. The content and conclusions of the report were entirely determined by the Evidence-based Practice Center researchers. The authors of this report have no financial interest in any company that makes or distributes the products reviewed in this report. Newer antiplatelet agents 7 of 98 Final Update 2 Report Drug Effectiveness Review Project INTRODUCTION Atherosclerosis often starts in late adolescence or early adulthood, although clinical manifestations typically occur years later. Statistics from 2008 indicate that approximately 82. An estimated 2200 Americans die of cardiovascular disease each day, an average of 1 death every 39 seconds. About 795 000 people will experience a new or recurrent stroke each year, meaning that on average, every 40 seconds 1 someone in the United States has a cerebrovascular accident. Ischemic coronary heart disease varies in its presentation and includes stable angina, unstable angina, non-ST segment elevation myocardial infarction, or ST segment elevation myocardial infarction. All of these presentations except stable angina are often referred to as acute coronary syndrome. Atherosclerotic cerebrovascular disease also varies in presentation from asymptomatic arterial stenosis (i. Likewise, peripheral arterial disease may manifest as intermittent claudication of the lower extremity, although other presentations include arterial aneurysms, typically of the aorta, and renovascular disease. Some patients with peripheral arterial disease may not even experience any symptoms at all. Although there are various approaches to secondary prevention of vascular disease, a principal component is the use of antiplatelet agents. Aspirin has been considered the standard agent for many years. Numerous studies have shown the efficacy of aspirin in reducing the occurrence of major cardiovascular events including death, recurrent myocardial infarction, recurrent angina, or progression to severe angina and nonfatal stroke. Various clinical practice guidelines have recently been published that provide current guidance and recommendations 2-8 regarding the use of aspirin for antiplatelet therapy. However, this Newer Antiplatelet Agents Update 2 Report does not address the role of aspirin as an antiplatelet agent. Over the past decade or more, newer antiplatelet agents have come to the forefront as adjuncts to or substitutes for aspirin in many clinical situations. However, the role of individual antiplatelet agents relative to each other is still evolving. The objective of this study is to review evidence on the comparative effectiveness/efficacy and comparative harms of the newer antiplatelet agents listed in Table 1 (aspirin 25 mg /extended-release dipyridamole 200 mg [Aggrenox ] and the thienopyridines, clopidogrel [Plavix ], prasugrel [Effient ], and ticlopidine [Ticlid ]) for treatment of 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, and to determine if there are any subgroups of patients based on demographics, socioeconomic status, other medications, or comorbidities for which any included drugs are more effective or associated with fewer harms. Table 1 below lists the interventions that are included in this report. Appendix B lists boxed warnings for the interventions. Newer antiplatelet agents 8 of 98 Final Update 2 Report Drug Effectiveness Review Project Table 1. Included interventions Drug Trade name Labeled indications Dosing Aspirin/ To reduce the risk of stroke in extended- patients who have had transient release Aggrenox ischemia of the brain or One capsule bid dipyridamole completed ischemic stroke due to 25 mg/200 mg thrombosis ACS NSTEMI: 300 mg loading dose, continue at 75 mg qd in combination with ASA 75 to 325 ACS mg qd • NSTEMI, including patients STEMI: 75 mg qd in combination managed medically and with 75-325 mg ASA with or those managed with without thrombolytics; Plavix coronary revascularization may be initiated with or without a a • STEMI loading dose Clopidogrel Plavix Recent MI, recent stroke or Recent MI, recent stroke or established PAD established PAD To reduce the rate of a combined 75 mg qd endpoint of new ischemic stroke CYP2C19 Poor Metabolizers (fatal or not), new MI (fatal or Appropriate dose regimen has not not), and other vascular death been established Use with PPI An appropriate dosing regimen has not yet been established To reduce the rate of thrombotic cardiovascular events in patients with ACS, managed with percutaneous coronary 60 mg loading dose then 10 mg ™ intervention as follows: qd; patients taking Effient should ™ Prasugrel Effient • Patients with unstable also take ASA 75-325 mg; angina or NSTEMI patients <60 kg should lower • Patients with STEMI when maintenance dose to 5 mg managed with primary or delayed percutaneous coronary intervention To reduce the risk of thrombotic stroke (fatal or nonfatal) in patients who have experienced Stroke stroke precursors, and in patients 250 mg bid who have had a completed a thrombotic stroke Coronary artery stenting Ticlopidine Generic only 250 mg bid with ASA for 30 days Adjunctive therapy with aspirin to of therapy following stent reduce the incidence of subacute implantation stent thrombosis in patients undergoing successful coronary stent implantation a As monotherapy or in combination with aspirin. Abbreviations: ACS, acute coronary syndrome; ASA, Aspirin; bid, twice daily; bid, twice daily; MI, myocardial infarction; NSTEMI, non-ST Segment Elevation Myocardial Infarction, PAD, peripheral arterial disease; PPI, proton pump inhibitor; qd, once daily; STEMI, ST Segment Elevation Myocardial Infarction. Newer antiplatelet agents 9 of 98 Final Update 2 Report Drug Effectiveness Review Project Purpose and Limitations of Systematic Reviews Systematic reviews, also called evidence reviews, are the foundation of evidence-based practice. They focus on the strength and limits of evidence from studies about the effectiveness of a clinical intervention. Systematic reviews begin with careful formulation of research questions. The goal is to select questions that are important to patients and clinicians then to examine how well the scientific literature answers those questions. Terms commonly used in systematic reviews, such as statistical terms, are provided in Appendix A and are defined as they apply to reports produced by the Drug Effectiveness Review Project.

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The safety and efficacy of Exelon in Alzheimers patients: A multicenter discount erectafil 20mg, randomized buy erectafil 20 mg online, 26 week study in Taiwan buy 20 mg erectafil visa. International Journal of Neuropsychopharmacology 2000;3 S 1:S 356 buy 20 mg erectafil free shipping. Wong WJ buy erectafil 20mg low cost, Liu HC, Fuh JL, Wang SJ, Hsu LC, Wang PN, et al. Knapp MJ, Knopman DS, Solomon PR, Pendlebury WW, Davis CS, Gracon SI. Gauthier S, Feldman H, Hecker J, Vellas B, Ames D, Subbiah P, et al. Gauthier S, Feldman H, Hecker J, Vellas B, Emir B, Subbiah P. Feldman H, Gauthier S, Hecker J, Vellas B, Emir B, Mastey V, et al. Potkin SG, Anand R, Hartman R, Veach J, Grossberg G. Rive B, Vercelletto M, Damier FD, Cochran J, Francois C. Minimal clinically important difference, sample size and trial duration. Watkins PB, Zimmerman HJ, Knapp MJ, Gracon SI, Lewis KW. International Journal of Geriatric Psychopharmacology 1998;1(Suppl 1):S20-S25. Adverse effects associated with the use of donepezil in general practice in England. Farlow M, Brashear A, Hui S, Schneider L, Unverzagt F, and TSG. Knopman D, Schneider L, Davis K, Talwalker S, Smith F, Hoover T, et al. Long-term tacrine (Cognex) treatment: effects on nursing home placement and mortality, Tacrine Study Group. Farlow MR, Lahiri DK, Poirier J, Davignon J, Schneider L, Hui SL. Emre M, Aarsland D, Albanese A, Byrne EJ, Deuschl G, De Deyn PP, et al. Erkinjuntti T, Kurz A, Gauthier S, Bullock R, Lilienfeld S, Damaraju CV. Grossberg GT, Stahelin HB, Messina JC, Anand R, Veach J. Lack of adverse pharmacodynamic drug interactions with rivastigmine and twenty-two classes of medications. Feldman H, GauthierS, Hecker J, Vellas B, Subbiah P, Whalen E, et al. Analysis of outcome in retrieved dropout patients in a rivastigmine vs placebo, 26-week, Alzheimer disease trial. Geldmacher DS, Provenzano G, McRae T, Mastey V, Ieni JR. Y ear:1998 PO PU L A T IO N G roupssimilar atbaseline:N R C H A R A C T ER IST IC S: A lzh eimer classification:M ild-m oderate rivastigmine4 mg/d rivastigmine6 mg/d placebo M eanage(years): 68. Y ear:1998 A DV ER SEEV EN T S: rivastigmine4 mg/d rivastigmine6 mg/d placebo O veralladverseeffectsreported: N R N R N R • N ausea 17% 31% 6% • V om iting 10% 18% 3% • D iarrhea 7% 12% 2% • D izziness 6% 20% 7% • H eadache 4% 13% 6% Significantdifferencesinadverse Significantlym orepatientssufferedfrom nausea,vom iting,diarrhea,dizziness,andheadacheinR IV events: groupsespeciallyathigherdoses;P = N R A N A L Y SIS: IT T :N o Postrandomizationexclusions:N R A DEQ U A T ER A N DO M IZ A T IO N : N R A DEQ U A T EA L L O C A T IO N Y es C O N C EA L M EN T : B L IN DIN G O F O U T C O M E Y es A SSESSO R S: A T T R IT IO N (overall): O veralllossto follow-up: 11. Y ear:2004 C H A R A C T ER IST IC S O F D O N givenatanydoseform orethanonedaywithparallelconcom itantplacebogroup;outcom em easures IN T ER V EN T IO N S: included:G lobalassessm ent(CIBIC-plus,G BS,M E N F IS,CD R -SB,A D A S-Cog,M M SE );A D L ’s(PD S, D A D ,IA D L ,PSM S,CM CS);behavioraldisturbances;Q O L ;caregiverstress;sideeffects M A IN R ESU L T S: Q ualityoflife • N osignificantdifferencebetweenD O N andplaceboforQ O L andbehavioraldisturbance A ctivitiesofdailyliving • Pooleddatafrom 2studiesprovidedevidenceof benefitof D O N at12and24weeks(P <0. Y ear:2004 A DV ER SEEV EN T S: W ith drawalsdueto adverseevents: A m eta-analysisof withdrawalsbeforetheendof treatm entshowed nosignificantdifferencesbetweenthe5m g/dgroup andtheplacebogroup at12and24weeks;therewere significantdifferencesforthe10m g/dgroup infavorof placeboat12,butnotat24and52weeks(29/184 D O N ,13/178placebo)(O R 2. Y ear:2004 C ountry:M ultinational F U N DIN G : N H S R &D E x ecutiveU K DESIG N : Studydesign:M eta-analysis N umber ofpatients:8trialsinvolving 3,450participants A IM S O F R EV IEW : Todeterm inetheclinicalefficacyandsafetyof R IV forpatientswithdem entiaof A lzheim er’stype ST U DIES IN C L U DEDIN A totalof 8studies:A gidetal. Y ear:2004 C H A R A C T ER IST IC S O F R IV givenatanydosewithparallelplacebocontrol;outcom em easuresincluded:dependency,global IN T ER V EN T IO N S: im pression,functionalperform ance,cognitivefunction,behavioraldisturbance,Q O L ,effectoncaregiver, death,institutionalizationrates,withdrawals,incidenceof adverseevents M A IN R ESU L T S: • M eta-analysisof A D A S-Cog W M D srevealsstatisticallysignificantbenefitof R IV 6/12m g/d over placeboat26weeks(W M D -2. Y ear:2004 A DV ER SEEV EN T S: • W ithdrawalsforanyreasonbeforetheendof treatm entshow thattherearenosignificant differencesbetweenwithdrawalsinthe1-4m g/dR IV group andplacebogroup at12and26weeks; therearesignificantdifferencesforthe6-12m g/dgroup infavorof placeboat12,18and26weeks; (20/133vs.

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Some updated guidelines are listed here: • European guidelines: http://penta-id buy discount erectafil 20 mg online. Table 3: Treatment indication discount erectafil 20 mg visa, according to age and clinical order 20 mg erectafil visa, immunological and virological criteria (Bamford 2015) Age purchase erectafil 20mg with visa, years PENTA 2015 guidelines <1 Start All 1–3 Start WHO stages 3 buy cheap erectafil 20mg,4 CD4 cells ≤1000/μl or <25% Consider all 3–5 Start WHO stages 3,4 CD4 cells ≤750/μl or <25% Consider if HIV RNA >100,000 or additional indications* ≥5 Start WHO stages 3,4 CD4 cells ≤350/μl Consider if CD4 ≤500 or HIV RNA >100,000 or additional indications * *Coinfection with HCV or TB, autoimmune manifestations (e. Successful treatment requires an interdisciplinary approach with the children and their families. Education of the child and the family regarding antiretroviral drugs is necessary. Sometimes a brief period of supervision in the hospital at the start of ART is useful to educate the child and family and gauge the tolerability of the regimen. In the prospective PACTG 377 study, adherence was defined as having not missed a single medication dose over the previous 3 days. According to this definition, only 70% of 125 children were found to be adherent within an observation period of 48 weeks (Van Dyke 2002). The modalities of the daily intake of medication need to be discussed in detail and adjusted to the daily and weekly routines of the family. Adherence is particularly problematic in adoles- cence, and successful reduction or control of viral load may only be achieved in a third of these patients (Ding 2009). In this age group, adherence often needs close follow-up including other health care professionals such as psychologists and social workers. In a meta-analysis, peer support and home-based nursing were shown to improve ART adherence (Bain-Brickley 2011). Sometimes (planned) periods off ART, despite the theoretical risk of clinical progression, have to be accepted in this group of patients. The BREATHER trial by the PENTA group in HIV+ adolescents (in whom virus was very well controlled) compared a 5-day short cycle to regular 7-day treat- ment. In this small study a short-cycle treatment was safe (www. Another promising approach to increasing adherence in children and adolescents is the use of once-daily regimens (e. Underdosing by the doctor has been shown to be a problem in daily practice (Menson 2006). Dosing by weight instead of body surface area (given as an alternative in some older guidelines) may result in underdosing and ongoing growth may not be adjusted for. Particular genotypes are associated with hypermetabolism of NNRTIs and PIs. Figure 2: Interdisciplinary care for children and families who are affected by HIV Antiretroviral Therapy in Children 561 Plasma levels of NNRTIs and PIs can be measured (therapeutic drug monitoring, TDM) to detect inter-individual differences in drug metabolism and lack of adher- ence, to check on dosages that may be too low or to prevent toxicities from too high a dosage (Fletcher 2009). Treatment strategy At present, eradication of HIV cannot be achieved. In some children viral load remains below detection for years and subsequently there are no HIV-specific anti- bodies detectable but ultrasensitive assays still detect HIV. The decision to start ART has fundamental consequences for the children and their families. From this point on it usually means that children will take the medication for life. A retrospective analysis of unplanned treatment interruptions in children demonstrated a significant decline of CD4 T cell percentages by 6. In the randomized PENTA 11 trial of CD4 guided, planned treatment inter- ruptions, there were no serious negative clinical outcomes. Younger children had better CD4 T cell recovery after treatment interruptions (PENTA 11). However, there are insufficient data on the long-term effects to recommend this strategy. Table 4: Recommended first-line ART (without HBV or TB coinfection) (Bamford 2015) <1 year 1–3 years 3–6 years 6–12 years >12 years 3rd Agent LPV/r LPV/r LPV/r ATV/r ATV/r NVP NVP EFV EFV DRV/r EFV Preferred ABC1/3TC ABC1/3TC ABC1/3TC ABC1/3TC TDF/FTC4 Backbone (+AZT if NVP)3 (+AZT if NVP ABC1/3TC and CNS (if VL<105) involvement or high VL)2 3rdAgent - - NVP NVP NVP DRV/r LPV/r LPV/r DRV/r RAL6 DTG Alternative AZT5/3TC AZT5/3TC AZT5/3TC AZT5/3TC ABC1/3TC Backbone TDF/3TC(FTC) TDF/3TC(FTC) 1 HLAB*5701 testing prior to abacavir. If positive, ABC should not be prescribed 2 In children <3 years consider adding AZT to NVP-based regimen if very high VL or CNS involvement until VL suppressed for at least 3 months 3 Four-drug induction for infants on NVP-based therapy may be considered until VL suppressed for at least 3 months, followed by 3-drug maintenance therapy 4 TDF/FTC is preferred in older children with VL >100,000 copies/ml. Some clinicians would advocate deferring the use of TDF until after puberty 5 AZT should be avoided if possible apart from the indications described above 6 In rare instances (transmitted resistance, toxicity) RAL in children <12 years of age Table 4 shows the current treatment concepts for choosing antiretroviral drug com- binations.

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Individual studies assessed shorter-term efficacy (0 to 6 hours) purchase erectafil 20 mg visa, longer-term efficacy (48 hours) discount erectafil 20 mg free shipping, and effect on vomiting only cheap erectafil 20mg, but again no differences were found erectafil 20 mg cheap. Placebo-controlled and active-control trials in children As with the head-to-head trials of adults undergoing surgical procedures discount erectafil 20mg line, no head-to-head trials of children undergoing surgical procedures reported outcomes reflective of quality of life, patient satisfaction, or resource utilization. Again, we included fair-quality placebo and active-control 122, 123, 125-127, 134-136, 138, 141, 142, 144 trials to address these gaps (Evidence Tables 11 and 12). Compared with placebo, granisetron significantly reduced hospital 123, 135 123, 125, 135 stay times in two of three trials , but did not significantly improve patient 125 satisfaction. In the only placebo-controlled trial of dolasetron in children undergoing surgical procedures, there were no differences between placebo and dolasetron in patient satisfaction 153 outcomes. Treatment of established postoperative nausea and vomiting Adults Direct comparisons Very little head-to-head trial evidence compares different 5-HT3 antagonists in treatment of 164 postoperative nausea and vomiting: In 1 head-to-head trial each, only dolasetron and 154 granisetron have been directly compared with ondansetron. In the trial that compared dolasetron with ondansetron, 76% of patients were women. Randomized patients were 92 (64%) out of 143 eligible adults who experienced postoperative 164 nausea and vomiting after a variety of surgical procedures. Similar proportions of patients randomized to dolasetron and ondansetron received unspecified prophylactic antiemetics (30% compared with 20%). Among the other 51 eligible patients, 47 were excluded because they “did not receive blinded study drug” and 4 patients chose not to participate. As the exclusion rate (36%) was considerable and reasons for not receiving blinded study drug were unclear, some doubt was raised about the results of this study. Compared with ondansetron, dolasetron significantly reduced the need for rescue medication, the primary outcome measure (40% compared with 70%, P=0. However, there was no significant difference between dolasetron and ondansetron in the number of patients who actually vomited (16% compared with 23%), Antiemetics Page 35 of 136 Final Report Update 1 Drug Effectiveness Review Project who were subsequently admitted to the hospital for the postoperative nausea and vomiting itself (2% compared with 2%), or who were satisfied with their antiemetic treatment (71% compared with 59%). The second trial assessed whether there was greater benefit with administration of intravenous granisetron 0. A total of 250 female patients who underwent unspecified nonemergency operations were enrolled and given prophylactic ondansetron. Among the remaining 243 patients, all 88 who required rescue medication for postoperative nausea and vomiting were randomized to blinded study drug. The trial assessed complete response, defined as resolution of postoperative nausea and vomiting with no further request for rescue medication. Substantial numbers of patients met criteria for a complete response after receiving granisetron 0. Likewise, no statistical differences among the 3 treatment arms were found on any other nausea or vomiting outcomes in the 24-hour follow-up period. Placebo-controlled and active-control trials 165-168 Four active-control and 1 placebo-controlled trial provided additional data on patient 169 satisfaction outcomes. It is not possible to indirectly compare ondansetron with granisetron from these studies, however, because they used different methods to measure patient satisfaction. In a study comparing ondansetron with acustimulation, there was no difference in rate of 165 patient satisfaction between treatment groups. The evidence for dolasetron is from 1 placebo- 169 controlled trial. Patients were more satisfied with dolasetron than placebo as measured by a visual analog scale. Children Direct comparisons No head-to-head studies for treatment of established postoperative nausea and vomiting were found. Placebo-controlled and active-control trials The evidence for treatment of established postoperative nausea and vomiting in children is 170 limited to 2 trials of ondansetron: 1 placebo-controlled trial in 375 children ages 2 to 12 years 171 and 1 active-control trial (compared with droperidol) in 29 children ages 2 to 10 years. This evidence does not provide indirect comparisons of newer antiemetics. The placebo-controlled trial reported complete control of vomiting at early and late time 170 points. Ondansetron was superior to placebo both early (within 2 hours; 78. Fewer ondansetron patients needed rescue medication (9% ondansetron compared with 27% placebo within 2 hours; 17% ondansetron compared with 51% placebo within 24 hours). Late control of nausea and vomiting and use of rescue medication were not assessed in this study. Prevention of nausea and vomiting associated with pregnancy Evidence on the use of newer antiemetics in pregnant women is extremely limited and is 172-174 noncomparative for our purposes.

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