Bariatric treatments for adult obesity - Institute of Health Economics

AEs for sibutramineAs compared to a placebo, sibutramine increased both systolic and diastolic blood pressure andheart rate (the proportion of patients who experienced these AEs were not reported). 20 These sideeffects of sibutramine are of particular concern because even mild increases in blood pressure can beexpected to result in an increase in cardiovascular events in a population already at risk. Patients withpre-existing cardiovascular disease were excluded from these trials.Other adverse effects associated with sibutramine, occurring in 7% to 20% of patients, includedinsomnia, nausea, dry mouth, and constipation. 20AEs for rimonabantPsychiatric disorders—including depression, anxiety, irritability, and aggression—occurred in 6% ofpatients treated with rimonabant. 20Dropout rates of drug therapyThe overall dropout rates were high and were comparable in groups taking the antiobesitymedication and in placebo groups, with overall dropout rates of 30% for orlistat, 34% forsibutramine, and 39% for rimonabant. 59 Median dropout rates due to drug side effects were highestfor rimonabant at 15.0% (ranging from 12.8% to 17.5%), intermediate for sibutramine at 9.3%(ranging from 0.0% to 12.2%), and lowest for orlistat at 7.1% (ranging from 0.0% to 12.8%).Risk ratios for discontinuation due to adverse events were significantly increased for rimonabant andorlistat, but not for sibutramine. 59 Compared to placebo, the risk difference was the largest forrimonabant, followed by orlistat, while no significant difference was observed for sibutramine. 59The most common adverse events leading to drug discontinuation were gastrointestinal side effectsfor orlistat (40%) and psychiatric side effects for rimonabant (47%). 59In summary, the major safety concerns are gastrointestinal adverse events for orlistat, increases inblood pressure and heart rate for sibutramine, and psychiatric disorders for rimonabant. Becausethere is a lack of direct head-to-head comparisons of the three drugs, the comparative safety of thethree drugs remains to be determined.Bariatric surgeryBoth the CADTH review 38 and the Cochrane review 62 provided detailed information regarding earlyand late adverse events associated with bariatric surgeries (see Appendix E: Table T.E.1). Since the2010 CADTH review included more RCTs and the majority of RCTs assessed in the Cochranereview 62 were also included in the CADTH review, 38 the section below will focus on the informationobtained from the CADTH review. Only information about RYGB, AGB, and sleeve gastrectomy issummarized in this report.HospitalizationTwo trials with 248 patients showed that patients who received AGB had significantly shorterhospital stays than patients who received RYGB.Results from seven trials with 507 patients indicated that patients who underwent laparoscopicsurgeries had significantly shorter hospital stays than did patients who had undergone open surgeries.Bariatric treatments for adult obesity 78