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Year : 2016  |  Volume : 7  |  Issue : 1  |  Page : 53  

Sibutramine: A banned innocent antiobesity drug

Department of Pediatrics, Sevome Shaban Hospital, Tehran, Iran

Date of Web Publication19-Feb-2016

Correspondence Address:
Majid Malaki
Department of Pediatrics, Sevome Shaban Hospital, Tehran
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/0976-9234.177078

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How to cite this article:
Malaki M. Sibutramine: A banned innocent antiobesity drug. J Pharm Negative Results 2016;7:53

How to cite this URL:
Malaki M. Sibutramine: A banned innocent antiobesity drug. J Pharm Negative Results [serial online] 2016 [cited 2020 Aug 14];7:53. Available from:


Obesity is a major public health problem. In spite of many dietaries and lifestyle suggestions, more than 80% of affected cases cannot achieve weight loss. [1] Sibutramine is a combined norepinephrine and serotonin reuptake inhibitor attribute to the enhancement of satiety and decrease in caloric intake instead of anorectic action. Sibutramine was approved in 1998 and has been widely evaluated in several trials, which take place between 16 and 52 weeks. The studies indicated that sibutramine can decrease systolic and diastolic blood pressure (BP) by clonidine-like mechanism and a small rise in heart rate, its other property is antiatherogenic by improving metabolic and inflammatory markers. [2] Before 2010, many studies approved the beneficial effects of sibutramine in compared to Orlistat , an antiobesity drug prevents fat absorption by lipase inhibition orlistat on weight loss. In addition, they found sibutramine was not associated with cardiovascular events and generally better tolerated than orlistat may be due to mood improvement effects by sibutramine compared to orlistat. [3],[4] The Sibutramine Cardiovascular Outcomes Trial (SCOUT) confirmed that subjects with preexisting cardiovascular disease (CVD) on long-term (5 years) treatment with sibutramine had significantly increased risk for nonfatal myocardial infarction and nonfatal stroke, but not cardiovascular death or all-cause mortality. The European Medicines Agency recommended the suspension of marketing authorizations, and in October 2010, it was withdrawn from the US market. It may be a response to a study [1] designed randomized in method but compared sibutramine and placebo in selected cases that their age was 63 years in average that show systolic and diastolic BP declined in both group sibutramine and placebo while heart rate increase 2 and 3 beats/min in sibutramine group. In addition, they followed patients for 3.4 years in average which near half of the patients left the study. It was different to other studies which denote just 2% of patients continue antiobesity drugs after 2 years which as approved period for antiobesity usage. [5] SCOUT confirmed nonfatal stroke (4.1%) and nonfatal myocardial infarction (2.6%) as the main adverse events following use of sibutramine in long term usage, [1] whereas nonfatal myocardial infarction is a term considered as inappropriate endpoint in clinical trials in cardiology. [6] At now, we face to a big question; should we attribute nonfatal stroke or nonfatal myocardial infarction or increase heart rate as much as 2 beats/min in a biased selected cases with advanced age who used Sibutramine beyond of recommended period?as reasons for sibutramine banning. In fact sibutramine could not be disapproved if orlistat was not discovered at the same time in spite that many studies hint benefits of sibutramine compared to orlistat in summary. Sibutramine was banned by powerful medical associations hastily without considering target patients who cannot use it safely by a black box.

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There are no conflicts of interest.

   References Top

James WP, Caterson ID, Coutinho W, Finer N, Van Gaal LF, Maggioni AP, et al. SCOUT Investigators. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med 2010;363:905-17.  Back to cited text no. 1
Scheen AJ. Cardiovascular risk-benefit profile of sibutramine. Am J Cardiovasc Drugs 2010;10:321-34.  Back to cited text no. 2
Derosa G, Cicero AF, Murdolo G, Ciccarelli L, Fogari R. Comparison of metabolic effects of orlistat and sibutramine treatment in Type 2 diabetic obese patients. Diabetes Nutr Metab 2004;17:222-9.  Back to cited text no. 3
Kiortsis DN, Tsouli S, Filippatos TD, Konitsiotis S, Elisaf MS. Effects of sibutramine and orlistat on mood in obese and overweight subjects: A randomised study. Nutr Metab Cardiovasc Dis 2008;18:207-10.  Back to cited text no. 4
Padwal R, Kezouh A, Levine M, Etminan M. Long-term persistence with orlistat and sibutramine in a population-based cohort. Int J Obes (Lond) 2007;31:1567-70.  Back to cited text no. 5
Fleiss JL, Bigger JT Jr, McDermott M, Miller JP, Moon T, Moss AJ, et al. Nonfatal myocardial infarction is, by itself, an inappropriate end point in clinical trials in cardiology. Circulation 1990;81:684-5.  Back to cited text no. 6

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