Sibutramine‐associated adverse effects: a practical guide for its safe use

Abstract

Obesity is a multifactorial chronic disorder which comprises a serious health problem nowadays. The effective management of obesity is difficult in contemporary societies where abundance of hypercaloric food and sedentary lifestyle is the rule. Apart from lifestyle interventions, which include diet, exercise and behavioural treatment, weight-loss medications can also be used for the management of obesity. Sibutramine, a selective monoamine reuptake inhibitor, is a drug with established efficacy in sustained weight reduction and an overall favourable safety profile. However, its action on the sympathetic nervous system has linked sibutramine to blood pressure and heart rate elevations. These potentially adverse effects as well as other sibutramine-associated side effects and their possible underlying mechanisms are reviewed in the present article. Compelling evidence from the majority of data in the literature shows that sibutramine can be effectively used in conjunction with caloric restriction and exercise in obese patients. Hypertension, if adequately treated and frequently monitored, is not an absolute contraindication for the prescription of sibutramine.

Cardiovascular Risk-Benefit Profile of Sibutramine

“…[62] An antihypertensive combination therapy regimen with angiotensin-converting enzyme inhibitors and calcium channel blockers was shown to be more advantageous than a beta-blocker/diuretic-based regimen in supporting the weight-reducing actions and concomitant metabolic changes induced by sibutramine in obese hypertensive patients. [63] Sibutramine treatment is unlikely to elicit a critical increase in BP even in hypertensive patients, although an effect on CVD outcome could not be totally excluded in some individuals.…”

The Effect of Sibutramine, a Serotonin-Norepinephrine Reuptake Inhibitor, on Platelets and Fibrin Networks of Male Sprague-Dawley Rats: A Descriptive Study

“…Sibutramine received FDA approval in 1997 for the treatment of obesity since numerous clinical trials indicated that sibutramine, in conjunction with a low calorie diet, produced initial and sustained weight-loss [3]. These studies also reported that weight loss induced by sibutramine was of great clinical significance as it also showed improvement in glycemic control and enhancement of insulin sensitivity, lipid profiles and significant reductions in cholesterol associated with cardiovascular risk in obese individuals [3,4]. Despite sibutramine's success as a weight-loss agent, it was removed from most markets based on the initial findings of the Sibutramine Cardiovascular OUTcome (SCOUT) trial performed by the FDA [5].…”

Body Weight Reduction Associated with the Sibutramine Treatment: Overall Results of the PRIMAVERA Primary Health Care Trial

“…Most studies showed no or only minimal changes in SBP, but a modest increase in DBP [24,25,26,27]. In patients who experience a clinically significant and sustained increase in blood pressure, the drug should be discontinued [24,28]. …”