Healthcare

Despite recent findings said that there is no increased risk of cardiovascular death or all-cause mortality in patient with preexisting cardiovascular condition who used long-term of sibutramine treatment, however, researchers said that long-term sibutramine use have an increased risk for non-fatal myocardial infarction and non-fatal stroke.

Based on Sibutramine Cardiovascular Outcomes (SCOUT), the study authors, W. Philip T. James, MD, DSC, from the London School of Hygiene and Tropical Medicine in Londong, U.K., and colleagues write, “sibutramine is not indicated for patients with a history of cardiovascular disease; otherwise, treatment with sibutramine is recommended for no more than 1 to 2 years in patients who achieve a 5% weight loss.”
According to the authors, SCOUT trial evaluated the long-term effects of sibutramine treatment combined with diet and exercise on the rates of cardiovascular events and cardiovascular death among subjects who were at high cardiovascular risk.

Published in September 2, 2010 at the New England Journal of Medicine, the authors write, “Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk for nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause.”

Despite this study have several limitation such lower overall event rate than originally anticipate that leads to reducal statistical power, lack of a true placebo group receiving no treatment at all, and selective recruitment of high-risk subjects, including subject in the SCOUT trial continued to receive therapy for up to 6 years (regardless of achieved weight loss, which could have altered the risk-benefit ration of sibutramine), the authors conclude, “the trial allowed us to assess the effect of intentional modest weight loss with sibutramine on the risks of cardiovascular events and death with the usual intention-to-treat approach among patients at high cardiovascular risk.”

They added, “On the basis of these results, sibutramine should continue to be excluded from use in patients with preexisting cardiovascular disease.”

However, the accompanying editorial disagree with the conclusion from SCOUT investigators that said no changes are indicated in the clinical use of sibutramine, which they say should continue to be limited to persons without preexisting cardiovascular disease.

According to accompanying editorial, Gregory D. Curfman, MD, and colleagues, the SCOUT investigator conclusion “based on a narrow interpretation of the SCOUT data, in which only the patients with preexisting cardiovascular disease had an increase in the risk for new cardiovascular events.”

They conclude and write, “The FDA advisory committee will now take up the matter. We surely need safe and effective medications to help overweight and obese patients lose weight and improve their long-term health. But given that sibutramine has minimal efficacy for weight loss, no apparent benefit for clinical outcomes, a worrisome cardiovascular risk profile, and a plausible mechanism to explain the risk, it is difficult to discern a credible rationale for keeping this medication on the market.”