Earlier this year, following the discovery of signals of potential danger in a large clinical trial, the weight loss drug sibutramine (Meridia) was withdrawn from the market in Europe while the FDA added a strongly-worded contraindiction to its use in people with cardiovascular disease. Now, two weeks before an FDA advisory panel will vote on whether the drug should remain on the market in the US, the results of the clinical trial that sparked the concerns have been published in the New England Journal of Medicine.
The Sibutramine Cardiovascular Outcomes (SCOUT) trial randomized 9804 overweight subjects with preexisting cardiovascular disease and/or diabetes to either sibutramine or placebo for 3.4 years. The combined rate of nonfatal MI, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death was 11.4% in the sibutramine group versus 10.0% in the placebo group (HR 1.16; 95% CI 1.03 to 1.31; P=0.02). The differences in nonfatal MI (4.1% versus 2.6%) and nonfatal stroke (3.2% and 1.9%) were significant by themself.
In an accompanying editorial, three NEJM editors, Gregory Curfman, Stephen Morrissey, and Jeffrey Drazen, take issue with the SCOUT investigators who concluded that sibutramine should continue to be available to people without cardiovascular disease:
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 cardiovascular risk, it is difficult to discern a credible rationale for keeping this medication on the market.
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I use Sebutramine 15 mg daily since about 3 months in addition to using oral laxative and daily 81 mg oral Aspirine. The indication of using Aspirine is existence of family history of heart ischemic diseases ,obesity ,and age (43 year). My weight before starting with medicine was 97 kg (hight 173 cm) and now is 84 kg. The only side effect noticed by me is moderate constipation and little drowsiness.
I do not know if I should continue with using of this medicine or no. Shall I continue with using Aspirine?How can I continue in loosing more kgs. Please advice.
Is there any trials/data on the effects of sibutramine and cardiovascular events when sibutramine is used in the age group 25-40 years?
Can it have the same effect as in the studypopulation of the SCOUT trial?
NOBODY DIED FROM USING SIBUTRAMINE!!!!!!
In conclusion, the SCOUT trial showed that among subjects who were receiving long-term treatment with sibutramine, those with preexisting cardiovascular conditions had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. On the basis of these results, sibutramine should continue to be excluded from use in patients with preexisting cardiovascular disease.
Background
The long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established.
READ THIS AGAIN!!!!Conclusions
Subjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause. (Funded by Abbott; Clinical Trials.gov number, NCT00234832.)