(September 1, 2010 - Insidermedicine)

The risk of nonfatal myocardial infarction (MI) and stroke is increased among patients with a history of cardiovascular disease being treated with sibutramine, according to a trial published in the New England Journal of Medicine.

Here are some recommendations regarding the use of pharmacological interventions to help with weight loss, from the National Collaborating Centre for Primary Care:

•    Drug treatment should be considered for patients who have not reached their target weight loss or have reached a plateau on dietary, activity and behavioral changes alone.

•    The decision to start drug treatment, and the choice of drug, should be made after discussing with the patient the potential benefits and limitations, including the mode of action, adverse effects and monitoring requirements, and their potential impact on the patient's motivation.

•    When drug treatment is prescribed, arrangements should be made for appropriate healthcare professionals to offer information, support and counseling on additional diet, physical activity and behavioral strategies.

Researchers out of the London School of Hygiene and Tropical Medicine randomized nearly 10,000 participants aged 55 or older with a BMI of 27 to 45 or a BMI of 25 to less than 27 as well as a waist circumference of at least 102 cm in men and 88 cm in women to receive sibutramine 10 mg daily or placebo. All participants had a history of cardiovascular disease, type 2 diabetes mellitus with at least one other cardiovascular risk factor, or both. The trial started with a 6-week test period in which those whose blood pressures or heart rates increased while taking the drug were excluded from the trial. All participants engaged in an individualized diet and exercise program.

The mean duration of treatment was 3.4 years. During the run-in period, mean weight loss was 2.6 kg. After randomization, sibutramine-treated patients achieved and maintained a further loss of 1.7 kg. Blood pressure dropped in both groups, but a greater reduction was seen among those on placebo. The risk of having a primary outcome event, defined as nonfatal MI, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death, was 11.4% in sibutramine-treated patients and 10.0% in controls. While rates of both fatal and nonfatal MI and stroke were higher in sibutramine-treated patients, rates of cardiovascular death or death from any cause were similar for both groups.

Today’s research suggests that patients with a history of cardiovascular disease should not be treated long-term with sibutramine.