The weight-loss drug sibutramine (Meridia) should be withdrawn from the U.S. market, suggests an editorialist in the September 2, 2010, New England Journal of Medicine. Based on a clinical study in the same issue, it’s more accurate to conclude that sibutramine shouldn’t be prescribed for people who aren’t supposed to be taking it in the first place.
Sibutramine is sold in the U.S. as Meridia and has been available since 1997. Judging from the patients I run across, it’s not a very popular drug. Why not? It’s expensive and most people don’t lose much weight.
The recent multi-continent SCOUT trial enrolled 9,800 male and female study subjects at least 55 years old (average age 63) who had either:
- 1) History of cardiovascular disease (here defined as coronary artery disease, stroke, or peripheral artery disease)
- 2) Type 2 diabetes plus one or more of the following: high blood pressure, adverse cholesterol levels, current smoking, or diabetic kidney disease.
- Or both of the above (which ended up being 60% of the study population)`.
Here’s a problem from the get-go (“git-go” if you’re from southern U.S.). For years, Meridia’s manufacturer and the U.S. Food and Drug Administration have told doctors they shouldn’t use the drug in patients with history of cardiovascular disease. It’s not the scary “black box warning,” but it’s clearly in the package insert of full prescribing information.
Half the subjects were randomized to sibutramine 10 mg/day and the other half to placebo. All were instructed in diet and exercise aiming for a 600 calorie per day energy deficit. They should lose about a pound a week if they followed the program. Average follow-up was 3.4 years.
What Did the Researchers Find?
Forty percent of both drug and placebo users dropped out of the study, a very high rate.
As measured at one year, the sibutramine-users averaged a weight loss of 9.5 pounds (4.3 kg), the majority of which was in the first 6 weeks. After the first year, they tended to regain a little weight, but kept most of it off.
Death rates were the same for sibutramine and placebo.
Sibutramine users with a history of cardiovascular disease had a 16% increase in non-fatal heart attack and stroke compared to placebo. To “cause” one heart attack or stroke in a person with known cardiovascular disease, you would have to treat 52 such patients.
Folks in the “diabetes plus risk factor(s)” group who took sibutramine had no increased risk of heart attack or stroke.
Average weight loss with sibutramine isn’t much. Nothing new there. [Your mileage may vary.]
People with cardiovascular disease shouldn’t take sibutramine. Nothing new there either.
Reference: James, W. Philip, et al. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. New England Journal of Medicine, 363 (2010): 905-917.