Chain Reaction

Too Quick to Kill Sibutramine?

Was the reaction to kill sibutramine after a cardiovascular safety study in 2010 a mistake? A new study in the International Journal of Obesity raises that question with new data.

Joseph Hayes and colleagues found found little risk of cardiovascular events in a cohort of more than 23,927 people receiving sibutramine, except in those people with pre-existing cardiovascular disease (for whom sibutramine was contraindicated). The authors conclude:

Risk Benefit in Obesity and DiabetesSibutramine’s marketing authorisation may have therefore been inappropriately withdrawn for people without cardiovascular disease.

At the time that decision was made, the same FDA committee that voted to withdraw approval for sibutramine considered a question of cardiovascular risk for another drug — rosiglitazone for diabetes. Rosiglitazone stayed on the market, even though the risks observed were seen in the population for which it was indicated. In testimony before that FDA committee in 2010, ConscienHealth founder Ted Kyle pointed out the imbalanced consideration of risks and benefits in obesity compared to diabetes.

Much has changed since then. Four new obesity drugs have been approved and more may be on the way. The balance between consideration of risk and benefit is a bit more reasonable.

Unfortunately, one option for treating obesity — sibutramine — is out of reach and will probably remain so. It was no miracle drug, but some people with obesity benefited.

Click here to read the study in the International Journal of Obesity.

Chain Reaction, photograph © Racineur / flickr

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