Will future prescription weight-loss drugs fly?
An account of the failed investigational weight-loss drug rimonabant, published Thursday, suggests that it may be even harder in the future to bring new prescription diet drugs to the market.
The drug, rimonabant, was in a large, multinational late-stage clinical trial when the study was abruptly halted in 2008 because of reports of psychiatric side effects, including some suicides and suicide attempts in people taking rimonabant as either part of the clinical trial or by prescription in countries where the drug had already been approved for marketing. (Rimonabant was never approved in the U.S.)
The postmortem, released Thursday in the Lancet is from one of the study’s investigators, Dr. Eric J. Topol, of Scripps Translational Science Institute in La Jolla. The so-called CRESCENDO study was designed to see whether rimonabant could reduce the risk of death by heart attacks or strokes. Previous studies showed that people lost weight on the medication and that it lowered bad cholesterol and other cardiovascular risk factors.
Topol’s account showed that after an average of 13.8 months, before the study’s termination, there was no evidence of reduced cardiovascular deaths in people taking the drug. However the rate of psychiatric side effects was 32% among rimonabant users, compared with 21% among the placebo group, and serious psychiatric side effects were also higher in rimonabant users. Four rimonabant users committed suicide compared with one person who took the placebo.
Because of the suicide risk, the trial was stopped after the drug was removed from the market in countries where it was already in use.
The completion of the study might have demonstrated a reduced risk of heart attacks and strokes, the authors wrote, as well as yielded additional information on the suicide risk and how it might be mitigated.
“In this setting, the performance of a long-term trial for an expanded cardiovascular indication was affected by the track record of the drug in clinical practice that was marketed for weight loss,” the authors wrote.
Authorities appear to be increasingly unwilling to risk serious side effects for a medication that is primarily for a cosmetic use, such as weight loss, said the authors of an editorial accompanying the study. Future prescription products aimed at weight loss will have to be super safe to get approved, they suggest -- a development that is apparently so unlikely they advise a return to good old diet and exercise.
“Focus should now return to motivating parents to control their caloric intake and increase physical activity. Although cumbersome, this approach is causal and safe,” they wrote.
-- Shari Roan / Los Angeles Times
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