Rimonabant: The Failed Weight Loss Drug
It appears that the axe has well and truly fallen on the trials of one potentially problematic weight loss drug, known as Rimonabant. An account published on yesterday in The Lancet of the failed drug, suggests that in the future it could possibly be more difficult to bring new prescription drugs for weight loss onto the market.
In 2008, Rimonabant was undergoing a large, late-stage clinical trial across several countries when the study had to be halted abruptly because of a spate of reports coming in of people developing psychiatric side effects to the drug. These side-effects were serious in that they included some suicides as well as attempted suicides.
This situation was occurring in people that were trialing the drug as part of the trial and also those obtaining the drug by prescription in those countries that had approved Rimonabant for marketing (not in the US).
Reduce Heart Attack Risk
Dr. Eric J. Topol, of Scripps Translational Science Institute in La Jolla was one of the study's investigators who produced the postmortem report in Thursday's edition of The Lancet.
The study was named CRESCENDO and it was designed to ascertain if Rimonabant was able to lower the risk of death cause by heart attacks or strokes. It had already been known from previous studies that people had lost weight when taking the medication as well as experiencing a lower level of bad LDL cholesterol along with other cardiovascular risks.
Topol's account highlighted the absence of any evidence to show a reduction in cardiovascular deaths in people taking the drug after an average of 13.8 months before the termination of the trials. Interestingly, there was a high rate of psychiatric side effects (32 percent) among users of Rimonabant, compared with 21 percent among the placebo group. There were also more instances of serious psychiatric side effects amongst Rimonabant users, four of whom committed suicide.
This compared with just one suicide from the placebo group.
Suicide Risk
It was because of the increased risk of suicide that the trial was halted following the removal of the drug from the market in those countries where it had already been approved for use. The authors wrote that a completed study might well have provided the evidence proving a lowered risk of strokes and heart attacks.
It may also have yielded additional information about the elevated risk of suicide and provided answers to how that might be mitigated.
The authors of an editorial which accompanied the study added that authorities seem increasingly unwilling to take the risk of serious side effects developing for medications primarily meant for cosmetic use, which includes those used as weight loss solutions. They suggested that in future, any prescription products meant for weight loss are going to have to prove their safety before they are approved.
As such a development is apparently unlikely, they advise people return to the staples of eating a good diet combined with getting adequate exercise to keep their body size in check.
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Posted on Fri, 13 Aug 2010 in News | 0 Comments