Potential Cardiovascular Benefit Colors CV Safety Expectations For Obesity Drugs
Only a superiority trial could give certainty of CV safety for weight-loss medications prior to approval, FDA’s Robert Temple tells the Endocrinologic and Metabolic Drugs Advisory Committee.
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In analyses of both a narrow and a broad search for cardiovascular events in lorcaserin’s clinical trials, the upper bound of the 95% confidence level was less than 2.0, allowing marketing with a full CV outcomes trial to come post-approval, FDA briefing documents reveal.
FDA’s Robert Temple says the trend in risk indicators is the important element when interpreting data from high-risk patients for low-risk patients, after some advisory panel members question the relevance of data from older, sicker participants to the younger patients who take obesity products.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee March 29 voted 17-6 that all obesity drugs should be vetted for cardiovascular risk, but some could rely on a meta-analysis rather than an outcomes trial.