After Statins, Rise Of The Subgroups? IMPROVE-IT Suggests Population Choice Key
Diabetics seem to have benefited from Zetia, but not rest of high-risk patients in IMPROVE-IT – suggesting next-step cholesterol drugs might wind up being targeted to subgroups.
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Sponsors of injectable PCSK9 biologics address questions about the implications of the IMPROVE-IT study, in which the soon-to-be-generic oral Zetia helped bring down LDL cholesterol to a very low level.
FDA approves antiplatelet inhibitor with a label that makes little mention of the safety concerns seen in lightweight patients, despite a vibrant FDA and advisory panel discussion on how to present the unfavorable data, but the company still has a big marketing challenge ahead.
While risks clearly outweigh benefits for niacin as an add-on therapy in the more than 25,000-patient HPS2-THRIVE study, investigators argue that the door is still open for other HDL-raising drugs. One panelist at the ACC meeting where results were presented calls for smaller, more targeted trials in the future.