Tredaptive Safety Hazards Cast Shadow Over AbbVie’s Niaspan
HPS2-THRIVE investigators say serious adverse bleeding and infection events are most likely due to the niacin component of Merck’s Tredaptive and advise caution using niacin in light of the risks. Abbvie’s Niaspan is the most likely branded casualty of the news, but the drug will be off-patent soon.
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New Cholesterol Guidelines Follow Long History Of Failed Outcomes Trials
The cardiology community is increasingly questioning the value of adding on a variety of lipid therapies to treatment with highly effective statins, based on accumulating evidence of the lack of value of affecting cholesterol parameters other than LDL.
Wary Of Surrogates, Payers Seek Outcomes Data For PCSK9 Class
Regeneron/Sanofi and Amgen stress the strengths of the Phase III PCSK9 development programs at the American College of Cardiology annual meeting. The mechanism of action holds appeal, but development is taking place at a time of skepticism about surrogate CV markers, following failed trials of other drugs.
HPS2-THRIVE Post-Mortem: Lessons Learned For CV Drug Developers
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.