Cardiovascular Outcomes With Merck’s Januvia: No Better Or Worse Than Conventional Care

Late Monday afternoon Merck released the top line results of TECOS, the cardiovascular outcomes trial with its blockbuster diabetes drug Januvia (sitagliptin).  The company said that the trial “achieved its primary endpoint of non-inferiority for the composite cardiovascular (CV) endpoint.” Merck announced only one additional detail: “Among secondary endpoints,” they reported, “there was no increase in hospitalization for…

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IMPROVE-IT Meets Endpoint And Demonstrates Real But Modest Clinical Benefit For Ezetimibe

Cannon

After all the waiting and all the controversy it turned out to be pretty simple. The IMPROVE-IT trial did what it set out to do and reached its primary endpoint. The benefit wasn’t very big or impressive but it will be enough to put to rest concerns that ezetimibe might have been an expensive placebo…

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What You Need To Know About IMPROVE-IT

The IMPROVE-IT trial will be big news when its results are finally presented on November 17 during the annual meeting of the American Heart Association. The results of the trial–underway for nearly a decade– have been long and eagerly awaited by everyone interested in cardiovascular medicine.  The trial could impact the future sales of a key Merck drug, ezetimibe, though because it is nearing…

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IMPROVE-IT Trial Scheduled For Presentation In November

Results of the eagerly-awaited and highly controversial IMPROVE-IT trial are finally going to be revealed. The American Heart Association has announced that the  trial will be presented by Chris Cannon on November 17 at 11:51 AM (central time) in Chicago at the group’s annual scientific sessions . IMPROVE-IT compared the effect on cardiovascular outcomes of the statin simvastatin with Vytorin (the combination of…

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Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In Italy

In response to repeated legal threats, a public health doctor in Italy has withdrawn advice to curtail use of a controversial drug. The drug, ezetimibe, is a key ingredient in Zetia and Vytorin, which is manufactured by Merck. The cholesterol-lowering drug has been the subject of fierce controversy because it has never been shown to improve…

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FDA Approves Novel Merck Drug To Prevent Heart Attacks And Strokes

The FDA today approved vorapaxar (Zontivity), Merck’s once-troubled platelet receptor antagonist, to reduce the risk of myocardial infarction (heart attack), stroke, cardiovascular death, and revascularization procedures. The drug is approved for use in people with a history of MI or peripheral arterial disease. The approval represents an amazing turnaround for a drug that had experienced nearly…

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FDA Advisory Panel Votes In Favor Of Approval For Merck’s Vorapaxar

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché might have been invented for this drug, which was the subject of tremendous early hopes followed by major disappointments and, finally, a subsequent revival. … Click here to read the entire…

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Packaging Defect Leads Merck To Recall All Lots of Liptruzet In US

Merck said today that it was recalling all lots of Liptruzet, its combination of the cholesterol-lowering drugs ezetimibe and atorvastatin, in the US. The company said the recall was due to a packaging defect which could potentially allow air and moisture to affect the quality of the drug, though the company said “the likelihood of the packaging…

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Merck’s Vorapaxar Gets Positive FDA Review

A few years ago a novel antiplatelet agent from Merck seemed all but dead. Vorapaxar, a thrombin receptor antagonist, was widely thought to have no future after unacceptably high serious bleeding rates were found in two large clinical trials studying the drug in a wide variety of acute and chronic cardiovascular patients. But hopes for the drug resurfaced with…

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Possible New Lease On Life For Two Cardiology Drugs From Merck And J&J

Early next year an FDA panel will review a new drug from Merck and a new indication for Xarelto (rivaroxaban), Johnson & Johnson’s highly successful new oral anticoagulant. Both drugs have had a rocky road getting to this stage and their success is by no means assured, but the announcement of the meeting of the FDA’s Cardiovascular and Renal…

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Why Is Actelion Suppressing Phase III Data?

I highly recommend a terrific article by Ian Parker in this week’s New Yorker about Merck’s efforts to develop a novel insomnia drug, suvorexant. Normally I don’t write about non-cardiology topics but I want here to call attention to one small, almost tangential detail buried in the middle of the story. It’s not about the Merck drug but about another orexin antagonist from Actelion, almorexant:…

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FDA Approves Combination Of Ezetimibe And Atorvastatin

The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin. Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a…

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HPS2-THRIVE Coming Attraction: First Look At What Went Wrong With Niacin

In a few weeks, on March 9, the main results of the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study will be presented in San Francisco at the annual meeting of the American College of Cardiology. These results have been eagerly awaited since Merck’s brief announcement in December that the trial had not met its primary endpoint…

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The Big Gamble of CETP Inhibitors

Merck has invested a substantial amount of money on the CETP inhibitor anacetrapib. Chemist and veteran pharma blogger Derek Lowe suspects that the company might as well have plunked the money down in a casino. In a provocative new post, Lowe wonders if big pharma, in its desperation, has abandoned rational research in favor of, essentially,…

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Merck Starts To Suspend Worldwide Availability Of Tredaptive

In the wake of the negative HPS2-THRIVE study announced last month, Merck said today that it was beginning to suspend the worldwide availability of Tredaptive, its combination of extended-release niacin and laropiprant. Click here to read the full story on Forbes….

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Merck’s Combination Of Ezetimibe And Atorvastatin Back On NDA Path

A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed…

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HPS2-THRIVE: No Benefit, Signal Of Harm For Niacin Therapy

The largest-ever study of niacin has failed to show a clinical benefit for niacin and even found a strong signal of harm. Merck announced today that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study did not meet its primary endpoint. In that study, the combination of a statin and Merck’s niacin compound, Tredaptive, a combination of extended-release…

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Bleeding Problems Continue To Bedevil Merck’s Novel Antiplatelet Agent Vorapaxar

In the large TRA-2P  study of more than 26,000 patients with  MI, ischemic stroke, or documented peripheral vascular disease, the novel antiplatelet agent vorapaxar significantly reduced the primary endpoint of CV death, MI, stroke or urgent coronary revascularization. But vorapaxar treatment resulted in a significant increase in bleeding, including intracranial hemorrhage. The fate of vorapaxar now appears to…

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