CardioExchange Archive

November 22nd, 2010

SHARP: A Tale of Two Press Releases

Larry Husten, PHD

Two press releases were issued about the SHARP trial : one from Merck, the much-maligned and criticized manufacturer of Vytorin (the combination of ezetimibe and simvastatin), and one from the group running the trial, the highly-respected Clinical Trials Service Unit (CTSU) at Oxford. Here’s the surprise: compared to the Oxford press release, the Merck release is a paragon, […]

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November 20th, 2010

SHARP Shows Benefit for Vytorin in Chronic Kidney Disease

Larry Husten, PHD

The long-awaited SHARP study has turned up positive results for Vytorin (ezetimibe and simvastatin) in a population of patients with chronic kidney disease. Results of SHARP (Study of Heart and Renal Protection) were presented on Saturday at the American Society of Nephrology meeting in Denver and were scheduled to be posted online on the trial’s website. SHARP […]

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November 19th, 2010

Darvon and Darvocet Withdrawn from U.S. Market

Larry Husten, PHD

The FDA announced today that Xanodyne Pharmaceuticals had agreed to withdraw Darvon and Darvocet from the U.S. market. The drugs contain the opioid propoxyphene, which the FDA said “puts patients at risk of potentially serious or even fatal heart rhythm abnormalities.” The FDA said it had asked generic manufacturers of propoxyphene to withdraw their products […]

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November 19th, 2010

Will This Be the HDL Decade? REVEAL Revealed, Mixed Results for Apo-A1

Larry Husten, PHD

For a long time, HDL has been called the “good cholesterol.” Are we now entering the HDL decade? Two HDL-related trials were presented Wednesday at the AHA, and an array of additional trials are planned or underway, prompting the lead investigator of one of those trials, Chris Cannon, to speculate that this decade may be […]

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November 18th, 2010

APPRAISE-2 Apixaban in ACS Study Discontinued Due to Increased Bleeding

Larry Husten, PHD

Bristol-Myers Squibb announced on Thursday evening the discontinuation of APPRAISE-2, the phase 3 trial comparing apixaban to placebo in patients with acute coronary syndrome. The decision was based on a recommendation from the data monitoring committee based on “a clinically important increase in bleeding among patients randomized to apixaban,” according to the company press release. […]

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November 17th, 2010

Anacetrapib: “Knock-Your-Socks-Off Effect on HDL and a Jaw-Dropping Effect on LDL”

Larry Husten, PHD

Following the failure of torcetrapib in 2006, the future of cholesteryl ester transfer protein (CETP) inhibitors appeared quite troubled. Now, with the results of  DEFINE (Determining the Efficacy and Tolerability of CETP Inhibition with Anacetrapib), presented at the AHA in Chicago and published online in the New England Journal of Medicine, the future for this novel […]

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November 16th, 2010

“Phone It In” Heart-Failure Monitoring Offers No Advantage Over Usual Care

Larry Husten, PHD

CardioExchange welcomes Sarwat I. Chaudhry, first author of an NHLBI-funded trial in which 1653 recently hospitalized heart-failure patients were randomized to telemonitoring or usual care. The findings, published in the New England Journal of Medicine, failed to show an advantage of telemonitoring in the primary endpoint: rehospitalization for any reason or death from any cause […]

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November 16th, 2010

GRAVITAS: No Benefit for Clopidogrel Dosing Based on Platelet Function Test

Larry Husten, PHD

The GRAVITAS (Gauging Responsiveness With A VerifyNow Assay ─ Impact on Thrombosis and Safety) trial enrolled 2214 patients with high residual platelet reactivity, as assessed by the VerifyNow P2Y12 Test measured 12 to 24 hours after the procedure. (The manufacturer of the test, Accumetrics, sponsored the trial.) Patients in the trial were randomized to either high-dose clopidogrel […]

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November 15th, 2010

Omega-3s Fail to Show Benefits in Atrial Fibrillation

Larry Husten, PHD

In sharp contrast to earlier studies suggesting a positive effect, a large study of high-dose prescription omega-3 fatty acids found no evidence of benefit in treating atrial fibrillation. The trial, called the Efficacy and Safety of Prescription Omega-3 Acid Ethyl Esters (P-OM3) for the Prevention of Recurrent Symptomatic Atrial Fibrillation, included 663 patients with AF (542 […]

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November 15th, 2010

ROCKET AF Hits Chicago

Larry Husten, PHD

ROCKET AF hit the AHA on Monday morning. Results of ROCKET AF (Stroke Prevention Using the Oral Direct Factor Xa Inhibitor Rivaroxaban Compared With Warfarin in Patients with Nonvalvular Atrial Fibrillation) had been the topic of intense speculation and interest. The trial showed that the experimental factor Xa inhibitor rivaroxaban was as effective as warfarin […]

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