March 22nd, 2013
Europe and U.S. Diverge on Two New Drugs
Larry Husten, PHD
The U.S. FDA and Europe’s Committee for Medicinal Products for Human Use (CHMP) have taken opposite views of two important and controversial new cardiovascular drugs. Although earlier this month the FDA rejected — for the second time — an ACS indication for the oral anticoagulant rivaroxaban (Xarelto), CHMP announced today that it had adopted a positive opinion for the […]
March 20th, 2013
Controversial PFO Closure Trials Published in NEJM
Larry Husten, PHD
Two controversial trials testing PFO closure in patients with cryptogenic stroke missed their primary endpoints but contained suggestions of possible benefit.
March 20th, 2013
Chlorthalidone Associated with More Electrolyte Problems Than Hydrochlorothiazide
The diuretics chlorthalidone and hydrochlorothiazide are similarly effective at preventing cardiovascular events among older adults with hypertension, but electrolyte abnormalities are more common with chlorthalidone, according to a study in the Annals of Internal Medicine. Canadian researchers used healthcare databases to identify nearly 30,000 adults over age 65 recently prescribed varying doses of chlorthalidone or hydrochlorothiazide. […]
March 20th, 2013
High Potency Statins Linked to Increased Risk for Acute Kidney Injury
Larry Husten, PHD
Although the beneficial effects of high-potency statins have been well-characterized in clinical trials, these same trials have lacked the power to illuminate rare but potentially important adverse events. A suggestion of one such area of concern, acute kidney injury, was first raised in the SATURN trial. Now, a new study published in BMJ provides further information about this area. […]
March 13th, 2013
FDA Officials Calm Concerns Over Excessive Bleeding with Dabigatran
Larry Husten, PHD
Concerns over excessive bleeding complications with dabigatran (Pradaxa, Boehringer Ingelheim) as compared with warfarin are most likely due to the heightened sensitivity and vigilance that can accompany a new drug, according to FDA officials in a perspective published online in the New England Journal of Medicine. “We believe that the large number of reported cases of bleeding associated […]
March 13th, 2013
Radiotherapy for Breast Cancer Increases Heart Disease Risk
Larry Husten, PHD
The increased risk of radiotherapy for breast cancer seen in this NEJM study may just be the tip of the iceberg.
March 9th, 2013
HPS2-THRIVE: A ‘Disappointing But Clear’ Result
Larry Husten, PHD
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters. The results of HPS2-THRIVE were “disappointing but clear,” said Jane Armitage, who presented the results this morning at the ACC […]
March 9th, 2013
Following an Embargo Break PREVAIL Trial Won’t be Presented at ACC
Larry Husten, PHD
For more of our ACC.13 coverage of late-breaking clinical trials, interviews with the authors of the most important research, and blogs from our fellows on the most interesting presentations at the meeting, check out our Coverage Headquarters. The already complicated story behind the PREVAIL trial, which was designed to confirm the safety and efficacy of the […]
February 28th, 2013
The Mediterranean Diet in Clinical Practice: Three Experts Weigh In
Walter Willett, MD, MPH, DrPH, Arthur Agatston, MD, Alice H. Lichtenstein, D.Sc. and John Ryan, MD
Esteemed nutrition experts Walter Willett, Arthur Agatston, and Alice Lichtenstein discuss the PREDIMED study’s finding that a Mediterranean diet can reduce the risk for CV disease.
February 27th, 2013
HPS2-THRIVE Coming Attraction: What Went Wrong with Niacin?
Larry Husten, PHD
In less than two 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. The results have been eagerly awaited since Merck’s brief announcement in December that the trial had not met its primary endpoint and that it […]