CardioExchange Archive

January 24th, 2014

European Setback for Novel Heart Failure Drug

Larry Husten, PHD

European regulators have dealt a setback to a novel heart failure drug under development by Novartis. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against giving market approval to serelaxin (Reasanz) for the treatment of acute heart failure. The recommendation is based largely on the committee’s analysis of the RELAX-AHF trial, which was published […]

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January 24th, 2014

Stent Remains Available Despite Trial Showing Dangers

Larry Husten, PHD

A leading critic says that the FDA has been remiss for not removing a stent from the market although strong evidence exists that its use leads to more deaths and strokes. The Wingspan intracranial stent, manufactured by Stryker Neurovascular, was approved in 2005 by the FDA through the humanitarian device exemption (HDE) for the rare condition […]

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January 23rd, 2014

Survival After MI: When and Where Make a Big Difference

Larry Husten, PHD

Two studies published this week offer fresh evidence that the time and place of a myocardial infarction (MI) make a big difference. 1. MI patients in the United Kingdom are more likely to die than MI patients in Sweden, according to a study published in the Lancet. Researchers in Sweden and the U.K. analyzed data from almost 120,000 Swedish patients […]

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January 21st, 2014

Dangerous Rapid Calcification Observed In Pediatric Patients After Aortic Valve Replacement

Larry Husten, PHD

Pediatric cardiac surgeons at Boston Children’s Hospital are warning the medical community about a potentially fatal problem in children and young adults who received a bioprosthetic valve manufactured by Sorin. The surgeons initially became concerned when a young, asymptomatic patient died suddenly after her valve underwent rapid calcification, only 7 months after a routine follow-up echocardiogram found […]

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January 20th, 2014

FDA Grants Earlier Than Expected Approval for Medtronic’s CoreValve

Larry Husten, PHD

The FDA today approved Medtronic’s CoreValve transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis who are unable to undergo conventional open-heart surgery. The approval came several months ahead of expectations and without an FDA advisory panel meeting. The approval was based largely on results from the Extreme Risk Study of the CoreValve […]

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January 17th, 2014

FDA Panel Once Again Rejects ACS Indication for Rivaroxaban

Larry Husten, PHD

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has once again turned down the supplemental new drug application for an acute coronary syndrome (ACS)  indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. Although originally the subject of high praise when […]

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January 16th, 2014

FDA Advisory Panel Votes in Favor of Approval for Merck’s Vorapaxar

Larry Husten, PHD

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. The committee voted in favor of the drug […]

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January 14th, 2014

All Lots of Liptruzet In U.S. Recalled Over Packaging Defect

Larry Husten, PHD

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

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January 13th, 2014

Minority Report: Five Guideline Authors Reject Change in Systolic Blood Pressure Goal

Larry Husten, PHD

It didn’t seem possible, but the guideline situation just got even more confusing. Last December, after  years of delay and other twists and turns, the Eighth Joint National Committee (JNC 8) hypertension guideline was published in JAMA. The previous guideline recommended that all adults have a target systolic blood pressure below 140 mm Hg. In the new guideline, […]

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January 13th, 2014

Merck’s Vorapaxar Gets Positive FDA Review

Larry Husten, PHD

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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