CardioExchange Archive

June 28th, 2013

FDA Turns Back New Indication for Rivaroxaban to Prevent Stent Thrombosis in ACS Patients

Larry Husten, PHD

Johnson & Johnson said today that it had received a complete response letter from the FDA for the supplemental new drug application (sNDA) for rivaroxaban (Xarelto) for the prevention of stent thrombosis in patients with acute coronary syndromes (ACS). Earlier this year the FDA turned down for the second time the sNDA for the  general use of […]

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June 27th, 2013

Novel Heart Failure Drug from Novartis Gains ‘Breakthrough Therapy’ Designation from FDA

Larry Husten, PHD

Serelaxin, the novel therapy under development for the treatment of acute heart failure, has received a “breakthrough therapy” designation from the FDA, according to Novartis, the company developing the drug. The designation, the FDA explains, “is intended to expedite the development and review of drugs for serious or life-threatening conditions” and requires “preliminary clinical evidence that demonstrates the […]

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June 26th, 2013

Some Patients with Minor Stroke or TIA May Benefit from Early Clopidogrel and Aspirin

Larry Husten, PHD

Some people with minor ischemic stroke or transient ischemic attack (TIA) may benefit from dual antiplatelet therapy with aspirin and clopidogrel, according to a large new study from China published in the New England Journal of Medicine. In the immediate period following a TIA or minor stroke, people are at high risk for having a major stroke. Aspirin […]

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June 24th, 2013

Large NIH Trial Finds No Cardiovascular Benefits for Weight Loss and Exercise in Type 2 Diabetics

Larry Husten, PHD

A large NIH-sponsored trial has found that an intensive lifestyle intervention was no better than standard care in reducing cardiovascular events in people with type 2 diabetes. The results of the Look AHEAD trial were presented today at the American Diabetes Association meeting and published simultaneously in the New England Journal of Medicine. A total of 5,145 people with type 2 […]

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June 24th, 2013

Roller Coaster Path to Approval for Eliquis Uncovered by FDA Documents

Larry Husten, PHD

After the presentation and publication of the pivotal ARISTOTLE trial,  the novel anticoagulant apixaban (Eliquis, Pfizer and Bristol-Myers Squibb) was widely expected to be  a blockbuster. But then it got bogged down at the FDA where initial hopes for a speedy approval were dashed after highly critical reviews. Approval of the drug was delayed for 9 months […]

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June 20th, 2013

Hypertension and Cholesterol Guidelines Delayed Again as NHLBI Gets Out of the Guidelines Business

Larry Husten, PHD

The National Heart, Lung and Blood Institute (NHLBI) will no longer issue guidelines, including the much-delayed and much-anticipated hypertension (JNC 8) and cholesterol (ATP 4) guidelines. Instead, the NHLBI will perform systematic evidence reviews that other organizations, including the American Heart Association and the American College of Cardiology, will use as a resource for their own guidelines. The […]

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June 19th, 2013

Top-Line Results: No Cardiovascular Benefits Found For Saxagliptin

Larry Husten, PHD

Top-line results of a large phase 4 study with saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) demonstrate that the drug is safe but has no cardiovascular benefits. AstraZeneca and Bristol-Myers Squibb today announced the top-line results for the SAVOR-TIMI-53 Cardiovascular Outcomes Trial of Onglyza®. The full results are scheduled to presented at the annual meeting of the European Society of Cardiology in Amsterdam on September 2 […]

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June 18th, 2013

FDA Raises Concerns About the Cybersecurity of Medical Devices

Larry Husten, PHD

The FDA has raised concerns about the vulnerability of medical devices to cyberattack. In one dramatic instance, reported by the Wall Street Journal, a VA catheterization laboratory in New Jersey was temporarily closed after malware infected the lab’s computer devices. The FDA last week recommended that device companies and medical facilities “take steps to assure that appropriate safeguards are […]

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June 14th, 2013

New European Hypertension Guidelines Released with Simplified Blood Pressure Target

Larry Husten, PHD

New hypertension guidelines from the European Society of Hypertension and the European Society of Cardiology were released in Milan today at the European Meeting on Hypertension & Cardiovascular Protection. The authors of the guidelines write that “despite overwhelming evidence that hypertension is a major cardiovascular risk, studies show that many are still unaware of the condition, that […]

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June 13th, 2013

Too Much, Too Fast? Cross-Country Skiing and Heart Arrhythmias

Larry Husten, PHD

When it comes to exercise, it may be true that you can do too much or go too fast. It might seem counterintuitive, but a new study finds that among cross-country skiers, the risk for having a cardiac arrhythmia is highest in those who race the fastest or most often. Although lack of exercise is almost […]

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