CardioExchange Archive

June 22nd, 2012

FDA Rejects ACS Indication for Rivaroxaban (Xarelto)

Larry Husten, PHD

The FDA has issued a complete response letter to the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) in patients with acute coronary syndrome (ACS). The action was expected, since last month the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against recommending the new indication, which was based on the pivotal ATLAS […]

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June 19th, 2012

Is Chronic Kidney Disease a CHD Risk Equivalent?

Larry Husten, PHD

A study published in the Lancet provides new data about whether chronic kidney disease (CKD) should, like diabetes, be considered a coronary heart disease (CHD) risk equivalent. Marcello Tonelli and colleagues analyzed data from a population of 1.25 million people in Alberta, Canada. During a median follow-up of 4 years, 11,340 people were admitted to the hospital […]

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June 19th, 2012

New Uses Found for a Traditional Walking Test

Larry Husten, PHD

The 6-minute walk test (6MWT) can improve risk prediction in people with stable coronary disease, according to a new study published in the Archives of Internal Medicine. The 6MWT may also be cost-effective and — and may help physicians motivate their patients to exercise, suggest the authors. Alexis Beatty and colleagues performed a 6MWT and a treadmill exercise […]

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June 18th, 2012

The Grim Impact of Loneliness and Living Alone

Larry Husten, PHD

Two new reports published in the Archives of Internal Medicine throw a spotlight on the grim effects of loneliness and living alone on health. As part of the Health and Retirement Study, 1604 people were followed for 6 years after answering a questionnaire about loneliness. Some 43% reported feeling lonely. Loneliness was associated with significantly increased risks […]

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June 14th, 2012

FDA Advisory Panel Recommends Expanded Indication for Sapien Transcatheter Heart Valve

Larry Husten, PHD

The FDA’s Circulatory System Devices Panel voted overwhelmingly on Wednesday to recommend an expanded indication for the Edwards Sapien Transcatheter Heart Valve in patients with symptomatic severe aortic stenosis who have high operative risk. The device is currently approved for use only in patients who are not surgical candidates. The committee voted 10-2 that the Sapien device was […]

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June 12th, 2012

ACC Releases Appropriate Use Criteria for Noninvasive Peripheral Vascular Tests

Larry Husten, PHD

The American College of Cardiology (ACC) has published appropriate use criteria (AUC) for peripheral vascular ultrasound and physiological testing. The criteria were developed in coordination with 10 other medical societies. “This is the first systematic and comprehensive evaluation looking at appropriate indications for vascular testing, such as ultrasound or functional testing,” said Emile Mohler III, the chair […]

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June 11th, 2012

FDA Reviewers Raise Questions About Sapien Heart Valve System

Larry Husten, PHD

FDA reviewers have raised a number of questions about the safety and efficacy of the Sapien heart valve system. The review was published online ahead of Wednesday’s meeting of the Circulatory System Devices Panel meeting to evaluate the Sapien system for use in patients eligible but at high risk for aortic valve surgery. The Sapien system was […]

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June 11th, 2012

Basal Insulin and Omega-3 Fatty Acids Fail to Improve Outcomes in Diabetics and Prediabetics

Larry Husten, PHD

A large new study has found no evidence of cardiovascular (CV) benefits for either basal insulin or omega-3 fatty acids in a population of people with diabetes or at risk for diabetes. Results of the ORIGIN (Outcome Reduction with Initial Glargine Intervention) study were presented today at the annual meeting of the American Diabetes Association […]

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June 9th, 2012

Transient Glucose Regulation Helps Prevent Progression to Diabetes in Prediabetics

Larry Husten, PHD

Prediabetics — people with impaired fasting glucose or impaired glucose tolerance — can reduce their high risk for progressing to diabetes if they achieve even a transient return to normal glucose regulation, according to results of the Diabetes Prevention Program Outcomes Study (DPPOS), presented at the American Diabetes Association meeting and published simultaneously online in the Lancet. Leigh Perreault […]

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June 7th, 2012

Growing Popularity of Dabigatran Leads to Increased Complications

Larry Husten, PHD

Since its approval in the United States in October 2010, dabigatran (Pradaxa) has been prescribed 3.2 million times to more than 600,000 patients with nonvalvular atrial fibrillation (AF), according to its manufacturer, Boehringer Ingelheim. The company also announced that, based on the pivotal RE-LY trial, the “Clinical Studies” section of the drug’s prescribing information now includes the statement […]

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