CardioExchange Archive

July 1st, 2011

Rivaroxaban (Xarelto) Gains First FDA Approval for DVT Prevention

Larry Husten, PHD

Rivaroxaban (Xarelto, Janssen) received FDA approval today for the prevention of deep-vein thrombosis in patients undergoing knee or hip replacement surgery. This oral anticoagulant has been approved for use at a 10-mg dose, once daily, for 35 days following hip replacement and for 12 days following knee replacement surgery. The company has also submitted an application […]

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June 25th, 2011

Limited Benefit Found for Early Aggressive Management of Diabetes

Larry Husten, PHD

In the ADDITION-Europe trial, 3055 patients without diabetes were randomized to either routine care or screening followed by intensive treatment of multiple risk factors. The results were presented at the American Diabetes Association meeting and published online in the Lancet. After five years, cardiovascular risk factors — HbA1c, lipids, and blood pressure — were “slightly but significantly better in the […]

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June 25th, 2011

Diabetes Growth Termed a Rising Global Hazard

Larry Husten, PHD

In 2008, some 347 million people in the world had diabetes, more than twice the 153 million in 1980, according to estimates contained in a report in the Lancet from the Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group. The paper appears in conjunction with the annual meeting of the American Diabetes Association. Throughout  the world […]

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June 22nd, 2011

JAMA: Skeptical Perspectives on Consumer Cardiac Tests and Vitamin D

Larry Husten, PHD

Two commentaries published in JAMA offer skeptical perspectives on the roles of direct-to-consumer (DTC) cardiac tests and vitamin D in cardiovascular health. In the first commentary, Kimberly Lovett and Bryan Liang write that DTC screening tests “likely pose more risk than benefit to patients,” and point out that for companies selling these tests there is no requirement […]

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June 21st, 2011

Meta-Analysis Examines Risk of Diabetes Associated with Statins

Larry Husten, PHD

Although the cardiovascular benefits of statin therapy are well-characterized, recent studies have raised concerns that intensive statin therapy increases the risk for developing type 2 diabetes. Now, a new meta-analysis published in JAMA provides a more precise estimate of the risk for diabetes associated with statin therapy and also weighs that risk against the cardiovascular […]

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June 16th, 2011

FDA: Varenicline (Chantix) May Increase Risk for CV Events

Larry Husten, PHD

The FDA said that the anti-smoking drug varenicline (Chantix) may increase the risk for cardiovascular events in people who already have cardiovascular disease. The new information will be added to the drug’s label and Medication Guide for patients. The FDA does not recommend that people with cardiovascular disease stop taking varenicline, but it says that physicians […]

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June 15th, 2011

NEJM: FDA Officials Explain the New Simvastatin Label

Larry Husten, PHD

In a perspective published in the New England Journal of Medicine, two FDA officials, Amy Egan and Eric Colman, explain in some detail the recent changes made by the FDA regarding simvastatin. They note that in the SEARCH trial, myopathy developed in 52 (0.9%) patients in the 80-mg group compared with only 1 (0.02%) patient […]

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June 12th, 2011

CardioExchange Panel: Whither High-Dose Simvastatin?

CardioExchange Editors, Staff

Last week, the FDA issued a warning high-dose simvastatin because of the risk of myopathy. CardioExchange got the reactions from a panel we assembled. Whose views do you agree with? What points did our panelists miss? See a similar panel’s reactions the publication of the SHARP Trial here. Given the FDA warning, do you see any role […]

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June 12th, 2011

CardioExchange Panel: Ezetimibe + Simvastatin for Chronic Kidney Disease — What’s the Point of SHARP?

CardioExchange Editors, Staff

Last week saw the publication of the SHARP trial (Study of Heart and Renal Protection) in which some 9,200 patients with chronic kidney disease (CKD) were randomized to  either placebo or the combination of simvastatin and ezetimibe. CardioExchange put questions about these data to a panel of experts. Whose views do you agree with? What points did […]

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June 8th, 2011

FDA Recommends Limiting Use of High-Dose Simvastatin

Larry Husten, PHD

The FDA today recommended significant limitations in the use of high-dose (80 mg) simvastatin because of the increased risk for myopathy. The FDA said the 80-mg dose should be used only in people who have been taking the high dose for at least one year and have had no evidence of myopathy. The high dose […]

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