CardioExchange Archive

September 22nd, 2010

PARTNER Results Boost Transcatheter Aortic-Valve Implantation

Larry Husten, PHD

Patients with aortic stenosis who are not candidates for aortic valve replacement surgery can benefit from transcatheter aortic-valve implantation (TAVI), according to results of the PARTNER (Placement of AoRTic TraNscathetER Valves) trial published in the New England Journal of Medicine. (The trial will also be presented at the TCT conference on Thursday.) Martin Leon and colleagues […]

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September 20th, 2010

Encouraging Observational Data on Clopidogrel and PPIs

Larry Husten, PHD

Compared with a PPI alone, the combination of clopidogrel and a PPI does not increase risk for cardiovascular events, according to a large observational study from Denmark published in the Annals of Internal Medicine. Mette Charlot and colleagues analyzed data from 56,406 Danish patients discharged after a first MI and found no difference between the […]

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September 20th, 2010

FDA Panel Unanimously Recommends Approval for Dabigatran

Larry Husten, PHD

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of  dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both dosages (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, although in an informal straw […]

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September 17th, 2010

FDA Announces Safety Review of Pioglitazone

Larry Husten, PHD

The FDA announced today that it was undertaking a safety review of pioglitazone (Actos). The review was initiated after the FDA received data from Takeda, the drug’s manufacturer, suggesting a possible increase in bladder cancer in patients taking the drug for more than 2 years. The data are taken from a planned 5-year analysis of […]

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September 17th, 2010

Study Identifies MicroRNA Pattern Linked to Diabetes

Larry Husten, PHD

Researchers in Britain and Europe have identified a microRNA pattern that may help identify people at risk for developing type 2 diabetes and who may go on to have cardiovascular events. “It’s very important for the clinician to define those diabetic patients who are at the highest risk of developing cardiovascular complications,” said the senior […]

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September 17th, 2010

FDA Grants Expanded Indication to CRT-D Devices

Larry Husten, PHD

The FDA has expanded the indication for CRT-D devices made by Boston Scientific. Previously, the devices had been approved only in NYHA Class III and IV patients. The expanded indication now includes Class I and II patients who have left bundle branch block. The expanded indication is based on data from the MADIT-CRT trial. “This […]

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September 16th, 2010

FDA: Dabigatran Gains, Lorcaserin Loses

Larry Husten, PHD

An alternative to warfarin is one step closer to reality. On Thursday, The FDA released briefing documents for next Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee to discuss the new drug application for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The FDA reviewers agreed that dabigatran was at […]

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September 15th, 2010

FDA: Ticagrelor Deadline Extended; No Clear Signal on Sibutramine

Larry Husten, PHD

FDA watchers require patience. AstraZeneca announced that the FDA had extended its review of ticagrelor (Brilinta) until December 16. The previous deadline had been September 16. In July, the FDA Cardiovascular and Renal Advisory Committee voted 7-1 in favor of approving ticagrelor for the indication of STEMI and NSTEMI patients, but the committee and the […]

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September 15th, 2010

TREAT Analysis: Target Dosing Is Tricky

Larry Husten, PHD

A new analysis of TREAT (Trial to Reduce Cardiovascular Events with Aranesp Therapy) is raising questions about the use of target-based strategies for the treatment of anemia in people with chronic kidney disease. (Last year, the main TREAT results showed that treatment with darbepoetin alfa was not beneficial – and was associated with an increase in the […]

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September 14th, 2010

AHA Rejects Smokeless Tobacco Products

Larry Husten, PHD

Smokeless tobacco products aren’t safe and won’t help people quit smoking, according to a policy statement from the American Heart Association published in Circulation. Although the statement acknowledges that the cardiovascular risks of smokeless tobacco products appear to be reduced compared with cigarette smoking, evidence cited in the statement links smokeless tobacco products to an increased […]

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