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New York Times Orbits JUPITER (31 Mar 2010)

A front page story in Wednesday’s New York Times questions the expanding use of statins, and particularly rosuvastatin, in “healthy people.” Following the recent approval of broad new indications for the drug based on results from the JUPITER trial, Times reporter Duff Wilson notes that millions of people may now take the drug “largely as prevention” and that some…

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• FDA Issues Complete Response Letter For Certriad
• U.K.’s NICE Goes Easier on Dronedarone
• U.S. Justice Dep’t & SEC Look Into Boston Scientific ICD Recall
(30 Mar 2010)

FDA Issues Complete Response Letter For Certriad: The FDA issued a complete response letter for the NDA for Certriad, Abbot’s and AstraZeneca’s combination pill composed of rosuvastatin and fenofibric acid delayed release. The companies did not release any details of the letter, but analysts think it will mean the drug’s approval will likely be delayed…

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• Screening for Type 2 Diabetes
• FDA Cracks Down on Unapproved Nitroglycerin
(29 Mar 2010)

Screening for Type 2 Diabetes: Kahn et al. used a sophisticated computer model to assess the impact of 8 different screening strategies to detect type 2 diabetes in the US. The researchers concluded that screening is cost effective when started between the ages of 30 and 45 years of age, with screening repeated every 3–5 years. The…

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Study Finds Long-Term Problems with Alcohol Septal Ablation (25 Mar 2010)

Although alcohol septal ablation (ASA) for the treatment of obstructive hypertrophic cardiomyopathy is now gaining increasing acceptance in many parts of the world, a new study finds that it may cause more problems than traditional surgical myectomy. Investigators from the Netherlands, led by Patrick Serruys, studied 91 consecutive ASA patients and compared them to 40 consecutive…

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• Hospital Volume and Mortality
• Coronary Artery Fistula Closure
(24 Mar 2010)

Hospital Volume and Mortality: Using Medicare data, Ross et al. investigated the association between hospital volume and the 30-day death rate for patients admitted for acute MI, heart failure, and pneumonia. In their report in the New England Journal of Medicine, the researchers found that increased volume was associated with reduced rates of death for…

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• High Blood Pressure in ICU Linked to Better Outcome
• Nissen and JAMA Editors Weigh In on Avandia
• Improving Informed Consent; Beta-Blocker Inventor Dies
(23 Mar 2010)

High Blood Pressure in ICU Linked to Better Outcome: Using data from nearly 120,000 patients admitted to the ICU for chest pain, Swedish investigators found, somewhat unexpectedly, that high systolic blood pressure at the time of admission was associated with improved outcome. The association remained evident even when patients with CHF or who went on to…

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• AHA Scientific Statement on Medication Errors in Acute CV Medicine
• BNP-Guided HF Therapy
(22 Mar 2010)

AHA Scientific Statement on Medication Errors in Acute CV Medicine: “Cardiovascular medications are the most common drug class associated with medication errors, and cardiovascular patients remain at high risk in the acute hospital phase, even with the current safety strategies,” said Andrew Michaels, chair of the writing committee for a new AHA scientific statement published…

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Friday March 19: FDA in the News: Warning About High Dose Simvastatin; Advisory Panel Supports Expanded Indication for CRT-Ds; Watchman Approval Delayed (19 Mar 2010)

FDA Warns About High Dose Simvastatin– The FDA issued a drug safety communication today about an ongoing review of high dose simvastatin and increased risk of myopathy based on data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial.FDA Panel Supports Expanded Indication for CRT-Ds– The FDA’s Circulatory System Devices Panel voted unanimously to support a…

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Wednesday, March 17 News: Thoracic Aortic Disease Guidelines Released (17 Mar 2010)

The AHA and the ACC released new practice guidelines for the management and treatment of thoracic aortic disease. Here is a press release about the guidelines. Here is the Executive Summary, with links to the full text, a slide set, and other material.

Tuesday, March 16 News Roundup: Cryoballoon Ablation Trial; FDA to Review ACCORD data; Trouble for Boston Scientific and Medtronic (16 Mar 2010)

STOP-AF: The STOP-AF trial compared a novel cryoballoon ablation technology with antiarrhythmic drug (AAD) therapy in 245 AF patients who had failed at least one AAD. Treatment success was achieved in 69.9% of cryoballoon patients versus 7.3% of AAD patients, a highly significant difference (p<0.001). Phrenic nerve palsy occurred in 13.5% of cryoballoon patients and 7.3% of…

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