March 19th, 2010
Friday March 19: FDA in the News: Warning About High Dose Simvastatin; Advisory Panel Supports Expanded Indication for CRT-Ds; Watchman Approval Delayed
Larry Husten, PHD
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 […]
March 17th, 2010
Wednesday, March 17 News: Thoracic Aortic Disease Guidelines Released
Larry Husten, PHD
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.
March 16th, 2010
Tuesday, March 16 News Roundup: Cryoballoon Ablation Trial; FDA to Review ACCORD data; Trouble for Boston Scientific and Medtronic
Larry Husten, PHD
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 […]
March 15th, 2010
Monday March 15 ACC News Roundup: RACE II; ZES versus SES; Optimal DAPT
Larry Husten, PHD
RACE II: Van Gelder et al. randomized 614 patients with AF to either strict rate control (resting heart rate < 80 bpm and heart rate during moderate exercise <110 bpm) or lenient rate control (resting heart rate < 80 bpm). The results were presented at the ACC in Atlanta and published simultaneously in the New England Journal of […]
March 14th, 2010
Sunday, March 14 ACC News Roundup: ACCORD, NAVIGATOR, EVEREST II
Larry Husten, PHD
The ACC started the day with the release of 3 highly-anticipated clinical trials. ACCORD (Action to Control Cardiovascular Risk in Diabetes Study) tested two separate therapeutic approaches in type 2 diabetics. In one arm, 5,518 patients already taking simvastatin were randomized to fenofibrate or placebo. After 4.7 years of followup, the annual rate of nonfatal MI, […]
March 14th, 2010
Saturday March 13 News: Phase 3 Mipomersen Study
Larry Husten, PHD
Frederic J Raal et al. report results in the Lancet of a phase 3 study in patients with homozygous familial hypercholesterolemia. Fifty one subjects on high dose lipid-lowering drugs were randomized (on a 2:1 basis) to either placebo or mipomersen, a novel antisense inhibitor of apolipoprotein B synthesis. Patients on mipomersen had a 24.7% decrease in LDL, […]
March 12th, 2010
Friday March 12: Plavix Gets a Black Box
Larry Husten, PHD
The FDA has added a black box warning to the Plavix (clopidogrel) label. The black box warns about people “who do not effectively metabolize the drug… and therefore may not receive the full benefits of the drug.” The warning also informs healthcare professionals about tests that can identify the underlying genetic differences in clopidogrel metabolism […]
March 11th, 2010
Thursday, March 11 News: Blood Pressure Variability Subject of 4 Simultaneous Papers in Lancet and Lancet Neurology
Larry Husten, PHD
Interest in blood pressure variability is likely to rise considerably with the publication of four simultaneous papers on the subject by Oxford’s Peter Rothwell in the Lancet and Lancet Neurology. Rothwell points out that by relying on traditional assessment of mean systolic blood pressure, researchers have been unable to fully understand the contribution of blood pressure to stroke […]
March 10th, 2010
Wednesday, March 10 News Roundup: Low Diagnostic Yield for Angiography; Is Acute MI Disappearing?
Larry Husten, PHD
Low Diagnostic Yield for Angiography: Coronary angiography as practiced in the U.S. has a startlingly low diagnostic yield, according to an important new study by Patel et al. in the New England Journal of Medicine using data from the ACC National Cardiovascular Data Registry. In 398,978 patients undergoing elective catheterization who did not have known coronary artery […]
March 9th, 2010
Tuesday, March 9 News Roundup: Clopidogrel After DES, Obama’s Calcium Scan
Larry Husten, PHD
Clopidogrel After DES: In a retrospective analysis of more than 9,000 patients who received a drug-eluting stent, Petersen et al. found that at 12 months, high use of clopidogrel was associated with a significant reduction in the risk of death or nonfatal MI but at the cost of more bleeding. Low use of clopidogrel was […]
