November 23rd, 2011
CardioMEMS CHAMPION Trial Undergoes Scrutiny From Wall Street Ahead of Next Month’s FDA Panel
Larry Husten, PHD
Note to readers: An earlier version of this story stated that the FDA may be concerned about the conduct of the CHAMPION trial. This statement could be construed as an implication of ethical misconduct or negligence on the part of the trial sponsors or investigators. I apologize if I conveyed this impression in the earlier story. […]
November 22nd, 2011
Study Examines Role of Surgery for Infective Endocarditis and Heart Failure
Larry Husten, PHD
Although current guidelines recommend valve surgery for patients with infective endocarditis and heart failure (HF), a large prospective registry finds that many of these patients do not undergo surgery — and have much worse outcomes. In a paper published in JAMA, Todd Kiefer and colleagues report on 4166 patients with infective endocarditis enrolled in the International Collaboration on Endocarditis […]
November 22nd, 2011
Long-Term Follow-up of HPS Shows Extended Benefits of Statins
Larry Husten, PHD
Long-term follow-up of patients enrolled in the Heart Protection Study (HPS) demonstrates continued benefits in the group originally randomized to receive simvastatin instead of placebo. The main results of the HPS, published in 2002, showed a significant 23% reduction at 5.3 years in major vascular events associated with simvastatin treatment among the 20,536 patients with coronary […]
November 22nd, 2011
Merck Pleads Guilty and Pays $950 Million for Illegal Promotion of Vioxx
Larry Husten, PHD
The US Department of Justice announced today that Merck, Sharp & Dohme will plead guilty to illegal promotion of Vioxx (rofecoxib) and will pay a $950 million in fines and penalties to the US government and individual states.
November 21st, 2011
Prominent Dutch Cardiovascular Researcher Fired for Scientific Misconduct
Larry Husten, PHD
UPDATE (Posted Monday, November 21): Over the weekend more details emerged about this story. An executive summary of the report from the investigative committee at Erasmus MC, dated November 16, appeared on the Erasmus website. Here is a brief summary, based on help received from Google Translate, Babel Fish, and native Dutch speakers: As previously reported […]
November 16th, 2011
ELEVATE-TIMI 56: One New Piece of the Clopidogrel Puzzle
Larry Husten, PHD
Tripling the maintenance dose of clopidogrel in most but not all patients with a common genetic variation will lower platelet reactivity to levels achieved in patients without the variation.
November 16th, 2011
Experts Clash Over AIM-HIGH
Larry Husten, PHD
Sparks flew at the AHA press conference yesterday when the designated discussant for the AIM-HIGH trial, Australia’s Philip Barter, said that “the design was such that in no way could it test the hypothesis” that niacin therapy may be beneficial. “This trial disturbs me greatly,” he said. The trial co-principal investigator, William Boden, defended his […]
November 15th, 2011
Hype Aside, Hope for Stem Cell Therapy May Be Emerging from Hibernation
Larry Husten, PHD
Two small studies of cardiac stem cells for the treatment of heart failure have shown promise, but ABC News, CBS News, and other media outlets are throwing around words like “medical breakthrough” and “heart failure cure.” ABC News correspondent Richard Besser was so enthusiastic that anchor Diane Sawyer commented that she had never seen him “so excited.” […]
November 15th, 2011
SATURN Regression Trial: Gorilla Statin and Statin King Battle to a Draw
Larry Husten, PHD
An epic battle comparing the two most potent statins — the reigning king atorvastatin versus “gorilla statin” rosuvastatin — has ended with a quiet draw. Results of SATURN (Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN) were presented at the AHA on Tuesday and published simultaneously in the New England Journal of Medicine. Stephen Nicholls and colleagues randomized 1039 […]
November 15th, 2011
AIM-HIGH: No Benefit for Niacin on Top of Statins
Larry Husten, PHD
The AIM-HIGH investigators aimed for the lofty target of proving the beneficial effects of niacin therapy. They did not succeed. Their findings were presented Tuesday morning at the AHA and published simultaneously in the New England Journal of Medicine. In AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes), 3414 […]