November 5th, 2012
Dalcetrapib: Another HDL-Raising CETP Inhibitor Bites the Dust
Larry Husten, PHD
Another HDL-raising CETP inhibitor has failed to demonstrate cardiovascular benefit in a large clinical trial. With the presentation of the dal-OUTCOMES trial at the American Heart Association in Los Angeles and simultaneous publication in the New England Journal of Medicine, dalcetrapib joins torceptrapib on the list of once-promising CETP inhibitors. In dal-OUTCOMES, 15,871 patients with a recent […]
November 4th, 2012
NIH Trial Gives Surprising Boost to Chelation Therapy
Larry Husten, PHD
The TACT trial finds that cardiovascular endpoints were lower with chelation therapy than placebo in patients with prior MI, but trial investigators and others have expressed considerable caution about the proper interpretation of the results.
November 4th, 2012
ASPIRE: Aspirin an Attractive Alternative After First VTE
Larry Husten, PHD
It is unclear what the best approach is for the long-term treatment of people who have had a first unprovoked episode of venous thromboembolism (VTE). Although warfarin is effective at preventing a recurrence, it is inconvenient and raises the risk for bleeding. Newer anticoagulants have not been tested or approved for this population. The ASPIRE (Aspirin […]
November 3rd, 2012
ALTITUDE Autopsy Shows What Went Wrong With Aliskiren
Larry Husten, PHD
In its short lifespan the direct renin inhibitor aliskiren (a.k.a., Rasilez or Tekturna) rapidly declined from being a highly promising, first-of-its kind drug to a major failure. The death blow was struck last December with the early termination of the ALTITUDE trial, after the data and safety monitoring committee found an increased risk in patients taking aliskiren. Now the final results […]
October 31st, 2012
PCSK9 Inhibitor Enhances Cholesterol-Lowering Effect of Atorvastatin
Larry Husten, PHD
When added to low-dose atorvastatin, a much-discussed new monoclonal antibody to PCSK9 significantly lowers cholesterol more effectively than atorvastatin alone, according to a phase 2 study published in the New England Journal of Medicine. Earlier this year, in March, the findings of three phase 1 trials demonstrating the cholesterol-lowering effects of the drug in healthy […]
October 30th, 2012
The Research Agrees: Smoking Is Really Bad for You
Larry Husten, PHD
Four new studies offer powerful evidence of the dangers of smoking and the health benefits of quitting or not being exposed to secondhand smoke. Smoking in the U.K. — Between 1996 amd 2001, the Million Women Study started following more than one million women aged 50 to 65 years of age. In a report published in […]
October 22nd, 2012
NIH Trial of Lifestyle Intervention for Type 2 Diabetes Stopped for Futility After 11 Years
Larry Husten, PHD
The NIH today announced the early termination of a large randomized trial testing a lifestyle intervention approach to weight loss in type 2 diabetics. More than 5,000 patients with type 2 diabetes were randomized to participate in an intensive lifestyle intervention program or a traditional program of diabetes support and education in Look AHEAD (Action for Health […]
October 18th, 2012
FDA Panel Recommends Approval of Mipomersen for Homozygous Familial Hypercholesterolemia
Larry Husten, PHD
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee gave a weak endorsement to mipomersen, an antisense oligonucleotide inhibitor manufactured by Genzyme, for use in homozygous familial hypercholesterolemia (FH). With its relatively close 9-6 vote, and with its comments, the committee expressed concerns about both the efficacy and safety of the drug, but ultimately the severity of […]
October 18th, 2012
FDA Reviewers Recommend Approval of Lomitapide for Homozygous Familial Hypercholesterolemia
Larry Husten, PHD
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13-2 on Wednesday to recommend approval of Aegerion Pharmaceuticals’ cholesterol-lowering drug lomitapide for use in patients with homozygous familial hypercholesterolemia (FH). The lopsided vote does not completely reflect the views of many of the panel members, who expressed considerable concern that the drug might be used in […]
October 18th, 2012
Should Hypercholesterolemia Treatments Start Much Sooner in Life?
Keeping LDL cholesterol low throughout life is more effective at preventing atherosclerotic disease than starting statins in middle age, a series of analyses in the Journal of the American College of Cardiology shows. Researchers first established the effects of several genetic variations on naturally lowering LDL. People with one or more of these variants had their […]