October 23rd, 2012
Setback for Trial Studying Dabigatran After Mechanical Valve Surgery
Larry Husten, PHD
Despite the recent advent of novel oral anticoagulants, the much-maligned warfarin remains the only current option available for patients who have received a mechanical valve. Now the first trial to explore this indication for a newer oral anticoagulant has suffered a setback. Last year, Boehringer Ingelheim announced the launch of the RE-ALIGN trial, a phase […]
October 23rd, 2012
High Rate of Warfarin Discontinuation Observed in Study
Larry Husten, PHD
One of the many potential problems with warfarin-based anticoagulant therapy is the poor rate of adherence and persistence among patients who are prescribed the drug. Now an observational study published in the Archives of Internal Medicine raises the possibility that the problem may be even worse than many have suspected, as discontinuation rates in clinical trials appear […]
October 22nd, 2012
Selections from Richard Lehman’s Literature Review: October 22nd
Richard Lehman, BM, BCh, MRCGP
This week’s topics include favorable lipid-level trends in U.S. adults, an angiotensin receptor neprilysin inhibitor for patients with HF and preserved systolic ejection fraction, and a long-term safety comparison of the Zotarolimus-eluting and Sirolimus-eluting coronary stents.
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 […]
October 22nd, 2012
FDA Approves the Sapien Transcatheter Heart Valve for High-Risk Patients
Larry Husten, PHD
The FDA today approved an expanded indication for Edwards Lifesciences’ Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve replacement surgery but are at high risk for serious surgical complications or death. Previously the Sapien valve was approved only for use in patients who were […]
October 22nd, 2012
The Highs and Lows of Fellowship Interviews
John Ryan, MD
Fellow John Ryan shares the story of an interview that goes awry; what has your experience been?
October 19th, 2012
“Aren’t You A Doctor, Baba? Can’t You Make Him Better?”
Paul S. Chan, MD, MS
After his five-year-old son asks a difficult question, a cardiologist hikes the Grand Canyon in a day to raise money to fight hunger.
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 […]
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 […]