CardioExchange Archive

To celebrate the holiday season, CardioExchange asked several of our contributors to choose the 3 most important cardiology-related events of the past year and  to make 3 predictions for 2011.  Here is the first installment in the series.

Looking back at 2010:

1. On September 23, the European Medicines Agency withdrew rosiglitazone from the market and the US FDA limited access to patients who have failed other diabetes therapies including pioglitazone. This decision ended a 3-year battle over the cardiovascular safety of a drug that was once the largest selling diabetes medication in the world.

2. The first alternative to warfarin was approved by the FDA in 2010. Dabigatran is a direct thrombin inhibitor that protected atrial fibrillation patients from stroke with similar efficacy to warfarin. It’s main advantage is the lack of need for monitoring anti-coagulant effect, potentially freeing patients from repeated INR testing. The major downside is the very high cost, approaching $8 day, which will limit use.

3. The ACCORD Lipid study was published, demonstrating no benefit for routine administration of fenofibrate in diabetic patients. This study re-emphasizes the hazards of approving medications based upon surrogate endpoints. Despite favorable affects on lipids, fenofibrate failed to reduce morbidity and mortality. Unfortunately a widely used drug marketed since the 1970’s, when finally studied, failed to show significant health outcome benefits.

Predictions for 2011:

1. The Office of Inspector General will launch a major national investigation of the overuse of stents in cardiovascular practice.

2.The American College of Cardiology will acknowledge that it has been too cozy with industry and announce that the organization will no longer accept funding from drug and device makers.

3. The new Congress will consider revisions to the HealthCare Reform legislation, but each effort will fail due to a filibuster in the Senate.