November 5th, 2012
Early Look: New Methods to Enhance Cholesterol Efflux
Larry Husten, PHD
Although clinical trials of HDL-boosting CETP inhibitors have so far failed to produce positive results, many other avenues of HDL-related research remain active. Conference attendees got a glimpse of the very early phases of two intriguing lines of research in this area on Monday. Apoliporotein A-I is thought to be the key HDL component that removes […]
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
FREEDOM Lends Strong Support to CABG for Diabetics with Multivessel Disease
Larry Husten, PHD
CABG is associated with better cardiovascular outcomes than PCI in patients with diabetes and multivessel disease.
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
ARCTIC Blows a Cold Wind on Platelet Function Tests
Larry Husten, PHD
The use of platelet-function tests to monitor and guide antiplatelet therapy in PCI patients has sparked heated debate. Cardiologists have sought to reconcile biological plausibility with the absence of clinical evidence. Now the ARCTIC (Assessment by a Double Randomization of a Conventional Antiplatelet Strategy versus a Monitoring-guided Strategy for Drug-Eluting Stent Implantation versus Continuation One […]
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 […]
November 3rd, 2012
Rivaroxaban Gains FDA Indications for Treating and Preventing DVT and PE
Larry Husten, PHD
The FDA has expanded the indication for rivaroxaban (Xarelto, Johnson & Johnson) to include the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk for recurrent DVT and PE. The oral anticoagulant is already approved to reduce postsurgical risk for DVT and PE after hip- and knee-replacement surgery and to reduce […]
November 2nd, 2012
FDA Investigation Finds No Excess Bleeding Risk for Dabigatran
Larry Husten, PHD
In its latest assessment of a highly controversial issue, the FDA has found no indication that bleeding rates for dabigatran (Pradaxa, Boehringer-Ingelheim) are any higher than the bleeding rates for warfarin. The FDA investigation was in response to the large number of post-marketing reports of bleeding in people taking dabigatran. Click here to for the full FDA […]
November 1st, 2012
DOJ Investigating Abiomed for Improper Marketing of Impella Circulatory Support System
Larry Husten, PHD
The U.S. Attorney’s Office is investigating Abiomed’s marketing and labeling of the Impella 2.5 circulatory support device, the company announced on Thursday. Abiomed also said that it believed that the FDA would begin a review to possibly reclassify its Impella devices as Class III devices, which would require FDA clearance using the more stringent premarket approval […]