October 31st, 2014
On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban (Savaysa). The outcome will likely result in a drug that will be on the market, but that few physicians will prescribe until further studies are performed. Edoxaban will almost certainly become the fourth new oral anticoagulant (NOAC) to […]
October 9th, 2014
The FDA’s Circulatory System Devices advisory panel gave an extremely cautious endorsement on Wednesday to Boston Scientific’s Watchman device, a novel catheter-delivered left atrial appendage closure device for people with atrial fibrillation. They signaled that although they thought the device should be made available they also thought that there should be significant restrictions on its use. The panel wrestled throughout […]
October 7th, 2014
A correction to the RE-LY trial results, partly brought to light because of litigation, has Harlan Krumholz wondering if this is another example of why we should have open access to clinical trial data.
August 21st, 2014
The FDA today approved an expanded indication for the oral anticoagulant apixaban (Eliquis, Bristol-Myers Squibb and Pfizer). Apixaban will now be indicated for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE (collectively known as venous thromboembolism) after initial therapy. The supplemental new […]
August 5th, 2014
Although thrombolysis for ischemic stroke has been widely recognized as beneficial, its use has been limited because of concerns about its effects in patients treated after 3 hours, in older patients, and in patients with mild and with severe strokes. Now a meta-analysis published in the Lancet offers evidence that the use of thrombolysis should be […]
July 23rd, 2014
Once again, dabigatran (Pradaxa) has raised the wrath of the critics. Several articles (see here, here, and here) and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the investigations editor for The […]
July 14th, 2014
Harlan Krumholz interviews Peter Berger, an editorialist for the HEAT-PPCI study, about the paper’s findings.
July 7th, 2014
Although there is broad consensus in the medical community that primary PCI is the best treatment for MI patients when it can be delivered promptly, there is no agreement about the best accompanying drug regimen, which usually entails a combination of antiplatelet and antithrombotic drugs. The role of one antithrombotic, bivalirudin (Angiomax, The Medicines Company) has […]
June 26th, 2014
Up to one third of ischemic strokes are of uncertain etiology or “cryptogenic,” meaning that there is no overt explanation such as severe carotid stenosis, intracranial stenosis, or documented atrial fibrillation (AF). For some of these patients, intermittent AF may be present and could explain the ischemic stroke. This issue has been addressed by two […]
June 17th, 2014
Jay Giri and Saurav Chatterjee discuss their meta-analysis of trials comparing thrombolytic therapy and conventional anticoagulation in patients at intermediate risk for pulmonary embolism.