October 20th, 2010
Dabigatran Is Approved
John Mandrola, MD, FACC
John Mandrola is a cardiac electrophysiologist and blogger on matters medical and general. Here is a recent post from his blog Dr John M. There can only be one cardiology story to discuss today. Tuesday, the FDA approved dabigatran (Pradaxa), an oral anticoagulant for the prevention of stroke in atrial fibrillation. Previously, the only drug approved to prevent stroke in […]
October 20th, 2010
FDA Approves Dabigatran for Stroke Prevention in Atrial Fibrillation
Larry Husten, PHD
The FDA announced on Tuesday that it has approved Pradaxa (dabigatran, Boehringer Ingelheim) for the prevention of stroke and blood clots in patients with atrial fibrillation. The drug will be available in 75-mg and 150-mg capsules. “Unlike warfarin, which requires patients to undergo periodic monitoring with blood tests, such monitoring is not necessary for Pradaxa,” said […]
October 13th, 2010
No Conflict, No Interest
Shanti Bansal, MD
On a brisk, cold evening I boarded an overnight plane from my hometown to Cincinnati. Once I landed, a gentleman dressed in a black suit with a grin over his face was waiting for me at the airport to drive me to my hotel. The driver led me through green untouched pastures and over a […]
September 30th, 2010
Don’t Take My Fun Away
John Mandrola, MD, FACC
John Mandrorla is a cardiac electrophysiologist and blogger on matters medical and general. In a recent post to his blog Dr John M, he celebrates his enduring sense that doctoring is still a great job.
September 28th, 2010
ICD Software Upgrade Can Reduce Inappropriate Shocks from Faulty Leads
Larry Husten, PHD
A software upgrade for ICDs can help reduce inappropriate shocks, according to a study published online in Circulation. Following reports of high failure rates of Sprint Fidelis defibrillation leads, a software program known as a lead-integrity alert (LIA) was developed for download into previously implanted ICDs. Charles Swerdlow and colleagues compared 213 ICD patients who received the […]
September 21st, 2010
See Everything
John Mandrola, MD, FACC
John Mandrola is a cardiac electrophysiologist and blogger on matters medical and general. Here is a recent post from his blog Dr John M. Do you see anything wrong with this picture? (Hint: see the right column) I guess the European electrophysiologists couldn’t wait for us in North America. They have published their own 54,000 word Euro-specific guidance […]
September 20th, 2010
FDA Panel Unanimously Recommends Approval for Dabigatran
Larry Husten, PHD
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favor of approval of dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF. The panel was split on whether both dosages (150 mg bid and 110 mg bid) used in the RE-LY trial should gain approval, although in an informal straw […]
September 17th, 2010
FDA Grants Expanded Indication to CRT-D Devices
Larry Husten, PHD
The FDA has expanded the indication for CRT-D devices made by Boston Scientific. Previously, the devices had been approved only in NYHA Class III and IV patients. The expanded indication now includes Class I and II patients who have left bundle branch block. The expanded indication is based on data from the MADIT-CRT trial. “This approval […]
August 31st, 2010
Apixaban Beats Aspirin for Stroke Prevention in AF
Larry Husten, PHD
The AVERROES (Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Strokes) trial randomized 5600 AF patients who were unable to take warfarin to receive either aspirin or apixaban, a factor Xa inhibitor. (Another trial still underway, ARISTOTLE, is a direct comparison of warfarin and apixaban in AF.) AVERROES was stopped early after the Data Monitoring Committee […]
August 29th, 2010
Superiority of Dabigatran More Evident in Places Where INR Is Not Well Controlled
Larry Husten, PHD
At last year’s ESC meeting, the RE-LY trial heightened interest in the prospect of dabigatran as a potential replacement for warfarin. Now the RE-LY investigators have analyzed the trial data in an attempt to see whether the local standard of care has an impact on the beneficial effects of switching to dabigatran. In a presentation […]