June 17th, 2014
Mixed Results for Thrombolysis in Pulmonary Embolism
Larry Husten, PHD
The role of thrombolytic therapy for the treatment of pulmonary embolism has been unclear, as it has been difficult to measure the precise balance between enhanced clot-dissolving efficacy and greater bleeding risk produced by thrombolysis when compared with conventional anticoagulation. A new meta-analysis published in JAMA analyzed data from 16 randomized trials including 2115 patients. Overall, […]
May 19th, 2014
Lytics in STEMI: A New Analysis of Data from FAST-MI
Nicolas Danchin, MD, PhD and John Ryan, MD
French researchers analyze data from FAST-MI and conclude that a fibrinolysis-based strategy may be valid for some patients with STEMI.
May 13th, 2014
FDA Study Provides Some Reassurance About Boehringer Ingelheim’s Pradaxa
Larry Husten, PHD
In the latest development in its ongoing review of the new oral anticoagulant dabigatran (Pradaxa, Boehringer Ingelheim), the FDA today offered largely reassuring news about the sometimes controversial drug. The FDA study of over 134,000 Medicare patients found that dabigatran was associated with a reduced risk for ischemic stroke, bleeding in the brain, and death, compared with […]
May 8th, 2014
Novel Antiplatelet Agent Vorapaxar Gains FDA Approval
Larry Husten, PHD
The FDA today approved vorapaxar (Zontivity), Merck’s once-troubled platelet receptor antagonist, to reduce the risk of myocardial infarction (MI), stroke, cardiovascular death, and revascularization procedures. The drug is approved for use in people with a history of MI or peripheral arterial disease. The approval represents an amazing turnaround for a drug that has experienced nearly as many […]
April 7th, 2014
Dabigatran Approved for Treatment of DVT and PE
Larry Husten, PHD
Boehringer Ingelheim announced on Monday that the FDA has approved dabigatran (Pradaxa) for the treatment of venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. All three of the new oral anticoagulants — dabigatran, rivaroxaban (Xarelto), […]
March 14th, 2014
Apixaban Gains Indication for DVT Prophylaxis After Knee and Hip Replacement Surgery
Larry Husten, PHD
The FDA has approved a new indication for apixaban (Eliquis), the anticoagulant drug manufactured by Bristol-Myers Squibb and Pfizer. The new indication is for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism in patients who have undergone hip or knee replacement surgery. The DVT prophylaxis indication joins the previously approved indication of stroke prevention in patients who have […]
March 4th, 2014
AF Patients with Chronic Kidney Disease Also Benefit from Warfarin
Larry Husten, PHD
Anticoagulation is a cornerstone of therapy for atrial fibrillation because it lowers the heightened risk for stroke in this population. People with chronic kidney disease are also at increased risk for stroke, but the benefits of anticoagulation are less clear in this group, and anticoagulation is used less often in AF patients who have CKD. […]
February 27th, 2014
U.K. Geriatrician: Statins, Antihypertensives “Greatly” Overprescribed for Adults 80 and Older
Nicholas Downing, MD
“The data strongly suggest that we are over-treating many healthy patients aged 80+ regarding stroke prevention,” concludes U.K. geriatrician Kit Byatt in a perspective published in Evidence-Based Medicine. Byatt offers a brief review of the evidence, noting that the large HYVET study in China and Europe showed only modest stroke-prevention benefits with antihypertensive therapy in those […]
February 24th, 2014
What Is “Non-Valvular” Atrial Fibrillation?
Shengshou Hu, M.D.
Wes Fisher attempts to figure out what the latest marketing phrase – non-valvular atrial fibrillation – really means.
February 14th, 2014
FDA Once Again Rejects New Indication For Rivaroxaban
Larry Husten, PHD
The third time wasn’t the charm. The FDA today turned turned down — for the third time — the supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Johnson & Johnson) for use in acute coronary syndrome patients to reduce MI, stroke, or death. In addition, the FDA — for the second time — turned down the sNDA for rivaroxaban in […]