CardioExchange Archive

Diabetes Doubles the Risk of Vascular Disease: An international group of investigators analyzed data from nearly 700,000 subjects without previous vascular disease enrolled in 102 prospective studies and found that diabetes appeared to double the risk of coronary disease, stroke, and other vascular deaths. In a presentation at the annual meeting of the American Diabetes Association and in a paper in The Lancet, the researchers estimated that diabetes accounts for 10-12% of all vascular deaths.

Once-Weekly Exenatide Performs Well in Study:  DURATION-3 was also published in The Lancet and presented at the ADA meeting. The trial randomized 456 type-2 diabetics with suboptimal glycemic control to either once-weekly exenatide or insulin glargine for 26 weeks. Exenatide treatment resulted in a greater reduction in HbA1c than insulin glargine, and was also associated with a mean weight loss of 2.6 kg per patient. But in an accompanying comment, Anoop Misra and Shashank Joshi write that “enthusiasm about this drug is similar to that seen in the initial phase of development and use curve of any new drug. Historical data that show novel and prohibitive adverse reactions with approved drugs have taught us to be cautiously optimistic. In particular, it will take time and specifically designed trials for accrual of valid cardiovascular safety data.”

New Agent to Control Glucose: Also presented at the ADA meeting and published in The Lancet were the results of a phase-3, double-blind, parallel-group, placebo-controlled trial of dapagliflozin, a novel agent that is a selective sodium-glucose cotransporter-2 inhibitor, in 546 type-2 diabet with inadequate glycemic control despite taking metformin. Clifford Bailey and colleagues report that the drug improves glycemic control independently of insulin and also causes weight loss. HbA1c decreased in a dose-dependent manner in the dapagliflozin groups, without causing any increase in hypoglycemia. On the worrisome side, genital infections occurred more frequently in the dapagliflozin groups, which may be a result of the increased glucose in the urine.
Vernakalant Gains Recommendation for Approval in Europe: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing approval for vernakalant (Brinavess, Merck, Cardiome), a novel IV anti-arrhythmic agent. The approved indication is for the “rapid conversion of recent onset of atrial fibrillation to sinus rhythm in adults” for non-surgery patients with atrial fibrillation of seven days or less and for post-cardiac surgery patients with atrial fibrillation of three days or less.