CardioExchange Archive

PFO Closure Trial Misses Primary Endpoint:  The CLOSURE 1 trial, which was designed to test the efficacy of PFO closure in preventing recurrent strokes and TIAs, failed to meet its primary endpoint, according to a press release from the trial’s sponsor, NMT Medical.  The primary endpoint of the trial, which was designed to compare PFO closure to medical therapy in 900 patients with documented stroke or TIA who had a PFO, was the two-year rate of stroke or TIA, as well as all-cause mortality for the first 30 days of follow-up or hospital discharge, whichever is longer, and neurological mortality from >31 days of follow-up.

New Concerns Raised Over Insulin Glargine and Taspoglutide: A study published online in Diabetes Care found an increase in the risk of cancer associated with higher doses of insulin glargine (Lantus, Sanofi). A Sanofi representative told Bloomberg News that the study was too small to be reliable. The study appears almost exactly one year after studies in Europe first raised cancer concerns over the drug.

The development of taspoglutide, which had been the subject of a series of promising press releases from its manufacturer, Roche, will now be delayed for at least 12-18 months. In a press release, Roche said it had found a higher than expected rate of hypersensitivity in phase-3 studies and that it would implement a risk-mitigation plan.
INTERSTROKE: Accounting for Stroke: Ten risk factors appear to account for 90% of the risk of stroke, according to INTERSTROKE, a large study presented at the World Congress of Cardiology in Beijing and published online in the Lancet. The study compared 3000 stroke patients (78% with ischemic stroke) in 22 countries and identified hypertension as the most important risk factor, associated with one-third the risk for all strokes. The other risk factors were smoking, waist-to-hip ratio, diet, physical activity, lipids, diabetes, alcohol intake, stress and depression, and cardiac disorders. For intracerebral hemorrhage, hypertension, smoking, waist-to-hip ratio, diet, and alcohol were independently significant.

With the exception of cardiac disorders, the risk factors are the same as those found in the related INTERHEART study of risk factors for MI, though the relative importance of the factors differed between the studies: lipids and not hypertension were the most important risk factor in INTERHEART. The authors conclude that “targeted interventions that reduce blood pressure and smoking, and promote physical activity and a healthy diet, could substantially reduce the global burden of stroke.”