CV analysis of saxagliptin provides neutral findings

摘要

THE diabetes drug saxagliptin did not increase risk of heart attack and stroke in a large postmarketing trial reported earlier this week. At the same time, although the drug improved glycaemic control, it did not provide any cardioprotective benefit. There was also an increase in hospital admissions for heart failure. The trial was reported at the European Society of Cardiology annual congress and simultaneously published online in The New England Journal of Medicine. Licensing authorities now require cardiovascular outcome studies to assess the safety of glucose-lowering drugs. The saxagliptin trial, known as SAVOR-TIMI 53, is the first of several gliptin outcome studies to be reported. The 26-counrry trial involved 16,492 patients with type 2 diabetes who had a history of cardiovascular events or were at high risk. They were given saxagliptin or placebo, on top of standard care, and then followed-up for two years. Saxagliptin neither increased nor reduced the risk of the primary composite endpoint of cardiovascular death, myocardial infarction or ischaemic stroke. It was non-inferior to placebo (P<0.001 for non-inferiority) but not superior (P=0.99 for superiority).