October 20, 2009

October 19, 2009 (Washington, DC) — The Food and Drug Administration (FDA) has approved an expanded indication for the angiotensin-receptor blocker (ARB) telmisartan (Micardis, Boehringer Ingelheim Pharmaceuticals).

The drug can now be used to reduce the risk of MI, stroke, or death from cardiovascular causes in patients 55 years of age or older who are intolerant to ACE inhibitors but at high risk for cardiovascular events.

The expanded indication follows the recommendations of the Cardiovascular and Renal Drugs Advisory Committee advisory panel that met earlier this summer to discuss the new indication. The panel voted unanimously against expanding the indication for all high-risk patients and instead focused on those intolerant to an ACE inhibitor, namely ramipril.

The decision was based on data from the ONTARGET study, a noninferiority trial comparing telmisartan and ramipril in patients with diabetes or at high risk for cardiovascular events. As reported by heartwire , discussions hinged on the statistical noninferiority design of the study and were also complicated by the PROFESS and TRANSCEND studies, two trials where telmisartan was not shown to be better than placebo.

In the end, they voted 5 to 2 in favor of approving telmisartan to reduce clinical events in high-risk patients unable to take an ACE inhibitor because of side effects.

Also, the FDA approved a new telmisartan/amlodipine (Twynsta, Boehringer Ingelheim) combination agent for the treatment of hypertension, alone or in combination with other antihypertensive drugs or as initial therapy for patients who are likely to need multiple drugs to achieve their blood-pressure goals. The ARB/calcium-channel blocker combination is expected to be in US pharmacies by November.

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