The FDA Cardiovascular and Renal Drugs Advisory Committee turned down the proposed indication for telmisartan to reduce risk of myocardial infarction (MI) but did recommend a more narrow indication in patients who are intolerant of an ACE inhibitor.
As Sanjay Kaul explained to CardioBrief, “the panel wanted to ensure that patients who could tolerate ACE inhibitor should be on it as first line therapy and only substitute it with telmisartan if intolerant to ACE inhibitor due to cough or angioedema. The recommendation was based on the results of the TRANSCEND trial which showed a clinically meaningful benefit with telmisartan relative to placebo with respect to cardiovascular death, nonfatal myocardial infarction or nonfatal stroke.”
The “bottom line,” said Kaul, is to “start ACE inhibitors first in patients at high risk for cardiovascular events. If patients can not tolerate ACE inhibitors–about 5 to 15% depending upon gender (higher in females) and ethnicity (higher in Asians)–telmisartan offers a reasonable alternative.”
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