Telmisartan was approved by the Food and Drug Administration for a new indication last month: reducing the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years or older who are at high risk of developing major cardiovascular events and cannot take ACE inhibitors.
Also approved by the FDA was a tablet formulation combining telmisartan with the calcium channel blocker amlodipine for treating hypertension.
Telmisartan, an angiotensin-II receptor blocker (ARB) marketed as Micardis, is manufactured by Boehringer Ingelheim Pharmaceuticals Inc. It was initially approved as an antihypertensive in 1998.
The revised label for telmisartan includes a statement that patients at high risk for cardiovascular (CV) events can use it with other needed treatments, such as antihypertensive, antiplatelet, or lipid-lowering therapy, but that use with an ACE inhibitor is not recommended. The approved dose for the cardiovascular risk reduction indication is 80 mg once daily.
The approval for CV risk reduction is supported by two studies involving patients aged 55 years and older who were at high CV risk, according to the revised label. In both, the primary end point was a composite of death from CV causes, MI, stroke, and hospitalization for heart failure; the secondary end point was a composite of CV death, MI, and stroke.
In ONTARGET (Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial), which compared 80 mg of telmisartan, 10 mg of ramipril, or the combination in 25,620 patients who did not have a history of intolerance to ACE inhibitors, the incidence of the primary end point was similar in patients treated with telmisartan (16.7%) and those treated with ramipril (16.5%) over a mean of about 54 months.
In TRANSCEND (Telmisartan Randomized Assessment Study in ACE Intolerant Subjects With Cardiovascular Disease), which compared 80 mg of telmisartan with placebo in almost 6,000 patients who had a history of intolerance to ACE inhibitors (mostly due to cough), the incidence of the primary end point was also similar in the two groups over a mean of 56 months: 15.7% among those on telmisartan and 17% among those on placebo. The incidence of the secondary end point, which did not include heart failure hospitalization, was significantly lower among those on telmisartan than in those on placebo (13% vs. 14.8%).
Although the rates of events in ONTARGET were similar between patients on telmisartan and those on ramipril, “the results did not unequivocally rule out that Micardis may not preserve a meaningful fraction of the effect of ramipril in reducing cardiovascular events,” the label states, but the results of both studies “do adequately support Micardis being more effective than placebo would be in this setting.”
The telmisartan-amlodipine combination tablet will be marketed under the trade name Twynsta, according to the company. There are four strengths: 40 mg of telmisartan with 5 mg or 10 mg of amlodipine and 80 mg of telmisartan with 5 mg or 10 mg of amlodipine.