Review: A Single-Pill Combination of Telmisartan plus Amlodipine for the Treatment of Hypertension

Abstract

Despite an increased proportion of patients with hypertension achieving recommended blood pressure (BP) targets, BP control remains suboptimal in many patients. A range of combination therapies utilizing medications with differing mechanisms of action have been shown to provide superior BP-lowering efficacy than monotherapy with individual components. Single-pill combinations deliver improved convenience and may help to improve patient compliance. A single-pill combination of the angiotensin receptor blocker (ARB) telmisartan and the calcium channel blocker (CCB) amlodipine has recently been approved in 4 different doses (telmisartan/amlodipine 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg) for antihypertensive use in the United States. In an 8-week clinical study (N = 1461), these combinations were superior to monotherapy with telmisartan or with amlodipine with respect to the primary endpoint, change in diastolic BP (DBP) from baseline (mean baseline BP, 153.2 [± 12.1]/101.7 [± 4.3] mm Hg) to study end (placebo-corrected reductions of 10.3, 14.0, 12.0, and 13.9 mm Hg, respectively), as well as in multiple secondary endpoints, including change in systolic BP (SBP), DBP response, SBP response, BP control (< 140/< 90 mm Hg), and DBP control (< 90 mm Hg). The telmisartan plus amlodipine combinations were well tolerated, with the incidence of adverse events similar to placebo; the incidence of peripheral edema was lower with the 40 mg/10 mg and 80 mg/10 mg combinations than with amlodipine 10 mg alone. In another study (N = 858), the highest-dose combination (80 mg/10 mg) demonstrated superior BP-lowering efficacy than same-dose monotherapy with either telmisartan or amlodipine in patients with severe hypertension (SBP ≤ 180 and DBP ≤ 95 mm Hg). Single-pill telmisartan plus amlodipine combination therapy appears to be an effective and well-tolerated treatment as initial therapy for patients likely to require > 1 antihypertensive agent to reach BP targets.