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.

Real-World Effectiveness and Safety of a Single-Pill Combination of Olmesartan/Amlodipine/Hydrochlorothiazide in Korean Patients with Hypertension and Cardiovascular Risk Factors

“…Among the subgroup of 385 patients taking 40/10/12.5 mg of O/A/H containing 10 mg of amlodipine, six patients (1.5%) experienced edema due to O/A/H administration. In comparison, a previous study by Guthrie reported a significantly higher edema incidence of 10.8% in a subset using an SPC of telmisartan and amlodipine 10 mg [30]. The lower edema incidence observed in the present study is likely due to the exclusion of patients who had previously experienced edema while using CCB before switching to O/A/H.…”

“…As previously mentioned, the target BP values in such patients are set lower than in those without concomitant risks. Although the more aggressive approach to antihypertensive treatment in patients with additional cardiovascular risk factors might theoretically lead to higher frequency of side effects associated with hypotension, the hypotension rate in the present study (1.51%) was within the range reported in previous studies on patients with similar characteristics (0.6–2.4%) [ 12 – 14 , 16 , 17 , 30 ]. An extension study of the TRINITY trial also showed that ADRs occurring in patients with additional cardiovascular risk were consistent with the established safety profile of O/A/H [ 15 ].…”

The Efficiency of Telmisartan in Hypertension Management as a Monotherapy or Combined; Literature Review

“…SPCs of telmisartan or hydrochlorothiazide have greater efficiency than monotherapy in all stages of hypertension [16]. Importantly, SPCs use resulted in fewer adverse effects, such as edema and hypokalemia, compared with amlodipine and hydrochlorothiazide monotherapy [16,17].…”

“…Similarly, an SPC of telmisartan and amlodipine, including all doses, provides superior BP reduction than other antihypertensive agents alone and demonstrates 24-hour BP control [17]. Indeed, telmisartan plus amlodipine might be a reasonable choice for hypertensive patients who likely will require more than one agent for BP control [17]. Furthermore, the use of SPC offers better patient adherence in comparison to a separate agent [17].…”

“…Indeed, telmisartan plus amlodipine might be a reasonable choice for hypertensive patients who likely will require more than one agent for BP control [17]. Furthermore, the use of SPC offers better patient adherence in comparison to a separate agent [17]. In comparing different ARB's combinations with telmisartan, a prospective, randomized, blinded multicenter trial comparing telmisartan plus hydrochlorothiazide with valsartan plus hydrochlorothiazide (V/HCTZ) [18].…”