Efficacy and Tolerability of Telmisartan Plus Amlodipine in Asian Patients Not Adequately Controlled on Either Monotherapy or on Low-Dose Combination Therapy

Dingliang Zhu,Pingjin Gao,Nobutaka Yagi,Helmut Schumacher

doi:10.1155/2014/475480

Abstract

Objective. To evaluate the efficacy and safety of the telmisartan plus amlodipine (T/A) single-pill combination (SPC) in Asian patients with hypertension whose blood pressure (BP) was not adequately controlled on either monotherapy or on low-dose combination therapy. Patients and Methods. Data are presented from five Boehringer Ingelheim-sponsored phase 3, double-blind, 8-week, studies: two studies in nonresponders to amlodipine (data pooled for amlodipine), two studies on nonresponders to telmisartan (pooled data), and one on nonresponders to low-dose T/A SPC. Results. After 8 weeks' treatment, mean reductions from the reference baseline in diastolic BP (DBP; primary endpoint), systolic BP (SBP), and SBP, DBP goal, and response rates were higher with the T/A SPC than respective monotherapies. The T80/A5 SPC resulted in greater reductions in DBP and SBP, and higher DBP goal and response rate than the low-dose T40/A5 SPC. Peripheral edema incidence was low (amlodipine 0.5%, telmisartan 0.0%, and T/A SPC 0.7%). Discussion and Conclusion. In Asian patients whose BP is not adequately controlled with telmisartan or amlodipine monotherapy, T/A SPC treatment results in greater BP reduction, and higher DBP and SBP goal and response rates. The safety and tolerability of the T/A SPC are comparable to those of the respective monotherapies and consistent with those reported in previous studies.

Highlights

In the Asia Pacific Cohort Studies Collaboration, up to 66% of some subtypes of cardiovascular (CV) disease in the Asia Pacific region were attributed to hypertension [1]
After 8 weeks’ treatment, mean reductions from the reference baseline in diastolic blood pressure (BP) (DBP; primary endpoint), systolic BP (SBP), and SBP, DBP goal, and response rates were higher with the telmisartan plus amlodipine (T/A) single-pill combination (SPC) than respective monotherapies
The telmisartan 80 mg/A5 (T80/A5) SPC resulted in greater reductions in DBP and SBP, and higher DBP goal and response rate than the low-dose telmisartan 40 mg/amlodipine mg (T40/A5) SPC

Summary

Introduction

In the Asia Pacific Cohort Studies Collaboration, up to 66% of some subtypes of cardiovascular (CV) disease in the Asia Pacific region were attributed to hypertension [1]. High blood pressure (BP) was associated with an increased risk for CV diseases, stroke, and heart disease among the Japanese [2,3,4] and Chinese population [5]. The Evidence for Cardiovascular Prevention from Observational Cohorts in Japan Research Group (EPOCH-JAPAN) study reported an approximate 20% hypertension prevalence in the Japanese population [6]. At least 75% of patients with hypertension require combination therapy to achieve early BP goal [10], and guidelines recommend fixed-dose singlepill combinations (SPC) for their simplicity of treatment, convenience, and cost effectiveness [11, 12]. SPCs improve treatment adherence, resulting in better BP control and longterm CV risk reduction [13,14,15]. Significant improvement in compliance and nonsignificant beneficial trends in BP and adverse effects have been observed with SPCs compared with free drug combinations [18]

Methods

Results

Discussion

Conclusion