Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan: A Randomized, Double-blind, Multicenter Study
- PMID: 27720505
- DOI: 10.1016/j.clinthera.2016.09.006
Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan: A Randomized, Double-blind, Multicenter Study
Abstract
Purpose: The objective of this study was to evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan (S-AM/TEL) compared with TEL monotherapy in patients with hypertension inadequately controlled by TEL monotherapy.
Methods: this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/TEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy. The primary end point was the change in the mean sitting diastolic blood pressure from baseline (week 0) after 8 weeks of therapy between treatment groups.
Findings: Of 325 patients screened, 183 were randomly assigned to 3 groups (61 in the S-AM/TEL 2.5/40-mg group, 60 in the S-AM/TEL 5/40-mg group, and 62 in the TEL 80-mg group). Mean (SD) age was 53.9 (7.5) years, and male patients comprised 87%. No significant differences were found among the 3 groups in baseline characteristics. The primary end points, the changes of mean (SD) diastolic blood pressure at week 8 from the baseline were -10.56 (7.23) mm Hg in the S-AM/TEL 2.5/40-mg group, -12.32 (9.23) mm Hg in the S-AM/TEL 5/40-mg group, and -2.44 (7.92) mm Hg in the TEL 80-mg group. Both the S-AM/TEL 2.5/40-mg group and the S-AM/TEL 5/40-mg group had a statistically superior hypotensive effect compared with the TEL 80-mg group (P < 0.0001 for both). For evaluation of the safety profile, the frequencies of adverse events (AEs) among the groups were also not significantly different (S-AM/TEL 2.5/40-mg group, 18.6%; S-AM/TEL 5/40-mg group, 20%; and TEL 80-mg group, 22.6%), and the incidences of AEs were not different among the groups. The most common AEs were respiratory disorders, followed by headache, dizziness, and peripheral edema.
Implications: Treatment with S-AM/TEL 2.5/40 mg and S-AM/TEL 5/40 mg was superior to increasing the TEL dose in terms of hypotensive effect in patients with hypertension inadequately controlled by TEL monotherapy. S-AM/TEL fixed-dose combinations are an effective and tolerable option for patients inadequately responding to TEL monotherapy and also a good option for improving patients' medication adherence. ClinicalTrials.gov identifier: NCT011426100.
Keywords: S-amlodipine; blood pressure; fixed-dose combinations; hypertension; single-pill combination; telmisartan.
Copyright © 2016. Published by Elsevier Inc.
Similar articles
-
Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus Telmisartan/Amlodipine Combination Therapy for Essential Hypertension Uncontrolled With Telmisartan/Amlodipine: The Phase III, Multicenter, Randomized, Double-blind TAHYTI Study.Clin Ther. 2018 Jan;40(1):50-63.e3. doi: 10.1016/j.clinthera.2017.11.006. Epub 2017 Dec 14. Clin Ther. 2018. PMID: 29248384 Clinical Trial.
-
Comparison of Fixed-dose Combinations of Amlodipine/Losartan Potassium/Chlorthalidone and Amlodipine/Losartan Potassium in Patients With Stage 2 Hypertension Inadequately Controlled With Amlodipine/Losartan Potassium: A Randomized, Double-blind, Multicenter, Phase III Study.Clin Ther. 2017 Oct;39(10):2049-2060. doi: 10.1016/j.clinthera.2017.08.013. Epub 2017 Sep 19. Clin Ther. 2017. PMID: 28939406 Clinical Trial.
-
Efficacy and safety of two fixed-dose combinations of S-amlodipine and telmisartan (CKD-828) versus S-amlodipine monotherapy in patients with hypertension inadequately controlled using S-amlodipine monotherapy: an 8-week, multicenter, randomized, double-blind, Phase III clinical study.Drug Des Devel Ther. 2016 Nov 23;10:3817-3826. doi: 10.2147/DDDT.S116847. eCollection 2016. Drug Des Devel Ther. 2016. PMID: 27920497 Free PMC article. Clinical Trial.
-
Review: a single-pill combination of telmisartan plus amlodipine for the treatment of hypertension.Postgrad Med. 2011 Nov;123(6):58-65. doi: 10.3810/pgm.2011.11.2495. Postgrad Med. 2011. PMID: 22104454 Review.
-
Telmisartan/amlodipine: single-pill combination in hypertension.Am J Cardiovasc Drugs. 2010;10(6):401-12. doi: 10.2165/11204880-000000000-00000. Am J Cardiovasc Drugs. 2010. PMID: 21090832 Review.
Cited by
-
Systematic Review with Network Meta-Analysis: Comparative Efficacy and Safety of Combination Therapy with Angiotensin II Receptor Blockers and Amlodipine in Asian Hypertensive Patients.Int J Hypertens. 2019 Nov 11;2019:9516279. doi: 10.1155/2019/9516279. eCollection 2019. Int J Hypertens. 2019. PMID: 31827918 Free PMC article.
-
S-Amlodipine: An Isomer with Difference-Time to Shift from Racemic Amlodipine.Int J Hypertens. 2018 May 20;2018:8681792. doi: 10.1155/2018/8681792. eCollection 2018. Int J Hypertens. 2018. PMID: 29887996 Free PMC article. Review.
-
Efficacy of single-pill combination in uncontrolled essential hypertension: A systematic review and network meta-analysis.Clin Cardiol. 2023 Aug;46(8):886-898. doi: 10.1002/clc.24082. Epub 2023 Jul 11. Clin Cardiol. 2023. PMID: 37432701 Free PMC article.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical