Effect of a fixed-dose combination of Telmisartan/S-amlodipine on circadian blood pressure compared with Telmisartan monotherapy: TENUVA-BP study

Bibliographic Details
Title: Effect of a fixed-dose combination of Telmisartan/S-amlodipine on circadian blood pressure compared with Telmisartan monotherapy: TENUVA-BP study
Authors: Bong-Joon Kim, Kyoung-Im Cho, Hyuck Moon Kwon, Seung-Min Choi, Chang-Hwan Yoon, Sang Wook Lim, Seung-Jae Joo, Nam Ho Lee, Sang-Yup Lim, Seong-Hoon Lim, Hyo-Soo Kim
Source: Clinical Hypertension, Vol 28, Iss 1, Pp 1-10 (2022)
Publisher Information: BMC, 2022.
Publication Year: 2022
Collection: LCC:Medicine
LCC:Internal medicine
Subject Terms: Amlodipine, Circadian rhythm, Drug combinations, Essential hypertension, Telmisartan, Medicine, Internal medicine, RC31-1245
More Details: Abstract Background This study evaluated the circadian efficacy of a telmisartan 40 mg/S-amlodipine 2.5 mg fixed-dose combination (Telmisartan40/S-Amlodipine2.5) compared to telmisartan 80 mg (Telmisartan80) in patients with essential hypertension who did not respond to 2–4 weeks’ treatment with telmisartan 40 mg. Methods Eligible patients with essential hypertension (clinic mean sitting systolic blood pressure [MSSBP] ≥140 mmHg, or ≥ 130 mmHg in those with diabetes mellitus or chronic kidney disease) were randomly assigned to Telmisartan40/S-Amlodipine2.5 or Telmisartan80 for 8 weeks. All patients underwent ambulatory BP monitoring (ABPM) at baseline and 8 weeks later. Primary endpoints were changes in mean 24-h SBP and DBP on 24-h ABPM from baseline after 8 weeks. Secondary endpoints were changes in daytime, nighttime, and morning SBP and DBP, and clinic MSSBP and MSDBP. Results A total of 316 Korean patients were enrolled, 217 patients were randomized to treatment, and 192 patients completed the study. Compared to Telmisartan80, Telmisartan40/S-Amlodipine2.5 showed significantly better reductions in 24-h mean SBP and DBP after 8 weeks. Telmisartan40/S-Amlodipine2.5 also significantly reduced secondary endpoints compared to Telmisartan80. Among 15 adverse events (7 [Telmisartan40/S-Amlodipine2.5] and 8 [Telmisartan80]), there were five adverse drug reactions; 14 events were mild, and none were identified with significant between-group differences. Conclusions Telmisartan40/S-Amlodipine2.5 was tolerable and more effective than Telmisartan80 in lowering 24-h mean ambulatory BP in patients with essential hypertension not responding adequately to Telmisartan40. Our findings support the fact that the combination of S-amlodipine with telmisartan is more appropriate than increasing the dose of telmisartan monotherapy. Trial registration ClinicalTrials.gov , NCT02231788 . Registered 4 September 2014.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2056-5909
Relation: https://doaj.org/toc/2056-5909
DOI: 10.1186/s40885-021-00184-0
Access URL: https://doaj.org/article/69629f725a79468083e3da1ae50fd505
Accession Number: edsdoj.69629f725a79468083e3da1ae50fd505
Database: Directory of Open Access Journals
More Details
ISSN:20565909
DOI:10.1186/s40885-021-00184-0
Published in:Clinical Hypertension
Language:English