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

• Published in: Clinical hypertension Vol. 28; no. 1; p. 7
• Main Authors: Kim, Bong-Joon, Cho, Kyoung-Im, Kwon, Hyuck Moon, Choi, Seung-Min, Yoon, Chang-Hwan, Lim, Sang Wook, Joo, Seung-Jae, Lee, Nam Ho, Lim, Sang-Yup, Lim, Seong-Hoon, Kim, Hyo-Soo
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 01-03-2022; BioMed Central; BMC; 대한고혈압학회
• Subjects: Amlodipine; Blood pressure; Care and treatment; Chronic kidney failure; Circadian rhythm; Comparative analysis; Diabetes; Dosage and administration; Drug combinations; Drug therapy, Combination; Essential hypertension; Hypertension; Medical research; Medicine, Experimental; Telmisartan; 내과학; South Korea; Amlodipine; Essential hypertension; Circadian rhythm; Drug combinations; Telmisartan
• ISSN: 2056-5909; 2635-6325; 2056-5909
• DOI: 10.1186/s40885-021-00184-0

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.
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.
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.
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.
ClinicalTrials.gov , NCT02231788 . Registered 4 September 2014.