Clin Hypertens.  2022;28(1):7. 10.1186/s40885-021-00184-0.

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

Affiliations
  • 1Division of Cardiology, Department of Internal Medicine, Kosin University College of Medicine, Gospel Hospital, Busan, Republic of Korea.
  • 2Cardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University, Seoul, Republic of Korea
  • 3Department of Cardiology, National Medical Center, Seoul, Republic of Korea.
  • 4Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
  • 5Division of Cardiology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Republic of Korea
  • 6Department of Internal Medicine, Jeju National University Hospital, Jeju, Republic of Korea
  • 7Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, Republic of Korea.
  • 8Department of Cardiology, Korea University Ansan Hospital, Ansan, Republic of Korea.
  • 9Cardiovascular Division, Department of Internal Medicine, Dankook University Hospital, Cheonan, Republic of Korea.
  • 10Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.

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.

Keyword

Amlodipine; Circadian rhythm; Drug combinations; Essential hypertension; Telmisartan
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