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
Division of Cardiology, Department of Internal Medicine, Kosin University College of Medicine, Gospel Hospital, Busan, Republic of Korea.
Cardiology Division, Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University, Seoul, Republic of Korea.
Clin Hypertens. 2022 Mar 1;28(1):7. 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.
本研究评估了替米沙坦40毫克/左旋氨氯地平2.5毫克固定剂量复方制剂（替米沙坦40/左旋氨氯地平2.5）与替米沙坦80毫克（替米沙坦80）相比，在接受40毫克替米沙坦治疗2 - 4周无反应的原发性高血压患者中的昼夜疗效。
符合条件的原发性高血压患者（诊室平均坐位收缩压[MSSBP]≥140毫米汞柱，糖尿病或慢性肾脏病患者≥130毫米汞柱）被随机分配至替米沙坦40/左旋氨氯地平2.5组或替米沙坦80组，治疗8周。所有患者在基线和8周后进行动态血压监测（ABPM）。主要终点是8周后24小时ABPM测得的24小时平均收缩压（SBP）和舒张压（DBP）相对于基线的变化。次要终点是日间、夜间和早晨的SBP和DBP变化，以及诊室MSSBP和平均舒张压（MSDBP）。
共纳入316例韩国患者，217例患者被随机分配接受治疗，192例患者完成研究。与替米沙坦80相比，替米沙坦40/左旋氨氯地平2.5在8周后24小时平均SBP和DBP降低方面表现出显著更好的效果。与替米沙坦80相比，替米沙坦40/左旋氨氯地平2.5在次要终点方面也有显著降低。在15例不良事件中（替米沙坦40/左旋氨氯地平2.5组7例，替米沙坦80组8例），有5例药物不良反应；14例事件为轻度，未发现组间有显著差异。
对于对40毫克替米沙坦反应不佳的原发性高血压患者，替米沙坦40/左旋氨氯地平2.5在降低24小时平均动态血压方面比替米沙坦80更有效且耐受性良好。我们的研究结果支持左旋氨氯地平和替米沙坦联合用药比增加替米沙坦单药剂量更合适这一事实。
ClinicalTrials.gov，NCT02231788。2014年9月4日注册。
