Park Chang Gyu, Ahn Tae Hun, Cho Eun Ju, Kim Won, Kim Hyung Seob, Yang Ju Yeong, Ryu Jae Geun, Kim Cheol Ho, Hyeon Min Soo, Tak Seung Je, Im Se Jung, Ha Jong Won, Pyeon Wook Beom, Jae Je Geon, Han Gyu Rok, Doh Jun Hyung, Im Sang Wook, Lee Myeong Muk
Cardiology Division, Korea University Guro Hospital, Seoul, Korea.
Gachon University Gil Medical Center, Seoul, Korea.
Clin Ther. 2016 Oct;38(10):2185-2194. doi: 10.1016/j.clinthera.2016.09.006. Epub 2016 Oct 6.
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.
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.
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.
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.
本研究的目的是评估固定剂量复方制剂氨氯地平与替米沙坦（S-AM/TEL）相较于替米沙坦单药治疗，在替米沙坦单药治疗血压控制不佳的高血压患者中的疗效和安全性。
本研究是一项随机、多中心、双盲、平行组、III期、为期8周的临床试验，比较S-AM/TEL 2.5/40毫克和S-AM/TEL 5/40毫克复方制剂与替米沙坦80毫克单药治疗的优越性。主要终点是治疗组治疗8周后平均坐位舒张压相对于基线（第0周）的变化。
在325例筛查患者中，183例被随机分配到3组（S-AM/TEL 2.5/40毫克组61例，S-AM/TEL 5/40毫克组60例，替米沙坦80毫克组62例）。平均（标准差）年龄为53.9（7.5）岁，男性患者占87%。3组基线特征无显著差异。主要终点，即第8周时平均（标准差）舒张压相对于基线的变化，在S-AM/TEL 2.5/40毫克组为-10.56（7.23）毫米汞柱，在S-AM/TEL 5/40毫克组为-12.32（9.23）毫米汞柱，在替米沙坦80毫克组为-2.44（7.92）毫米汞柱。S-AM/TEL 2.5/40毫克组和S-AM/TEL 5/40毫克组的降压效果在统计学上均优于替米沙坦80毫克组（两组P均<0.0001）。为评估安全性，各组不良事件（AE）发生率也无显著差异（S-AM/TEL 2.5/40毫克组为18.6%，S-AM/TEL 5/40毫克组为20%，替米沙坦80毫克组为22.6%），且各组AE发生率无差异。最常见的AE是呼吸系统疾病，其次是头痛、头晕和外周水肿。
对于替米沙坦单药治疗血压控制不佳的高血压患者，S-AM/TEL 2.5/40毫克和S-AM/TEL 5/40毫克治疗在降压效果方面优于增加替米沙坦剂量。S-AM/TEL固定剂量复方制剂对于替米沙坦单药治疗反应不佳的患者是一种有效且可耐受的选择，也是提高患者用药依从性的良好选择。ClinicalTrials.gov标识符：NCT011426100。
