Hacettepe University Faculty of Medicine, Ankara, Turkey.
Hitit University Corum Training and Research Hospital, Corum, Turkey.
Biomed Res Int. 2020 Sep 5;2020:2123601. doi: 10.1155/2020/2123601. eCollection 2020.
Maintaining regular blood pressure control usually requires multidrug regimens rather than monotherapy. The objective of this study was to describe the effectiveness and safety of an angiotensin-converting enzyme inhibitor and a nondihydropyridine calcium channel blocker in a single-tablet combination in patients with hypertension, a heart rate higher than 70 beats/min, and type 2 diabetes mellitus (T2DM). This study was conducted in Turkey as a prospective, noninterventional, observational study. At 22 clinical sites, the data of 200 patients with hypertension were used for efficacy analysis; however, 262 patients received at least one dose of trandolapril/verapamil fixed-dose combination at two dose strengths. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate, PR interval, glycated haemoglobin (HbA1c), and albumin/creatinine ratios were recorded during 8 weeks of treatment. With treatment, the mean (±SD) SBP that was recorded as 162.8 (±14.642) mm Hg at baseline was reduced to 131.7 ± 11.1 mm Hg at week 8 ( < 0.05). Similarly, the mean DBP was reduced from 93.76 ± 9.16 mm Hg to 77.6 ± 7.6 mm Hg ( < 0.001). Following 8 weeks of treatment, SBP and DBP values were reduced below 140 mm Hg and 90 mm Hg in most patients (81.5%), respectively. The mean heart rate as evaluated using electrocardiography measurements was reduced to 78.25 beats/min at week 8 as compared with baseline during trandolapril/verapamil single-pill combination treatment ( < 0.001). Treatment with trandolapril and verapamil was well tolerated over 8 weeks with no unexpected safety signals. In conclusion, the single-pill combination of trandolapril and verapamil was considered effective in reducing and controlling blood pressure in patients with hypertension and T2DM. There was a significant improvement in HbA1c and ACR levels in a smaller subgroup of the patient cohort. The trandolapril/verapamil combination was evaluated as being safe and well-tolerated following a treatment period of 8 weeks. This trial was registered with NCT02298556.
维持规律的血压控制通常需要多药物治疗方案，而不是单一药物治疗。本研究的目的是描述血管紧张素转换酶抑制剂和非二氢吡啶类钙通道阻滞剂在单一片剂联合治疗中对高血压、心率高于 70 次/分钟和 2 型糖尿病（T2DM）患者的有效性和安全性。这项研究在土耳其进行，是一项前瞻性、非干预性、观察性研究。在 22 个临床地点，对 200 名高血压患者的数据进行了疗效分析；然而，有 262 名患者接受了两种剂量强度的曲多普利/维拉帕米固定剂量联合治疗，至少服用了一剂。在 8 周的治疗期间，记录收缩压（SBP）、舒张压（DBP）、心率、PR 间期、糖化血红蛋白（HbA1c）和白蛋白/肌酐比值。治疗后，基线时记录的平均（±SD）SBP 为 162.8（±14.642）mmHg，第 8 周降至 131.7±11.1mmHg（<0.05）。同样，平均 DBP 从 93.76±9.16mmHg 降至 77.6±7.6mmHg（<0.001）。经过 8 周的治疗，大多数患者（81.5%）的 SBP 和 DBP 值分别降至 140mmHg 和 90mmHg 以下。与曲多普利/维拉帕米单一片剂联合治疗的基线相比，使用心电图测量的平均心率在第 8 周时降至 78.25 次/分钟（<0.001）。曲多普利和维拉帕米联合治疗 8 周耐受性良好，无意外安全信号。总之，曲多普利和维拉帕米的单一片剂联合治疗可有效降低和控制高血压合并 T2DM 患者的血压。在患者队列的一个较小亚组中，HbA1c 和 ACR 水平显著改善。在 8 周的治疗期间，曲多普利/维拉帕米联合治疗被评估为安全且耐受良好。该试验在 NCT02298556 注册。
