Strategic Marketing and Market Support Department, Bosnalijek d.d., Bosnia and Herzegovina.
Scientific Research Unit, Bosnalijek d.d., Bosnia and Herzegovina.
Acta Med Acad. 2022 Dec;51(3):163-174. doi: 10.5644/ama2006-124.385. Epub 2022 Dec 15.
The objective of this non-interventional post-marketing clinical trial was to analyze the antihypertensive effect and safety of a fixed combination of perindopril and indapamide in the treatment of unregulated essential hypertension.
The prospective clinical trial included patients aged 20 to 75 years with essential hypertension and blood pressure values ≥ 140/90 mmHg at baseline. On the basis of the investigator's decision, patients received 2 mg perindopril + 0.625 mg indapamide (group 2+0.625) or 4 mg perindopril + 1.25 mg indapamide (group 4+1.25).
The study included 1173 patients (426 patients in group 2+0.625 and 747 patients in group 4+1.25) at 27 investigational centers in Bosnia and Herzegovina. Mean blood pressure values at baseline and visits after nine months were significantly higher in the 4+1.25 group compared to the 2+0.625 group. There was a significant drop in systolic and diastolic blood pressure in both groups. The target values of systolic and diastolic blood pressure, according to the European Society of Cardiology (2018), were reached after nine months of therapy by more than 80% of patients in the 2+0.625 group, and this number was significantly higher compared to the 4+1.25 group where more than 60% of patients reached target values. Newly diagnosed patients had a better response to therapy. The percentage of patients receiving additional antihypertensive therapy decreased by the end of the study. Age, gender and the existence of diabetes mellitus were identified as negative predictors of target blood pressure achievement. The therapy showed a good safety profile.
A fixed combination of perindopril and indapamide was effective and safe in the treatment of unregulated essential hypertension.
本非干预性上市后临床研究旨在分析培哚普利与吲达帕胺固定复方制剂治疗未控制的原发性高血压的降压效果和安全性。
这项前瞻性临床试验纳入了年龄在 20 至 75 岁之间、基线时血压值≥140/90mmHg 的原发性高血压患者。根据研究者的决定，患者接受 2mg 培哚普利+0.625mg 吲达帕胺（2+0.625 组）或 4mg 培哚普利+1.25mg 吲达帕胺（4+1.25 组）治疗。
该研究在波斯尼亚和黑塞哥维那的 27 家研究中心纳入了 1173 例患者（2+0.625 组 426 例，4+1.25 组 747 例）。与 2+0.625 组相比，4+1.25 组的基线和 9 个月时的平均血压值显著更高。两组的收缩压和舒张压均显著下降。根据欧洲心脏病学会（2018 年）的标准，2+0.625 组中有超过 80%的患者在 9 个月的治疗后达到了收缩压和舒张压的目标值，这一数字显著高于 4+1.25 组，该组中超过 60%的患者达到了目标值。新诊断的患者对治疗的反应更好。在研究结束时，接受额外降压治疗的患者比例下降。年龄、性别和糖尿病的存在被确定为血压目标达标率的负预测因素。该治疗方案显示出良好的安全性。
培哚普利与吲达帕胺固定复方制剂治疗未控制的原发性高血压有效且安全。
