People's Friendship University of Russia, Moscow, Russia.
Department of Medical Affairs, Servier Russia, Moscow, Russia.
Adv Ther. 2023 Jun;40(6):2725-2740. doi: 10.1007/s12325-023-02462-9. Epub 2023 Apr 8.
This study assessed the real-life effectiveness of a single-pill combination (SPC) of bisoprolol/perindopril for controlling blood pressure (BP) and symptoms of angina in patients with hypertension and a history of myocardial infarction (MI).
Eligible patients with arterial hypertension and a history of MI were aged 18-79 years and had initiated bisoprolol/perindopril SPC within 3 months of study enrollment as part of routine Russian clinical practice. The primary endpoint was mean change in systolic and diastolic BP (SBP/DBP) at week 12 compared with baseline (data collected retrospectively). Secondary endpoints were assessed at weeks 4 and 12 and included mean change in resting heart rate (HR), proportion of patients reaching target level of resting HR, antianginal effectiveness of the SPC, and proportion of patients reaching target BP levels.
A total of 504 patients were enrolled, of whom 481 comprised the full analysis set (mean age 61.4 ± 8.9 years, 68% men). Mean baseline SBP/DBP and HR values were 148.9 ± 16.8/87.7 ± 11.0 mmHg and 77.4 ± 10.5 bpm, respectively. Mean durations of hypertension and CAD were 12.8 ± 8.4 and 6.1 ± 6.3 years, respectively, and time since MI was 3.8 ± 5.3 years. At week 12, SBP/DBP had decreased by 24.9/12.2 mmHg (P < 0.001 vs baseline). Target BP (< 140/90 mmHg) was achieved by 69.8% and 95.9% of patients at weeks 4 and 12, respectively, and target HR (55-60 bpm) by 17.3% and 34.5% at weeks 4 and 12 versus 3.1% at baseline (P < 0.001). Reductions in angina attacks, nitrate consumption, and improvements in HR were statistically significant. Treatment was well tolerated.
Treatment of symptomatic patients with CAD, hypertension, and a history of MI with a bisoprolol/perindopril SPC was associated with significant decreases in SBP/DBP and a high proportion of patients achieving BP treatment goals. This was accompanied by improvements in angina symptoms and reductions in HR in a broad patient population representative of those seen in everyday clinical practice.
ClinicalTrials.gov Identifier NCT04656847.
本研究评估了比索洛尔/培哚普利单片复方制剂(SPC)在控制血压(BP)和高血压合并心肌梗死(MI)病史患者心绞痛症状方面的真实疗效。
年龄在 18-79 岁之间的符合条件的患者患有动脉高血压和 MI 病史,且在研究入组后 3 个月内开始接受比索洛尔/培哚普利 SPC 治疗,作为俄罗斯常规临床实践的一部分。主要终点是与基线相比,第 12 周收缩压和舒张压(SBP/DBP)的平均变化(数据回顾性收集)。次要终点在第 4 周和第 12 周进行评估,包括静息心率(HR)的平均变化、达到静息 HR 目标水平的患者比例、SPC 的抗心绞痛疗效以及达到目标 BP 水平的患者比例。
共纳入 504 名患者,其中 481 名患者为全分析集(平均年龄 61.4±8.9 岁,68%为男性)。平均基线 SBP/DBP 和 HR 值分别为 148.9±16.8/87.7±11.0mmHg 和 77.4±10.5bpm。高血压和 CAD 的平均病程分别为 12.8±8.4 年和 6.1±6.3 年,MI 后时间为 3.8±5.3 年。第 12 周时,SBP/DBP 降低了 24.9/12.2mmHg(P<0.001 与基线相比)。第 4 周和第 12 周时,分别有 69.8%和 95.9%的患者达到了目标 BP(<140/90mmHg),第 4 周和第 12 周时,分别有 17.3%和 34.5%的患者达到了目标 HR(55-60bpm),而基线时为 3.1%(P<0.001)。心绞痛发作次数减少、硝酸酯类药物使用减少和 HR 改善均具有统计学意义。治疗耐受性良好。
在患有 CAD、高血压和 MI 病史的症状性患者中使用比索洛尔/培哚普利 SPC 治疗可显著降低 SBP/DBP,且有很大比例的患者达到 BP 治疗目标。这伴随着心绞痛症状的改善和 HR 的降低,代表了在日常临床实践中看到的广泛患者人群。
ClinicalTrials.gov 标识符 NCT04656847。