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比索洛尔与培哚普利单片复方制剂在日常临床实践中治疗动脉高血压合并稳定型冠状动脉疾病患者的有效性和耐受性:STYLE研究

Effectiveness and Tolerability of the Single-Pill Combination of Bisoprolol and Perindopril in Patients with Arterial Hypertension and Stable Coronary Artery Disease in Daily Clinical Practice: The STYLE Study.

作者信息

Boytsov Sergey A, Burtsev Yuri P, Khomitskaya Yunona V, Karpov Yuri A

机构信息

Department of Angiology, National Medical Research Center of Cardiology of the Ministry of Health of Russia, Moscow, Russia.

Department of Medical Affairs, Servier Russia, Moscow, Russia.

出版信息

Adv Ther. 2021 Jun;38(6):3299-3313. doi: 10.1007/s12325-021-01754-2. Epub 2021 May 15.

Abstract

INTRODUCTION

Combination antihypertensive therapy is required by most patients to achieve guideline-recommended blood pressure (BP) goals. This study assessed the effectiveness and tolerability of bisoprolol/perindopril (Bis/Per) single-pill combination (SPC) in Russian patients with hypertension and coronary artery disease (CAD) treated in routine clinical practice.

METHODS

STYLE (NCT03730116) was an open-label, uncontrolled, prospective observational study conducted in patients who were already receiving Bis/Per SPC, switched to SPC from Bis or Per monotherapy, or switched from a free combination of Bis and Per. Primary endpoint criteria were assessed at 1 and 3 months and included change in mean office systolic/diastolic blood pressure (SBP/DBP), proportion achieving target BP (< 140/90 mmHg), and measures of antianginal effectiveness.

RESULTS

The full analysis set comprised 1892 subjects. Mean age was 61.9 ± 8.8 years, 53.2% were women, and mean durations of hypertension and CAD were 12.5 ± 7.9 and 7.2 ± 6.4 years, respectively. Mean SBP/DBP decreased by 22.3/11.0 mmHg and 31.5/15.9 mmHg at 1 and 3 months, respectively (P < 0.0001 vs baseline). Target BP was achieved by 49.2% and 86.7% of patients at 1 and 3 months, respectively. Reductions in mean number of angina attacks and nitrate consumption and improvements in heart rate were statistically significant. Treatment was well tolerated.

CONCLUSION

Treatment of patients with hypertension and CAD with Bis/Per SPC for 3 months was associated with significant decreases in SBP/DBP and a high proportion of patients achieving BP treatment goals. This was accompanied by an improvement in angina symptoms. Treatment was well tolerated in a broad patient population representative of those seen in everyday clinical practice.

摘要

引言

大多数患者需要联合使用抗高血压药物来实现指南推荐的血压目标。本研究评估了比索洛尔/培哚普利(Bis/Per)单片复方制剂(SPC)在俄罗斯高血压合并冠状动脉疾病(CAD)患者常规临床治疗中的有效性和耐受性。

方法

STYLE(NCT03730116)是一项开放标签、非对照、前瞻性观察性研究,研究对象为已接受Bis/Per SPC治疗、从比索洛尔或培哚普利单药治疗转换为SPC治疗或从比索洛尔和培哚普利自由联合治疗转换而来的患者。在1个月和3个月时评估主要终点标准,包括诊室平均收缩压/舒张压(SBP/DBP)变化、达到目标血压(<140/90 mmHg)的比例以及抗心绞痛有效性指标。

结果

完整分析集包括1892名受试者。平均年龄为61.9±8.8岁,53.2%为女性,高血压和CAD的平均病程分别为12.5±7.9年和7.2±6.4年。1个月和3个月时,平均SBP/DBP分别下降22.3/11.0 mmHg和31.5/15.9 mmHg(与基线相比,P<0.0001)。1个月和3个月时分别有49.2%和86.7%的患者达到目标血压。心绞痛发作平均次数和硝酸酯类药物消耗量减少,心率改善,差异有统计学意义。治疗耐受性良好。

结论

高血压合并CAD患者使用Bis/Per SPC治疗3个月可使SBP/DBP显著降低,且大部分患者达到血压治疗目标。同时心绞痛症状有所改善。在日常临床实践中具有代表性的广泛患者群体中,该治疗耐受性良好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1888/8189988/c9b7ffedf8a5/12325_2021_1754_Fig1_HTML.jpg

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