高血压一线单药治疗策略比较：培哚普利/氨氯地平与缬沙坦/氨氯地平对比

Comparison of single-pill strategies first line in hypertension: perindopril/amlodipine versus valsartan/amlodipine.

作者信息

Mancia Giuseppe, Asmar Roland, Amodeo Celso, Mourad Jean-Jacques, Taddei Stefano, Gamba Marco Antonio Alcocer, Chazova Irina E, Puig Juan G

机构信息

aUniversity of Milano-Bicocca, Centro Interuniversitario di Fisiologia Clinica e Ipertensione, Istituto Auxologico Italiano IRCCS, Milan, Italy bFoundation Medical Research Institutes, Paris, France cInstituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil dCHU Avicenne, Unité Médecine Interne-Hypertension Artérielle, Bobigny, France eUniversity of Pisa/School of Medicine, Pisa, Italy fInstituto de Corazón de Querétaro, Querétaro, Mexico gMinistry of Health of the Russian Federation, Cardiology Research Complex, Moscow, Russia hServicio de Medicina Interna, Unidad Metabólico-Vascular, Hospital Universitario La Paz, IdiPaz, Madrid, Spain.

出版信息

J Hypertens. 2015 Feb;33(2):401-11. doi: 10.1097/HJH.0000000000000409.

DOI:10.1097/HJH.0000000000000409

PMID:25380149

Abstract

OBJECTIVES

An international double-blind, parallel-group, randomized controlled trial was performed to determine the efficacy and safety of a new first-line strategy in mild to moderate hypertension based on a single-pill combination of perindopril/amlodipine versus a validated stepped-care strategy (initiation with valsartan monotherapy, up-titrating to valsartan/amlodipine after 2 months).

METHODS

At inclusion, patients received perindopril/amlodipine 3.5/2.5 mg or valsartan 80 mg. At 1, 2, and 3 months, patients were up-titrated if they had uncontrolled hypertension (≥140/90 mmHg). The up-titration steps were: perindopril/amlodipine 7/5 mg, 14/10 mg, and 14/10 mg + indapamide sustained release 1.5 mg; or valsartan 160 mg, valsartan/amlodipine 160/5 mg, and 160/10 mg. The two groups were similar at baseline (55.5 years, 53% men, blood pressure 163.5/100.2 mmHg); 881 perindopril/amlodipine and 876 valsartan/amlodipine patients were analyzed for efficacy.

RESULTS

After 1 month, the rate of controlled hypertension was 33% with perindopril/amlodipine versus 27% with valsartan/amlodipine (estimate of difference, +6.1%; P = 0.005); this between-strategy difference remained significant at every visit (P < 0.05). After 3 months, blood pressure was 137.8 ± 12.4/83.3 ± 8.7 and 139.7 ± 13.3/84.8 ± 9.0 mmHg, respectively, with greater reductions from baseline with perindopril/amlodipine (primary endpoint -2.0/-1.5 mmHg; both P < 0.001). Similar results were observed at all other visits (all P ≤ 0.001). The safety of the two strategies was equivalent.

CONCLUSIONS

The three-step strategy of initiation with single-pill perindopril/amlodipine produces greater reductions in blood pressure, and better and quicker rates of control of hypertension. This can be expected to be associated with benefits beyond blood pressure control, notably improved compliance and better cardioprotection.

摘要

目的

开展一项国际双盲、平行组、随机对照试验，以确定基于培哚普利/氨氯地平单片复方制剂的新一线治疗策略用于轻度至中度高血压的疗效和安全性，并与经验证的阶梯式治疗策略（起始使用缬沙坦单药治疗，2个月后上调至缬沙坦/氨氯地平）进行比较。

方法

入组时，患者接受培哚普利/氨氯地平3.5/2.5毫克或缬沙坦80毫克治疗。在第1、2和3个月时，如果患者高血压未得到控制（收缩压≥140毫米汞柱和/或舒张压≥90毫米汞柱），则上调治疗剂量。上调步骤为：培哚普利/氨氯地平7/5毫克、14/10毫克、14/10毫克+吲达帕胺缓释片1.5毫克；或缬沙坦160毫克、缬沙坦/氨氯地平160/5毫克、160/10毫克。两组在基线时情况相似（年龄55.5岁，男性占53%，血压163.5/100.2毫米汞柱）；对881例接受培哚普利/氨氯地平治疗和876例接受缬沙坦/氨氯地平治疗的患者进行了疗效分析。

结果

1个月后，培哚普利/氨氯地平组高血压控制率为33%，缬沙坦/氨氯地平组为27%（差异估计值为+6.1%；P=0.005）；每次随访时，这种治疗策略间的差异均有统计学意义（P<0.05）。3个月后，培哚普利/氨氯地平组和缬沙坦/氨氯地平组血压分别为137.8±12.4/83.3±8.7毫米汞柱和139.7±13.3/84.8±9.0毫米汞柱，培哚普利/氨氯地平组血压较基线下降幅度更大（主要终点-2.0/-1.5毫米汞柱；P均<0.001）。在所有其他随访中均观察到类似结果（所有P≤0.001）。两种治疗策略的安全性相当。