Daskalopoulou Stella S, Papacostas-Quintanilla Helena, Brzozowska-Villatte Romualda
Vascular Health Unit, Department of Medicine, Faculty of Medicine, Research Institute of McGill University Health Centre, McGill University, Glen Site, 1001 Decarie Boulevard, EM1.2210, Montreal, QC, Canada.
Global Medical and Patient Affairs, Servier, Suresnes, France.
Adv Ther. 2025 Feb;42(2):1108-1130. doi: 10.1007/s12325-024-03091-6. Epub 2024 Dec 28.
The aim of the observational SIMPLE study was to assess real-life effectiveness and safety of a single-pill combination (SPC) of perindopril arginine/amlodipine in a broad range of subjects with newly diagnosed mild-to-moderate hypertension treated in Canadian general practice.
Treatment-naïve participants aged 18-65 years with mild-to-moderate hypertension, whose physicians decided to initiate the perindopril/amlodipine SPC, were recruited from Canadian clinical practice from October 2017 to February 2019. Participants were followed at 3- (M3) and 6-month (M6) visits after treatment initiation. The recommended starting dose of 3.5 mg/2.5 mg once daily was up-titrated, at the discretion of the treating physician, if blood pressure (BP) remained above target at subsequent visits. The primary endpoint was change in mean office systolic BP (SBP) and diastolic BP (DBP) at M6.
The full analysis set included 1179 participants with a mean age of 51.5 ± 8.7 years; 61% were male. Mean SBP/DBP at baseline was 153.4 ± 11.5/94.8 ± 7.7 mmHg. Treatment was initiated at 3.5 mg/2.5 mg in 76.0% participants. Over the 6-month treatment period, significant (P < 0.001) decreases from baseline were observed for SBP (- 22.9 ± 14.5 mmHg) and DBP (- 13.4 ± 9.1 mmHg), with 70.2% of participants achieving their BP target. Across all perindopril/amlodipine SPC dose groups, 61.4% of participants achieved BP targets at M3; mean SBP was reduced by 20.8 ± 14.7 mmHg and DBP by 11.7 ± 9.2 mmHg (both P < 0.001). Analysis by baseline subgroup revealed significant BP reductions across age groups, sex, hypertension grades, and diabetes status. Participants with Grade 2 hypertension had a significantly greater decrease than those with Grade 1 (P < 0.001). Treatment with the SPC was well tolerated, and in the 6.1% with treatment-related adverse events, the majority were mild to moderate. High (99%) self-reported adherence (< 20 missed doses) in the 49.4% with available data and high physician satisfaction with treatment (82%) were reported.
Data from routine Canadian clinical practice indicate that a perindopril/amlodipine SPC is associated with significant BP reductions from baseline in a broad range of participants with different cardiovascular risk factors and may represent an appropriate first-line treatment for subjects with newly diagnosed hypertension.
观察性SIMPLE研究的目的是评估在加拿大全科医疗中，对广泛的新诊断为轻度至中度高血压患者使用培哚普利精氨酸/氨氯地平单片复方制剂（SPC）的实际疗效和安全性。
2017年10月至2019年2月从加拿大临床实践中招募年龄在18 - 65岁、未接受过治疗且患有轻度至中度高血压、其医生决定开始使用培哚普利/氨氯地平SPC的参与者。治疗开始后，在3个月（M3）和6个月（M6）随访时对参与者进行观察。如果后续随访时血压（BP）仍高于目标值，治疗医生可自行决定将推荐的起始剂量3.5毫克/2.5毫克每日一次进行上调。主要终点是M6时诊室平均收缩压（SBP）和舒张压（DBP）的变化。
完整分析集包括1179名参与者，平均年龄为51.5±8.7岁；61%为男性。基线时平均SBP/DBP为153.4±11.5/94.8±7.7毫米汞柱。76.0%的参与者以3.5毫克/2.5毫克开始治疗。在6个月的治疗期内，观察到SBP（-22.9±14.5毫米汞柱）和DBP（-13.4±9.1毫米汞柱）较基线有显著（P＜0.001）下降，70.2%的参与者达到了血压目标。在所有培哚普利/氨氯地平SPC剂量组中，61.4%的参与者在M3时达到血压目标；平均SBP降低了20.8±14.7毫米汞柱，DBP降低了11.7±9.2毫米汞柱（均P＜0.001）。按基线亚组分析显示，各年龄组、性别、高血压分级和糖尿病状态的血压均有显著降低。2级高血压患者的血压下降幅度显著大于1级患者（P＜0.001）。SPC治疗耐受性良好，在6.1%发生治疗相关不良事件的患者中，大多数为轻度至中度。在有可用数据的49.4%的参与者中，自我报告的依从性较高（99%，漏服剂量＜20次），医生对治疗的满意度也较高（82%）。
来自加拿大常规临床实践的数据表明，培哚普利/氨氯地平SPC可使广泛的具有不同心血管危险因素的参与者血压较基线显著降低，可能是新诊断高血压患者的一种合适的一线治疗药物。
