Ábrahám György, Dézsi Csaba András
Hypertension-Nephrology Center, 1st Department of Internal Medicine, 'Albert Szent-Györgyi' Health Center, University of Szeged Faculty of Medicine, Szeged, Hungary.
Department of Cardiology, Petz Aladár County Teaching Hospital, Gyor, Hungary.
Adv Ther. 2017 Jul;34(7):1753-1763. doi: 10.1007/s12325-017-0572-1. Epub 2017 Jun 23.
The etiology of essential hypertension is multifactorial. Therefore, treatment with combinations of antihypertensive agents acting on multiple targets is necessary for successful therapy in the majority of patients. According to the experience and clinical data accumulated so far, combination therapy with three agents from different pharmacological classes is required in approx. 30% of patients in order to achieve long-term blood pressure control. The primary objective of the PETRA study was to evaluate the efficacy of blood pressure (BP) control with once daily administration of the different dosage strengths of the once-daily, triple fixed combination of perindopril, indapamide, and amlodipine. The evaluation was based on office BP readings and ambulatory blood pressure monitoring (ABPM) data gathered in routine clinical practice.
Data from 11,209 hypertensive patients (the proportion of female subjects was 47.6%) were processed and interpreted in a 3-month-long prospective, observational, non-interventional, open-label study conducted in 997 centers in Hungary.
Mean baseline office BP was 156.58 ± 16.10/91.56 ± 9.33 mmHg (mean ± SD), whereas the mean duration of hypertension was 9.48 ± 7.19 years. Mean office BP decreased by 24.81 ± 15.47/11.41 ± 9.90 mmHg after switching to the triple fixed combination of perindopril, indapamide, and amlodipine (p < 0.0001). At the final visit 45.1% of patients took the 5/1.25/5 mg, 33.5% of them 10/2.5/5 mg, and 21.4% of them 10/2.5/10 mg strength of the perindopril/indapamide/amlodipine triple fixed combination. The 24-h blood pressure was obtained in 76 subjects. The mean 24-h BP decreased from 155.51 ± 17.43/85.28 ± 11.48 to 134.63 ± 12.51/77.83 ± 8.99 mmHg (p < 0.0001). Statistically significant (p < 0.0001) and clinically relevant improvement of a number of metabolic parameters-including total cholesterol (-8.6%), LDL-cholesterol (-11.4%), triglyceride (-12.1%), and fasting blood glucose (-6.6%) levels-was observed over the 3-month study period.
During the 3 months of the PETRA study, the outstanding 24-h antihypertensive efficacy of the triple fixed combination of perindopril, indapamide, and amlodipine was confirmed both by office BP readings and by ABPM recordings. This combination may offer a new therapeutic option for hypertensive patients who have failed to achieve the desired BP target on their previous dual combination therapy.
EGIS Pharmaceuticals PLC.
原发性高血压的病因是多因素的。因此，对于大多数患者而言，采用作用于多个靶点的抗高血压药物联合治疗对于成功治疗是必要的。根据目前积累的经验和临床数据，约30%的患者需要三种不同药理类别的药物联合治疗，以实现长期血压控制。PETRA研究的主要目的是评估培哚普利、吲达帕胺和氨氯地平每日一次、三联固定复方制剂不同剂量强度每日一次给药对血压（BP）控制的疗效。该评估基于常规临床实践中收集的诊室血压读数和动态血压监测（ABPM）数据。
在匈牙利997个中心进行的一项为期3个月的前瞻性、观察性、非干预性、开放标签研究中，对11209例高血压患者（女性受试者比例为47.6%）的数据进行了处理和分析。
平均基线诊室血压为156.58±16.10/91.56±9.33 mmHg（平均值±标准差），而高血压的平均病程为9.48±7.19年。改用培哚普利、吲达帕胺和氨氯地平三联固定复方制剂后，平均诊室血压下降了24.81±15.47/11.41±9.90 mmHg（p<0.0001）。在最后一次随访时，45.1%的患者服用5/1.25/5 mg、33.5%的患者服用10/2.5/5 mg、21.4%的患者服用10/2.5/10 mg强度的培哚普利/吲达帕胺/氨氯地平三联固定复方制剂。76名受试者获得了24小时血压数据。平均24小时血压从155.51±17.43/85.28±11.48降至134.63±12.51/77.83±8.99 mmHg（p<0.0001）。在3个月的研究期间，观察到包括总胆固醇（-8.6%）、低密度脂蛋白胆固醇（-11.4%）、甘油三酯（-12.1%）和空腹血糖（-6.6%）水平在内的多项代谢参数有统计学意义（p<0.0001）且具有临床相关性的改善。
在PETRA研究的3个月期间，培哚普利、吲达帕胺和氨氯地平三联固定复方制剂出色的24小时降压疗效通过诊室血压读数和ABPM记录均得到了证实。这种联合用药可能为之前接受双联联合治疗未能达到理想血压目标的高血压患者提供一种新的治疗选择。
EGIS制药公司。
