D.No.8-2-330/A/2, CARE Hospital, Banjara Hills, Road No. 5, Opposite Nokia Towers, Hyderabad, India.
Adv Ther. 2013 Feb;30(2):176-89. doi: 10.1007/s12325-013-0005-8. Epub 2013 Jan 25.
Numerous randomized clinical trials have demonstrated the efficacy and tolerability of aliskiren and aliskiren hydrochlorothiazide (aliskiren HCT) single-pill combination therapy in patients with hypertension. The objective of the present study was to evaluate the effectiveness and safety of aliskiren-based therapy under daily life conditions in a multiethnic population.
This observational, multicenter, noninterventional study, conducted at 420 centers in Asia and the Middle East, included adult patients with hypertension who received treatment with aliskiren or aliskiren HCT as single or add-on therapy for a planned treatment period of at least 26 weeks. The main effectiveness assessments included the proportion of patients achieving therapeutic blood pressure (BP) goal (defined as systolic BP [SBP]/diastolic BP [DBP]<140/90 mmHg, or <130/80 mmHg in patients with diabetes) and BP response, and change in mean sitting BP from baseline to study end.
Of 4,826 patients (mean age 51.4 years, 65.9% male, 64.5% Asian, 41.5% diabetic) included in the study, 3,473 received aliskiren and 1,353 received aliskiren HCT. Almost half the study population (48.1%) received aliskiren or aliskiren HCT as add-on therapy. The therapeutic BP goal was achieved in 49.5% of patients treated with aliskiren and 48.3% of patients receiving aliskiren HCT; attainment of BP goal increased to more than 70% when a classic BP target of <140/90 mmHg was applied for all patients. Reductions in mean sitting SBP/DBP were significantly lower versus baseline for both aliskiren (24.1/12.2 mmHg) and aliskiren HCT (27.6/14.1 mmHg) and BP response rates were consistently achieved in more than 80% of all patients during the study. Aliskiren treatment was well tolerated with only a small proportion of patients experiencing adverse events (AEs; 2.1%) and serious AEs (0.3%).
In this real-world, naturalistic setting, antihypertensive treatment with an aliskiren-based regimen was effective and well-tolerated in this multiethnic population with arterial hypertension.
多项随机临床试验已证实阿利吉仑及其与氢氯噻嗪的复方制剂（阿利吉仑 HCT）单一片剂联合治疗在高血压患者中的疗效和耐受性。本研究的目的是评估在多民族人群中，日常生活条件下基于阿利吉仑的治疗的有效性和安全性。
本观察性、多中心、非干预性研究在亚洲和中东的 420 个中心进行，纳入接受阿利吉仑或阿利吉仑 HCT 单药或联合治疗的成年高血压患者，计划治疗期至少 26 周。主要疗效评估包括达到治疗性血压（BP）目标的患者比例（定义为收缩压[BP]/舒张压[DBP]<140/90mmHg，或糖尿病患者<130/80mmHg）和 BP 反应，以及从基线到研究结束时平均坐位 BP 的变化。
在纳入的 4826 例患者（平均年龄 51.4 岁，65.9%为男性，64.5%为亚洲人，41.5%为糖尿病患者）中，3473 例接受阿利吉仑治疗，1353 例接受阿利吉仑 HCT 治疗。近一半的研究人群（48.1%）接受阿利吉仑或阿利吉仑 HCT 作为联合治疗。接受阿利吉仑治疗的患者中有 49.5%达到治疗性 BP 目标，接受阿利吉仑 HCT 治疗的患者中有 48.3%达到治疗性 BP 目标；当对所有患者应用<140/90mmHg 的经典 BP 目标时，达到治疗性 BP 目标的比例增加至 70%以上。与基线相比，接受阿利吉仑治疗的患者平均坐位 SBP/DBP 显著降低（24.1/12.2mmHg），接受阿利吉仑 HCT 治疗的患者平均坐位 SBP/DBP 显著降低（27.6/14.1mmHg），且在研究期间，超过 80%的所有患者的 BP 反应率均持续达到。阿利吉仑治疗耐受性良好，仅有少数患者（2.1%）出现不良事件（AE）和严重 AE（0.3%）。
在这种真实世界、自然发生的环境中，基于阿利吉仑的治疗方案在伴有动脉高血压的多民族人群中具有疗效且耐受性良好。
