PDF(Pubmed)
Abstract：
BACKGROUND: In China, the prevalence of hypertension is high and the use of combination antihypertensive therapy is low, which contributes to inadequate blood pressure (BP) control. The availability of simplified treatments combining complementary BP-lowering agents may help more patients achieve their goals.
METHODS: This Phase III, multicenter, randomized, double-blind, noninferiority study included Chinese adults with mild-to-moderate hypertension. Following a 1-month run-in on perindopril/indapamide bi-therapy, patients with uncontrolled systolic/diastolic BP (≥140/90 mmHg) were randomized to perindopril 5 mg/indapamide 1.25 mg/amlodipine 5 mg (Per/Ind/Aml) single-pill combination (SPC) or perindopril 4 mg/indapamide 1.25 mg plus amlodipine 5 mg (Per/Ind + Aml) for 6 months. Uptitration was permitted from month 2 onwards. The primary efficacy objective was the noninferiority of Per/Ind/Aml in lowering office systolic BP at 2 months. The secondary objectives included the effectiveness of SPC on diastolic BP, uptitration efficacy, and office BP control (systolic/diastolic <140/90 mmHg). A subgroup of patients participated in 24-h ambulatory BP monitoring (ABPM).
RESULTS: A total of 532 patients were randomized: Per/Ind/Aml ( n = 262) and Per/Ind + Aml ( n = 269). Overall, the mean (±SD) age was 55.7 ± 8.8 years, 60.7% were male, and the mean office systolic/diastolic BP at baseline on Per/Ind was 150.4/97.2 mmHg. Systolic BP decreased in both groups at 2 months from baseline: -14.99 ± 14.46 mmHg Per/Ind/Aml versus -14.49 ± 12.87 mmHg Per/Ind +Aml. A predefined noninferiority margin of 4 mmHg was observed ( P < 0.001). The effectiveness of the Per/Ind/Aml SPC was also demonstrated for all secondary endpoints. ABPM demonstrated sustained BP control over 24 h. Both treatments were well tolerated.
CONCLUSIONS: Per/Ind/Aml is an effective substitute for Per/Ind + Aml, providing at least equivalent BP control over 24 h in a single pill, with comparable safety.
METHODS: This Phase III, multicenter, randomized, double-blind, noninferiority study included Chinese adults with mild-to-moderate hypertension. Following a 1-month run-in on perindopril/indapamide bi-therapy, patients with uncontrolled systolic/diastolic BP (≥140/90 mmHg) were randomized to perindopril 5 mg/indapamide 1.25 mg/amlodipine 5 mg (Per/Ind/Aml) single-pill combination (SPC) or perindopril 4 mg/indapamide 1.25 mg plus amlodipine 5 mg (Per/Ind + Aml) for 6 months. Uptitration was permitted from month 2 onwards. The primary efficacy objective was the noninferiority of Per/Ind/Aml in lowering office systolic BP at 2 months. The secondary objectives included the effectiveness of SPC on diastolic BP, uptitration efficacy, and office BP control (systolic/diastolic <140/90 mmHg). A subgroup of patients participated in 24-h ambulatory BP monitoring (ABPM).
RESULTS: A total of 532 patients were randomized: Per/Ind/Aml ( n = 262) and Per/Ind + Aml ( n = 269). Overall, the mean (±SD) age was 55.7 ± 8.8 years, 60.7% were male, and the mean office systolic/diastolic BP at baseline on Per/Ind was 150.4/97.2 mmHg. Systolic BP decreased in both groups at 2 months from baseline: -14.99 ± 14.46 mmHg Per/Ind/Aml versus -14.49 ± 12.87 mmHg Per/Ind +Aml. A predefined noninferiority margin of 4 mmHg was observed ( P < 0.001). The effectiveness of the Per/Ind/Aml SPC was also demonstrated for all secondary endpoints. ABPM demonstrated sustained BP control over 24 h. Both treatments were well tolerated.
CONCLUSIONS: Per/Ind/Aml is an effective substitute for Per/Ind + Aml, providing at least equivalent BP control over 24 h in a single pill, with comparable safety.
摘要：
背景：在中国，高血压患病率高，联合降压治疗的使用低，这导致血压（BP）控制不足。结合补充降血压药物的简化治疗方法的可用性可以帮助更多的患者实现他们的目标。
方法：第三阶段，多中心，随机化，双盲,非劣效性研究纳入了患有轻度至中度高血压的中国成年人.经过1个月的培多普利/茚达帕胺双重治疗，收缩压/舒张压血压不受控制(≥140/90mmHg)的患者被随机分为两组,两组分别接受培多普利5mg/茚达胺1.25mg/氨氯地平5mg(Per/Ind/Aml)单药联合治疗(SPC)或培多普利4mg/茚达帕胺1.25mg+氨氯地平5mg(Per/Ind+Aml)治疗6个月.从第2个月起允许增加滴定。主要疗效目标是Per/Ind/Aml在降低2个月时的办公室收缩压方面的非劣效性。次要目标包括SPC对舒张压的有效性，向上滴定功效，和办公室血压控制（收缩压/舒张压<140/90mmHg）。一组患者参加了24小时动态BP监测（ABPM）。
结果：共有532名患者被随机分配：Per/Ind/Aml（n=262）和Per/Ind+Aml（n=269）。总的来说,平均（±SD）年龄为55.7±8.8岁，60.7%为男性，基线时Per/Ind的平均办公室收缩压/舒张压为150.4/97.2mmHg。从基线开始2个月时，两组的收缩压均降低：-14.99±14.46mmHg/Ind/Aml与-14.49±12.87mmHg/IndAml。观察到预定义的非劣效性边缘为4mmHg（P<0.001）。对于所有次要终点,也证明了Per/Ind/AmlSPC的有效性。ABPM在24小时内表现出持续的BP控制。两种治疗均具有良好的耐受性。
结论：Per/Ind/Aml是Per/Ind+Aml的有效替代品，在单一药丸中在24小时内提供至少等效的BP控制，具有可比的安全性。
方法：第三阶段，多中心，随机化，双盲,非劣效性研究纳入了患有轻度至中度高血压的中国成年人.经过1个月的培多普利/茚达帕胺双重治疗，收缩压/舒张压血压不受控制(≥140/90mmHg)的患者被随机分为两组,两组分别接受培多普利5mg/茚达胺1.25mg/氨氯地平5mg(Per/Ind/Aml)单药联合治疗(SPC)或培多普利4mg/茚达帕胺1.25mg+氨氯地平5mg(Per/Ind+Aml)治疗6个月.从第2个月起允许增加滴定。主要疗效目标是Per/Ind/Aml在降低2个月时的办公室收缩压方面的非劣效性。次要目标包括SPC对舒张压的有效性，向上滴定功效，和办公室血压控制（收缩压/舒张压<140/90mmHg）。一组患者参加了24小时动态BP监测（ABPM）。
结果：共有532名患者被随机分配：Per/Ind/Aml（n=262）和Per/Ind+Aml（n=269）。总的来说,平均（±SD）年龄为55.7±8.8岁，60.7%为男性，基线时Per/Ind的平均办公室收缩压/舒张压为150.4/97.2mmHg。从基线开始2个月时，两组的收缩压均降低：-14.99±14.46mmHg/Ind/Aml与-14.49±12.87mmHg/IndAml。观察到预定义的非劣效性边缘为4mmHg（P<0.001）。对于所有次要终点,也证明了Per/Ind/AmlSPC的有效性。ABPM在24小时内表现出持续的BP控制。两种治疗均具有良好的耐受性。
结论：Per/Ind/Aml是Per/Ind+Aml的有效替代品，在单一药丸中在24小时内提供至少等效的BP控制，具有可比的安全性。
