培哚普利与吲达帕胺极低剂量组合（百普乐）与西拉普利单药治疗对血压控制不佳患者的疗效比较——一项随机、双盲、附加研究

Efficacy of a very-low-dose combination of perindopril and indapamide--preterax compared with cilazapril monotherapy in patients with inadequate blood pressure control--a randomized, double-blind, add-on study.

作者信息

Sung Shih-Hsien, Wu Tao-Cheng, Lin Shing-Jong, Chen Jaw-Wen

机构信息

Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC.

出版信息

J Chin Med Assoc. 2008 May;71(5):247-53. doi: 10.1016/S1726-4901(08)70115-1.

DOI:10.1016/S1726-4901(08)70115-1

PMID:18490229

Abstract

BACKGROUND

Combined regimen may be superior to monotherapy in blood pressure (BP) control. Since BP control is critically related to cardiovascular mortality and morbidity in hypertensive patients, this study aimed to evaluate the efficacy and safety of a low-dose combined regimen of preterax compared with cilazapril monotherapy for better BP control in treated hypertensive patients.

METHODS

Stable hypertensive patients were evaluated if their systolic BP (SBP) was > 130 mmHg and/or diastolic BP (DBP) was > 85 mmHg even with up to 2 antihypertensive drugs. Patients were excluded if they were on angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers or a diuretic. They were then randomized to receive either preterax (perindopril 2 mg and indapamide 0.625 mg) or cilazapril 2.5 mg once daily in a double-blind fashion for a period of 12 weeks after a 2-week placebo run-in phase. Sitting BP was recorded and the safety and efficacy were evaluated at each visit every 4 weeks. Response was defined as positive if SBP was < or = 140 mmHg and DBP was < or = 90 mmHg at the last visit or there was > 20 mmHg reduction in SBP and/or > 10 mmHg reduction in DBP using either treatment. Plasma biochemical analysis was performed both before and after the treatment.

RESULTS

Among the 47 patients initially enrolled, 41 completed the study (21 in the preterax group, 20 in the cilazapril group). There was no difference in the number of adverse events between the 2 groups. SBP was significantly reduced by preterax (13.43 +/- 12.48mmHg, p < 0.0001) and cilazapril (9.00 +/- 13.75 mmHg, p < 0.05). However, DBP was significantly reduced only by preterax (7.67 +/- 9.40 mmHg, p = 0.0009) but not by cilazapril (3.60 +/- 8.37 mmHg, p > 0.05). The response rate was significantly higher to preterax (100%) than to cilazapril (70%) (p = 0.0086).

CONCLUSION

Though similar in safety, combined regimen preterax was more effective than cilazapril to facilitate adequate BP control in already-treated hypertensives. It can be added on to other antihypertensives for better BP control in clinical hypertension.

摘要

背景

联合用药方案在血压控制方面可能优于单一疗法。由于血压控制与高血压患者的心血管死亡率和发病率密切相关，本研究旨在评估低剂量培哚普利吲达帕胺联合用药方案与西拉普利单一疗法相比，在治疗高血压患者中实现更好血压控制的疗效和安全性。

方法

对收缩压（SBP）>130 mmHg和/或舒张压（DBP）>85 mmHg的稳定高血压患者进行评估，即使他们已经使用了多达2种抗高血压药物。正在使用血管紧张素转换酶抑制剂、血管紧张素II受体阻滞剂或利尿剂的患者被排除。然后，在为期2周的安慰剂导入期后，患者被随机分为两组，双盲接受培哚普利吲达帕胺（培哚普利2 mg和吲达帕胺0.625 mg）或西拉普利2.5 mg，每日一次，为期12周。记录坐位血压，并每4周随访一次，评估安全性和疗效。如果在最后一次随访时SBP≤140 mmHg且DBP≤90 mmHg，或者使用任何一种治疗方法后SBP降低>20 mmHg和/或DBP降低>10 mmHg，则定义为治疗有反应。在治疗前后进行血浆生化分析。

结果

最初纳入的47例患者中，41例完成了研究（培哚普利吲达帕胺组21例，西拉普利组20例）。两组不良事件数量无差异。培哚普利吲达帕胺显著降低SBP（13.43±12.48 mmHg，p<0.0001），西拉普利也显著降低SBP（9.00±13.75 mmHg，p<0.05）。然而，仅培哚普利吲达帕胺显著降低DBP（7.67±9.40 mmHg，p = 0.0009），西拉普利未显著降低DBP（3.60±8.37 mmHg，p>0.05）。培哚普利吲达帕胺的反应率（100%）显著高于西拉普利（70%）（p = 0.0086）。