非洛地平缓释片与硝苯地平控释片治疗轻至中度动脉高血压的多中心比较研究

[Multicenter comparative study of felodipine-ER and nifedipine-OROS in the treatment of mild-to-moderate arterial hypertension].

作者信息

Batlouni M, Leite Luna R, Castro I, Silveira Sbissa A, Armaganijan D, Chaves Junior H de C, Nobre F, Pereira da Cunha C

机构信息

Instituto Dante Pazzanese de Cardiologia, São Paulo, SP.

出版信息

Arq Bras Cardiol. 1996 Apr;66(4):247-51.

PMID:8935693

Abstract

PURPOSE

To compare the efficacy and tolerance of felodipine-ER and nifedipine OROS, both once daily, in the treatment of mild-to-moderate uncomplicated arterial hypertension (AH).

METHODS

This was a multicentric, opened, randomized, paralled trial, that selected 121 patients with uncomplicated, mild to moderate essential AH (diastolic blood pressure (DBP) > or = 95 and < or = 110 mmHg; not under anti-hypertensive medication. All patients received placebo for two weeks. After that period, they would take either 5mg/day of felodipine, or 30mg/day of nifedipine OROS, both once daily, in a randomized fashion. Patients underwent laboratory tests and electrocardiogram (ECG) at the begining and at the end of the study, and heart rate and blood pressure (BP) measurements, nearly 24 hours after the last active drug dose.

RESULTS

Completed the study 111 patients, 60 in the felodipine group and 51 in the nifedipine group. Compared to baseline, the average of systolic BP and DBP decreased from 162.5 +/- 14.3mmHg and from 102.2 +/- 5.1mmHg to 143.3 +/- 14.6 and 87.9 +/- 7.2mmHg, respectively, at the end of the treatment in the felodipine group; and from 160.5 +/- 16.3mmHg and 102.5 +/- 6.2mmHg to 136.1 +/- 14.2 and 86.7 +/- 7.0mmHg, respectively in nifedipine group (p < 0.0001 for all diferences). Adequate BP response to the treatment (DBP normalization or reduction > 10mmHg from baseline) occured in 47/60 (78.3%) patients in the felodipine group and in 38/51 (74.5%) in the nifedipine group (NS). Side effects, occured in approximately 15% of the cases, and were similar in both groups. These were usually moderate and transient, but were responsible for the withdrawal from the study of two cases in the felodipine group and of three cases in the nifedipine group.

CONCLUSION

Felodipine-ER and nifedipine OROS, are similarly effective and generally well tolerated in patients with mild-to-moderate essential hypertension.

摘要

目的

比较每日一次服用缓释非洛地平和硝苯地平控释片治疗轻至中度单纯性动脉高血压（AH）的疗效和耐受性。

方法

这是一项多中心、开放、随机、平行试验，选取121例轻至中度原发性单纯性AH患者（舒张压（DBP）≥95且≤110 mmHg；未接受抗高血压药物治疗）。所有患者先接受两周安慰剂治疗。此后，他们将随机每日一次服用5mg非洛地平或30mg硝苯地平控释片。患者在研究开始和结束时进行实验室检查和心电图（ECG）检查，并在最后一次服用活性药物近24小时后测量心率和血压（BP）。

结果

111例患者完成研究，非洛地平组60例，硝苯地平组51例。与基线相比，非洛地平组治疗结束时收缩压和DBP平均值分别从162.5±14.3mmHg和102.2±5.1mmHg降至143.3±14.6mmHg和87.9±7.2mmHg；硝苯地平组分别从160.5±16.3mmHg和102.5±6.2mmHg降至136.1±14.2mmHg和86.7±7.0mmHg（所有差异p<0.0001）。非洛地平组47/60（78.3%）患者和硝苯地平组38/51（74.5%）患者对治疗有充分的血压反应（DBP恢复正常或较基线降低>10mmHg）（无显著性差异）。副作用发生率约为15%，两组相似。这些副作用通常为中度且短暂，但导致非洛地平组2例患者和硝苯地平组3例患者退出研究。