Russo Pierluigi, Capone Alessandro, Sturani Alessandra, Degli Esposti Ezio
Department of Human Physiology and Pharmacology, University of Rome "La Sapienza," Rome, Italy.
Outcomes Research Engineering Consulting, Rome, Italy.
Curr Ther Res Clin Exp. 2004 Sep;65(5):398-412. doi: 10.1016/j.curtheres.2004.10.003.
Large-scale clinical trials have shown that antihypertensive drugs reduce the risk for cardiovascular events. However, little is known about the effectiveness of these drugs in the primary care setting.
The aim of this study was to investigate the frequency of cardiovascularevents during treatment with either of 2 of the most frequently prescribed antihypertensive drugs.
This observational, longitudinal, cohort study considered the entirepopulation listed in the administrative databases of the Local Health Authority of Ravenna, Italy (356,000 residents). The demographic registry and the pharmaceutical and nosocomial databases were cross-linked to determine drug treatment, as well as the frequency of cardiovascular events on a patient-by-patient basis. Each patient aged >18 years receiving a first prescription for amlodipine or enalapril in the period between January 1, 1996, and December 31, 2000, with ≥6 months of continuous treatment with the drug was included. The follow-up period varied from 6 months to 4.5 years.
Of the 7500 patients analyzed (4092 women and 3408 men; mean[SD] age, 68.0 [12.4] years), 2231 (29.7%) were given amlodipine and 5269 (70.3%) were given enalapril. The observed rate of cardiovascular events was higher among patients treated with amlodipine (54 per 1000 patient-years vs 46 per 1000 patient-years; P = 0.007), with a hazard ratio 17% higher compared with enalapril (95% Cl, 5.0-24.0; P = 0.007). The result was also confirmed using Cox multivariate regression analysis. The combination of enalapril plus diuretic showed the lowest risk for cardiovascular events (0.73; 95% Cl, -36.0 to -16.0; P < 0.001).
This analysis showed that treatment with enalapril was associatedwith a significantly lower frequency of cardiovascular events compared with amlodipine.
大规模临床试验表明，降压药物可降低心血管事件风险。然而，对于这些药物在基层医疗环境中的有效性知之甚少。
本研究旨在调查两种最常用降压药物治疗期间心血管事件的发生频率。
这项观察性、纵向队列研究纳入了意大利拉韦纳地方卫生当局行政数据库中的全部人口（35.6万居民）。将人口登记册与药品和医院数据库进行交叉链接，以确定药物治疗情况以及逐个患者的心血管事件发生频率。纳入1996年1月1日至2000年12月31日期间首次开具氨氯地平或依那普利处方且持续治疗≥6个月的每位年龄>18岁的患者。随访期为6个月至4.5年。
在分析的7500例患者中（4092例女性和3408例男性；平均[标准差]年龄为68.0[12.4]岁），2231例（29.7%）服用氨氯地平，5269例（70.3%）服用依那普利。氨氯地平治疗的患者中观察到的心血管事件发生率较高（每1000患者年54例 vs 每1000患者年46例；P = 0.007），与依那普利相比，风险比高17%（95%可信区间，5.0 - 24.0；P = 0.007）。使用Cox多变量回归分析也证实了该结果。依那普利加利尿剂联合使用显示心血管事件风险最低（0.73；95%可信区间， - 36.0至 - 16.0；P < 0.001）。
该分析表明，与氨氯地平相比，依那普利治疗的心血管事件发生频率显著更低。
