Rumboldt Z, Simunić M, Bagatin J, Rumboldt M, Marinković M, Janezić A
Clinical Hospital Centre Split, Department of Medicine, Croatia.
Int J Clin Pharmacol Res. 1993;13(1):35-41.
The antihypertensive efficacy and safety of lisinopril (L), a novel ACE inhibitor, were compared to those of captopril (C), the familiar drug of the same class, in a multicentre controlled trial. The study included 91 mild-to-moderate, middle-aged hypertensives of both genders, 46 of which were randomized to C and 45 to L. After a two-week placebo period the examinees were receiving either L o.d. in increasing dosage of 10, 20, or 40 mg per day (amount necessary to achieve normotension), or C b.i.d. in a corresponding daily dose of 25, 50, or 100 mg. During the eight-week formal part of the trial, L decreased the systolic blood pressure from the initial values by an average of 14.9%, and the diastolic pressure by some 15.2%. The same parameters were lowered on C by 11.2%, and 11.7%, respectively. The mean arterial pressure from an initial average of 125.5 mmHg was lowered to 110.9 mmHg on C (11.6% reduction, p < 0.01), and from 125.3 mmHg to 108.2 mmHg on L (13.6% reduction, p < 0.01). Although the L effects were more pronounced, the observed between-group differences did not reach the level of statistical significance, except for the achievement of normotension, which disclosed the superiority of L (p < 0.05). The tolerability of both drugs was good and only one examinee had to be excluded because of side-effects (proteinuria). It is concluded that both ACEIs under study showed comparable efficacy and safety, L being marginally more potent and longer acting.
在一项多中心对照试验中,将新型血管紧张素转换酶(ACE)抑制剂赖诺普利(L)与同一类的常用药物卡托普利(C)的降压疗效及安全性进行了比较。该研究纳入了91例轻至中度、中年的男女高血压患者,其中46例随机分配至C组,45例分配至L组。经过两周的安慰剂期后,受试者分别接受L每日一次,剂量递增至10、20或40毫克/天(达到血压正常所需剂量),或C每日两次,相应日剂量为25、50或100毫克。在试验的八周正式阶段,L使收缩压从初始值平均降低了14.9%,舒张压降低了约15.2%。C使相同参数分别降低了11.2%和11.7%。平均动脉压从初始平均125.5 mmHg在C组降至110.9 mmHg(降低11.6%,p<0.01),在L组从125.3 mmHg降至108.2 mmHg(降低13.6%,p<0.01)。尽管L的效果更显著,但观察到的组间差异未达到统计学显著水平,除了血压正常这一指标显示L具有优越性(p<0.05)。两种药物的耐受性都良好,只有一名受试者因副作用(蛋白尿)被排除。结论是,所研究的两种ACE抑制剂显示出相当的疗效和安全性,L的效力略强且作用时间更长。