James I G V, Jones A, Davies P
Spring House Surgery, Bolton, Lancashire, UK.
J Hum Hypertens. 2002 Aug;16(8):605-10. doi: 10.1038/sj.jhh.1001430.
A double-blind, double-dummy, randomised, multicentre study to compare the efficacy and tolerability of lercanidipine with losartan. Patients with mild to moderate hypertension (supine diastolic blood pressure (DBP) 95-115 mm Hg) were enrolled and underwent a placebo run-in period of 14-30 days before random allocation to lercanidipine tablets 10 mg once-daily (n = 234) or losartan tablets 50 mg once-daily (n = 231) during the assessment period (approximately 16 weeks). Titration to lercanidipine 20 mg once-daily (two 10 mg tablets) or losartan 100 mg once-daily (two 50 mg tablets) was allowed after 8 weeks, if necessary. At the end of the study, 71% of patients who received lercanidipine tablets had achieved normalised DBP (ie, < or =90 mm Hg) and 81% had responded to treatment (ie, DBP < or =90 mm Hg or a decrease in DBP > or =10 mm Hg). The corresponding numbers in the losartan tablets group were 65% and 78%, respectively. In those patients who required dose titration, there was evidence of a greater response with lercanidipine tablets than with losartan tablets. Both treatments were well tolerated with a low incidence of adverse drug reactions and a low withdrawal rate. In conclusion, the antihypertensive effects of lercanidipine tablets were comparable with those of losartan tablets; both treatments gave a high response rate for an antihypertensive monotherapy and were very well tolerated.
一项双盲、双模拟、随机、多中心研究,旨在比较乐卡地平与氯沙坦的疗效和耐受性。纳入轻度至中度高血压患者(仰卧位舒张压(DBP)95 - 115 mmHg),在随机分配至乐卡地平片10 mg每日一次(n = 234)或氯沙坦片50 mg每日一次(n = 231)进行评估期(约16周)之前,先经历14 - 30天的安慰剂导入期。如有必要,8周后允许将乐卡地平滴定至20 mg每日一次(两片10 mg片剂)或氯沙坦滴定至100 mg每日一次(两片50 mg片剂)。研究结束时,接受乐卡地平片治疗的患者中71%的DBP恢复正常(即≤90 mmHg),81%对治疗有反应(即DBP≤90 mmHg或DBP下降≥10 mmHg)。氯沙坦片组的相应数字分别为65%和78%。在那些需要剂量滴定的患者中,有证据表明乐卡地平片比氯沙坦片有更大的反应。两种治疗耐受性均良好,药物不良反应发生率低,停药率低。总之,乐卡地平片的降压效果与氯沙坦片相当;两种治疗作为单一降压疗法均有较高的反应率,且耐受性良好。