Hammond J J, Cutler S A
Melbourne Hypertension Clinic, Vic., Australia.
Blood Press. 1993 Sep;2(3):205-11. doi: 10.3109/08037059309077552.
The aim of this study was to compare the tolerability and efficacy of isradipine and felodipine in the treatment of mild-moderate hypertension. After a 4 week placebo period, 143 patients entered a randomized, double-blind, multicentre study of 12 weeks duration. Patients received either isradipine (n = 72) or felodipine (n = 71) 2.5 mg twice daily. Doubling of this dose and the addition of enalapril (2.5 mg once daily) was permitted if DBP was > 90 mmHg at weeks 4 and 8, respectively. Isradipine monotherapy reduced BP from 165/104 +/- 13/6 mmHg at baseline to 149/91 +/- 14/10 mmHg at week 8 (p < 0.001), while felodipine alone reduced BP from 171/104 +/- 17/6 at baseline to 151/92 +/- 19/9 (p < 0.001). Following the addition of enalapril to 35% of patients in the isradipine group BP was further reduced to 144/88 +/- 13/8 mmHg at week 12 (p < 0.001). The addition of enalapril to 24% of the felodipine group further reduced BP to 150/92 +/- 19/9 mmHg at week 12 (p < 0.001). No differences in BP were found between the 2 groups while on monotherapy. However, the isradipine group had a significantly lower DBP than the felodipine group at the conclusion of the study (p = 0.008; 95% CI 0.7 to 6.9 mmHg). Similar incidences of headache, flushing, dizziness and tachycardia were reported in both groups. However, the incidence of ankle oedema was significantly lower in the isradipine group (p = 0.028). Overall, ankle oedema was reported more often by female patients and was not associated with an increase in weight.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究旨在比较伊拉地平与非洛地平治疗轻中度高血压的耐受性和疗效。经过4周的安慰剂期后,143例患者进入了一项为期12周的随机、双盲、多中心研究。患者每日两次服用伊拉地平(n = 72)或非洛地平(n = 71),剂量为2.5mg。如果在第4周和第8周时舒张压分别> 90mmHg,则允许将该剂量加倍并加用依那普利(每日一次,2.5mg)。伊拉地平单药治疗使血压从基线时的165/104±13/6mmHg降至第8周时的149/91±14/10mmHg(p < 0.001),而非洛地平单药治疗使血压从基线时的171/104±17/6mmHg降至151/92±19/9mmHg(p < 0.001)。伊拉地平组35%的患者加用依那普利后,第12周血压进一步降至144/88±13/8mmHg(p < 0.001)。非洛地平组24%的患者加用依那普利后,第12周血压进一步降至150/92±19/9mmHg(p < 0.001)。单药治疗时两组血压无差异。然而,在研究结束时,伊拉地平组的舒张压显著低于非洛地平组(p = 0.008;95%CI 0.7至6.9mmHg)。两组报告的头痛、潮红、头晕和心动过速发生率相似。然而,伊拉地平组的踝部水肿发生率显著较低(p = 0.028)。总体而言,女性患者报告踝部水肿的情况更常见,且与体重增加无关。(摘要截断于250字)