Taylor S H, Jackson N C, Allen J, Pool P E
Am J Cardiol. 1987 Jan 30;59(3):123B-129B. doi: 10.1016/0002-9149(87)90091-9.
Angina pectoris is one of the major syndromes against which to test the therapeutic effectiveness of any new calcium antagonist. An interim analysis of the efficacy and safety of a new dihydropyridine calcium antagonist (PN 200-110 [isradipine]) in patients with confirmed coronary artery disease is reported. The study was carried out in 3 centers; 50 patients of an anticipated 96 have completed the double-blind comparative phases in 3 separate studies. Preliminary results from the placebo-controlled study indicate that PN 200-110 was significantly more effective than placebo in reducing the anginal attack rate and glyceryl trinitrate consumption in the 15 patients so far enrolled. Dose-response comparisons against nifedipine in 21 patients and against isosorbide dinitrate in 14 patients demonstrate that PN 200-110 has a similar antianginal efficacy profile to both drugs. No significant change in any of the monitored safety factors was noted in any of the patients taking PN 200-110. The side-effects profile compared favorably with that of nifedipine. These interim results suggest that PN 200-110 will prove to be an effective and safe drug for the treatment of angina pectoris.
心绞痛是用以检验任何新型钙拮抗剂治疗效果的主要综合征之一。本文报道了一种新型二氢吡啶类钙拮抗剂（PN 200 - 110[伊拉地平]）在确诊为冠状动脉疾病患者中的疗效和安全性的中期分析。该研究在3个中心进行；预期的96例患者中有50例在3项独立研究中完成了双盲比较阶段。来自安慰剂对照研究的初步结果表明，在目前已入组的15例患者中，PN 200 - 110在降低心绞痛发作率和硝酸甘油消耗量方面明显比安慰剂更有效。对21例患者与硝苯地平以及14例患者与硝酸异山梨酯进行的剂量反应比较表明，PN 200 - 110与这两种药物具有相似的抗心绞痛疗效。服用PN 200 - 110的任何患者的任何监测安全因素均未发现显著变化。其副作用情况优于硝苯地平。这些中期结果表明，PN 200 - 110将被证明是一种治疗心绞痛的有效且安全的药物。
