Weiss R J
Androscoggin Cardiology Associates, Auburn, Maine.
Clin Ther. 1994 Jul-Aug;16(4):647-52.
Isradipine is a dihydropyridine calcium-entry blocker. Previous controlled and blinded trials have demonstrated the safety and efficacy of isradipine in lowering blood pressure in patients with hypertension. The purpose of this study was to reassess this safety and efficacy in a large number of patients in an open-label, long-term, multicenter trial. A total of 501 patients with essential hypertension (diastolic blood pressure 95 to 114 mm Hg) received 5 to 10 mg/d of isradipine in two divided doses for a period of 32 weeks. The mean dose used was 7.4 mg/d with titration at week 4 from 5 mg/d (2.5 mg BID) to 10 mg/d (5 mg BID) if the diastolic pressure was still > 90 mm Hg. After 32 weeks of isradipine treatment, systolic blood pressure decreased from 154.9 +/- 16.4 mm Hg to 140.2 +/- 13.9 mm Hg (P < 0.001) and diastolic pressure from 101.2 +/- 5.2 mm Hg to 86.6 +/- 7.9 mm Hg (P < 0.001). This monotherapy was successful in reducing diastolic blood pressure > 10 mm Hg in 62.5% of the patients. Significant adverse effects were noted in 92 (18.4%) of the 501 patients; only 30 (6.0%) withdrew from the study because of adverse events. In this large, long-term, community-based study, isradipine was effective and well tolerated in most patients.
伊拉地平是一种二氢吡啶类钙通道阻滞剂。先前的对照和双盲试验已证明伊拉地平在降低高血压患者血压方面的安全性和有效性。本研究的目的是在一项开放标签、长期、多中心试验中对大量患者重新评估这种安全性和有效性。共有501例原发性高血压患者（舒张压95至114毫米汞柱）接受5至10毫克/天的伊拉地平，分两次服用，为期32周。使用的平均剂量为7.4毫克/天，若舒张压仍>90毫米汞柱，则在第4周时从5毫克/天（2.5毫克，每日两次）滴定至10毫克/天（5毫克，每日两次）。伊拉地平治疗32周后，收缩压从154.9±16.4毫米汞柱降至140.2±13.9毫米汞柱（P<0.001），舒张压从101.2±5.2毫米汞柱降至86.6±7.9毫米汞柱（P<0.001）。这种单一疗法在62.5%的患者中成功降低舒张压>10毫米汞柱。501例患者中有92例（18.4%）出现明显不良反应；仅30例（6.0%）因不良事件退出研究。在这项大型、长期、基于社区的研究中，伊拉地平对大多数患者有效且耐受性良好。
