D'Hont G, Meurant J P, Clement D L, Rorive G, Hermans L, De Keyser P, Westelinck K J
Department of Cardiology, University Hospital, Ghent, Belgium.
J Cardiovasc Pharmacol. 1992;19 Suppl 3:S46-8.
At the end of a short-term (3-month) study of antihypertensive treatment of mild-to-moderate hypertension, 141 of the 200 study patients continued into a 2-year follow-up of isradipine as monotherapy or in combination with other antihypertensive agents. Although all 141 patients completed the first year, only 102 completed the study. Twenty-four patients dropped out: 2 with flushing; 1 each with arrhythmia, edema, angina, and headache; 12 who were noncompliant; 2 with disease unrelated to the study drug; and 4 for reasons unknown. Before the follow-up, 70% of the 141 patients were taking isradipine; after 2 years, 63% were still taking isradipine as monotherapy. During the follow-up study, the blood pressure remained stable (142.9/86.8 mm Hg after 3 months, and 142.9/86.2 mm Hg after 2 years), whereas the normalization rate was only slightly changed (73 vs. 75.2%). The incidence of reported adverse events decreased with time. At the end of the short-term study, 44.7% of patients had reported one or more adverse events; after 2 years of treatment, only 14.4% reported adverse events. Two patients had ECG signs of left ventricular hypertrophy: one showed no relevant changes while the other presented clear signs of regression. No clinically relevant laboratory abnormalities were noted during the study. In conclusion, isradipine is effective, well tolerated and safe in the long-term treatment of mild-to-moderate hypertension.
在一项针对轻度至中度高血压患者进行的短期（3个月）抗高血压治疗研究结束时，200名研究患者中有141名继续接受为期2年的伊拉地平单药治疗或与其他抗高血压药物联合治疗的随访。尽管所有141名患者都完成了第一年的治疗，但只有102名完成了研究。24名患者退出：2名出现潮红；1名分别出现心律失常、水肿、心绞痛和头痛；12名不依从；2名出现与研究药物无关的疾病；4名原因不明。随访前，141名患者中有70%服用伊拉地平；2年后，63%仍在接受伊拉地平单药治疗。在随访研究期间，血压保持稳定（3个月后为142.9/86.8毫米汞柱，2年后为142.9/86.2毫米汞柱），而血压正常化率仅略有变化（73%对75.2%）。报告的不良事件发生率随时间下降。在短期研究结束时，44.7%的患者报告了一种或多种不良事件；治疗2年后，只有14.4%的患者报告了不良事件。两名患者有左心室肥厚的心电图迹象：一名无相关变化，另一名有明显的消退迹象。研究期间未发现临床相关的实验室异常。总之，伊拉地平在轻度至中度高血压的长期治疗中有效、耐受性良好且安全。
