Hermans L, Bogaert M, Degaute J P, Rorive G, Six R, Bara L, Lanssiers P, De Keyser P, Westelinck K J
Medical Department, Sandoz Belgium, Brussels.
J Cardiovasc Pharmacol. 1992;19 Suppl 3:S38-45.
The tolerability of isradipine was evaluated in an open trial of patients with mild-to-moderate essential hypertension as treated in general practice. The primary objective was to identify all adverse reactions, especially those that were newly occurring (greater than or equal to 6 reports), with a frequency greater than 1/1,000. Over 1,100 general practitioners and 5,526 patients participated in this trial. After a 2-week washout period, and a 3-week placebo run-in, patients with diastolic blood pressure (DBP) greater than or equal to 95 mm Hg were initially given isradipine at 1.25 mg twice daily. After 4 weeks, doses were doubled if DBP was greater than 90 mm Hg. If, after a further 4 weeks with doubled dosages, the DBP was still greater than 90 mm Hg, a second (nonspecified free-choice) antihypertensive agent was added to the treatment. Adverse events were recorded by open questioning. The incidence of adverse events was found to be similar to that with placebo; adverse events were generally mild or moderate in intensity and disappeared over time. No newly occurring adverse events were found. In conclusion, isradipine is safe and well tolerated at effective antihypertensive doses in patients with mild-to-moderate hypertension as treated in general practice.
在一项针对一般医疗中治疗的轻至中度原发性高血压患者的开放性试验中，对伊拉地平的耐受性进行了评估。主要目的是确定所有不良反应，尤其是那些新出现的（报告次数大于或等于6次）、发生率高于千分之一的不良反应。超过1100名全科医生和5526名患者参与了该试验。在经过2周的洗脱期和3周的安慰剂导入期后，舒张压（DBP）大于或等于95 mmHg的患者最初给予伊拉地平，每日两次，每次1.25 mg。4周后，如果DBP大于90 mmHg，则剂量加倍。如果在剂量加倍的情况下再过4周，DBP仍大于90 mmHg，则添加第二种（未指定的自由选择）抗高血压药物进行治疗。通过开放式询问记录不良事件。发现不良事件的发生率与安慰剂相似；不良事件的强度一般为轻度或中度，并随时间消失。未发现新出现的不良事件。总之，在一般医疗中治疗的轻至中度高血压患者中，伊拉地平在有效的抗高血压剂量下是安全且耐受性良好的。
