Benvenuti C, Guerini Rocco C, Trezzi P
Minerva Cardioangiol. 1995 Sep;43(9):399-408.
This trial was designed to confirm the hypotensive action and safety of slow-release nicardipine, as a single drug or together with other hypotensive drugs, for the short-term treatment of mild-to-moderate hypertension, on a large case list of patients in 57 centers throughout Italy. A total of 1011 patients (502 M, 509 F) were admitted, mean age 58.6 +/- 9.1 years (range 25-87), mean weight 72.7 +/- 11.1 kg (range 43-128), with essential (972 cases) or secondary hypertension (39 cases). Nicardipine was given orally at a mean daily dosage of 80 mg (range 40-120), for four weeks. Clinically and statistically significant reductions in systolic and diastolic BP were observed at the end of treatment, with no noteworthy changes in heart rate. Nicardipine single-drug therapy restored normal blood pressure in 79.7% of patients with essential hypertension, and in 72.0% of those with secondary hypertension; nicardipine associated with other hypotensive agents achieved normal blood pressure in respectively 65.9% and 42.9%. Blood pressure returned to normal in 77.3% of patients with essential hypertension aged 65 years or under, and in 66.9% of those over 65 years old. These figures were respectively 70.8% and 46.7% for patients with secondary hypertension. The treatment was very well tolerated by 86.2% of patients; 140 (13.8%) presented adverse reactions, requiring dose reductions in 12, and discontinuation of treatment only in 24 cases. Five patients taking nicardipine together with another drug presented adverse reactions. These results confirm that slow-release nicardipine is effective and extremely well tolerated in the treatment of mild-to-moderate essential or secondary hypertension, in adults and the elderly.
本试验旨在在意大利全国57个中心的大量患者病例中，确认缓释尼卡地平作为单一药物或与其他降压药联合使用，用于短期治疗轻至中度高血压的降压作用和安全性。共纳入1011例患者（男性502例，女性509例），平均年龄58.6±9.1岁（范围25 - 87岁），平均体重72.7±11.1千克（范围43 - 128千克），其中原发性高血压患者972例，继发性高血压患者39例。尼卡地平口服给药，平均日剂量为80毫克（范围40 - 120毫克），疗程四周。治疗结束时观察到收缩压和舒张压在临床和统计学上均有显著降低，心率无明显变化。尼卡地平单药治疗使79.7%的原发性高血压患者和72.0%的继发性高血压患者血压恢复正常；尼卡地平与其他降压药联合使用分别使65.9%的原发性高血压患者和42.9%的继发性高血压患者血压恢复正常。65岁及以下的原发性高血压患者中77.3%血压恢复正常，65岁以上患者中这一比例为66.9%。继发性高血压患者的相应比例分别为70.8%和46.7%。86.2%的患者对该治疗耐受性良好；140例（13.8%）出现不良反应，其中12例需要减量，仅24例停药。5例同时服用尼卡地平与另一种药物的患者出现不良反应。这些结果证实，缓释尼卡地平在治疗成人和老年人的轻至中度原发性或继发性高血压方面有效且耐受性极佳。
