Fogari R, Zoppi A, Lusardi P, Mugellini A
Universita' degli Studi di Pavia, Dipartimento di Medicina Interna e Terapia Medica, Italy.
Blood Press Suppl. 1996;5:24-8.
The aim of this multicenter study was to evaluate the efficacy and tolerability of manidipine hydrochloride, a new calcium-antagonist of the dihydropyridine group, in the long-term treatment of mild to moderate hypertension. After a 2-week run-in period on placebo, 183 patients, 98 males and 85 females, with mean age of 53.8 years, sitting DBP > or = 95 and < or = 115 mmHg and SBP < or = 210 mmHg, were given manidipine 10 mg once daily. Two weeks later, patients whose DBP was > or = 90 mmHg or with a reduction in DBP < 10 mmHg were administered with manidipine 20 mg once daily. Follow-up visits were performed at 6, 10, 14, 26, 38 and 52 weeks after starting manidipine treatment. All BP (by mercury sphygmomanometer, Korotkoff I and V) and heart rate (HR) measures were made 24 h after dosing. Adverse events and laboratory data were recorded. Particular attention was paid to the collection of possible major cardiovascular (angina pectoris, myocardial infarction) and cerebrovascular (IRA, stroke) events, observed during the treatment period. One-hundred-and-fifty-one patients completed the study (79 on a 10 mg dose and 72 on a 20 mg dose), whereas 32 dropped out (11 lost to follow-up, 11 insufficient therapeutic response, 7 ADRs, 3 other causes). Significant reductions of BP values were achieved during the manidipine 10 mg treatment period. Analysis of covariance between doses confirmed a more potent hypotensive effect of manidipine 20 mg as compared to 10 mg on sitting DBP and mean BP and on standing SBP, especially in patients with moderate hypertension. At the end of 1 year of treatment the success rates (defined as sitting DBP > or = 90 mmHg or a reduction of > or = 10 mmHg vs baseline) were similar in the two groups (manidipine 10 mg: 96.1%; manidipine 20 mg: 94.5%). No clinically relevant change in HR was observed. Overall, 28 patients (17 in the manidipine 20 mg and 11 in the manidipine 10 mg treated group) complained of adverse events, the most common being ankle oedema (4.9%), headache (3.8%), palpitation (2.7%) and flushing (2.2%). Neither cardiovascular nor cerebrovascular events or other serious adverse event were reported. In conclusion, a significant and constant reduction of BP values was observed with long-term treatment with manidipine. The reduction in BP was dose-related especially in patients suffering from moderate hypertension. Adverse events were mild and relatively more frequent with the higher manidipine dosage.
这项多中心研究的目的是评估新型二氢吡啶类钙拮抗剂盐酸马尼地平在长期治疗轻至中度高血压中的疗效和耐受性。在接受2周的安慰剂导入期后，183例患者（男性98例，女性85例），平均年龄53.8岁，坐位舒张压≥95且≤115 mmHg，收缩压≤210 mmHg，给予盐酸马尼地平10 mg每日1次。两周后，舒张压≥90 mmHg或舒张压降低<10 mmHg的患者给予盐酸马尼地平20 mg每日1次。在开始盐酸马尼地平治疗后的第6、10、14、26、38和52周进行随访。所有血压（采用汞柱式血压计，柯氏音I期和V期）和心率（HR）测量均在给药24小时后进行。记录不良事件和实验室数据。特别关注在治疗期间观察到的可能的主要心血管（心绞痛、心肌梗死）和脑血管（缺血性卒中、中风）事件的收集。151例患者完成了研究（79例接受10 mg剂量，72例接受20 mg剂量），而32例退出（11例失访，11例治疗反应不足，7例出现药物不良反应，3例因其他原因）。在盐酸马尼地平10 mg治疗期间，血压值显著降低。剂量间的协方差分析证实，与10 mg相比，20 mg盐酸马尼地平对坐位舒张压、平均血压和站立位收缩压具有更强的降压作用，尤其是在中度高血压患者中。在治疗1年末，两组的成功率（定义为坐位舒张压≥90 mmHg或较基线降低≥10 mmHg）相似（盐酸马尼地平10 mg组：96.1%；盐酸马尼地平20 mg组：94.5%）。未观察到HR有临床相关变化。总体而言，28例患者（盐酸马尼地平20 mg治疗组17例，盐酸马尼地平10 mg治疗组11例）抱怨有不良事件，最常见的是踝部水肿（4.9%）、头痛（3.8%）、心悸（2.7%）和潮红（2.2%）。未报告心血管或脑血管事件或其他严重不良事件。总之，长期使用盐酸马尼地平治疗可观察到血压值显著且持续降低。血压降低与剂量相关，尤其是在中度高血压患者中。不良事件较轻且在较高剂量的盐酸马尼地平治疗时相对更频繁。
