Smilde J G
Department of Internal Medicine, Refaja-Hospital, Stadskanaal, The Netherlands.
Int J Clin Pract Suppl. 2000 Nov(114):20-6.
Two multicentre trials have investigated the efficacy and tolerability of treatment with once-daily barnidipine, in patients with mild to moderate essential hypertension. The long-term efficacy and safety of barnidipine were demonstrated in a long-term, multicentre, open-label study. In total, 106, 79 and 32 patients were followed for the first, second and third year, respectively. Patients received barnidipine at a dose titrated to achieve a sitting DBP > or = 90 mmHg or a decrease in sitting BDP > or = 10 mmHg. If necessary, another antihypertensive agent was added to achieve normalisation of blood pressure. In the first year, normalisation of blood pressure was achieved in 91% of patients. This was maintained in 91% and 81% of patients in the second and third years, respectively. At the end of treatment in both years, over 60% of patients remained on barnidipine monotherapy (10 or 20 mg/day). A low incidence of adverse events possibly or probably related to barnidipine (10 or 20 mg/day) monotherapy was reported in the first and second years with headache, peripheral oedema and palpitations the most commonly reported. In the third year of follow-up, only one adverse event, an ECG abnormality, was considered to be possibly related to the study medication. The effective 24 hour control of blood pressure with barnidipine monotherapy was confirmed in a randomised, double-blind, placebo-controlled, cross-over study of 20 patients. These patients were given 6 week regimens of both barnidipine (20 mg/day) and placebo. Office and 24 hour ambulatory blood pressures were recorded at the end of each treatment phase. Barnidipine lowered blood pressure to a significantly greater extent than placebo both at night and during the day. Adverse events were classified as mild or moderate and fewer adverse events were reported with barnidipine treatment compared with placebo. Barnidipine monotherapy (20 mg/day) is safe and effective in providing 24 hour control of blood pressure. Furthermore, the efficacy and tolerability of barnidipine monotherapy (10 or 20 mg/day) are maintained for at least 2 years.
两项多中心试验研究了每日一次服用巴尼地平治疗轻度至中度原发性高血压患者的疗效和耐受性。在一项长期、多中心、开放标签研究中证实了巴尼地平的长期疗效和安全性。分别有106例、79例和32例患者在第一年、第二年和第三年接受随访。患者接受巴尼地平治疗，剂量根据需要进行调整，以使坐位舒张压≥90 mmHg或坐位舒张压下降≥10 mmHg。必要时，加用另一种抗高血压药物以使血压恢复正常。在第一年，91%的患者血压恢复正常。第二年和第三年分别有91%和81%的患者维持血压正常。在这两年治疗结束时，超过60%的患者仍接受巴尼地平单药治疗（10或20 mg/天）。在第一年和第二年报告了可能或很可能与巴尼地平（10或20 mg/天）单药治疗相关的不良事件发生率较低，最常报告的是头痛、外周水肿和心悸。在随访的第三年，仅1例不良事件（心电图异常）被认为可能与研究药物有关。在一项对20例患者进行的随机、双盲、安慰剂对照、交叉研究中证实了巴尼地平单药治疗可有效24小时控制血压。这些患者接受了为期6周的巴尼地平（20 mg/天）和安慰剂治疗方案。在每个治疗阶段结束时记录诊室血压和24小时动态血压。巴尼地平在夜间和白天均比安慰剂更显著地降低血压。不良事件被分类为轻度或中度，与安慰剂相比，巴尼地平治疗报告的不良事件较少。巴尼地平单药治疗（20 mg/天）在24小时控制血压方面安全有效。此外，巴尼地平单药治疗（10或20 mg/天）的疗效和耐受性至少维持2年。
