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首页> 美国卫生研究院文献>NPG Open Access >Long-term safety and efficacy of high-dose controlled-release nifedipine (80 mg per day) in Japanese patients with essential hypertension
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Long-term safety and efficacy of high-dose controlled-release nifedipine (80 mg per day) in Japanese patients with essential hypertension

机译：大剂量控释硝苯地平（每天80μmg/天）对日本原发性高血压患者的长期安全性和有效性

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High-dose calcium channel blocker (CCB) shows strong blood pressure (BP) lowering effect. Currently available of controlled-release (CR) nifedipine 80 mg per day clinical data are limited to monotherapy and short-term or long-term retrospective studies. We report the safety and efficacy results of a 52-week, prospective open-label study, in which Japanese patients with essential hypertension were treated with CR nifedipine [80 mg per day; 40 mg bis in die (BID; twice daily)] in combination with other antihypertensive drugs. The patients with inadequate BP control despite treatment with CR nifedipine (40 mg once daily) in combination with other antihypertensive drugs were enrolled. The primary objective of this study was to assess the long-term safety of CR nifedipine (80 mg per day). Efficacy variables included changes in the mean sitting BP, the target BP achievement rate and the BP response rate. CR nifedipine (80 mg per day) was generally well tolerated, with the most common drug-related treatment-emergent adverse event being tachycardia (6.9% of patients). Serious treatment-emergent adverse events were reported in three (4.2%) patients. By week 52, the mean reductions in sitting systolic and diastolic BP were 19.4 and 13.6 mm Hg, respectively. The target BP achievement and BP response rates after 52 weeks of treatment were 32.4 and 63.4%, respectively. Based on these findings, long-term treatment with CR nifedipine at 40 mg BID in combination with antihypertensive drugs was well tolerated and effective in Japanese patients with essential hypertension.
机译：大剂量钙通道阻滞剂（CCB）表现出强大的降低血压（BP）的作用。目前每天可获得的控释（CR）硝苯地平每天80 mg的临床数据仅限于单药治疗和短期或长期回顾性研究。我们报告了一项为期52周的前瞻性开放标签研究的安全性和有效性结果，该研究中，日本原发性高血压患者接受CR硝苯地平[每天80 mg /天；与其他降压药合用40毫克之二（每日两次；每日两次）。入选尽管硝苯地平CR（每日一次40μmg）与其他降压药联合治疗但血压控制不佳的患者。这项研究的主要目的是评估CR硝苯地平的长期安全性（每天80微克）。功效变量包括平均坐位血压，目标血压达成率和血压反应率的变化。一般对CR硝苯地平（每天80 mg /日）的耐受性良好，最常见的药物相关的治疗性不良事件为心动过速（6.9％的患者）。在三名（4.2％）患者中报告了严重的治疗紧急不良事件。到第52周时，坐姿收缩压和舒张压的平均降低分别为19.4和13.6mmmmHg。治疗52周后的目标BP达成率和BP缓解率分别为32.4％和63.4％。基于这些发现，在日本原发性高血压患者中，长期接受40 mg BID的硝苯地平CR联合抗高血压药的治疗耐受性良好且有效。

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