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坎地沙坦酯对轻至中度高血压患者的长期疗效及耐受性

Long-term efficacy and tolerability of candesartan cilexetil in patients with mild to moderate hypertension.

作者信息

Sever P, Holzgreve H

机构信息

Imperial College School of Medicine at St Mary's Hospital, London, UK.

出版信息

J Hum Hypertens. 1997 Sep;11 Suppl 2:S69-73.

PMID:9331014
Abstract

The long-term efficacy and tolerability of candesartan cilexetil was assessed in two open-label, prospective multicentre studies in patients with mild to moderate essential hypertension. When administered in a flexible dosage regimen of 4-16 mg once-daily, candesartan cilexetil effectively lowered blood pressure (BP) and maintained its antihypertensive effects over the long term (< or =12 months). At the end of treatment, 81.1% of patients showed a clinically significant response (reduction in sitting diastolic BP of > or =10 mm Hg or reduction to <90 mm Hg), and 73.8% experienced normalisation of sitting diastolic BP (<90 mm Hg). Only a small proportion (10.7%) of patients prematurely discontinued treatment due to lack of efficacy. Candesartan cilexetil was well tolerated and was devoid of clinically relevant biochemical, haematological or cardiac effects. Only 12% of adverse events were judged to be causally related to the drug and only about 5% of patients withdrew from therapy due to adverse events. The most common adverse events were typical of hypertensive patients in general. Most adverse events appeared during the first 3 months of treatment and their incidence decreased steadily with time. Tolerability was unrelated to gender, age (<65 vs > or =65 years) or dosage. These results demonstrate that candesartan cilexetil maintains its antihypertensive effects and tolerability during long-term administration.

摘要

在两项开放性、前瞻性多中心研究中,对坎地沙坦酯在轻至中度原发性高血压患者中的长期疗效和耐受性进行了评估。当以4 - 16mg每日一次的灵活剂量方案给药时,坎地沙坦酯能有效降低血压(BP),并在长期(≤12个月)维持其降压效果。治疗结束时,81.1%的患者显示出具有临床意义的反应(坐位舒张压降低≥10mmHg或降至<90mmHg),73.8%的患者坐位舒张压恢复正常(<90mmHg)。只有一小部分(10.7%)患者因缺乏疗效而提前停药。坎地沙坦酯耐受性良好,没有临床相关的生化、血液学或心脏方面的影响。只有12%的不良事件被判定与药物有因果关系,只有约5%的患者因不良事件退出治疗。最常见的不良事件是一般高血压患者常见的典型事件。大多数不良事件出现在治疗的前3个月,其发生率随时间稳步下降。耐受性与性别、年龄(<65岁与≥65岁)或剂量无关。这些结果表明,坎地沙坦酯在长期给药期间能维持其降压效果和耐受性。

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