Belcher G, Hübner R, George M, Elmfeldt D, Lunde H
Clinical Research and Drug Safety, Takeda Euro R&D Centre, Frankfurt/Main, Germany.
J Hum Hypertens. 1997 Sep;11 Suppl 2:S85-9.
The tolerability and safety of candesartan cilexetil has been evaluated in over 5000 subjects enrolled into double-blind or open-label clinical studies. In double-blind clinical trials in patients with primary hypertension, candesartan cilexetil 2-16 mg once-daily was associated with a low incidence of adverse events and drug-related withdrawals, similar to placebo. The drug showed no evidence of dose-dependent adverse events and it was equally well tolerated by men and women and by elderly (> or =65 years) and younger (<65 years) patients alike. Candesartan cilexetil had no effect on blood glucose control or serum lipid profile in patients with type II diabetes. It was very well tolerated also when given in combination with hydrochlorothiazide or amlodipine and during long-term open-label therapy (up to 1 year). Candesartan cilexetil therefore possesses an excellent tolerability profile that extends to a wide variety of patients including the elderly and it does not aggravate co-existing risk factors such as hyperlipidaemia or glucose intolerance. It therefore appears to offer a better tolerated alternative to other commonly used antihypertensive agents.
坎地沙坦酯的耐受性和安全性已在5000多名纳入双盲或开放标签临床研究的受试者中进行了评估。在原发性高血压患者的双盲临床试验中，每日一次服用2 - 16毫克坎地沙坦酯的不良事件发生率和与药物相关的撤药率较低，与安慰剂相似。该药物未显示出剂量依赖性不良事件的证据，男性和女性、老年（≥65岁）和年轻（<65岁）患者对其耐受性相同。坎地沙坦酯对II型糖尿病患者的血糖控制或血脂谱没有影响。与氢氯噻嗪或氨氯地平联合使用时以及在长期开放标签治疗（长达1年）期间，其耐受性也非常好。因此，坎地沙坦酯具有出色的耐受性，适用于包括老年人在内的广泛患者群体，并且不会加重诸如高脂血症或葡萄糖不耐受等并存的危险因素。因此，它似乎为其他常用抗高血压药物提供了一种耐受性更好的替代选择。
