Trenkwalder P, Dahl K, Lehtovirta M, Mulder H
Department of Internal Medicine, Starnberg Hospital, Ludwig Maximilian University Munich, Germany.
Blood Press. 1998 May;7(3):170-5. doi: 10.1080/080370598437385.
This multicentre, randomized, controlled clinical trial assessed the effects of candesartan cilexetil (cand.cil.), a novel angiotensin II antagonist selective for the AT1 receptor with long-lasting antihypertensive activity, compared to placebo on glucose homeostasis and serum lipid profile in mild hypertensives with type II diabetes. A total of 161 men and women, 30-75 years old, with mild hypertension (sitting diastolic blood pressure 90-100 mmHg) and type II diabetes (HbA1c 5.5-9.0%), both measured after a 4-week placebo run-in period, were randomized to double-blind treatment with cand.cil. 8 mg o.i.d. (n = 83) or placebo (n = 78). Dose was increased to 16 mg o.i.d. if diastolic blood pressure remained >90 mmHg. At randomization and after 12 weeks of treatment HbA1c (primary effect variable), blood glucose and the serum lipid profile (including total cholesterol, HDL and LDL cholesterol, triglycerides) were assessed. The statistical analysis of the differences between treatments was based on changes from randomization to the end of the study. Cand.cil. had no significant effect on HbA1c, blood glucose and serum lipids compared to placebo. The median HbA1c both at baseline and after 12 weeks was 7.1% in patients on cand.cil., and 7.2% and 7.1% in patients on placebo. The 95% confidence interval for the median difference in change between the groups was narrow (-0.25; 0.16), including zero, which excluded any clinically important difference. The same held true for blood glucose (-1.10; 0.20), total cholesterol (-0.40; 0.20) and the other lipid parameters. More than 60% of the patients reached a diastolic blood pressure <90 mmHg; adverse events and withdrawals were similar in both groups. Thus, in patients with mild hypertension and type II diabetes, cand.cil. 8-16 mg o.i.d. for 12 weeks does not affect glucose homeostasis and serum lipids. Blood pressure was controlled in most patients, and cand.cil. was well tolerated.
这项多中心、随机、对照临床试验评估了新型血管紧张素II拮抗剂坎地沙坦酯（cand.cil.）对伴有II型糖尿病的轻度高血压患者糖稳态和血脂谱的影响。坎地沙坦酯对AT1受体具有选择性，具有持久的降压活性，将其与安慰剂进行比较。共有161名年龄在30至75岁之间的男性和女性参与研究，他们患有轻度高血压（坐位舒张压90 - 100 mmHg）和II型糖尿病（糖化血红蛋白HbA1c 5.5 - 9.0%），这些指标均在经过4周安慰剂导入期后测量。患者被随机分为两组，进行双盲治疗，一组服用坎地沙坦酯8 mg，每日口服3次（n = 83），另一组服用安慰剂（n = 78）。如果舒张压仍>90 mmHg，则将剂量增加至16 mg，每日口服3次。在随机分组时以及治疗12周后，评估糖化血红蛋白（主要效应变量）、血糖和血脂谱（包括总胆固醇、高密度脂蛋白和低密度脂蛋白胆固醇、甘油三酯）。对治疗组之间差异的统计分析基于从随机分组到研究结束的变化情况。与安慰剂相比，坎地沙坦酯对糖化血红蛋白、血糖和血脂没有显著影响。服用坎地沙坦酯的患者在基线和12周后的糖化血红蛋白中位数均为7.1%，服用安慰剂的患者分别为7.2%和7.1%。两组之间变化中位数差异的95%置信区间很窄（-0.25；0.16），包括零，这排除了任何具有临床意义的差异。血糖（-1.10；0.20）、总胆固醇（-0.40；0.20）和其他血脂参数也是如此。超过60%的患者舒张压<90 mmHg；两组的不良事件和退出情况相似。因此，对于患有轻度高血压和II型糖尿病的患者，每日口服3次8 - 16 mg坎地沙坦酯，持续12周，不会影响糖稳态和血脂。大多数患者的血压得到控制，且坎地沙坦酯耐受性良好。
