Randomised controlled trial of dual blockade of renin-angiotensin system in patients with hypertension, microalbuminuria, and non-insulin dependent diabetes: the candesartan and Lisinopril microalbuminuria (CALM) study
Randomised controlled trial of dual blockade of renin-angiotensin system in patients with hypertension, microalbuminuria, and non-insulin dependent diabetes: the candesartan and Lisinopril microalbuminuria (CALM) study
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DOI：
10.1136/bmj.321.7274.1440
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发表时间：
2000-12-09
影响因子：
105.7
通讯作者：
Cooper, ME
中科院分区：
文献类型：
--
作者：
Mogensen, CE;Neldam, S;Cooper, ME
目的评价和比较坎地沙坦和赖诺普利或两者合用对微量白蛋白尿、高血压和2型糖尿病患者血压和尿白蛋白排泄的影响。设计前瞻性、随机、平行、双盲研究，在4个国家(37个中心)进行为期4周的安慰剂治疗和12周的单用坎地沙坦或赖诺普利治疗，然后进行12周的单一治疗或联合治疗。结果12条小溪平均(95%可信区间)舒张压分别下降9.5 mm Hg(7.7 mm Hg~11.2 mm Hg，P<；0.002)和9.7 mm Hg(7.9 mm Hg~115 mm Hg，P<；0.001)，尿白蛋白/肌酐比值为30%(15%~42%，P<；0.001)。坎地沙坦和赖诺普利分别为0.001%和46%(35%至56%，P<；0.001)。在24周时，联合治疗的舒张压的平均降幅(16.3 mm Hg，13.6 mm Hg至18.9 mm Hg，P<；0.001)显著大于坎地沙坦(10.4 mm Hg，7.7 mm Hg至13.1 mm Hg，P<；0.001)或赖诺普利(平均10.7 mm Hg)。8毫米汞柱至13.5毫米汞，P<；0.001)。联合治疗后尿白蛋白/肌酐比值明显下降(50%、36%至61%，P
Objectives To assess and compare the effects of candesartan or lisinopril, or both, on blood pressure and urinary albumin excretion in patients with microalbuminuria, hypertension, and type 2 diabetes.Design Prospective, randomised, parallel group, double blind study with four week placebo run in period and 12 weeks' monotherapy with candesartan or lisinopril followed by 12 weeks' monotherapy or combination treatmentSetting Tertiary hospitals and primary care centres in four countries (37 centres).Participants 199 patients aged 30-75 years.Interventions Candesartan 16 mp; once daily, lisinopril 20 mg once daily.Main outcome measures Blood pressure and urinary albumin:creatinine ratio.Results At 12 creeks mean (95% confidence interval) reductions in diastolic blood pressure were 9.5 mm Hg (7.7 mm Hg to 11.2 mm Hg, P < 0.002) and 9.7 mm Hg (7.9 mm Hg to 115 mm Hg, P < 0.001), respectively, and in urinary albumin:creatinine ratio were 30% (15% to 42%, P < 0.001) and 46% (35% to 56%, P < 0.001) for candesartan and lisinopril, respectively. At 24 weeks the mean reduction in diastolic blood pressure with combination treatment (16.3 mm Hg, 13.6 mm Hg to 18.9 mm Hg, P < 0.001) was significantly greater than that with candesartan (10.4 mm Hg, 7.7 mm Hg to 13.1 mm Hg, P < 0.001) or lisinopril (mean 10.7 mm Hg. 8.0 nun Hg to 13.5 mm Hg, P < 0.001). Furthermore, the reduction in urinary albumin:creatinine ratio with combination treatment (50%, 36% to 61%, P