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

C. E. Mogensen, S. Neldam, I. Tikkanen, S. Oren, R. Viskoper, R. W. Watts, M. E. Cooper

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960 Scopus citations

Abstract

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 treatment. Setting: Tertiary hospitals and primary care centres in four countries (37 centres). Participants: 199 patients aged 30-75 years. Interventions: Candesartan 16 mg once daily, lisinopril 20 mg once daily. Main outcome measures: Blood pressure and urinary albumin:creatinine ratio. Results: At 12 weeks mean (95% confidence interval) reductions in diastolic blood pressure were 9.5 mm Hg (7.7 mm Hg to 11.2 mm Hg, P < 0.001) and 9.7 mm Hg (7.9 mm Hg to 11.5 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 mm 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 < 0.001) was greater than with candesartan (24%, 0% to 43%, P = 0.05) and lisinopril (39%, 20% to 54% P < 0.001). All treatments were generally well tolerated. Conclusion: Candesartan 16 mg once daily is as effective as lisinopril 20 mg once daily in reducing blood pressure and microalbuminuria in hypertensive patients with type 2 diabetes. Combination treatment is well tolerated and more effective in reducing blood pressure.

Original languageEnglish
Pages (from-to)1440-1444
Number of pages5
JournalThe BMJ
Volume321
Issue number7274
DOIs
StatePublished - 9 Dec 2000
Externally publishedYes

ASJC Scopus subject areas

  • Medicine (all)

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