BMJ 2000;321:1440-1444 ( 9 December )

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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

Carl Erik Mogensen, professor of medicine, a Steen Neldam, general practitioner, b Ilkka Tikkanen, associate professor of medicine (nephrology), c Shmuel Oren, physician, d Reuven Viskoper, physician, d Richard W Watts, physician, e Mark E Cooper, professor of medicine, f for the CALM study group.

a Department of Medicine, M, Kommunehospitalet, University Hospital, DK-8000 Aarhus C, Denmark, b Rødovre Centrum 294, DK-2610, Denmark, c Helsinki University Hospital, Clinic of Internal Diseases, Helsinki, FIN-00029 HYKS, Finland, d Barzilai Medical Centre, Ashkelon, Israel, e 19 Oxford Terrace, Port Lincoln, SA 5606, Australia, f Department of Medicine, University of Melbourne (Repatriation Campus), W Heidelberg, Victoria 3084, Australia

Correspondence to: C E Mogensen cem{at}afdm.au.dk

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.


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Rapid Responses:

Read all Rapid Responses

Benefit of combination over single therapy not supported by the data
James P McCormack, et al.
bmj.com, 13 Dec 2000 [Full text]
The role of Angiotensin converting enzyme inhibitors in the prevention of diabetic nephropathy in...
Alia El-Kadiki
bmj.com, 9 Jan 2001 [Full text]
Considering patient-oriented outcomes is the crucial issue
David C Slawson
bmj.com, 16 Mar 2001 [Full text]
Statistical flaws?
Lionel Lim
bmj.com, 2 Jun 2001 [Full text]
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