What question did this study set out to answer?

To compare the efficacy of candesartan, lisinopril, and their combination on blood pressure and urinary albumin excretion in hypertensive patients with type 2 diabetes and microalbuminuria.

December 9, 2000BMJOpen Access

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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Why the study?

Does combination therapy with candesartan and lisinopril reduce blood pressure and urinary albumin excretion more effectively than either monotherapy in patients with hypertension, microalbuminuria, and type 2 diabetes?

Population

199 patients aged 30-75 years with hypertension, microalbuminuria, and type 2 diabetes across 37 centres in…

Comparison

Combination treatment of candesartan 16 mg once… vs Monotherapy with candesartan 16 mg once daily or…

Design

RCT, randomised, parallel group, double blind

Follow-up

24 weeks

Authors

CMC. E. MogensenAarhus University Hospital SNSteen NeldamUniversity of Copenhagen ITI. TikkanenMinerva Foundation

Discussion

Member takes

Implication

Supports dual RAS blockade with candesartan plus lisinopril for superior BP and albuminuria control in diabetic hypertension; extends monotherapy evidence from prior trials.

Key Points

To compare the efficacy of candesartan, lisinopril, and their combination on blood pressure and urinary albumin excretion in hypertensive patients with type 2 diabetes and microalbuminuria.
Prospective, randomised, parallel-group, double-blind study conducted across 37 tertiary and primary care centers in four countries involving 199 patients aged 30–75 years.
Patients completed a 4-week placebo run-in, received 12 weeks of monotherapy with candesartan 16 mg once daily or lisinopril 20 mg once daily, followed by 12 weeks of continued monotherapy or combination therapy.
At 12 weeks, mean diastolic blood pressure reductions were 9.5 mm Hg (95% CI: 7.7 to 11.2, P<0.001) for candesartan and 9.7 mm Hg (95% CI: 7.9 to 11.5, P<0.001) for lisinopril, with urinary albumin:creatinine ratio reductions of 30% (95% CI: 15% to 42%, P<0.001) and 46% (95% CI: 35% to 56%, P<0.001), respectively.
At 24 weeks, combination treatment reduced diastolic blood pressure by a mean of 16.3 mm Hg (95% CI: 13.6 to 18.9, P<0.001), significantly greater than candesartan (10.4 mm Hg, 95% CI: 7.7 to 13.1, P<0.001) or lisinopril (10.7 mm Hg, 95% CI: 8.0 to 13.5, P<0.001).
At 24 weeks, combination therapy achieved a 50% reduction in urinary albumin:creatinine ratio (95% CI: 36% to 61%, P<0.001), surpassing candesartan monotherapy (24%, 95% CI: 0% to 43%, P=0.05) and lisinopril monotherapy (39%, 95% CI: 20% to 54%, P<0.001).

Structured PICO

Population

199 patients aged 30-75 years with hypertension, microalbuminuria, and type 2 diabetes across 37 centres in four countries.

Intervention

Combination treatment of candesartan 16 mg once daily and lisinopril 20 mg once daily (administered after an initial 12 weeks of monotherapy) for 12 weeks.

Comparator

Monotherapy with candesartan 16 mg once daily or lisinopril 20 mg once daily for 24 weeks.

Outcome

Blood pressure and urinary albumin:creatinine ratio at 12 and 24 weeks.surrogate

Dual blockade of the renin-angiotensin system with candesartan and lisinopril is more effective than either monotherapy in reducing blood pressure and microalbuminuria in patients with type 2 diabetes and hypertension.

Cite This Study

Mogensen et al. (2000) studied this question.

synapsesocial.com/papers/6a6f311c53da1ffdb5078c70 https://doi.org/10.1136/bmj.321.7274.1440

Topics

Hypertension management

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Implication

Supports dual RAS blockade with candesartan plus lisinopril for superior BP and albuminuria control in diabetic hypertension; extends monotherapy evidence from prior trials.

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

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

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

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Topics

Also Consider