CALM study
Last reviewed 04/2023
This study was designed to examine the effects of candesartan and lisinopril, or both, on blood pressure and urinary albumin excretion rate in patients with hypertension, microalbuminuria, and type 2 diabetes mellitus.
- randomised, double blind, controlled trial with 24 weeks follow-up
- patients: 199 patients with type 2 diabetes aged between 30 and 75 years; also patients had microalbuminuria, and diastolic pressure between 90 and 110 mmHg while receiving placebo
- intervention:
- 4 week placebo run in period
- then patients allocated to 1 of 4 groups; candesartan for 24 weeks (n=66), lisinopril for 24 weeks (n=64), candesartan for 12 weeks with the addition of lisinopril for a subsequent 12 weeks (n=34), or lisinopril for 12 weeks with the addition of candesartan for a subsequent 12 weeks (n=35). The doses used were candesartan 16 mg once daily, and lisinopril 20mg once daily
- results:
- at 24 weeks the mean reduction from baseline in diastolic BP was greater with combination treatment (16.3 mmHg) than with candesartan alone (10.4 mmHg, p=0.003), or lisinopril alone (10.7mmHg, p=0.005). Similarly the mean reduction from baseline in systolic BP was greater with combination treatment than either monotherapy. Also combination treatment was associated with a greater mean reduction from baseline in urinary albumin to creatinine ratio than candesartan alone (50% v 24%, p=0.04) but not lisinopril alone (50% v 39%, p>0.2)
The more recent CALM II Study revealed that there was no statistically significant difference between lisinopril 40 mg once daily and lisinopril 20 mg in combination with candesartan 16 mg once daily in reducing systolic blood pressure in hypertensive patients with diabetes (2)
Reference:
- Mgensen CE et al for the CALM Study Group. 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. BMJ 2000; 321: 1440-4.
- Andersen NH et al. Long-term dual blockade with candesartan and lisinopril in hypertensive patients with diabetes: the CALM II study. Diabetes Care 2005; 28:273-7