COMPARISON OF EFFICACY IN RENOPROTECTION BETWEEN AZILSARTAN AND ENALAPRIL: A RANDOMIZED CONTROLLED TRIAL

Abstract

Background: Angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin-receptor blockers (ARBs) are reported to improve renal outcomes among patients with hypertension and chronic kidney disease (CKD), but there might be substantial differences in their renoprotective effects. Azilsartan medoxomil is a relatively new available ARB, highly specific angiotensin type 1 receptor and superior in terms of blood pressure reduction, with respect to other ARBs.
 Methods: The study employed a randomized controlled trial; hypertensive subjects with albuminuria >30 mg/g creatinine at the outpatient clinic, Phramongkutklao Hospital, Bangkok, Thailand were randomly assigned to azilsartan 40-80 mg/day (n=27) or enalapril 10-40 mg/day (n=23) for 24 weeks. The primary outcome was the change in urine albumin creatinine ratio (UACR). UACR, estimated glomerular filtration rate (GFR), blood pressure and serum electrolytes were evaluated at baseline, 12 and 24 weeks.
 Results: A total of 50 patients with hypertension and albuminuria were recruited. At the end of treatment, systolic blood pressure level was significantly reduced in the azilsartan group compared with the enalapril group (-12.2 mmHg [95%CI -18.9 to -5.5] vs. -1.1 mmHg [95% -7.8 to 5.7], p=0.021). In addition, at 24 weeks, significantly reduced median UACR was observed in the azilsartan group compared with that of the enalapril group (-59.9 mg/g Cr [95% CI -284.6 to -31.0] vs. -40.4 mg/gCr [95% CI -129.4 to 88.3], p=0.026)). No statistically significant difference was found between the two groups in hyperkalemia, estimated GFR, acute kidney injury and serious adverse events.
 Conclusion: This study demonstrated that azilsartan had superior antihypertensive and albuminuric efficacy compared with the standard dose of enalapril without increasing adverse events.