ROLE OF ANGIOTENSIN RECEPTOR BLOCKERS IN DELAYING PROGRESSION OF DIABETIC NEPHROPATHY IN NORMOTENSIVE TYPE 2 DIABETES MELLITUS PATIENTS: AN OPEN-LABEL RANDOMISED CONTROLLED TRIAL

Abstract

Background: Diabetic nephropathy is the most common cause of end-stage renal disease worldwide, and while we know ARBs to be renoprotective in diuretic treated diabetic patients with hypertension, the evidence for DRR in normotensive patients is uncertain. We report a prospective, open-label randomized controlled trial of patients with type 2 diabetes mellitus and new diabetic nephropathy living in a normotensive sustainable lifestyle intervention, showing that renoprotective effects from ARBs should be extended to those living in a normotensive state. Methods: 84 normotensive patients were randomized to receive either increasing renoprotective doses of ARB (n=42) or standard care without RAS blockade (n=42). Serum creatinine, creatinine clearance (eGFR), and urine protein/creatinine ratios were determined at baseline and again at 12 months after therapy. Results: Patients randomized  to ARBs had significantly improved eGFR compared to the control group greater differences in terms of renal function were increased 4.8 ml/min/1.73m2 difference compared with no increase in eGFR in non ARB treatment group p=0.03). These patients also had significantly less proteinuria, (media of reduction in PCR 0.42 vs 0.08 median PCR reduction p=0.01) normotensive patients benefited most if they had baseline microalbuminuria and had the greatest overall benefit. Conclusion: This open-label RCT provides evidence that ARB therapy offers significant renoprotection to normotensive type 2 diabetes patients.