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PREVENTION OF MICROALBUMINURIA: PREDICTORS FOR A GOOD RESPONSE TO OLMESARTAN TREATMENT (ROADMAP TRIAL): PP.16.85

Objective: Microalbuminuria (MAU) is an early sign of diabetic nephropathy and increased cardiovascular risk. We investigated whether early treatment with an angiotensin receptor blocker (ARB) in diabetic subjects with normal albumin excretion delays the occurrence of MAU and analysed subgroups that would benefit most from treatment. Design and Method: We studied 4,447 subjects with type 2 diabetes and at least one additional cardiovascular risk factor in a randomized, double-blind, multicentre, controlled, and event-driven (MAU) trial. They received either 40 mg olmesartan medoxomil (OM) or placebo (Pb) od. for a median duration of 3.2 years. In both groups, additional antihypertensive treatment (except ACE inhibitors or ARBs) was used to reach the target BP of <130/80 mmHg. Results: During the double blind period, 178 (8.2%) subjects in the OM group and 210 (9.8 %) subjects in the Pb group developed MAU (HR: 0.770; 95.1% CI: 0.630 to 0.941, p: 0.01). To identify factors influencing the response to OM treatment, explorative post-hoc subgroup analysis using the corresponding median at baseline as a cut-off were performed. This analysis revealed that the treatment effect on time to onset of MAU was better in subjects with a SBP >135 mmHg than with SBP values ≤135 mmHg. A baseline HbA1c ≤7.3% and an eGFR >83.79 were predictors for a better response to OM treatment. Furthermore, less than 5% of patients with a baseline UACR ≤4 mg/g developed MAU during the study and the rate was similar between the OM and Pb treated patients. In contrast, 13.9% in the OM group and 18.1% in the placebo group with a baseline UACR >4 mg/g developed MAU (HR: 0.75, 95% CI: 0.60 to 0.96, p-value= 0.02). Conclusions: In subjects with type 2 diabetes olmesartan showed a significant 23% risk reduction regarding time to onset of microalbuminuria. Patients with a baseline SBP >135 mmHg, an eGFR ≤83.79, or an UACR >4 mg/g benefit most from olmesartan treatment.