Prevention of Transition From Incipient to Overt Nephropathy With Telmisartan in Patients With Type 2 Diabetes

Abstract

The randomized, multicenter, double-blind, placebo-controlled trial was performed in patients aged from 30 to 74 years with type 2 diabetes and urinary albumin-to-creatinine ratio (UACR) 100–300 mg/g and serum creatinine <1.5 mg/dl (men) and <1.3 mg/dl (women). Exclusion criteria included type 1 diabetes, age of diabetes onset 300 mg/g and increase ≥30% from baseline at two consecutive 4-week visits). Secondary end point was microalbuminuria remission (UACR <30 mg/g). Frequency and severity of adverse events were also assessed. The Kaplan-Meier method was used to determine transition rates to overt nephropathy; log-rank test was used for pairwise comparison between treatment groups. Effect of blood pressure reduction on transition rate was estimated using Cox's proportional hazard model. The protocol conformed to the principles of the Declaration of Helsinki and was approved by the institutional review boards at the 142 study centers (7). Patients provided written informed consent before enrollment.