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

Abstract

To date, evidence for long-term renoprotection with angiotensin receptor blockers (ARBs) has come almost exclusively from Caucasian patients (1–3), despite Japanese people being at high risk of diabetic nephropathy and very susceptible to end-stage renal disease (4–6). We conducted the INNOVATION Study (Incipient to Overt: Angiotensin II Blocker, Telmisartan, Investigation on Type 2 Diabetic Nephropathy) to evaluate the efficacy of an ARB in preventing transition from microalbuminuria to overt nephropathy in Japanese patients (7). This study is the first large-scale clinical study to investigate prevention of overt diabetic nephropathy using an ARB in normotensive and hypertensive Japanese patients with type 2 diabetes. 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 <30 years, seated systolic blood pressure (SBP)/diastolic blood pressure (DBP) ≥180/100 mmHg, and definable chronic kidney disease …