Prevention of Transition From Incipient to Overt Nephropathy With Telmisartan in Patients With Type 2 Diabetes
- Hirofumi Makino, MD1,
- Masakazu Haneda, MD2,
- Tetsuya Babazono, MD3,
- Tatsumi Moriya, MD4,
- Sadayoshi Ito, MD5,
- Yasuhiko Iwamoto, MD6,
- Ryuzo Kawamori, MD7,
- Masahiro Takeuchi, SCD, MPH8,
- Shigehiro Katayama, MD9 and
- for the INNOVATION Study Group
- 1Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
- 2Department of Medicine, Division of Metabolism and Biosystemic Science, Asahikawa Medical College, Hokkaido, Japan
- 3Division of Nephrology and Hypertension, Diabetes Center, Tokyo Women's Medical University School of Medicine, Tokyo, Japan
- 4Department of Endocrinology, Diabetes, and Metabolism, Kitasato University School of Medicine, Kanagawa, Japan
- 5Division of Nephrology, Tohoku University Graduate Medical School, Miyagi, Japan
- 6Department of Medicine, Diabetes Center, Tokyo Women's Medical University School of Medicine, Tokyo, Japan
- 7Department of Medicine, Medical School, Juntendo University, Tokyo, Japan
- 8Division of Biostatistics, School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan
- 9Division of Endocrinology and Diabetes, Department of Medicine, Saitama Medical School, Saitama, Japan
- Address correspondence and reprint requests to Professor Hirofumi Makino, Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, 2-5-1 Shikata-cho, Okayama, Japan. E-mail: makino{at}md.okayama-u.ac.jp
- ARB, angiotensin receptor blocker
- DBP, diastolic blood pressure
- SBP, systolic blood pressure
- UACR, urinary albumin-to-creatinine ratio
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.
RESEARCH DESIGN AND METHODS—
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 …
