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

  1. Hirofumi Makino, MD1,
  2. Masakazu Haneda, MD2,
  3. Tetsuya Babazono, MD3,
  4. Tatsumi Moriya, MD4,
  5. Sadayoshi Ito, MD5,
  6. Yasuhiko Iwamoto, MD6,
  7. Ryuzo Kawamori, MD7,
  8. Masahiro Takeuchi, SCD, MPH8,
  9. Shigehiro Katayama, MD9 and
  10. for the INNOVATION Study Group
  1. 1Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
  2. 2Department of Medicine, Division of Metabolism and Biosystemic Science, Asahikawa Medical College, Hokkaido, Japan
  3. 3Division of Nephrology and Hypertension, Diabetes Center, Tokyo Women's Medical University School of Medicine, Tokyo, Japan
  4. 4Department of Endocrinology, Diabetes, and Metabolism, Kitasato University School of Medicine, Kanagawa, Japan
  5. 5Division of Nephrology, Tohoku University Graduate Medical School, Miyagi, Japan
  6. 6Department of Medicine, Diabetes Center, Tokyo Women's Medical University School of Medicine, Tokyo, Japan
  7. 7Department of Medicine, Medical School, Juntendo University, Tokyo, Japan
  8. 8Division of Biostatistics, School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan
  9. 9Division of Endocrinology and Diabetes, Department of Medicine, Saitama Medical School, Saitama, Japan
  1. 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

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 …

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  1. Diabetes Care vol. 30 no. 6 1577-1578
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