Authors: Makino, H.; Haneda, M.; Babazono, T.; Moriya, T.; Ito, S.; Iwamoto, Y.; Kawamori, R.; Takeuchi, M.; Katayama, S.

Source: The Journal of International Medical Research, Volume 33, Number 6, November 2005 , pp. 677-686(10)

Publisher: Field House Publishing

Abstract:

We planned the INNOVATION study to determine whether telmisartan, an angiotensin-2-receptor blocker, delays the progression of renal disease from incipient nephropathy to overt nephropathy in hypertensive or normotensive Japanese patients with type 2 diabetes mellitus. The INNOVATION study is a randomized, double-blind, placebo-controlled trial. Eligible patients must have incipient nephropathy (defined as a urinary albumin to creatinine ratio of 100 - 300 mg/g creatinine) and a serum creatinine concentration of < 1.5 mg/dl for men and < 1.3 mg/dl for women. Patients who need treatment with angiotensin II receptor blockers or angiotensin-converting enzyme inhibitors are excluded. Eligible patients are randomly assigned to three groups: telmisartan titrated to 40 mg; telmisartan titrated to 80 mg; or placebo. The primary endpoint is the time from baseline visit to first detection of overt nephropathy (defined by a urinary albumin to creatinine ratio that is > 300 mg/g creatinine and 30% higher than the baseline on at least two consecutive visits). A total of 1855 patients have been enrolled from 160 study centres. In 527 randomized patients (28.4% of the enrolled patients), mean (SD) urinary albumin to creatinine ratio and serum creatinine concentration at baseline were 173.3 (47.2) mg/g creatinine and 0.78 (0.19) mg/dl. Sixty-eight per cent of the patients had hypertension at baseline. Mean (SD) systolic and diastolic blood pressures at baseline were 137.1 (14.6) and 77.5 (10.3) mmHg. The INNOVATION study will determine whether telmisartan, an angiotensin II receptor blocker, provides clinical benefits in hypertensive or normotensive patients with diabetes mellitus and diabetic nephropathy.

Articles that cite this article?

Keywords: INCIPIENT NEPHROPATHY; OVERT NEPHROPATHY; DIABETES MELLITUS; URINARY ALBUMIN CREATININE RATIO; ANGIOTENSIN II RECEPTOR BLOCKER; TELMISARTAN

Document Type: Research article

Publication date: 2005-11-01

More about this publication?

• The Journal of International Medical Research (JIMR) is a leading peer reviewed journal offering exceptional publication speed for medical, clinical and pre-clinical research. Reviews, case studies, preliminary communications, post-marketing surveillance, pharmacoeconomic and managed care studies are also welcome. Supplements publish symposium proceedings or collections of medical, pre-clinical or clinical data and enquiries from potential sponsors are welcome. JIMR is widely indexed and abstracted, including Medline, Current Contents and Excerpta Medica (EMBASE).
• Editorial Board
• Information for Authors
• Submit a Paper
• Subscribe to this Title
• Information for Advertisers
• Terms & Conditions
• ingentaconnect is not responsible for the content or availability of external websites

Related content

• In this: publication
• By this: publisher
• In this Subject: Internal Medicine ,  Pharmacology ,  Public Health
• By this author: Makino, H. ;  Haneda, M. ;  Babazono, T. ;  Moriya, T. ;  Ito, S. ;  Iwamoto, Y. ;  Kawamori, R. ;  Takeuchi, M. ;  Katayama, S.

Website © Publishing Technology. Article copyright remains with the publisher, society or author(s) as specified within the article.

• Terms and conditions
• Privacy policy
• Information for advertisers