Original InvestigationEffect of intensive blood pressure control on the course of type 1 diabetic nephropathy
Section snippets
Subjects and methods
This study is a prospective, randomized, clinical trial performed in 17 centers of the Collaborative Study Group. The study conforms to the recommendations for clinical trials, set out in the Declaration of Helsinki (Hong Kong revision, 1989) and was approved by the institutional review boards at each center. Before entering onto the study, all subjects were informed about the nature of, purpose of, and risks involved in the study and gave informed written consent.
Clinical management
At baseline of the present study, the observed MAP was similar between the randomized groups (Table 1). However, within 3 months of randomization, the distribution of MAP became significantly different between the two groups and remained so for the duration of the trial (Fig 1; P = 0.009).
Discussion
We conclude that the renal outcome of patients with type 1 diabetic nephropathy who are receiving ACE inhibitors is strongly influenced by the degree of blood pressure control achieved. The present study is the first to show that using an intent-to-treat protocol, random assignment to an MAP goal of 92 mm Hg or less leads to a better renal outcome than assignment to an MAP of 100 to 107 mm Hg, if defined as including a decrease in proteinuria. Patients who were able to keep their MAP controlled
Acknowledgements
Acknowledgment: The support and efforts of all the study coordinators and patients on this study made this work possible. The authors thank Neil Smith of Hoechst-Roussel Pharmaceuticals International for his unfailing encouragement and support.
References (20)
- et al.
Early aggressive antihypertensive treatment reduces rate of decline in kidney function in diabetic nephropathy
Lancet
(1983) - et al.
Properties of the urn randomization in clinical trials
Control Clin Trials
(1988) - et al.
Measurement of glomerular filtration rate utilizing a single subcutaneous injection of 125I-iothalamate
Kidney Int
(1973) - et al.
Long-term beneficial effects of angiotensin-converting enzyme inhibition in patients with nephrotic proteinuria
Am J Kidney Dis
(1992) - et al.
The changing natural history of nephropathy in type 1 diabetes
Am J Med
(1985) - et al.
The effect of angiotensin-converting enzyme inhibition on diabetic nephropathy
N Engl J Med
(1993) Diabetic nephropathy in insulin-dependent patients
Am J Kidney Dis
(1992)Progression of nephropathy in long-term diabetics with proteinuria and effect of initial antihypertensive treatment
Scand J Clin Lab
(1976)- et al.
Prediction of creatinine clearances from serum creatinine
Nephron
(1986) - et al.
Two-sample asymptomatically distribution-free tests for incomplete multivariate observations
J Am Stat Assoc
(1984)
Cited by (0)
Supported in part by a grant from Hoechst-Roussel Pharmaceuticals International.
Address reprint requests to Julia Breyer Lewis, MD, Vanderbilt University School of Medicine, Division of Nephrology, S-3223 Medical Center North, Nashville, TN 37232-2372. E-mail: [email protected]