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6 March 2001 | Volume 134 Issue 5 | Pages 370-379
Purpose: To determine whether response of albumin excretion rate to angiotensin-converting enzyme (ACE) inhibitors has a threshold in patients with type 1 diabetes mellitus and microalbuminuria and to examine treatment effect according to covariates.
Data Sources: Studies were identified by searching MEDLINE and related bibliographies.
Study Selection: Selected studies included at least 10 normotensive patients with type 1 diabetes mellitus and microalbuminuria, had a placebo or nonintervention group, and included at least 1 year of follow-up.
Data Extraction: Raw data were obtained for 698 patients from the 12 identified trials. Analysis of treatment effect at 2 years was restricted to trials with at least 2 years of follow-up (646 patients from 10 trials).
Data Synthesis: In patients receiving ACE inhibitors, progression to macroalbuminuria was reduced (odds ratio, 0.38 [95% CI, 0.25 to 0.57]) and the odds ratio for regression to normoalbuminuria was 3.07 (CI, 2.15 to 4.44). At 2 years, albumin excretion rate was 50.5% (CI, 29.2% to 65.5%) lower in treated patients than in those receiving placebo (P < 0.001). Estimated treatment effect varied by baseline albumin excretion rate (74.1% and 17.8% in patients with a rate of 200 µg/min and 20 µg/min, respectively [P = 0.04]) but not by patient subgroup. Adjustment for change in blood pressure attenuated the treatment difference in albumin excretion rate at 2 years to 45.1% (CI, 18.6% to 63.1%; P < 0.001).
Conclusions: In normotensive patients with type 1 diabetes mellitus and microalbuminuria, ACE inhibitors significantly reduced progression to macroalbuminuria and increased chances of regression. Beneficial effects were weaker at the lowest levels of microalbuminuria but did not differ according to other baseline risk factors. Changes in blood pressure cannot entirely explain the antiproteinuric effect of ACE inhibitors.
*For members of the ACE Inhibitors in Diabetic Nephropathy Trialist Group, see Appendix.
Author and Article Information
From University of Birmingham, Birmingham, South Cleveland Hospital, Middlesbrough, University of Warwick, Warwick, and Imperial College of Medicine at St. Mary's, University College London, and King's College London, London, United Kingdom; University Hospital, Linkoping, Sweden; University of Padua and Sassari and National Research Centre for the Study of Aging, Padua, Italy; Austin and Repatriation Medical Centre, Heidelberg, Australia; Hôpital Broussais, Paris, France; Steno Diabetes Centre, Copenhagen, and Aarhus University Hospital, Aarhus, Denmark; and Joslin Diabetes Center, Boston, Massachusetts.
Acknowledgments: An educational grant for a meeting to plan this work was provided by Zeneca Pharmaceuticals.
Requests for Single Reprints: Nish Chaturvedi, MRCP, MD, Department of Epidemiology and Public Health, Imperial College at St. Mary's, Norfolk Place, London W2 1PG, United Kingdom; e-mail, n.chaturvedi{at}ic.ac.uk. ARTICLE
Should All Patients with Type 1 Diabetes Mellitus and Microalbuminuria Receive Angiotensin-Converting Enzyme Inhibitors?
A Meta-Analysis of Individual Patient Data
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