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In addition, on further examination of the data on albuminuria from the Veterans Affairs Diabetes Trial, we found that the data set that we used to evaluate the progression of disease was constructed improperly. As a result, the rates of progression to microalbuminuria and macroalbuminuria were reported in Table 3 of our article as being lower than they actually were. An error in the computer code resulted in the replacement of post-randomization albumin-to-creatinine ratios with the baseline albumin-to-creatinine ratio in certain patients. Because of this error, an increase in the albumin-to-creatinine ratio was not reported for some patients. Table 3, which has been corrected at NEJM.org, now has slightly smaller sample sizes than those shown in the original version of the table. Patients who had only one follow-up visit were included in the original table. By definition, these patients could not have had progression, since an elevated albumin-to-creatinine ratio for 2 successive years was required to show progression.
Both progression from normal to either microalbuminuria or macroalbuminuria (P=0.03) and progression from either normal or microalbuminuria to macroalbuminuria (P=0.04) favor intensive treatment. Any progression of albuminuria is now highly statistically significant (P<0.01); 13.8% of the patients in the standard-therapy group, as compared with 9.1% of patients in the intensive-therapy group, had worsening albuminuria.
We appreciate the opportunity to update our results regarding nephropathy, but we regret any confusion this may cause. The rest of Table 3 remains unaffected. As a consequence of these changes in Table 3, parts of the Abstract, Results, and Discussion are affected (see the correction notice in this issue of the Journal), but the overall conclusions of the trial are similar. We regret these errors.
Thomas Moritz, M.S.
Hines Veterans Affairs Hospital
Hines, IL
thomas.moritz{at}va.gov
William Duckworth, M.D.
Phoenix VA Health Care System
Phoenix, AZ
Carlos Abraira, M.D.
Miami VA Medical Center
Miami, FL
References
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