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Volume 50, Issue 6, Pages 946-951 (December 2007)


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A Randomized Trial of a 6-Week Course of Celecoxib on Proteinuria in Diabetic Kidney Disease

Marvin Sinsakul, MD1Corresponding Author Informationemail address, Mohammed Sika, PhD2, Roger Rodby, MD1, John Middleton, MD3, Yu Shyr, PhD2, Heidi Chen, PhD2, Ernest Han, MD2, Ruediger Lehrich, MD3, Stephen Clyne, MD2, Gerald Schulman, MD2, Raymond Harris, MD2, Julia Lewis, MD2

Received 21 February 2007; accepted 14 September 2007.

Background

Preclinical data suggest that cyclooxygenase 2 inhibitors decrease proteinuria and preserve glomerular structure in animal models of diabetic nephropathy. The objective of this study is to compare the efficacy and safety of celecoxib with placebo for decreasing proteinuria in patients with diabetic nephropathy.

Study Design

Placebo-controlled double-blinded crossover design.

Setting & Participants

24 patients with type 1 or 2 diabetes mellitus, proteinuria with protein of 500 mg/d or greater, and serum creatinine level of 3.0 mg/dL or less.

Intervention

Patients were randomly assigned to: (1) 6 weeks of celecoxib followed by a 3-week washout period, followed by 6 weeks of placebo followed by another 3-week washout; or (2) 6 weeks of placebo followed by a 3-week washout, followed by 6 weeks of celecoxib followed by another 3-week washout period. All patients were administered quinapril, 20 to 40 mg/d, or irbesartan, 150 to 300 mg/d. All patients were administered aspirin, 81 mg/d.

Outcomes & Measurements

Proteinuria was assessed by means of protein-creatinine ratio. Data were analyzed using the mixed-effect statistical model.

Results

There was no significant difference in urinary proteinuria after 6 weeks of treatment with placebo or celecoxib (proteinuria ratio, celecoxib versus placebo, 1.041; 95% confidence interval, 0.846 to 1.282). Celecoxib had no significant effect on potassium or estimated glomerular filtration rate. Frequencies of adverse events were similar between the placebo and celecoxib treatments.

Limitations

This pilot study was not designed to evaluate the safety or long-term clinical effects of celecoxib.

Conclusions

Celecoxib, 200 mg/d, for 6 weeks did not alter proteinuria. Few adverse events were noted in this high-risk population.

1 Rush University Medical Center, Chicago, IL

2 Vanderbilt University Medical Center, Nashville, TN

3 Duke University Medical Center, Durham, NC.

Corresponding Author InformationAddress correspondence to Marvin Sinsakul, MD, Rush University Medical Center, 1426 W Washington Blvd, Chicago, IL 60607.

 Trial registration: www.clinicaltrials.gov; study number: NCT00065559.

PII: S0272-6386(07)01247-4

doi:10.1053/j.ajkd.2007.09.005


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