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Pirfenidone effective in treating diabetic nephropathy
Sharma K. J Am Soc Nephrol. 2010;doi:10.1681/ASN.2010101049.
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Pirfenidone, an experimental oral antifibrotic agent, appears to be a promising treatment option for patients who have overt diabetic nephropathy.
Findings from a new study showed that pirfenidone given in a low dose (1,200 mg) significantly improved kidney function at 1 year. Mean estimated glomerular filtration rate increased 3.3 ml/min per 1.73 m2 in patients assigned pirfenidone compared with a 2.2 ml/min per 1.73 m2 decrease in patients assigned placebo (P=.026).
“The dramatic finding of this exploratory study is that an appropriate dose of pirfenidone not only halted decline but actually improved kidney function in these patients,” Kumar Sharma, MD, professor of medicine in the University of California, San Diego, division of nephrology and director of the Center for Renal Translational Medicine, said in a press release.
The randomized, double blind, placebo-controlled study included 77 patients who had elevated albuminuria and reduced eGFR (20 ml/min per 1.73 m2 to 75 ml/min per 1.73 m2). Researchers randomly assigned the participants to three treatment groups: high-dose pirfenidone (2,400 mg); low-dose pirfenidone (1,200 mg); or placebo.
When the researchers measured eGFR in the high-dose pirfenidone group, they found no seeming benefit; the mean change was not significantly different from the placebo group (–1.9 ml/min per 1.73 m2). This finding suggests that higher doses may not be tolerable in the diabetic population with moderate to advanced chronic kidney disease, the researchers said.
In addition, the high-dose pirfenidone group had a high dropout rate — 11 of 25 participants left the study.
Five patients in the study cohort initiated hemodialysis; four were assigned to placebo and one was assigned to high-dose pirfenidone.
Sharma said the next step is to perform a larger clinical study and to identify personalized biomarkers to determine which patients are most likely to show improvement with pirfenidone.
“To date, therapies for diabetic nephropathy have been limited to drugs that improve blood pressure or control blood sugar levels,” he said in the release. Pirfenidone seems to work by blocking transforming growth factor beta, in effect shutting down the growth factors that cause renal fibrosis.
“This drug might also be useful in treating other types of fibrotic disease,” he added.
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