MONDAY, Feb. 16 (HealthDay News) -- In patients with diabetic nephropathy and macroalbuminuria, treatment with avosentan in combination with standard therapy significantly decreases the urinary albumin excretion rate, according to a study published ahead of print Jan. 14 in the Journal of the American Society of Nephrology.
Rene R. Wenzel, M.D., of Paracelsus University Salzburg in Austria, and colleagues randomly assigned 286 patients to receive either 12 weeks of avosentan at dosages of 5, 10, 25 or 50 milligrams, or placebo, in addition to standard therapy with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers.
The researchers found that avosentan was associated with decreases of the median relative urinary albumin excretion rate ranging from 28.7 percent to 44.8 percent but had no significant effect on creatinine clearance, blood pressure or liver enzymes. They also found that adverse events -- primarily peripheral edema -- were mainly associated with dosages of 25 mg or higher and prompted 21 (7.3 percent) of the avosentan patients to stop taking the medication.
"A large outcome trial is mandatory to confirm these findings and to determine whether avosentan's antiproteinuric effects can be translated into long-term benefits also with lower dosages of avosentan, which are likely to have an optimal tolerability," the authors conclude. "Nevertheless, the marked and significant reduction in macroalbuminuria after 12 weeks of avosentan treatment suggests a clinically valuable nephroprotective effect."
The study was supported by SPEEDEL Pharma AG and a grant from the Deutsche Forschungsgemeinschaft, and some study authors have financial ties to SPEEDEL.
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