FRIDAY, Feb. 19 (HealthDay News) -- The endothelin antagonist avosentan reduces urinary protein loss in patients with type 2 diabetes and nephropathy, but substantially increases the risk of cardiovascular events, according to a study published online Feb. 18 in the Journal of the American Society of Nephrology.
Johannes F.E. Mann, M.D., of the University of Erlangen in Munich, Germany, and colleagues randomized 1,392 subjects with type 2 diabetes and diabetic nephropathy to continued standard therapy with angiotensin-converting enzyme inhibition and/or angiotensin receptor blockade treatment plus either avosentan oral dose of 25 mg/d, avosentan oral dose of 50 mg/d, or placebo.
The investigators ended the trial after a median follow-up of just four months because of an excess of cardiovascular events with avosentan, especially congestive heart failure and fluid overload such as pulmonary edema. The median albumin-to-creatinine ratio reduction was 44.3 percent for patients treated with 25 mg/d avosentan, 49.3 percent for patients treated with 50 mg/d, and 9.7 percent for placebo. Death occurred in 4.6 percent, 3.6 percent and 2.6 percent of subjects in the 25 mg/d avosentan, 50 mg/d avosentan, and placebo groups, respectively.
"In conclusion, avosentan reduces albuminuria when added to standard treatment in people with type 2 diabetes and overt nephropathy but induces significant fluid overload and congestive heart failure," the authors write.
Two study authors are employed by Speedel Pharma Ltd., which sponsored the study. All other study authors reported receiving consulting honoraria from the sponsor.
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