Fenoldopam flops in preventing renal replacement therapy after AKI

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 - drug label, medication, pharmaceutical

Fenoldopam was found to be ineffective at reducing risks for renal replacement therapy in cardiovascular patients with acute kidney injury (AKI) according to a study published Sept. 29 in JAMA. It was also ineffective at reducing risk of death over placebo.

Italian researchers led by Tiziana Bove, MD, of the IRCCS San Raffaele Scientific Institute in Milan, randomized 667 multisite patients with early AKI post-cardiac surgery into either a group administered fenoldopam (Corlopam, Hospira) or a placebo. Patients given fenoldopam were treated with a mean dose of 0.12 micrograms per kilogram per minute for 62 hours, while patients taking the placebo were given a mean dose of 0.13 micrograms per kilogram per minute for 65 hours.

They found that whether patients were given fenoldopam or placebo, the rates of renal replacement therapy were similar (20 percent vs. 18 percent). Mortality rates were also similar. ICU mortality occurred in 17 percent of fenoldopam patients and 18 percent of placebo patients. Thirty-day mortality rates for fenoldopam and the placebo were 23 percent and 22 percent, respectively. Hypotension rates were much higher among patients given fenoldopam at 26 percent vs. 15 percent on placebo.

The study, which spanned March of 2008 through April, 2013, was ended early “for futility, as recommended by study safety committee based on a planned interim analysis,” wrote Bove et al.

“Our trial demonstrates that fenoldopam is not effective for the treatment of AKI in cardiac surgery and, in addition, suggests that it might not be effective for other patients with early AKI,” the research team noted. That these findings hold with other studies using dopamine.

“Given the cost of fenoldopam, the lack of effectiveness, and the increased incidence of hypotension, the use of this agent for renal protection in these patients is not justified.”