Oral inotropic agent fails to benefit in chronic-HF phase 2 trial

June 08, 2006

Espoo, Finland - An oral form of the inotropic agent levosimendan failed to improve clinical outcomes compared with placebo in a phase 2 study containing "about 300" patients with chronic heart failure, according to a press release issued by its manufacturer, Orion Pharmaceuticals [1]. The calcium sensitizer's intravenous form, which is unavailable in the US, is marketed for the treatment of acute decompensated HF in much of the world as Simdax.

"The results did not show clear enough significance level for the primary end points," which reflected symptom status, hospitalization, and mortality, according to the company statement.

The trial, called PERSIST, randomized patients with "severe" chronic HF despite standard therapy to three groups, one that received a placebo and two given oral levosimendan at different dosage levels. In neither of the active-therapy groups did patients fare significantly better than those in the control arm with respect to the prespecified primary end points. "The study results are not sufficient for starting phase 3 clinical trials," according to the press release, which did not specify how long the patients continued therapy or the time frame for following outcomes.

The literature provides only limited data suggesting that levosimendan, which has complementary peripheral-vessel relaxing properties and doesn't promote arrhythmias, as do inotropes in other drug families, may have promise in chronic HF [2] [3]. The drug has had mixed success in trials of acute decompensated HF.

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