Decompensated heart failure: Levosimendan does not improve survival, compared to Dobutamine


The drug Levosimendan ( Simdax ) did not improve survival for patients with decompensated heart failure when compared with a more widely-used treatment for this condition, Dobutamine.

Acute decompensated heart failure ( ADHF ) remains a common cause of hospitalization worldwide, but appropriate treatment is not always clear. Dobutamine improves symptoms but has been associated with an increased risk of death and other cardiovascular events.
In a previous study, secondary analyses indicated that the drug Levosimendan was associated with lower risk of death compared to Dobutamine.

Alexandre Mebazaa, of the Université Paris Diderot and Hospital Lariboisière AP-HP, Paris, and colleagues with the SURVIVE trial ( Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support ) conducted a study in which the primary purpose of the trial was to assess long-term survival outcomes for 1,327 ADHF patients who received Levosimendan or Dobutamine.
The trial was conducted at 75 centers in 9 countries and patients were randomized between March 2003 and December 2004. Patients received either intravenous Levosimendan ( n = 664 ) or intravenous Dobutamine ( n = 663 ).

The researchers found that during the 180 days after drug infusion, there were 173 deaths ( 26 percent ) in the Levosimendan group and 185 deaths in the Dobutamine group ( 28 percent ).
There were no statistical differences between treatment groups for most secondary end points ( all-cause death at 31 days, number of days alive and out of the hospital, patient global assessment, patient assessment of dyspnea at 24 hours, and cardiovascular death at 180 days ).

Compared with Dobutamine-treated patients, Levosimendan-treated patients were less likely to experience cardiac failure and more likely to experience atrial fibrillation, hypokalemia, and headache during the initial 31 days following study drug administration.

" In conclusion, the SURVIVE trial demonstrated no survival difference between Levosimendan and Dobutamine during long-term follow-up despite evidence for an early reduction of plasma B-type natriuretic peptide level for Levosimendan. These findings may be related to the short duration of treatment in the trial, a selective effect of Levosimendan in specific subgroups, or the lack of a true difference between the 2 drugs." the authors write.

Source: Journal of American Medical Association, 2007

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