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Nieminen, M.S. et al.

Markku S. Nieminen, John G. F. Cleland, Jaan Eha, Yuri Belenkov, Matti Kivikko, Pentti Põder, Toni Sarapohja,

Oral levosimendan in patients with severe chronic heart failure --the PERSIST study.

BACKGROUND: Intravenous levosimendan improves symptoms in acutely decompensated heart failure. AIMS: To evaluate the effects of oral levosimendan in severe chronic heart failure (CHF). METHODS: 307 patients with NYHA IIIB-IV CHF were randomly assigned, double-blind, to levosimendan 1 mg once or twice daily or placebo for at least 180 days. An exploratory primary end-point, the Patient Journey, a composite consisting of repeated symptom assessments, worsening heart failure and mortality during 60 days was used. Minnesota Living with Heart Failure quality of life score (MLHFQoL) and NT-proBNP were assessed repeatedly. RESULTS: Patients assigned to a lower dose of levosimendan had more severe CHF at baseline. No differences in symptoms emerged and worsening heart failure events and death were similar resulting in a similar Patient Journey score with levosimendan and placebo (p=0.567). Compared to placebo, a net improvement of 3-4 points in MLHFQoL at several time-points in favour of the combined levosimendan groups was observed (p<0.001) which was accompanied by a substantial and persistent reduction in NT-proBNP (-30-40%) (p<0.001). CONCLUSION: Levosimendan improved QoL and decreased NT-proBNP but did not improve the Patient Journey composite in patients with severe CHF. Further research with this compound is warranted to clarify safety and efficacy.[1]

References

Oral levosimendan in patients with severe chronic heart failure --the PERSIST study. Nieminen, M.S., Cleland, J.G., Eha, J., Belenkov, Y., Kivikko, M., Põder, P., Sarapohja, T. Eur. J. Heart Fail. (2008) [Pubmed]

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