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Cardoso JS, Ferreira J, Oliveira-Soares A, et al.
Rev Port Cardiol 2009;28:143-154.
The Portuguese authors evaluated the clinical effectiveness and safety of levosimendan in daily clinical practice. The study was prospective, non-randomised with 15 centres and 129 consecutive patients involved (PORTLAND-study). Eligible patients were those admitted to hospital with NYHA-class III-IV, LVEF ≤40 %, and evidence of decompensation which in the opinion of the investigator required treatment of inotropes.
The primary endpoint was a composite consisting of subjective parameters (NYHA-class and patient self-evaluation) and objective parameters (body weight, pulmonary congestion, urine output, serum creatinine, oral or intravenous heart failure medication). Among the secondary endpoints were adverse events, the number and length of hospital readmissions due to heart failure during the 6 months following levosimendan compared with the 6 months prior treatment.
Levosimendan was given with an optional loading dose of 12 µg/kg for 10 minutes followed by a continuous infusion of 0.05 – 0.2 µg/kg/minute. The patients were evaluated at baseline (before starting levosimendan infusion) and at 24 hours, 5 days, 3 months and at 6 months.
The primary combined endpoint was reached by approximately 80% of the patients at 24 hours and at 5 days. There were significant improvements in NYHA-class, urine output and serum creatinine levels at 24 hours and 5 days following levosimendan infusion. The most frequent adverse event was hypotension (n=5).
The number of heart failure hospitalisations (mean ± SD) per patient were 1.3 ± 1.0 6 months before, and 0.4 ± 0.7 6 months after the initiation of levosimendan (p<0.001). The number of days of hospitalisation for heart failure per patients was 14.9 ± 14.6 6 months before compared to 3.1 ± 7.6 6 months after the initiation of levosimendan (p<0.001).
The authors stated that the marked reduction in heart failure hospitalisations during the subsequent 6 months indicates that levosimendan can help decrease the total costs involved in the management of patients with heart failure who need inotropic support.
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