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Introduction: The European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)) was a retrospective, non-interventional, multicenter study which evaluated the safety and effectiveness of daptomycin therapy in patients with Gram-positive infections including infective endocarditis (IE)., Methods: Data from the EU-CORE registry were collected for patients with IE who had received at least one dose of daptomycin between January 2006 and April 2012, across 18 countries in Europe (12), Latin America (5) and Asia (1). Clinical outcomes were assessed as success (cured or improved), failure or non-evaluable. Adverse events (AEs) were recorded during treatment and for up to 30 days post-treatment; follow-up data were collected for 2 years., Results: Of 6075 patients included in the EU-CORE registry, 610 were diagnosed with IE as primary infection; 149 (24.4%) right-sided IE (RIE), 414 (67.9%) left-sided IE (LIE), and 47 (7.7%) with both right- and left-sided IE (BRLIE). Overall clinical success was achieved in 80.0% of patients (RIE 88.6%, LIE 76.6% and BRLIE 82.9%). Success rates for methicillin-resistant Staphylococcus aureus (MRSA) infections were 90.9%, 71.7% and 66.6% in patients with RIE, LIE and BRLIE, respectively. The overall sustained clinical success rate in patients followed for up to 2 years was 86.7% (RIE 93.5%, LIE 88.3% and BRLIE 77.8%). AEs deemed possibly related to daptomycin in the investigator's opinion were reported in 2 (1.3%) RIE, 18 (4.3%) LIE and 1 (2.1%) BRLIE patients. There were 11 (1.8%) patients (2 with RIE, 8 with LIE and 1 with BRLIE) with AEs of creatine phosphokinase elevation reported as possibly related to daptomycin., Conclusion: Data from this real-world clinical setting showed that daptomycin was well tolerated and effective for the treatment of LIE and BRLIE in addition to RIE caused by Gram-positive bacteria, including MRSA. Two-year follow-up data showed that a high proportion of patients had a sustained response.

Introduction: The objective of this analysis was to describe in real-life settings the clinical outcomes and safety associated with daptomycin treatment in a cohort of patients with complicated skin and soft tissues infection (cSSTI)., Methods: All patients with cSSTI who had received at least one dose of daptomycin between January 2006 and April 2012 were identified from a non-interventional, multicenter, retrospective registry (European Cubicin(®) Outcome Registry and Experience; EU-CORE(SM))., Results: Of the 6075 patients included in the EU-CORE registry, 1927 (31.7%) were diagnosed with cSSTI (male, 63.8%; median age, 63 years). The most frequent underlying diseases were cardiovascular disease (58.1%) and diabetes mellitus (40.7%). The most frequent cSSTIs included surgical site infections (34.9%), wound infections (20.2%) and diabetic foot infections (19.9%). The most frequently prescribed doses of daptomycin were 4 mg/kg/day (38.9%) and 6 mg/kg/day (35.2%). A total of 1126 (58.4%) patients received antibiotics prior to daptomycin treatment; treatment failure (53.7%) was the most common reason for switching to daptomycin. The majority of hospitalized patients (61.8%) were treated with concomitant antibiotics. Among patients with positive cultures, Staphylococcus aureus (51.9%; 673/1297) was the most common pathogen. The overall clinical success rate was 84.6%; for infections caused by S. aureus, the success rate was 87.2% (methicillin susceptible, 87.8%; methicillin resistant, 87.0%). Adverse events possibly related to daptomycin treatment were reported in 2.4% of patients and adverse events led to drug discontinuation in 2.4% of patients., Conclusion: Daptomycin treatment resulted in high clinical success rates in patients with different cSSTI subtypes, the majority of whom having failed previous antibiotic therapy. Daptomycin was well tolerated and there were no new or unexpected safety findings.