Dataset Information

Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORE(SM) Registry.

ABSTRACT:

Introduction

The aim of this study was to evaluate the clinical outcomes and safety of daptomycin therapy in patients with serious Gram-positive infections.

Methods

Patients were enrolled in the European Cubicin(®) Outcomes Registry and Experience (EU-CORE(SM)), a non-interventional, multicenter, observational registry. The real-world data were collected across 18 countries (Europe, Latin America, and Asia) for patients who had received at least one dose of daptomycin between January 2006 and April 2012. Two-year follow-up data were collected until 2014 for patients with endocarditis, intracardiac/intravascular device infection, osteomyelitis, or orthopedic device infection.

Results

A total of 6075 patients were enrolled. The most common primary infections were complicated skin and soft tissue infection (31.7%) and bacteremia (20.7%). Staphylococcus aureus was the most frequently reported pathogen (42.9%; methicillin-resistant S. aureus [MRSA], 23.2%), followed by Staphylococcus epidermidis and other coagulase-negative staphylococci (CoNS, 28.5%). The most commonly prescribed dose of daptomycin was 6 mg/kg/day (43.6%), and the median duration of therapy was 11 (range 1-300) days. Overall clinical success rate was 80.5%, and was similar whether daptomycin was used as first-line (82.9%) or second-line (79.2%) therapy. Clinical success rates were high in patients with S. aureus (83.9%; MRSA 83.0%) and CoNS (including S. epidermidis, 82.5%) infections. The majority of patients with endocarditis or intracardiac/intravascular device infection (86.7%) or osteomyelitis/orthopedic device infection (85.9%) had a sustained response during the 2-year follow-up period. There were no new or unexpected safety findings.

Conclusion

Results from real-world clinical experience showed that daptomycin is a valuable therapeutic option in the management of various difficult-to-treat Gram-positive infections.

Funding

This study was funded by Novartis Pharma AG.

SUBMITTER: Gonzalez-Ruiz A

PROVIDER: S-EPMC4486780 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionEvolution of antibacterial resistance in pathogenic enterococcal strains poses a growing therapeutic challenge. Daptomycin, a cyclic lipopeptide, exhibits broad antibiotic activity against Gram-positive bacteria.MethodsThe European Cubicin(®) Outcomes Registry and Experience, a multicenter, retrospective, non-interventional study, recorded clinical outcomes following daptomycin treatment.ResultsOverall, 472 patients (predominantly elderly Caucasian males) were treated for enterococcal infections. Of those, 72.7% received antibiotics prior to daptomycin treatment, whereas 77.1% received other antibiotics concomitantly. Failure of previous therapy, resistant or non-susceptible pathogen, and narrowing of antibiotic therapy were the main reasons for switching to daptomycin treatment. Nosocomial infections comprised 55.8% of the cohort. Bacteremia (29.9%), complicated skin and soft tissue infection (29.2%) and endocarditis (12.3%) were the most common primary infections. Clinical success was achieved in 77.1% of patients, with similar success rates across all primary infection categories. The overall clinical success rate was marginally higher (82.5% vs 74.6%, p = 0.09) with daptomycin use as first-line versus second-line therapy. Patients receiving higher doses of daptomycin exhibited the highest clinical success rates (85.7% for ≥8 mg/kg/day vs 75.8% for <8 mg/kg/day, p = 0.08). While 81 (17.2%) patients reported at least one adverse event (AE), only 11 (2.3%) and 3 (0.6%) had treatment-related AEs and serious AEs, respectively. Separate microbiologic findings from Leipzig University Hospital demonstrate small proportions of Enterococcus faecium isolates with daptomycin minimum inhibitory concentrations = 4 mg/L (4%) or ≥8 mg/L (0.8%), which are regarded as non-susceptible.ConclusionFor enterococcal infections, daptomycin appears to be an effective and well-tolerated treatment option, exhibiting highest clinical success rates at higher doses.