Daptomycin in the Clinical Setting: 8-Year Experience with Gram-positive Bacterial Infections from the EU-CORESM Registry

Abstract

IntroductionThe aim of this study was to evaluate the clinical outcomes and safety of daptomycin therapy in patients with serious Gram-positive infections.MethodsPatients were enrolled in the European Cubicin® Outcomes Registry and Experience (EU-CORESM), 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.ResultsA 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.ConclusionResults from real-world clinical experience showed that daptomycin is a valuable therapeutic option in the management of various difficult-to-treat Gram-positive infections.FundingThis study was funded by Novartis Pharma AG.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0220-6) contains supplementary material, which is available to authorized users.

Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE

“…Increased use of first-line daptomycin treatment for suspected and confirmed resistant pathogens, such as MRSA, reflects increasing awareness of daptomycin use for resistant pathogens and the limitations of available treatment options [ 31 , 32 , 44 ]. This pooled analysis reinforces the data from the previously published real-world reports (CORE and EU-CORE) [ 33 , 35 ].…”

“…Rege et al have reported good tolerability and high clinical success rates with daptomycin when administered for >14 days, in a patient population from the USA [ 34 ]. Similarly, the results from an 8-year clinical experience with daptomycin showed favorable safety and effectiveness profiles with lower overall clinical failure rates in Europe, Latin America, and Asia [ 33 , 40 , 43 ]. These results complement the previously published data from randomized clinical trials [ 31 , 32 ].…”

“…The Cubicin ® Outcomes Registry and Experience (CORE) and the European Cubicin ® Outcomes Registry and Experience (EU-CORE), both multicenter, retrospective, non-interventional registries, were conducted to collect real-world data on the characteristics and clinical outcomes of patients receiving daptomycin [ 33 , 34 ]. CORE included data from approximately 164 sites in the United States of America (USA) [ 35 – 37 ], whereas EU-CORE comprised data from 310 sites across 18 countries in Europe (12), Latin America (5), and Asia (1).…”

“…CORE included data from approximately 164 sites in the United States of America (USA) [ 35 – 37 ], whereas EU-CORE comprised data from 310 sites across 18 countries in Europe (12), Latin America (5), and Asia (1). Various independent reports on the results from CORE (2004–2009) and EU-CORE (2006–2012) have been published [ 33 – 36 , 38 ]. The results of CORE and EU-CORE showed that daptomycin is also used for treating infections other than those approved [ 35 , 39 ].…”

Daptomycin for the treatment of gram-positive periprosthetic hip infections: Can daptomycin prevent the implant removal?

“…The increased frequency of gram-positive infections and the rise in resistance to commonly used antibiotics have led to the need of novel antibiotic therapies, such as DAP, which has high antimicrobial penetration into biofilms with low bactericidal concentration [13]. According to the European Registry, DAP was effective and safe in patients with osteomyelitis or those with orthopedic device infections; it was also a valuable treatment option for the management of gram-positive infections [3,14]. However, in the treatment of PJIs by using DAP, there is no consensus whether the implant should be removed or not.…”