title: Real-world daptomycin use across wide geographical regions: results from a pooled analysis of CORE and EU-CORE.
abstract: BACKGROUND
  Pooled data from two large registries, Cubicin(®) Outcomes Registry and Experience (CORE; USA) and European Cubicin(®) Outcomes Registry and Experience (EU-CORE; Europe, Latin America, and Asia), were analyzed to determine the characteristics and clinical outcomes of daptomycin therapy in patients with Gram-positive infections across wide geographical regions.
  
  
  METHODS
  Patients receiving at least one dose of daptomycin between 2004 and 2012 for the treatment of Gram-positive infections were included. Clinical success was defined as an outcome of 'cured' or 'improved'. Post-treatment follow-up data were collected for a subset of patients (CORE: osteomyelitis and orthopedic foreign body device infection; EU-CORE: endocarditis, intracardiac/intravascular device infection, osteomyelitis, and orthopedic device infection). Safety was assessed for up to 30 days after daptomycin treatment.
  
  
  RESULTS
  In 11,557 patients (CORE, 5482; EU-CORE, 6075) treated with daptomycin (median age, 62 [range, 1-103] years), the most frequent underlying conditions were cardiovascular disease (54.7 %) and diabetes mellitus (28.0 %). The most commonly treated primary infections were complicated skin and soft tissue infection (cSSTI; 31.2 %) and bacteremia (21.8 %). The overall clinical success rate was 77.2 % (uncomplicated SSTI, 88.3 %; cSSTI, 81.0 %; osteomyelitis, 77.7 %; foreign body/prosthetic infection (FBPI), 75.9 %; endocarditis, 75.4 %; and bacteremia, 69.5 %). The clinical success rate was 79.1 % in patients with Staphylococcus aureus infections (MRSA, 78.1 %). An increasing trend of high-dose daptomycin (>6 mg/kg/day) prescribing pattern was observed over time. Clinical success rates were higher with high-dose daptomycin treatment for endocarditis and FBPI. Adverse events (AEs) and serious AEs possibly related to daptomycin therapy were reported in 628 (5.4 %) and 133 (1.2 %) patients, respectively.
  
  
  CONCLUSIONS
  The real-world data showed that daptomycin was effective and safe in the treatment of various Gram-positive infections, including those caused by resistant pathogens, across wide geographical regions.
authors.affiliation: Queen Elizabeth University Hospital, Glasgow, UK.
authors.forename: R Andrew
authors.initials: RA
authors.lastname: Seaton
authors.affiliation: Darent Valley Hospital, Dartford, UK.
authors.forename: Armando
authors.initials: A
authors.lastname: Gonzalez-Ruiz
authors.affiliation: University of Tennessee Health Science Center, Memphis, TN, USA.
authors.forename: Kerry O
authors.initials: KO
authors.lastname: Cleveland
authors.affiliation: Infectious Diseases Pharmacy Associates, Inc., Stevensville, MD, USA.
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Couch
authors.affiliation: Novartis Healthcare Pvt. Ltd., Hyderabad, India.
authors.forename: Rashidkhan
authors.initials: R
authors.lastname: Pathan
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. kamal.hamed@novartis.com.
authors.forename: Kamal
authors.identifier: http://orcid.org/0000-0003-1896-9736
authors.initials: K
authors.lastname: Hamed
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001208:Asia; D002648:Child; D002675:Child, Preschool; D017576:Daptomycin / Q000627:therapeutic use*; D005060:Europe; D005260:Female; D006094:Gram-Positive Bacteria / Q000187:drug effects / Q000502:physiology; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007843:Latin America; D008297:Male; D008875:Middle Aged; D012042:Registries; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D017576:Daptomycin
keywords: CORE; Daptomycin; EU-CORE; Efficacy; Gram-positive infections; High dose; MRSA; Real-world; Safety; Staphylococcus aureus