Postmarketing Clinical Experience in Patients with Skin and Skin-Structure Infections Treated with Daptomycin

Abstract

A registry describing daptomycin’s clinical use was analyzed to describe treatment of skin and skin-structure infections (SSSIs). The Cubicin Outcomes Registry and Experience (CORE) 2004 retrospectively collected demographic, microbiologic, and clinical outcome information of patients treated with daptomycin (Cubicin; Cubist Pharmaceuticals, Inc., Lexington, MA). The database was accessed to identify patients with a diagnosis of an SSSI with an outcome determined. Of 577 patients identified with a SSSI, 522 (90%) were evaluable. Diabetes mellitus and peripheral vascular disease were present in 27% and 10% of the population, respectively. Pathogens were identified for 65% of all patients— Staphylococcus aureus (75%; 85% methicillin-resistant) and Enterococcus species (19%; 44% vancomycin-resistant) most commonly. Concomitant use of other antibiotics was common (42%). Of 522 patients studied, 334 (64%) had complicated infections (cSSSIs), and 188 (36%) had uncomplicated infections (uSSSIs). Overall cure, improved, and failure rates were 53%, 43%, and 4%, respectively, for cSSSI and 66%, 32%, and 2%, respectively, for uSSSI. The median dose administered was 4.0 mg/kg for cSSSI (mean, 4.5 ± 1.0 mg/kg; range, 2.3 to 12 mg/kg) and 4.0 mg/kg for uSSSI (mean, 4.2 ± 0.8 mg/kg; range, 2.1 to 9 mg/kg); the dose was significantly higher in cSSSI ( P <0.001, median test). Median daptomycin treatment duration was 12 days (range, 1 to 148 days) and was longer for cSSSI than for uSSSI (14 vs. 10 days, P = 0.002). The results of this study support previously published reports and suggest that daptomycin is effective for the treatment of skin infections due to gram-positive pathogens.