title: Safety of daptomycin in patients completing more than 14 days of therapy: results from the Cubicin® Outcomes Registry and experience.
abstract: Patients with complicated infections may receive daptomycin for extended periods. This retrospective analysis was conducted to describe the safety profile of daptomycin in patients completing >14 days of therapy. In the Cubicin(®) Outcomes Registry and Experience (CORE(®)) 2005-2009, a retrospective, multicentre, observational registry, patients completing >14 days of daptomycin were studied. Investigators assessed adverse events (AEs) using ICH-E2A definitions of seriousness/severity ≤30 days after completing daptomycin. AEs were grouped by onset at ≤14, 15-28 and >28 days after starting daptomycin. In total, 2263 patients received >14 days of daptomycin. The most common indications were complicated skin and skin-structure infection (25.5%) and osteomyelitis (21.7%). Regarding AEs, 205 patients (9.1%) experienced AEs with an onset ≤14 days of therapy, 168 (7.4%) between 15-28 days and 108 (4.8%) >28 days; a total of 389/2263 patients experienced 814 AEs. The most common AE was increased blood creatine phosphokinase (CPK), occurring in 49 patients (2.2%) during ≤14 days of therapy, 32 (1.4%) between 15-28 days and 10 (0.4%) >28 days. In 183/2263 patients (8.1%), 264 AEs were possibly related to daptomycin. Serious AEs occurred in 153/2263 patients (6.8%). Eighty-nine (3.9%) of 2263 patients had daptomycin discontinued due to AEs, with 36 discontinued due to increased CPK. The overall mortality rate was 63/2263 (2.8%); 4 patients died of a possibly related AE. The most common AEs with onset <14 days were similar to those occurring between 15-28 days and >28 days. Daptomycin appears to be safe in patients treated for >14 days.
authors: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, USA. shruta.rege@cubist.com
authors: Shruta
authors: S
authors: Rege
authors: John
authors: J
authors: Mohr
authors: Kenneth C
authors: KC
authors: Lamp
authors: Min
authors: M
authors: Yoon
authors: Kimberly C
authors: KC
authors: Lindfield
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002648:Child; D017576:Daptomycin / Q000009:adverse effects* / Q000627:therapeutic use*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D028761:Withholding Treatment / Q000706:statistics & numerical data; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D017576:Daptomycin