title: Safety and clinical outcomes among older adults receiving daptomycin therapy: Insights from a patient registry.
abstract: BACKGROUND
  Serious gram-positive bacterial infections are an important cause of morbidity and mortality among older adults and can present significant challenges to clinicians. Data evaluating the safety and effectiveness of newer agents in this population are limited.
  
  
  OBJECTIVE
  Daptomycin is a lipopeptide with activity against resistant gram-positive organisms. To better understand the overall safety and effectiveness of daptomycin in older adults (≥66 years of age), the authors reviewed the data that were collected as part of an ongoing registry maintained by Cubist Pharmaceuticals, Inc. (Lexington, Massachusetts), the manufacturer of daptomycin.
  
  
  METHODS
  The Cubicin Outcomes Registry and Experience (CORE) is a multicenter, retrospective registry designed to collect postmarketing clinical data on patients who received daptomycin. The CORE data collected from 58 institutions across the United States between January 1, 2005, and December 31, 2007, were analyzed to better understand the overall safety profile of daptomycin and the clinical outcomes of older adults who were treated with this agent. Patients were considered to be nonevaluable if the medical record did not contain sufficient information to determine response at the end of therapy. Nonevaluable patients were excluded from the clinical outcome analysis but included in the safety analysis.
  
  
  RESULTS
  The registry contained 1073 patients aged ≥66 years who received daptomycin; 23.8% (255/1073) were ≥81 years of age. Overall, 18.1% (194/1073) of patients experienced 324 adverse events, and 6.2% (67/1073) of patients experienced 97 adverse events that were considered possibly related to treatment with daptomycin. The most frequently reported adverse events that were considered possibly treatment related included creatine phosphokinase (CPK) elevations, gastrointestinal disorders, and skin rashes. Among the 67 patients who experienced ≥1 adverse event that was possibly related to daptomycin, 30 discontinued therapy due to the adverse event (13 due to CPK elevation). Overall, 78.7% (844/1073) of patients were considered evaluable for clinical outcomes. The clinical success rate for all evaluable patients was 90.2% (761/844). The success rate for evaluable patients ≥81 years of age (88.6% [171/193]) was comparable to that of the overall population.
  
  
  CONCLUSIONS
  Experience with daptomycin in this group of older adults suggests good tolerability and clinical outcomes that are consistent with the results of other studies published to date.
authors.affiliation: Departments of Pharmacy Services and Clinical, Social, and Administrative Sciences, University of Michigan Health System and College of Pharmacy, Ann Arbor, Michigan, USA. daryl.depestel@cubist.com
authors.forename: Daryl D
authors.initials: DD
authors.lastname: DePestel
authors.forename: Ellie
authors.initials: E
authors.lastname: Hershberger
authors.forename: Kenneth C
authors.initials: KC
authors.lastname: Lamp
authors.forename: Preeti N
authors.initials: PN
authors.lastname: Malani
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017576:Daptomycin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011358:Product Surveillance, Postmarketing; D012042:Registries / Q000706:statistics & numerical data; D012189:Retrospective Studies; D016896:Treatment Outcome; D014481:United States
chemical_list: D000900:Anti-Bacterial Agents; D017576:Daptomycin