title: Safety of Dalbavancin in the Treatment of Skin and Skin Structure Infections: A Pooled Analysis of Randomized, Comparative Studies.
abstract: BACKGROUND
  Dalbavancin is a new lipoglycopeptide that is active against Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus. It has a half-life of 14.4 days, permitting intravenous treatment of acute bacterial skin and skin structure infections without the need for daily dosing.
  
  
  OBJECTIVE
  The objective of these analyses was to compare the adverse event profile of dalbavancin with that of the comparator agents in the treatment of skin and skin structure infections.
  
  
  METHODS
  Data on adverse events and laboratory assessments collected from 3002 patients enrolled in seven late-stage, randomized clinical trials were analyzed for patients receiving dalbavancin or a comparator antibiotic.
  
  
  RESULTS
  Overall adverse event rates were similar or lower for patients receiving dalbavancin (799/1778; 44.9%) compared with those receiving comparator agents (573/1224; 46.8%, p = 0.012). The most common treatment-emergent adverse events were nausea, headache, diarrhea, constipation, vomiting, rash, urinary tract infection, pruritus, and insomnia. The duration and timing of the onset of adverse events were similar for patients receiving dalbavancin relative to the comparators.
  
  
  CONCLUSIONS
  Dalbavancin exhibits a favorable overall safety profile for treatment of acute bacterial skin and skin structure infections due to Gram-positive bacteria.
authors.affiliation: Durata Therapeutics, Inc., 322 East Main Street, Branford, CT, 06405, USA. michael.w.dunne@comcast.net.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Dunne
authors.affiliation: Talbot Advisors, LLC, Anna Maria, FL, USA.
authors.forename: George H
authors.initials: GH
authors.lastname: Talbot
authors.affiliation: Division of Infectious Diseases and Geographic Medicine, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA.
authors.forename: Helen W
authors.initials: HW
authors.lastname: Boucher
authors.affiliation: Microbiology, Leeds Teaching Hospital, Leeds, UK.|Old Medical School, University of Leeds, Leeds, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Wilcox
authors.affiliation: Durata Therapeutics, Inc., 322 East Main Street, Branford, CT, 06405, USA.
authors.forename: Sailaja
authors.initials: S
authors.lastname: Puttagunta
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000209:etiology; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012867:Skin / Q000187:drug effects* / Q000382:microbiology; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D017334:Teicoplanin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D017334:Teicoplanin; C469289:dalbavancin