title: Safety and efficacy of duloxetine in the treatment of diabetic peripheral neuropathic pain in older patients.
abstract: OBJECTIVE
  We present a post-hoc analysis of the safety and efficacy of duloxetine, a selective serotonin/norepinephrine reuptake inhibitor, for treatment of diabetic peripheral neuropathic pain (DPNP) in older patients.
  
  
  METHODS
  Data from three double-blind, placebo-controlled trials in adult patients with DPNP were pooled and stratified by age (<65, >or=65 years). Patients were randomized to duloxetine (DLX) 60 mg once-daily, 60 mg twice-daily, or placebo for 12 weeks, followed by a 52-week extension phase (re-randomization to routine care or DLX 120 mg/day). Intent-to-treat analyses were used for safety and efficacy assessment.
  
  
  RESULTS
  In the acute phase, overall TEAE rates did not differ significantly by age. A greater percentage of older patients discontinued due to TEAEs (P<0.001), regardless of treatment group. Duloxetine improved weekly mean 24-hour average pain scores versus placebo in both age groups (P<0.01). In the extension phase, a significant therapy-by-age interaction (P<0.05) was observed in overall TEAE rate; with routine care, 86.6% of older patients had >or=1 TEAE versus 74.6% of younger patients.
  
  
  CONCLUSIONS
  Although TEAEs more frequently lead to discontinuation in older patients, duloxetine was well tolerated and efficacious for treatment of DPNP regardless of age. These data suggest duloxetine may be beneficial for treatment of DPNP in patients>or=65.
authors.affiliation: Department of Anesthesiology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. AWASAN@PARTNERS.ORG
authors.forename: Ajay D
authors.initials: AD
authors.lastname: Wasan
authors.forename: Melissa J
authors.initials: MJ
authors.lastname: Ossanna
authors.forename: Joel
authors.initials: J
authors.lastname: Raskin
authors.forename: Joachim F
authors.initials: JF
authors.lastname: Wernicke
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Robinson
authors.forename: Jerry A
authors.initials: JA
authors.lastname: Hall
authors.forename: Sara E
authors.initials: SE
authors.lastname: Edwards
authors.forename: Sarah
authors.initials: S
authors.lastname: Lipsius
authors.forename: Adam L
authors.initials: AL
authors.lastname: Meyers
authors.forename: Bill H
authors.initials: BH
authors.lastname: McCarberg
mesh_terms: D000367:Age Factors; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D004311:Double-Blind Method; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes