title: Health care costs in patients with painful diabetic peripheral neuropathy prescribed pregabalin or duloxetine.
abstract: BACKGROUND
  Pregabalin and duloxetine are two FDA-approved medications for the treatment of pain associated with diabetic peripheral neuropathy (pDPN). The objective of this study was to compare changes in all-cause and pDPN-related health care costs in patients with pDPN initiated on pregabalin or duloxetine.
  
  
  METHODS
  Patients at least 18 years of age initiating pregabalin or duloxetine between March 1, 2006 and December 31, 2008 were identified from a large U.S. managed care plan database. The date of the first pregabalin or duloxetine prescription was defined as the index date. Patients with claims-based evidence of pDPN and who had continuous enrollment for 6-month pre- and post-index periods were selected for study inclusion. Duloxetine patients with depression or generalized anxiety disorder (GAD) were excluded. All-cause and pDPN-related total health care costs (over 6 month pre-index and post-index periods) were analyzed with difference-in-differences (DiD) models.
  
  
  RESULTS
  A total of 2,136 patients (1,785 pregabalin and 351 duloxetine) were identified. No significant differences in gender, age, or pre-index Quan-Charlson comorbidity score were observed between the two cohorts. No significant differences (pregabalin vs. duloxetine) in pre-index to post-index change in mean all-cause health care costs ($1,411 vs. $1,560, P = 0.93) or mean pDPN-related health care costs ($704 vs. -$240, P = 0.22) were found. The DiD models showed no significant difference in all-cause (mean) costs attributable to pregabalin vs. duloxetine therapy between pre-index and post-index periods (mean cost ratio = 0.97, 95% CI: 0.75 to 1.26), but showed that patients receiving pregabalin had a significantly higher increase in pDPN-related costs compared with patients receiving duloxetine (mean cost ratio = 2.35, 95% CI: 1.01 to 5.46). However, the difference (pre- to post-index) in pDPN-related costs attributable to pregabalin vs. duloxetine therapy was nonsignificant (mean cost ratio = 2.30, 95% CI: 0.93 to 5.68) in a sensitivity analysis in which patients with depression and GAD were excluded from both cohorts.
  
  
  CONCLUSIONS
  No differences were noted in all-cause costs attributable to pregabalin or duloxetine. Although patients receiving pregabalin had a significantly greater pre- to post-index increase in pDPN-related health care costs compared with patients receiving duloxetine, this may have been due to an imbalance in patient exclusion criteria between cohorts.
authors.affiliation: OPTUM Insight, Eden Prairie, Minnesota Pfizer, Inc., New York, New York, USA. james.burke@i3innovus.com
authors.forename: James P
authors.initials: JP
authors.lastname: Burke
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Sanchez
authors.forename: Ashish V
authors.initials: AV
authors.lastname: Joshi
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Cappelleri
authors.forename: Mahesh
authors.initials: M
authors.lastname: Kulakodlu
authors.forename: Rachel
authors.initials: R
authors.lastname: Halpern
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000191:economics* / Q000627:therapeutic use; D015331:Cohort Studies; D003929:Diabetic Neuropathies / Q000188:drug therapy / Q000191:economics*; D000068736:Duloxetine Hydrochloride; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006296:Health Services / Q000191:economics / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D008329:Managed Care Programs / Q000706:statistics & numerical data; D008875:Middle Aged; D000069583:Pregabalin; D013876:Thiophenes / Q000191:economics* / Q000627:therapeutic use; D014481:United States; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
chemical_list: D000700:Analgesics; D013876:Thiophenes; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D000068736:Duloxetine Hydrochloride