title: Pain intensity and interference with functioning and well-being in subgroups of patients with chronic pain treated with once-daily hydrocodone tablets.
abstract: BACKGROUND
  A previous 52-week trial of patients with chronic noncancer, non-neuropathic pain (CNNP) showed clinically meaningful improvement in pain intensity, pain interference, and physical health-related quality of life (HRQL) following daily treatment with an extended-release, once-daily hydrocodone (Hysingla(®) ER; HYD) bitartrate tablet.
  
  
  OBJECTIVE
  To examine treatment response within patient subgroups and to assess between-subgroup differences in effectiveness and side effect profile.
  
  
  METHODS
  Data were from an open-label 52-week trial of treatment with HYD tablets (20-120 mg, once-daily) for patients with moderate-to-severe CNNP. Binary subgroups were defined for the following six factors: age, gender, opioid experience, baseline pain severity, history of depression, and stable HYD dose at completion of a 45-day dose-titration period. Univariable and multivariable models examined changes in average pain intensity (API; 11-point numeric rating scale), pain interference (Brief Pain Inventory-Interference subscale [BPI-I]), physical and mental HRQL (36-item Short Form health survey Physical and Mental Component Summaries [PCS and MCS]), and sleep quality (Medical Outcomes Study Sleep Scale Sleep Problems Index [SPI]) from baseline to maintenance, and subgroup differences in adverse events.
  
  
  RESULTS
  All subgroups showed clinically meaningful improvements in API, BPII, and PCS scores; no subgroups showed improvements in MCS or SPI. Between subgroup comparisons found greater improvements for opioid-naïve patients and for patients with severe baseline pain. Incidence of adverse events differed minimally between subgroups.
  
  
  CONCLUSIONS
  Regardless of subgroup, patients with CNNP treated with HYD showed clinically meaningful improvements in pain intensity, pain interference, and physical HRQL, although not in mental HRQL or sleep quality. Improvements were generally larger for opioid-naïve patients and patients with severe baseline pain.
authors.affiliation: San Francisco Pain Management Center, San Francisco, California.
authors.forename: Adrian
authors.initials: A
authors.lastname: Bartoli
authors.affiliation: Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Edward
authors.initials: E
authors.lastname: Michna
authors.affiliation: Purdue Pharma L.P., Stamford, Connecticut.
authors.forename: Ellie
authors.initials: E
authors.lastname: He
authors.affiliation: Purdue Pharma L.P., Stamford, Connecticut.
authors.forename: Warren
authors.initials: W
authors.lastname: Wen
mesh_terms: D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D059350:Chronic Pain / Q000188:drug therapy* / Q000523:psychology; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006853:Hydrocodone / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011788:Quality of Life; D013607:Tablets
chemical_list: D000701:Analgesics, Opioid; D013607:Tablets; D006853:Hydrocodone