title: Controlled-release oxycodone and pregabalin in the treatment of neuropathic pain: results of a multicenter Italian study.
abstract: OBJECTIVE
  The aim of our study was to compare the efficacy, safety, and quality of life of combination therapy with controlled-release (CR) oxycodone plus pregabalin versus monotherapy with either CR oxycodone or pregabalin in patients with neuropathic pain.
  
  
  METHODS
  Patients with moderate to severe neuropathic pain, despite the use of various pharmacologic treatments prior to study entry, were enrolled (n = 409) and treated with CR oxycodone plus pregabalin (n = 169), CR oxycodone (n = 106), and pregabalin (n = 134). Pain intensity was rated on an 11-point numerical rating scale (NRS).
  
  
  RESULTS
  The combination of CR oxycodone plus pregabalin and CR oxycodone monotherapy were both more effective for alleviating neuropathic pain than pregabalin monotherapy (reduction in NRS value: 80, 76, and 46%, respectively; p </= 0.003). Significantly greater improvements from baseline in quality of life were reported with combination therapy than with monotherapy (p = 0.0009). At the end of treatment, the majority (91.2%) of patients receiving CR oxycodone plus pregabalin found that the treatment had been 'effective' or 'very effective'. Combination therapy also allowed a dose reduction of both agents (22% for CR oxycodone and 51% for pregabalin) compared with the dosages of the respective monotherapies. Combination therapy had a superior safety profile compared with pregabalin monotherapy.
  
  
  CONCLUSIONS
  The combination of CR oxycodone plus pregabalin may represent a valuable addition to the existing pharmacotherapy for neuropathic pain and warrants further investigation.
authors.affiliation: Dipartimento AFA Servizio di Anestesia e Terapia del Dolore, Ospedale Tor Vergata, Viale Oxford 81, Rome, Italy. antonio.gatti@ptvonline.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Gatti
authors.forename: Alessandro Fabrizio
authors.initials: AF
authors.lastname: Sabato
authors.forename: Roberto
authors.initials: R
authors.lastname: Occhioni
authors.forename: Gianni
authors.initials: G
authors.lastname: Colini Baldeschi
authors.forename: Carlo
authors.initials: C
authors.lastname: Reale
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy*; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects; D010147:Pain Measurement; D000069583:Pregabalin; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D000700:Analgesics; D003692:Delayed-Action Preparations; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D010098:Oxycodone