title: Impact of pregabalin treatment on pain, pain-related sleep interference and general well-being in patients with neuropathic pain: a non-interventional, multicentre, post-marketing study.
abstract: OBJECTIVE
  Numerous controlled clinical trials have demonstrated the safety and efficacy of pregabalin in the treatment of neuropathic pain. The objectives of the present study were to assess the impact of pregabalin under real-world conditions on pain, pain-related sleep interference and general well-being, and to assess the tolerability and safety of pregabalin in patients diagnosed with neuropathic pain of central or peripheral origin.
  
  
  METHODS
  This was a non-interventional, multicentre study in which pregabalin was administered for 8 weeks, at the therapeutic dosages of 150-600 mg/day, to patients with a diagnosis of neuropathic pain. Pain intensity and pain-related sleep interference were measured using 11-point numerical rating scales, while well-being was assessed by documenting how often emotions associated with anxiety or depression were felt over the past week. Patient and Clinician Global Impression of Change (PGIC and CGIC) were assessed at the final visit.
  
  
  RESULTS
  In the 668 patients included in the full analysis set, there were significant (p < 0.0001) reductions in mean pain and pain-related sleep interference scores of 4.16 and 4.02, respectively. Indicators of general well-being showed improvement from baseline to final visit. The majority of patients were rated as 'much improved' (43.7% and 36.7%) or 'very much improved' (24.0% and 26.2%) on CGIC and PGIC scores, respectively. Discontinuation because of lack of efficacy occurred in 0.7% of 691 patients in the safety analysis set while discontinuation because of adverse events occurred in 5.1% of this population; 76.4% continued treatment after the study ended.
  
  
  CONCLUSIONS
  Significant reductions in pain and pain-related sleep interference, combined with reductions in feelings of anxiety and depression, suggest that pregabalin under real-world conditions improves the overall health and well-being of patients with neuropathic pain.
authors.affiliation: Department of Anaesthesiology and Pain Clinic, Thriassio General Hospital, Athens, Greece.
authors.forename: Emmanouil
authors.initials: E
authors.lastname: Anastassiou
authors.forename: Christos A
authors.initials: CA
authors.lastname: Iatrou
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Vlaikidis
authors.forename: Marianthi
authors.initials: M
authors.lastname: Vafiadou
authors.forename: Georgia
authors.initials: G
authors.lastname: Stamatiou
authors.forename: Eleni
authors.initials: E
authors.lastname: Plesia
authors.forename: Leonidas
authors.initials: L
authors.lastname: Lyras
authors.forename: Athina
authors.initials: A
authors.lastname: Vadalouca
mesh_terms: D000368:Aged; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000150:complications / Q000188:drug therapy*; D010523:Peripheral Nervous System Diseases / Q000150:complications / Q000188:drug therapy*; D000069583:Pregabalin; D011358:Product Surveillance, Postmarketing; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology; D011795:Surveys and Questionnaires; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid