title: Pharmacovigilance in hospice/palliative care: net effect of pregabalin for neuropathic pain.
abstract: BACKGROUND
  Real-world effectiveness of many medications has been poorly researched, including in hospice/palliative care. Directly extrapolating findings from other clinical settings may not yield robust clinical advice. Pharmacovigilance studies provide an opportunity to understand better the net impact of medications. The study aimed to examine immediate and short-term benefits and harms of pregabalin in routine practice for neuropathic pain in hospice/palliative care.
  
  
  METHODS
  A consecutive cohort of 155 patients from 62 centres in 5 countries was started on pregabalin and studied prospectively. Data were collected at three time points: baseline; day 7 (immediate, short-term harms); ad hoc reports of any harms ≤21 days; and day 21 (short-term benefits).
  
  
  RESULTS
  Median dose for 155 patients at day 21 was 150 mg/24 h. Benefits were reported by 61 patients (39%), of whom 11 (7%) experienced complete pain resolution. Harms were reported by 51 (35%) patients at or before 7 days, the most frequent of which were somnolence, fatigue, cognitive disturbance and dizziness. 10 patients (6%) ceased pregabalin due to harms, but 82 patients (53%) were being treated at 21 days. In regression modelling, people with worse baseline pain derived more benefit (OR=8.5 (95% CI 2.5 to 28.68).
  
  
  CONCLUSIONS
  Pregabalin delivered benefit to many patients, with 4 of 10 experiencing pain reductions by 21 days. Harms, occurring in 1 in 3 patients, may be difficult to detect in clinical practice, as they mostly involve worsening of symptoms prevalent at baseline.
authors.affiliation: Department of Palliative Medicine, Calvary Health Care Sydney, Sydney, New South Wales, Australia CareSearch, Flinders University, Adelaide, South Australia, Australia.
authors.forename: Christine
authors.initials: C
authors.lastname: Sanderson
authors.affiliation: Flinders Clinical Effectiveness, Flinders University, Adelaide, South Australia, Australia.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Quinn
authors.affiliation: CareSearch, Flinders University, Adelaide, South Australia, Australia Department of Palliative Care, Braeside Hospital, HammondCare, Sydney, New South Wales, Australia.
authors.forename: Meera
authors.initials: M
authors.lastname: Agar
authors.affiliation: Sacred Heart Palliative Care Services, Darlinghurst, New South Wales, Australia.
authors.forename: Richard
authors.initials: R
authors.lastname: Chye
authors.affiliation: Department of Palliative Care, Calvary Mater Hospital, Newcastle, New South Wales, Australia.
authors.forename: Katherine
authors.initials: K
authors.lastname: Clark
authors.affiliation: Clinical Pharmacologist & Endocrinologist University of Otago Christchurch & Canterbury District Health Board, Christchurch, New Zealand.
authors.forename: Matthew
authors.initials: M
authors.lastname: Doogue
authors.affiliation: Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia.
authors.forename: Belinda
authors.initials: B
authors.lastname: Fazekas
authors.affiliation: Department of Palliative Medicine, Concord Hospital, Sydney, New South Wales, Australia.
authors.forename: Jessica
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Palliative Care, Braeside Hospital, HammondCare, Sydney, New South Wales, Australia.
authors.forename: Melanie R
authors.initials: MR
authors.lastname: Lovell
authors.affiliation: Drug and Therapeutic Information Services, Repatriation General Hospital, Daw Park, Adelaide, South Australia, Australia.
authors.forename: Debra
authors.initials: D
authors.lastname: Rowett
authors.affiliation: Pain and Palliative Care, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Odette
authors.initials: O
authors.lastname: Spruyt
authors.affiliation: CareSearch, Flinders University, Adelaide, South Australia, Australia Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia.
authors.forename: David C
authors.initials: DC
authors.lastname: Currow
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use*; D005260:Female; D017051:Hospice Care / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy*; D010166:Palliative Care / Q000379:methods*; D060735:Pharmacovigilance; D000069583:Pregabalin / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000700:Analgesics; D000069583:Pregabalin
keywords: Hospice care; Pain