title: Pharmacovigilance in hospice/palliative care: net effect of gabapentin for neuropathic pain.
abstract: OBJECTIVE
  Hospice/palliative care patients may differ from better studied populations, and data from other populations cannot necessarily be extrapolated into hospice/palliative care clinical practice. Pharmacovigilance studies provide opportunities to understand the harms and benefits of medications in routine practice. Gabapentin, a γ-amino butyric acid analogue antiepileptic drug, is commonly prescribed for neuropathic pain in hospice/palliative care. Most of the evidence however relates to non-malignant, chronic pain syndromes (diabetic neuropathy, postherpetic neuralgia, central pain syndromes, fibromyalgia). The aim of this study was to quantify the immediate and short-term clinical benefits and harms of gabapentin in routine hospice/palliative care practice.
  
  
  METHODS
  Multisite, prospective, consecutive cohort.
  
  
  METHODS
  127 patients, 114 of whom had cancer, who started gabapentin for neuropathic pain as part of routine clinical care.
  
  
  METHODS
  42 centres from seven countries. Data were collected at three time points-at baseline, at day 7 (and at any time; immediate and short-term harms) and at day 21 (clinical benefits).
  
  
  RESULTS
  At day 21, the average dose of gabapentin for those still using it (n=68) was 653 mg/24 h (range 0-1800 mg) and 54 (42%) reported benefits, of whom 7 (6%) experienced complete pain resolution. Harms were reported in 39/127 (30%) patients at day 7, the most frequent of which were cognitive disturbance, somnolence, nausea and dizziness. Ten patients had their medication ceased due to harms. The presence of significant comorbidities, higher dose and increasing age increased the likelihood of harm.
  
  
  CONCLUSIONS
  Overall, 42% of people experienced benefit at a level that resulted in continued use at 21 days.
authors.affiliation: Department of Palliative Medicine, Calvary Health Care, Sydney, New South Wales, Australia Discipline, Palliative and Supportive Services, 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: Discipline, Palliative and Supportive Services, 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: Christchurch & Canterbury District Health Board, University of Otago, 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 Therapeutics Information Service, Repatriation General Hospital, Adelaide, Australia.
authors.forename: Debra
authors.initials: D
authors.lastname: Rowett
authors.affiliation: Department of 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: Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia Flinders Clinical Effectiveness, 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; D000588:Amines / Q000009:adverse effects*; D000700:Analgesics / Q000009:adverse effects*; D003509:Cyclohexanecarboxylic Acids / Q000009:adverse effects*; D005260:Female; D000077206:Gabapentin; D017051:Hospice Care / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009437:Neuralgia / Q000188:drug therapy*; D010166:Palliative Care / Q000379:methods*; D060735:Pharmacovigilance; D011446:Prospective Studies; D005680:gamma-Aminobutyric Acid / Q000009:adverse effects*
chemical_list: D000588:Amines; D000700:Analgesics; D003509:Cyclohexanecarboxylic Acids; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin
keywords: Drug administration; Pain; Terminal care