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Pharmacovigilance in hospice/palliative care: net effect of pregabalin for neuropathic pain
  1. Christine Sanderson1,2,
  2. Stephen J Quinn3,
  3. Meera Agar2,4,
  4. Richard Chye5,
  5. Katherine Clark6,
  6. Matthew Doogue7,
  7. Belinda Fazekas8,
  8. Jessica Lee9,
  9. Melanie R Lovell4,
  10. Debra Rowett10,
  11. Odette Spruyt11 and
  12. David C Currow2,8
  1. 1Department of Palliative Medicine, Calvary Health Care Sydney, Sydney, New South Wales, Australia
  2. 2CareSearch, Flinders University, Adelaide, South Australia, Australia
  3. 3Flinders Clinical Effectiveness, Flinders University, Adelaide, South Australia, Australia
  4. 4Department of Palliative Care, Braeside Hospital, HammondCare, Sydney, New South Wales, Australia
  5. 5Sacred Heart Palliative Care Services, Darlinghurst, New South Wales, Australia
  6. 6Department of Palliative Care, Calvary Mater Hospital, Newcastle, New South Wales, Australia
  7. 7Clinical Pharmacologist & Endocrinologist University of Otago Christchurch & Canterbury District Health Board, Christchurch, New Zealand
  8. 8Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia
  9. 9Department of Palliative Medicine, Concord Hospital, Sydney, New South Wales, Australia
  10. 10Drug and Therapeutic Information Services, Repatriation General Hospital, Daw Park, Adelaide, South Australia, Australia
  11. 11Pain and Palliative Care, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia
  1. Correspondence to Professor David C Currow, Discipline, Palliative and Supportive Services, Flinders University, Bedford Park, Adelaide, SA 5041, Australia; david.currow{at}health.sa.gov.au

Abstract

Introduction 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.

  • Hospice care
  • Pain
  • Received 18 November 2014.
  • Revision received 8 December 2015.
  • Accepted 2 February 2016.

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  • Received 18 November 2014.
  • Revision received 8 December 2015.
  • Accepted 2 February 2016.
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