Pharmacovigilance in hospice/palliative care: Net effect of pregabalin for neuropathic pain

Sanderson, C; Quinn, SJ; Agar, M; Chye, R; Clark, K; Doogue, M; Fazekas, B; Lee, J; Lovell, MR; Rowett, D; Spruyt, O; Currow, DC

Pharmacovigilance in hospice/palliative care: Net effect of pregabalin for neuropathic pain

Sanderson, C

Quinn, SJ Agar, M

Chye, R Clark, K Doogue, M Fazekas, B Lee, J Lovell, MR

Rowett, D Spruyt, O Currow, DC

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Publication Type:: Journal Article
Citation:: BMJ Supportive and Palliative Care, 2016, 6 (3), pp. 323 - 330
Issue Date:: 2016-09-01

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Field	Value	Language
dc.contributor.author	Sanderson, C https://orcid.org/0000-0001-5423-5778	en_US
dc.contributor.author	Quinn, SJ	en_US
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119	en_US
dc.contributor.author	Chye, R	en_US
dc.contributor.author	Clark, K	en_US
dc.contributor.author	Doogue, M	en_US
dc.contributor.author	Fazekas, B	en_US
dc.contributor.author	Lee, J	en_US
dc.contributor.author	Lovell, MR https://orcid.org/0000-0002-1407-2748	en_US
dc.contributor.author	Rowett, D	en_US
dc.contributor.author	Spruyt, O	en_US
dc.contributor.author	Currow, DC https://orcid.org/0000-0003-1988-1250	en_US
dc.date.available	2016-02-02	en_US
dc.date.issued	2016-09-01	en_US
dc.identifier.citation	BMJ Supportive and Palliative Care, 2016, 6 (3), pp. 323 - 330	en_US
dc.identifier.issn	2045-435X	en_US
dc.identifier.uri	http://hdl.handle.net/10453/117939
dc.description.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.	en_US
dc.relation.ispartof	BMJ Supportive and Palliative Care	en_US
dc.relation.isbasedon	10.1136/bmjspcare-2014-000825	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Neuralgia	en_US
dc.subject.mesh	Analgesics	en_US
dc.subject.mesh	Treatment Outcome	en_US
dc.subject.mesh	Palliative Care	en_US
dc.subject.mesh	Hospice Care	en_US
dc.subject.mesh	Prospective Studies	en_US
dc.subject.mesh	Adult	en_US
dc.subject.mesh	Aged	en_US
dc.subject.mesh	Aged, 80 and over	en_US
dc.subject.mesh	Middle Aged	en_US
dc.subject.mesh	Female	en_US
dc.subject.mesh	Male	en_US
dc.subject.mesh	Young Adult	en_US
dc.subject.mesh	Pharmacovigilance	en_US
dc.subject.mesh	Pregabalin	en_US
dc.title	Pharmacovigilance in hospice/palliative care: Net effect of pregabalin for neuropathic pain	en_US
dc.type	Journal Article
utslib.citation.volume	3	en_US
utslib.citation.volume	6	en_US
utslib.for	1110 Nursing	en_US
utslib.for	1117 Public Health and Health Services	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	/University of Technology Sydney/Students
utslib.copyright.status	closed_access
pubs.issue	3	en_US
pubs.publication-status	Published	en_US
pubs.volume	6	en_US

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.

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http://hdl.handle.net/10453/117939