Pharmacovigilance in hospice/palliative care: the net immediate and short-term effects of dexamethasone for anorexia.
OBJECTIVE
Loss of appetite is prevalent in palliative care and distressing for patients and families. Therapies include corticosteroids or progestogens. This study explores the net effect of dexamethasone on anorexia.


METHODS
Prospective data were collected when dexamethasone was started for anorexia as part of routine care. The National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCICTCAE) Likert scales assessed severity of anorexia and immediate and short-term harms at 2 time points: baseline and 7 days.


RESULTS
This study (41 sites, 8 countries) collected data (July 2013 to July 2014) from 114 patients (mean age 71 (SD 11), 96% with cancer). Median Australian-modified Karnofsky Performance Scale was 50% (range 20-70). Mean baseline NCICTCAE anorexia score was 2.7 (SD 0.6; median 3). 6 patients died by day 7. Of 108 evaluable patients, 74 (68.5%; 95% CI 59.0% to 76.7%) reported ≥1 reduction anorexia scores by day 7, of whom 30 were 0. Mean dexamethasone dose on day 7 was 4.1 mg/day (SD 3.4; median 4; range 0-46 mg). 24 patients reported ≥1 harms (32.4% CI 22.6% to 44.1%; insomnia n=10, depression n=7, euphoria n=7 and hyperglycaemia n=7). Of 24 patients with no benefit, 10 reported ≥1 harms.


CONCLUSIONS
This study shows positive and negative effects of 7 days of dexamethasone as an appetite stimulant in patients with advanced life-limiting illnesses. Identifying clinicodemographic characteristics of people most at risk of harms with no benefit is a crucial next step. Longer term follow-up will help to understand longer term and cumulative harms.
Department of Psychiatry, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia.
Yutaka
Y
Hatano
MariaTeresa Chiantore Seràgnoli Hospice Foundation, Bologna, Italy.
Matteo
M
Moroni
Palliative Medicine and Medical Oncology, School of Medicine, University of Nottingham, Nottingham, UK.
Andrew
A
Wilcock
School of Medicine, Flinders University, Adelaide, South Australia, Australia.
Stephen
S
Quinn
Hospice-Palliative Department, UP MS Family Medicine Institute, Pecs, Hungary.
Ágnes
Á
Csikós
Director of Palliative Care, Arohanui Hospice, Palmerston North, New Zealand.
Simon G
SG
Allan
Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia Braeside Hospital, HammondCare, Sydney, New South Wales, Australia.
Meera
M
Agar
Department of Palliative Care, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.
Katherine
K
Clark
HammondCare Palliative and Supportive Care Service, Greenwich Hospital, Sydney, New South Wales, Australia.
Josephine M
JM
Clayton
Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia.
David C
DC
Currow
D000368:Aged; D000369:Aged, 80 and over; D000855:Anorexia / Q000188:drug therapy*; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017051:Hospice Care / Q000379:methods*; D006801:Humans; D010166:Palliative Care / Q000379:methods*; D060735:Pharmacovigilance; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome
D003907:Dexamethasone
Drug administration; Pharmacology; Terminal care