No excess harms from sustained-release morphine : A randomised placebo-controlled trial in chronic breathlessness

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Johnson, Miriam J.Hull York Medical School (author)

No excess harms from sustained-release morphine : A randomised placebo-controlled trial in chronic breathlessness

Article/chapterEnglish2020

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2019-11-12
BMJ,2020
8 s.

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LIBRIS-ID:oai:lup.lub.lu.se:587f081b-164d-4e00-9ebe-55fa6fd82133
https://lup.lub.lu.se/record/587f081b-164d-4e00-9ebe-55fa6fd82133URI
https://doi.org/10.1136/bmjspcare-2019-002009DOI

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Language:English
Summary in:English

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Objectives: We aimed to identify and evaluate: (1) treatment-emergent adverse events (TEAE (worse or new since baseline)) and the subgroup of severe TEAEs in a placebo-controlled 7-day randomised trial of regular, low-dose, sustained-release oral morphine for chronic breathlessness and (2) clinical characteristics associated with TEAE. Methods: Safety analysis of trial data. Adults with chronic breathlessness (modified Medical Research Council breathlessness score ≥2) due to heart or lung disease, or cancer, not on regular opioids were eligible. Symptoms associated with opioids (TEAE of special interest) were systematically sought using Common Terminology Criteria for Adverse Events (CTCAE) grading. Other harms could be reported at any time. The relationship between characteristics and presence of ≥1 TEAE of special interest was explored using univariable logistic regression analyses. Results: 1449/5624 (26%) Adverse Events from 279 participants were TEAE of which 150/1449 (10%) were severe (CTCAE grades 3-5). 1086/5624 (75%) were events of special interest of which 41/1086 (4%) were severe. Compared with placebo, morphine was not associated with more TEAE or severe TEAE of special interest (TEAE: OR 0.53, 95% CI 0.21 to 1.38, p=0.20; severe TEAE: OR 0.96, 95% CI 0.27 to 3.41, p=0.95) nor with CTCAE severity grade (χ2=4.39, p=0.50). Among the 26/150 (17%) with severe TEAEs, study withdrawal was more common in the morphine arm (18/26 (69%) morphine arm; 8/26 (30%) placebo arm). None of the severe TEAEs was a respiratory harm. Conclusions: Severe morphine-associated toxicity was uncommon and not associated with study arm. Clinical consequences were minor and self-limiting.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Lungmedicin och allergi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Respiratory Medicine and Allergy hsv//eng
chronic breathlessness
dyspnea
harms
Morphine
safety

Added entries (persons, corporate bodies, meetings, titles ...)

Sbizzera, IllaryUniversity of York (author)
Fairhurst, CarolineUniversity of York (author)
Fazekas, BelindaUniversity of Technology Sydney (author)
Agar, MeeraUniversity of Technology Sydney (author)
Ekstrom, MagnusLund University,Lunds universitet,Lungmedicin, allergologi och palliativ medicin,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Andfåddhet och kronisk andningssvikt,Forskargrupper vid Lunds universitet,Respiratory Medicine, Allergology, and Palliative Medicine,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Breathlessness and chronic respiratory failure,Lund University Research Groups(Swepub:lu)med-mue (author)
Currow, David C.University of Technology Sydney,Hull York Medical School (author)
Hull York Medical SchoolUniversity of York (creator_code:org_t)

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In:BMJ Supportive and Palliative Care: BMJ10:4, s. 421-4282045-435X2045-4368

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