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No excess harms fro...
No excess harms from sustained-release morphine : A randomised placebo-controlled trial in chronic breathlessness
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- Johnson, Miriam J. (författare)
- Hull York Medical School
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- Sbizzera, Illary (författare)
- University of York
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- Fairhurst, Caroline (författare)
- University of York
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- Fazekas, Belinda (författare)
- University of Technology Sydney
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- Agar, Meera (författare)
- University of Technology Sydney
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- Ekstrom, Magnus (författare)
- Lund 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
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- Currow, David C. (författare)
- University of Technology Sydney,Hull York Medical School
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(creator_code:org_t)
- 2019-11-12
- 2020
- Engelska 8 s.
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Ingår i: BMJ Supportive and Palliative Care. - : BMJ. - 2045-435X .- 2045-4368. ; 10:4, s. 421-428
- Relaterad länk:
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http://dx.doi.org/10...
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https://hull-reposit...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Lungmedicin och allergi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Respiratory Medicine and Allergy (hsv//eng)
Nyckelord
- chronic breathlessness
- dyspnea
- harms
- Morphine
- safety
Publikations- och innehållstyp
- art (ämneskategori)
- ref (ämneskategori)
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