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dc.contributor.authorJohnson, MJen
dc.contributor.authorCockayne, Sen
dc.contributor.authorCurrow, DCen
dc.contributor.authorBell, Ken
dc.contributor.authorHicks, Ken
dc.contributor.authorFairhurst, Cen
dc.contributor.authorGabe, Ren
dc.contributor.authorTorgerson, Den
dc.contributor.authorJefferson, Len
dc.contributor.authorOxberry, Sen
dc.contributor.authorGhosh, Jen
dc.contributor.authorHogg, KJen
dc.contributor.authorMurphy, Jen
dc.contributor.authorAllgar, Ven
dc.contributor.authorCleland, JGFen
dc.contributor.authorClark, ALen
dc.date.accessioned2021-08-09T11:21:42Z
dc.date.issued2019-12en
dc.identifier.urihttp://hdl.handle.net/10026.1/17471
dc.description.abstract

AIMS: Morphine is shown to relieve chronic breathlessness in chronic obstructive pulmonary disease. There are no definitive data in people with heart failure. We aimed to determine the effectiveness and cost-effectiveness of 12 weeks morphine therapy for the relief of chronic breathlessness in people with chronic heart failure compared with placebo. METHODS AND RESULTS: Parallel group, double-blind, randomized, placebo-controlled, phase III trial of 20 mg daily oral modified release morphine was conducted in 13 sites in England and Scotland: hospital/community cardiology or palliative care outpatients. The primary analysis compared between-group numerical rating scale average breathlessness/24 hours at week 4 using a covariance pattern linear mixed model. Secondary outcomes included treatment-emergent harms (worse or new). The trial closed early due to slow recruitment, randomizing 45 participants [average age 72 (range 39-89) years; 84% men; 98% New York Heart Association class III]. For the primary analysis, the adjusted mean difference was 0.26 (95% confidence interval, -0.86 to 1.37) in favour of placebo. All other breathlessness measures improved in both groups (week 4 change-from-baseline) but by more in those assigned to morphine. Neither group was excessively drowsy at baseline or week 4. There were no between-group differences in quality of life (Kansas) or cognition (Montreal) at any time point. There was no exercise-related desaturation and no change between baseline and week 4 in either group. There was no change in vital signs at week 4. The natriuretic peptide measures fell in both groups but by more in the morphine group [morphine 2169 (1092, 3851) pg/mL vs. placebo 2851 (1694, 5437)] pg/mL. There was no excess serious adverse events in the morphine group. Treatment-emergent harms during the first week were more common in the morphine group; all apart from 1 were ≤ grade 2. CONCLUSIONS: We could not answer our primary objectives due to inadequate power. However, we provide novel placebo-controlled medium-term benefit and safety data useful for clinical practice and future trial design. Morphine should only be prescribed in this population when other measures are unhelpful and with early management of side effects.

en
dc.format.extent1149 - 1160en
dc.languageengen
dc.language.isoengen
dc.subjectBreathlessnessen
dc.subjectDyspnoeaen
dc.subjectHeart failureen
dc.subjectMorphineen
dc.subjectRandomized controlled trialen
dc.subjectAdministration, Oralen
dc.subjectAdulten
dc.subjectAgeden
dc.subjectAged, 80 and overen
dc.subjectChronic Diseaseen
dc.subjectDouble-Blind Methoden
dc.subjectDyspneaen
dc.subjectFemaleen
dc.subjectHeart Failureen
dc.subjectHumansen
dc.subjectMaleen
dc.subjectMiddle Ageden
dc.subjectMorphineen
dc.subjectNarcoticsen
dc.titleOral modified release morphine for breathlessness in chronic heart failure: a randomized placebo-controlled trial.en
dc.typeJournal Article
plymouth.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/31389157en
plymouth.issue6en
plymouth.volume6en
plymouth.publication-statusPublisheden
plymouth.journalESC Heart Failen
dc.identifier.doi10.1002/ehf2.12498en
plymouth.organisational-group/Plymouth
plymouth.organisational-group/Plymouth/Faculty of Health
plymouth.organisational-group/Plymouth/Faculty of Health/Peninsula Medical School
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA
plymouth.organisational-group/Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine
plymouth.organisational-group/Plymouth/Research Groups
plymouth.organisational-group/Plymouth/Research Groups/Plymouth Institute of Health and Care Research (PIHR)
plymouth.organisational-group/Plymouth/Users by role
plymouth.organisational-group/Plymouth/Users by role/Academics
dc.publisher.placeEnglanden
dcterms.dateAccepted2019-06-18en
dc.rights.embargodate9999-12-31en
dc.identifier.eissn2055-5822en
dc.rights.embargoperiodNot knownen
rioxxterms.versionofrecord10.1002/ehf2.12498en
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
rioxxterms.licenseref.startdate2019-12en
rioxxterms.typeJournal Article/Reviewen


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