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dc.contributor.authorFerreira, Diana
dc.contributor.authorEkstrom, Magnus
dc.contributor.authorSajkov, Dimitar
dc.contributor.authorVandersman, Zac
dc.contributor.authorEckert, Danny J
dc.contributor.authorCurrow, David Christopher
dc.date.accessioned2018-10-05T06:08:32Z
dc.date.available2018-10-05T06:08:32Z
dc.date.issued2018-07-19
dc.identifier.citationFerreira, D. H., Ekström, M., Sajkov, D., Vandersman, Z., Eckert, D. J., & Currow, D. C. (2018). Extended-Release Morphine for Chronic Breathlessness in Pulmonary Arterial Hypertension—A Randomized, Double-Blind, Placebo-Controlled, Crossover Study. Journal of Pain and Symptom Management, 56(4), 483–492.en_US
dc.identifier.issn1873-6513
dc.identifier.urihttp://hdl.handle.net/2328/38384
dc.descriptionThis author accepted manuscript is made available following 12 month embargo from date of publication (July 2019) in accordance with the publisher’s archiving policy. This manuscript version is made available under the CC-BY-NC-ND 4.0 license: http://creativecommons.org/licenses/by-nc-nd/4.0/ which permits use, distribution and reproduction in any medium, provided the original work is properly cited.en_US
dc.description.abstractContext Pulmonary arterial hypertension (PAH) affects people of all ages and is associated with poor prognosis. Chronic breathlessness affects almost all people with PAH. Objectives This randomized, placebo-controlled, double-blind, crossover study aimed to evaluate the effects of regular, low-dose, extended-release (ER) morphine for PAH-associated chronic breathlessness. Methods Participants with PAH-associated chronic breathlessness were randomized to 1) seven days of ER morphine 20 mg, 2) seven-day washout, and 3) seven days of identically looking placebo, or vice versa. Primary end points were breathlessness “right now”—morning and evening—measured with a Visual Analogue Scale. Secondary end points included additional breathlessness measures, quality of life, function, harms, and blinded treatment preference (ACTRN12609000209291). Results Within a period of seven years, 50 patients were assessed in detail and 23 (46%) were randomized (despite broad eligibility criteria). Four participants withdrew while taking morphine. Nineteen participants completed the study. Breathlessness “right now” was higher on morphine compared with placebo both for morning [mean (M) ± SD 31.7 ± 25 mm vs. 26.9 ± 22 mm; effect size (80% CI) = −0.22 (−0.6 to 0.2)] and evening [(M ± SD 33.5 ± 28 mm vs. 25.6 ± 21 mm; effect size (80% CI) = −0.33 (−0.8 to 0.1)]. All secondary measures of breathlessness were higher with morphine as were nausea and constipation. Conclusion This study does not support a Phase III study of ER morphine for people with PAH-associated chronic breathlessness. Recruiting to the target sample size was difficult, the direction of effect in every measure of breathlessness favored placebo and morphine generated more harms.en_US
dc.description.sponsorshipThis work was supported by discretionary funds held by the Discipline, Palliative and Supportive Services, Flinders University, Adelaide, Australia.en_US
dc.language.isoenen_US
dc.publisherElsevieren_US
dc.rights© 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. This manuscript version is made available under the CC-BY-NC-ND 4.0 license: http://creativecommons.org/licenses/by-nc-nd/4.0/en_US
dc.subjectChronic breathlessnessen_US
dc.subjecteffectiveness studyen_US
dc.subjectrandomized controlled trialen_US
dc.subjectmorphineen_US
dc.subjectpulmonary arterial hypertensionen_US
dc.titleExtended-Release Morphine for Chronic Breathlessness in Pulmonary Arterial Hypertension—A Randomized, Double-Blind, Placebo-Controlled, Crossover Studyen_US
dc.typeArticleen
dc.identifier.doihttps://doi.org/10.1016/j.jpainsymman.2018.07.010en_US
dc.rights.holder© 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc.en_US
dc.rights.licenseCC-BY-NC-ND


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