Intractable restless legs syndrome: role of prolonged-release oxycodone–naloxone

Stefano de Biase,1 Mariarosaria Valente,1,2 Gian Luigi Gigli1,21Neurology Unit, Department of Experimental and Clinical Medical Sciences, University of Udine Medical School, 2Department of Neurosciences, Santa Maria della Misericordia University Hospital, Udine, ItalyAbstract: Restless legs syndrome...

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Autores principales:	de Biase S, Valente M, Gigli GL
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	augmentation dopamine oxycodone-naloxone restless legs syndrome Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/dc949b9b5cc94a8facd797f64a976ef7
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spelling	oai:doaj.org-article:dc949b9b5cc94a8facd797f64a976ef72021-12-02T02:54:00ZIntractable restless legs syndrome: role of prolonged-release oxycodone–naloxone1178-2021https://doaj.org/article/dc949b9b5cc94a8facd797f64a976ef72016-02-01T00:00:00Zhttps://www.dovepress.com/intractable-restless-legs-syndrome-role-of-prolonged-release-oxycodone-peer-reviewed-article-NDThttps://doaj.org/toc/1178-2021Stefano de Biase,1 Mariarosaria Valente,1,2 Gian Luigi Gigli1,21Neurology Unit, Department of Experimental and Clinical Medical Sciences, University of Udine Medical School, 2Department of Neurosciences, Santa Maria della Misericordia University Hospital, Udine, ItalyAbstract: Restless legs syndrome (RLS) is a common neurological disorder characterized by an irresistible urge to move the legs accompanied by uncomfortable sensations that occur at night or at time of rest. Pharmacological therapy should be limited to patients who suffer from clinically relevant symptoms. Chronic RLS is usually treated with either a dopamine agonist (pramipexole, ropinirole, rotigotine) or an α2δ calcium-channel ligand (gabapentin, gabapentin enacarbil, pregabalin). Augmentation is the main complication of long-term dopaminergic treatment, and frequently requires a reduction of current dopaminergic dose or a switch to nondopaminergic medications. Opioids as monotherapy or add-on treatment should be considered when alternative satisfactory regimens are unavailable and the severity of symptoms warrants it. In a recent Phase III trial, oxycodone–naloxone prolonged release (PR) demonstrated a significant and sustained effect on patients with severe RLS inadequately controlled by previous treatments. The adverse-event profile was consistent with the safety profile of opioids. The most frequent adverse events were fatigue, constipation, nausea, headache, hyperhidrosis, somnolence, dry mouth, and pruritus. Adverse events were usually mild or moderate in intensity. No cases of augmentation were reported. Oxycodone–naloxone PR is approved for the second-line symptomatic treatment of adults with severe to very severe idiopathic RLS after failure of dopaminergic treatment. Further studies are needed to evaluate if oxycodone–naloxone PR is equally efficacious as a first-line treatment. Moreover, long-term comparative studies between opioids, dopaminergic drugs and α2δ ligands are needed.Keywords: augmentation, dopamine, oxycodone–naloxone, restless legs syndromede Biase SValente MGigli GLDove Medical Pressarticleaugmentationdopamineoxycodone-naloxonerestless legs syndromeNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2016, Iss Issue 1, Pp 417-425 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	augmentation dopamine oxycodone-naloxone restless legs syndrome Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	augmentation dopamine oxycodone-naloxone restless legs syndrome Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 de Biase S Valente M Gigli GL Intractable restless legs syndrome: role of prolonged-release oxycodone–naloxone
description	Stefano de Biase,1 Mariarosaria Valente,1,2 Gian Luigi Gigli1,21Neurology Unit, Department of Experimental and Clinical Medical Sciences, University of Udine Medical School, 2Department of Neurosciences, Santa Maria della Misericordia University Hospital, Udine, ItalyAbstract: Restless legs syndrome (RLS) is a common neurological disorder characterized by an irresistible urge to move the legs accompanied by uncomfortable sensations that occur at night or at time of rest. Pharmacological therapy should be limited to patients who suffer from clinically relevant symptoms. Chronic RLS is usually treated with either a dopamine agonist (pramipexole, ropinirole, rotigotine) or an α2δ calcium-channel ligand (gabapentin, gabapentin enacarbil, pregabalin). Augmentation is the main complication of long-term dopaminergic treatment, and frequently requires a reduction of current dopaminergic dose or a switch to nondopaminergic medications. Opioids as monotherapy or add-on treatment should be considered when alternative satisfactory regimens are unavailable and the severity of symptoms warrants it. In a recent Phase III trial, oxycodone–naloxone prolonged release (PR) demonstrated a significant and sustained effect on patients with severe RLS inadequately controlled by previous treatments. The adverse-event profile was consistent with the safety profile of opioids. The most frequent adverse events were fatigue, constipation, nausea, headache, hyperhidrosis, somnolence, dry mouth, and pruritus. Adverse events were usually mild or moderate in intensity. No cases of augmentation were reported. Oxycodone–naloxone PR is approved for the second-line symptomatic treatment of adults with severe to very severe idiopathic RLS after failure of dopaminergic treatment. Further studies are needed to evaluate if oxycodone–naloxone PR is equally efficacious as a first-line treatment. Moreover, long-term comparative studies between opioids, dopaminergic drugs and α2δ ligands are needed.Keywords: augmentation, dopamine, oxycodone–naloxone, restless legs syndrome
format	article
author	de Biase S Valente M Gigli GL
author_facet	de Biase S Valente M Gigli GL
author_sort	de Biase S
title	Intractable restless legs syndrome: role of prolonged-release oxycodone–naloxone
title_short	Intractable restless legs syndrome: role of prolonged-release oxycodone–naloxone
title_full	Intractable restless legs syndrome: role of prolonged-release oxycodone–naloxone
title_fullStr	Intractable restless legs syndrome: role of prolonged-release oxycodone–naloxone
title_full_unstemmed	Intractable restless legs syndrome: role of prolonged-release oxycodone–naloxone
title_sort	intractable restless legs syndrome: role of prolonged-release oxycodone–naloxone
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/dc949b9b5cc94a8facd797f64a976ef7
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Intractable restless legs syndrome: role of prolonged-release oxycodone&ndash;naloxone

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