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Transdermal lisuride: short-term efficacy and tolerability study in patients with severe restless legs syndrome.
Sleep Med. 2006 Jan; 7(1):31-5.SM

Abstract

BACKGROUND AND PURPOSE

Restless legs syndrome (RLS) patients suffer from symptoms not only at bedtime but also with variable circadian patterns. Transdermal application forms of dopamine agonists are expected to lead to a stable plasma concentration of the active drug which could ease treatment for RLS patients with daytime symptoms and avoid side effects of oral dopaminergic therapies.

PATIENTS AND METHODS

In this controlled pilot study, 10 patients (six females, four males, mean age 58 years) with severe and long-lasting idiopathic RLS were treated during an initial open-label phase for 2 weeks either with one (n=3 patients) or, if required, two patches of lisuride every other day (dose per patch: 3mg lisuride, nominal effective release rate 7.0 microg lisuride/h). Patients were then randomized to double-blind treatment with lisuride (n=5) or placebo (n=4) for 1 week.

RESULTS

Severity of RLS clearly improved during open-label and double-blind treatment with lisuride but became worse under placebo according to the International Restless Legs Syndrome Study Group Rating Scale (IRLS), RLS-6, and Clinical Global Impressions (CGIs) scales, and actigraphy assessments (periodic leg movement index) in the 1-week double-blind period.

CONCLUSION

The explorative findings of this small controlled study suggest that lisuride patches might be an efficacious treatment for RLS patients without clinically relevant tolerability problems.

Authors+Show Affiliations

Somni bene Institute for Medical Research and Sleep Medicine Schwerin Ltd, Arsenalstrasse 10, 19053 Schwerin, Germany. heike.benes@somnibene.de

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16194624

Citation

Benes, Heike. "Transdermal Lisuride: Short-term Efficacy and Tolerability Study in Patients With Severe Restless Legs Syndrome." Sleep Medicine, vol. 7, no. 1, 2006, pp. 31-5.
Benes H. Transdermal lisuride: short-term efficacy and tolerability study in patients with severe restless legs syndrome. Sleep Med. 2006;7(1):31-5.
Benes, H. (2006). Transdermal lisuride: short-term efficacy and tolerability study in patients with severe restless legs syndrome. Sleep Medicine, 7(1), 31-5.
Benes H. Transdermal Lisuride: Short-term Efficacy and Tolerability Study in Patients With Severe Restless Legs Syndrome. Sleep Med. 2006;7(1):31-5. PubMed PMID: 16194624.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Transdermal lisuride: short-term efficacy and tolerability study in patients with severe restless legs syndrome. A1 - Benes,Heike, Y1 - 2005/09/27/ PY - 2005/01/18/received PY - 2005/05/06/revised PY - 2005/05/17/accepted PY - 2005/10/1/pubmed PY - 2006/6/6/medline PY - 2005/10/1/entrez SP - 31 EP - 5 JF - Sleep medicine JO - Sleep Med. VL - 7 IS - 1 N2 - BACKGROUND AND PURPOSE: Restless legs syndrome (RLS) patients suffer from symptoms not only at bedtime but also with variable circadian patterns. Transdermal application forms of dopamine agonists are expected to lead to a stable plasma concentration of the active drug which could ease treatment for RLS patients with daytime symptoms and avoid side effects of oral dopaminergic therapies. PATIENTS AND METHODS: In this controlled pilot study, 10 patients (six females, four males, mean age 58 years) with severe and long-lasting idiopathic RLS were treated during an initial open-label phase for 2 weeks either with one (n=3 patients) or, if required, two patches of lisuride every other day (dose per patch: 3mg lisuride, nominal effective release rate 7.0 microg lisuride/h). Patients were then randomized to double-blind treatment with lisuride (n=5) or placebo (n=4) for 1 week. RESULTS: Severity of RLS clearly improved during open-label and double-blind treatment with lisuride but became worse under placebo according to the International Restless Legs Syndrome Study Group Rating Scale (IRLS), RLS-6, and Clinical Global Impressions (CGIs) scales, and actigraphy assessments (periodic leg movement index) in the 1-week double-blind period. CONCLUSION: The explorative findings of this small controlled study suggest that lisuride patches might be an efficacious treatment for RLS patients without clinically relevant tolerability problems. SN - 1389-9457 UR - https://www.unboundmedicine.com/medline/citation/16194624/Transdermal_lisuride:_short_term_efficacy_and_tolerability_study_in_patients_with_severe_restless_legs_syndrome_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(05)00111-5 DB - PRIME DP - Unbound Medicine ER -