Safety and efficacy of rotigotine transdermal patch in patients with restless legs syndrome: a post-hoc analysis of patients taking 1 - 3 mg/24 h for up to 5 years.

Abstract

OBJECTIVE:

This post-hoc analysis of a prospective open-label study investigated patients with restless legs syndrome (RLS) taking approved dosages (1, 2 or 3 mg/24 h) of rotigotine transdermal patch for up to 5 years.

RESEARCH DESIGN AND METHODS:

Following 6 weeks' double-blind treatment, patients with moderate-to-severe RLS received open-label rotigotine titrated to optimal dosage.

MAIN OUTCOME MEASURES:

Safety was assessed by adverse events (AEs) and efficacy was assessed by the International Restless Legs Syndrome Study Group Rating Scale (IRLS).

RESULTS:

Of 295 patients who entered the open-label study, 198 (67%) began the maintenance period taking rotigotine dosages of 1 - 3 mg/24 h, or increased their dosage from 0.5 mg in the first 3 months of the maintenance period. Of the 198 patients, 45 patients (23%) completed 5 years of follow-up within this dosage range, 79 patients (40%) had their dosage adjusted outside this range during follow-up and 74 patients (37%) withdrew (including 49 [25%] due to AEs and 6 [3%)] for lack of efficacy). Application site reactions were the most common AEs (102 of 198 patients [52%]), with an incidence of 35% (69 of 198) in year 1, 19% (19 of 102) in year 2, and 4 - 6% during each of years 3 - 5. Mean IRLS total score decreased from 27.1 ± 6.0 at double-blind baseline to 6.5 ± 6.5 at the beginning of maintenance, and to 7.4 ± 8.4 after 5 years' treatment on 1 - 3 mg/24 h (n = 45); 21 patients (47%) were classified as symptom-free (IRLS = 0).

CONCLUSIONS:

Consistent with the results for the overall population, rotigotine transdermal patch at approved dosages of 1 - 3 mg/24 h was generally well tolerated after the first year, with sustained efficacy in patients who completed 5 years of treatment at dosages of 1 - 3 mg/24 h.

• Authors: Elisabeth Dohin, Birgit Högl, Luigi Ferini-Strambi, Erwin Schollmayer, Andreas Fichtner, Lars Bauer, Diego García-Borreguero
• Journal: Expert opinion on pharmacotherapy (Expert Opin Pharmacother) Vol. 14 Issue 1 Pg. 15-25 (Jan 2013) ISSN: 1744-7666 [Electronic] England
• PMID: 23256574 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Dopamine Agonists
• Tetrahydronaphthalenes
• Thiophenes
• rotigotine

Topics

• Administration, Cutaneous
• Adult
• Aged
• Dopamine Agonists (adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• International Cooperation
• Male
• Middle Aged
• Prospective Studies
• Restless Legs Syndrome (diagnosis, drug therapy, physiopathology)
• Severity of Illness Index
• Tetrahydronaphthalenes (adverse effects, therapeutic use)
• Thiophenes (adverse effects, therapeutic use)
• Transdermal Patch
• Treatment Outcome