PMID- 23256574 OWN - NLM STAT- MEDLINE DCOM- 20130620 LR - 20171116 IS - 1744-7666 (Electronic) IS - 1465-6566 (Linking) VI - 14 IP - 1 DP - 2013 Jan TI - 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. PG - 15-25 LID - 10.1517/14656566.2013.758251 [doi] AB - 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. FAU - Dohin, Elisabeth AU - Dohin E AD - UCB Pharma, Movement and Sleep Disorders, Allee de la Recherche 60, 1070 Brussels, Belgium. elisabeth.dohin@ucb.com FAU - Hogl, Birgit AU - Hogl B FAU - Ferini-Strambi, Luigi AU - Ferini-Strambi L FAU - Schollmayer, Erwin AU - Schollmayer E FAU - Fichtner, Andreas AU - Fichtner A FAU - Bauer, Lars AU - Bauer L FAU - Garcia-Borreguero, Diego AU - Garcia-Borreguero D LA - eng SI - ClinicalTrials.gov/NCT00498186 PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20121221 PL - England TA - Expert Opin Pharmacother JT - Expert opinion on pharmacotherapy JID - 100897346 RN - 0 (Dopamine Agonists) RN - 0 (Tetrahydronaphthalenes) RN - 0 (Thiophenes) RN - 87T4T8BO2E (rotigotine) SB - IM MH - Administration, Cutaneous MH - Adult MH - Aged MH - Dopamine Agonists/adverse effects/*therapeutic use MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Female MH - Humans MH - International Cooperation MH - Male MH - Middle Aged MH - Prospective Studies MH - Restless Legs Syndrome/diagnosis/*drug therapy/physiopathology MH - Severity of Illness Index MH - Tetrahydronaphthalenes/adverse effects/*therapeutic use MH - Thiophenes/adverse effects/*therapeutic use MH - *Transdermal Patch MH - Treatment Outcome EDAT- 2012/12/22 06:00 MHDA- 2013/06/21 06:00 CRDT- 2012/12/22 06:00 PHST- 2012/12/22 06:00 [entrez] PHST- 2012/12/22 06:00 [pubmed] PHST- 2013/06/21 06:00 [medline] AID - 10.1517/14656566.2013.758251 [doi] PST - ppublish SO - Expert Opin Pharmacother. 2013 Jan;14(1):15-25. doi: 10.1517/14656566.2013.758251. Epub 2012 Dec 21.