TY - JOUR
T1 - Safety and efficacy of rotigotine transdermal patch in patients with restless legs syndrome
T2 - A post-hoc analysis of patients taking 1-3 mg/24 h for up to 5 years
AU - Dohin, Elisabeth
AU - Högl, Birgit
AU - Ferini-Strambi, Luigi
AU - Schollmayer, Erwin
AU - Fichtner, Andreas
AU - Bauer, Lars
AU - García-Borreguero, Diego
PY - 2013/1
Y1 - 2013/1
N2 - 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.
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.
KW - Dopamine receptor agonists
KW - Restless legs syndrome
KW - Transdermal patch
UR - http://www.scopus.com/inward/record.url?scp=84871558778&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84871558778&partnerID=8YFLogxK
U2 - 10.1517/14656566.2013.758251
DO - 10.1517/14656566.2013.758251
M3 - Article
C2 - 23256574
AN - SCOPUS:84871558778
VL - 14
SP - 15
EP - 25
JO - Expert Opinion on Pharmacotherapy
JF - Expert Opinion on Pharmacotherapy
SN - 1465-6566
IS - 1
ER -