TY - JOUR
T1 - Augmentation in the treatment of restless legs syndrome with transdermal rotigotine
AU - Beneš, Heike
AU - García-Borreguero, Diego
AU - Ferini-Strambi, Luigi
AU - Schollmayer, Erwin
AU - Fichtner, Andreas
AU - Kohnen, Ralf
PY - 2012/6
Y1 - 2012/6
N2 - Objective: To assess the risk of augmentation under treatment with the transdermally delivered dopamine agonist rotigotine for restless legs syndrome (RLS). Methods: Experts in RLS augmentation retrospectively reviewed data from two double-blind, placebo-controlled 6-month trials (745 rotigotine and 214 placebo subjects, NCT00136045 and NCT00135993) and from two open-label 1-year trials (620 rotigotine subjects, NCT00498108 and NCT00263068). All study visits were systematically evaluated applying the Max Planck Institute (MPI) criteria for the diagnosis of both augmentation and clinically relevant augmentation. Results: MPI criteria for augmentation were met on at least one visit by 8.2% of all subjects in the double-blind trials with 12 subjects meeting the criteria for clinically relevant augmentation: 11 under rotigotine (1.5%) and one under placebo treatment. In the open-label trials, 9.7% of all subjects met the MPI criteria for augmentation and 2.9% met the criteria for clinically relevant augmentation. None of the patients treated with rotigotine for up to 1.5. years (double-blind plus open-label trial) discontinued prematurely owing to augmentation. Neither could dose-dependency or a time pattern for clinically relevant augmentation episodes be detected. Conclusions: Our analyses suggest that the risk for clinically relevant augmentation for the duration of up to 18. months of rotigotine treatment is low.
AB - Objective: To assess the risk of augmentation under treatment with the transdermally delivered dopamine agonist rotigotine for restless legs syndrome (RLS). Methods: Experts in RLS augmentation retrospectively reviewed data from two double-blind, placebo-controlled 6-month trials (745 rotigotine and 214 placebo subjects, NCT00136045 and NCT00135993) and from two open-label 1-year trials (620 rotigotine subjects, NCT00498108 and NCT00263068). All study visits were systematically evaluated applying the Max Planck Institute (MPI) criteria for the diagnosis of both augmentation and clinically relevant augmentation. Results: MPI criteria for augmentation were met on at least one visit by 8.2% of all subjects in the double-blind trials with 12 subjects meeting the criteria for clinically relevant augmentation: 11 under rotigotine (1.5%) and one under placebo treatment. In the open-label trials, 9.7% of all subjects met the MPI criteria for augmentation and 2.9% met the criteria for clinically relevant augmentation. None of the patients treated with rotigotine for up to 1.5. years (double-blind plus open-label trial) discontinued prematurely owing to augmentation. Neither could dose-dependency or a time pattern for clinically relevant augmentation episodes be detected. Conclusions: Our analyses suggest that the risk for clinically relevant augmentation for the duration of up to 18. months of rotigotine treatment is low.
KW - Augmentation
KW - Dopamine agonist
KW - Loss of efficacy
KW - Restless legs syndrome
KW - Rotigotine
KW - Transdermal delivery
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U2 - 10.1016/j.sleep.2011.09.016
DO - 10.1016/j.sleep.2011.09.016
M3 - Article
C2 - 22503658
AN - SCOPUS:84861933926
VL - 13
SP - 589
EP - 597
JO - Sleep Medicine
JF - Sleep Medicine
SN - 1389-9457
IS - 6
ER -