TY - JOUR
T1 - Progressive development of augmentation during long-term treatment with levodopa in restless legs syndrome
T2 - Results of a prospective multi-center study
AU - Högl, Birgit
AU - García-Borreguero, Diego
AU - Kohnen, Ralf
AU - Ferini-Strambi, Luigi
AU - Hadjigeorgiou, Georgios
AU - Hornyak, Magdolna
AU - De Weerd, Al
AU - Happe, Svenja
AU - Stiasny-Kolster, Karin
AU - Gschliesser, Viola
AU - Egatz, Renata
AU - Frauscher, Birgit
AU - Benes, Heike
AU - Trenkwalder, Claudia
AU - Hening, Wayne A.
AU - Allen, Richard P.
N1 - Funding Information:
This study was supported by an unrestricted educational grant from Pharmacia (now Pfizer) USA to Diego García-Borreguero which was used for compensation of travel expenses for a planning meeting. Development of the study protocol and the case record forms, study management, statistical analysis and reporting was provided on a non-profit basis by RPS Germany (Ralf Kohnen).
PY - 2010/2
Y1 - 2010/2
N2 - The European Restless Legs Syndrome (RLS) Study Group performed the first multi-center, long-term study systematically evaluating RLS augmentation under levodopa treatment. This prospective, open-label 6-month study was conducted in six European countries and included 65 patients (85% treatment naive) with idiopathic RLS. Levodopa was flexibly up-titrated to a maximum dose of 600 mg/day. Presence of augmentation was diagnosed independently by two international experts using established criteria. In addition to the augmentation severity rating scale (ASRS), changes in RLS severity (International RLS severity rating scale (IRLS), clinical global impression (CGI)) were analyzed. Sixty patients provided evaluable data, 35 completed the trial and 25 dropped out. Augmentation occurred in 60% (36/60) of patients, causing 11.7% (7/60) to drop out. Median time to occurrence of augmentation was 71 days. The mean maximum dose of levodopa was 311 mg/day (SD: 105). Patients with augmentation compared to those without were significantly more likely to be on higher doses of levodopa (≥300 mg, 83 vs. 54%, P = 0.03) and to show less improvement of symptom severity (IRLS, P = 0.039). Augmentation was common with levodopa, but could be tolerated by most patients during this 6-month trial. Patients should be followed over longer periods to determine if dropout rates increase with time.
AB - The European Restless Legs Syndrome (RLS) Study Group performed the first multi-center, long-term study systematically evaluating RLS augmentation under levodopa treatment. This prospective, open-label 6-month study was conducted in six European countries and included 65 patients (85% treatment naive) with idiopathic RLS. Levodopa was flexibly up-titrated to a maximum dose of 600 mg/day. Presence of augmentation was diagnosed independently by two international experts using established criteria. In addition to the augmentation severity rating scale (ASRS), changes in RLS severity (International RLS severity rating scale (IRLS), clinical global impression (CGI)) were analyzed. Sixty patients provided evaluable data, 35 completed the trial and 25 dropped out. Augmentation occurred in 60% (36/60) of patients, causing 11.7% (7/60) to drop out. Median time to occurrence of augmentation was 71 days. The mean maximum dose of levodopa was 311 mg/day (SD: 105). Patients with augmentation compared to those without were significantly more likely to be on higher doses of levodopa (≥300 mg, 83 vs. 54%, P = 0.03) and to show less improvement of symptom severity (IRLS, P = 0.039). Augmentation was common with levodopa, but could be tolerated by most patients during this 6-month trial. Patients should be followed over longer periods to determine if dropout rates increase with time.
KW - Augmentation
KW - Clinical study
KW - Diagnosis
KW - Rating scale
KW - Restless legs syndrome (RLS)
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U2 - 10.1007/s00415-009-5299-8
DO - 10.1007/s00415-009-5299-8
M3 - Article
C2 - 19756826
AN - SCOPUS:77749340689
VL - 257
SP - 230
EP - 237
JO - Deutsche Zeitschrift fur Nervenheilkunde
JF - Deutsche Zeitschrift fur Nervenheilkunde
SN - 0340-5354
IS - 2
ER -