One-year treatment with standard and sustained-release levodopa: Appropriate long-term treatment of restless legs syndrome?

✍ Scribed by Claudia Trenkwalder; Victor Collado Seidel; Jörg Kazenwadel; Thomas C. Wetter; Wolfgang Oertel; Roland Selzer; Ralf Kohnen

• Publisher: John Wiley and Sons
• Year: 2003
• Tongue: English
• Weight: 71 KB
• Volume: 18
• Category: Article
• ISSN: 0885-3185
• DOI: 10.1002/mds.10503

✦ Synopsis

Abstract

To investigate the long‐term efficacy and safety of sustained‐release (SR) in combination with regular‐release (RR) levodopa/benserazide in the treatment of restless legs syndrome (RLS), an open‐label, prospective, extension study of a preceding double‐blind crossover trial was performed for 12 months. Twenty‐three severely disturbed RLS patients (7 men, 16 women) received a combination of RR and SR levodopa. Patients were treated on average for 10 months with a mean daily dose of 203 ± 101 mg of RR and of 185 ± 93 mg of SR levodopa. The mean daily total dose was 388 ± 162 mg levodopa. Efficacy was documented using patient's rating scales, sleep diaries, and investigator's global ratings with the Clinical Global Impressions (CGI). Ten of 23 patients completed the 1‐year extension. Between baseline of the crossover trial and endpoint of the extension study (last‐observation‐carried‐forward method, intention‐to‐treat population), quality of sleep improved (+3.5 ± 1.9, 7‐point scale), sleep latency was shortened (−131 ± 152 minutes), and total sleep time lengthened (+ 190 ± 136 minutes). Severity of RLS at time of falling asleep (−6.5 ± 3.4, 11‐point scale) and during the night (−6.0 ± 3.5) was markedly lower at the end of the extension but severity of RLS during the day (+1.9 ± 5.0) slightly increased. Of 13 dropouts, 8 patients discontinued therapy because of worsening RLS during the day. This trial shows that long‐term treatment with the combination of RR and SR levodopa/benserazide in RLS patients with late‐night problems was efficacious and not limited by tolerability problems in 40% of patients, whereas in the majority of patients, aggravating daytime problems required termination of the levodopa therapy within the 1‐year treatment period. © 2003 Movement Disorder Society