096 TEN-YEAR FOLLOW-UP EVALUATION OF EFFICACY AND AUGMENTATION ON PRAMIPEXOLE AND METHADONE TREATMENT OF RESTLESS LEG SYNDROME

Abstract

s of 3rd International Congress of the Association of Sleep Medicine (WASM) / Sleep Medicine 10, Suppl. 2 (2009) S1–S83 S27 in patients with RLS in the examined population. These findings may suggest that RLS increases vascular risk. 096 TEN-YEAR FOLLOW-UP EVALUATION OF EFFICACY AND AUGMENTATION ON PRAMIPEXOLE AND METHADONE TREATMENT OF RESTLESS LEG SYNDROME N. Silver, R.P. Allen, C.J. Earley. Johns Hopkins Univ Introduction: The major limiting factor in the dopaminergic treatment of Restless Leg Syndrome (RLS) has been the development of augmentation with long-term treatment. Augmentation appears to be drug effect that depends on the dose and duration of treatment. It develops mostly after the first 12 weeks of treatment and apparently continues to increase throughout the first 23 years of treatment. There is no clear indication of a critical treatment duration at which it stops occurring. The controlled efficacy studies of the dopamine agonists never exceed one year. The assessment of augmentation risk requires longer studies. Objectives: To determine the rates of augmentation and the degree of continuing efficacy for RLS patients treatedwith pramipexole ormethadone over a 10-year period. Methods: All RLS patient medication records in a tertiary sleep medicine clinic from 1997-2007 were reviewed. The start and, where present, stopping date for the medication was noted along with the reason for stopping, given as “augmentation” or “other cause”. All records with at least one year of observation were included. Those still in active treatment were entered as “continuing on themedication”. Datawere analyzed for the rate of discontinuing and the rate of augmentation occurring for each year the patients were on treatment, i.e., number starting year x of treatment who during that year stopped. Results: 164 patients on pramipexole and 76 on methadone met the inclusion criteria. Discontinuing rates for the first year of treatment were 17% for pramipexole and 15% for methadone. For the subsequent 9 years discontinuing rates were stable at 9% (mean) per year for pramipexole and 0% for methadone. Continued efficacy over 5 years was 58% on pramipexole and 87% on methadone. Severe augmentation producing discontinuation occurred mainly after the first year, but also occurred every year thereafter for the next 9 years at a fairly constant average rate of 6% per year for pramipexole and 0% for methadone. Conclusion: For patients seen in a tertiary care setting, RLS augmentation leading to the termination of the medication appears to persist for at least 10 years for patients on pramipexole. There was no indication of a critical time point after which augmentation risk diminished. Methadone, in contrast, showed no augmentation after the first year of treatment. The tertiary care setting in this study may bias these results by including the more difficult cases. These results, nonetheless, suggest augmentation occurs over several years of dopaminergic treatment, significantly limiting the long-term benefits of this treatment. 097 INTRAINDIVIDUAL VARIABILITY OF REM SLEEP BEHAVIOR DISORDER IN PARKINSON’S DISEASE F. Sixel-Doring, B. Mollenhauer, C. Trenkwalder. Paracelsus-Elena-Klinik,