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T-L-104 SAFETY AND EFFICACY OF LONG-TERM TREATMENT WITH ROTIGOTINE IN JAPANESE PATIENTS WITH RESTLESS LEGS SYNDROME
S86
Abstracts of 4th International Congress of WASM & 5th Conference of CSS / Sleep Medicine 12, Suppl. 1 (2011) S1–S130
sue from KPS; and to posit that the RLS symptoms are generated in the peripheral sensorial nervous system. Acknowledgements: We are much indebted to Dr Arthur S. Walters, Professor of Neurology Vanderbilt School of Medicine, Nashville, Tennesee, USA, for helpful criticism of the manuscript and kind attention.
T-L-103
RESTLESS LEGS SYNDROME: THE RESPONSE OF RLS TO COMPREHENSIVE VARICOSE VEIN CARE
Jeffrey Gibson, J. Theodore King. Vein Clinics of America, United States Introduction and Objectives: Restless Legs Syndrome (RLS) is a progressive disorder of uncomfortable sensations in the legs that leads to unwanted motor restlessness. Recent research has suggested a correlation between RLS and chronic venous disorders (CVD). The purpose of this study is to determine the effect that comprehensive vein treatment has in relieving RLS symptoms in those patients who have both RLS and CVD. Materials and Methods: This study is a case series report of a physician’s detailed account of 54 consecutive patients (mean age: 46±13 years) who presented to a specialty phlebology practice with CVD (CEAP C1 to C5) and who also had RLS conforming to the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria. The IRLSSG Rating Scale (RLSRS) ten question survey instrument (score: 0-40) was administered to each patient prior to treatment. Each patient was treated with sclerotherapy, with or without endovenous laser treatment, according to the presentation of their CVD. Each patient’s RLS symptoms were subsequently re-evaluated at predetermined intervals within their treatment course, using the RLSRS survey instrument. The study end points were defined as complete RLS symptom relief (score = 0) or completion of vein treatment protocol, whichever came first. No patients were prescribed any other pharmacologic intervention for their RLS. Results: Fifty patients completed the study. Four patients did not complete the study and/or their treatment and were lost to follow-up. The mean RLSRS baseline score was 22±6 (range: 9–36). Forty-eight of the 50 patients (96%) experienced complete relief of their restless legs symptoms (RLSRS = 0, p<0.001). The mean RLSRS score at the end of the study was 0.5±1 (p<0.01). Two patients (4%) experienced significant but incomplete relief. Conclusion: While the pathology of RLS is unclear, treating a patient’s concomitant chronic venous insufficiency provided them with complete or significant relief of their RLS symptoms. Patients having RLS should be evaluated for concomitant CVD and appropriately treated. Acknowledgements: JS Gibson, JT King, RC Guptan, Vein Clinics of America and Venous Research Foundation, IL, USA
T-L-104
SAFETY AND EFFICACY OF LONG-TERM TREATMENT WITH ROTIGOTINE IN JAPANESE PATIENTS WITH RESTLESS LEGS SYNDROME
Yuichi Inoue 1 , Koichi Hirata 2 , Kenichi Hayashida 3 , Diego García-Borreguero 4, Nobutaka Hattori 5 . 1 Department of Somnology, Tokyo Medical University, Japan; 2 Department of Neurology, Dokkyo Medical University, Japan; 3 Sleep & Stress Clinic, Japan; 4 Sleep Research Institute, Spain; 5 Department of Neurology, Juntendo University School of Medicine, Japan Introduction and Objectives: The aims of this trial were to assess safety and efficacy of long-term treatment with rotigotine transdermal patch in patients with restless legs syndrome (RLS), and to investigate incidence of clinically significant persistent augmentation, the most problematic complication of dopaminergic treatment. Materials and Methods: This open-label extension trial consisted of 6-week dose-titration and 48-week dose-maintenance period. Rotigotine was administered to 185 patients enrolled from the preceding double-blind phase 2b trial. The dosage was initiated from 1 mg/24h with a weekly optimal titration up to 3 mg/24h, and dose adjustment was not permitted after optimal dose was determined. Efficacy was evaluated with the severity scale (IRLS) developed by the International Restless Legs Syndrome Study Group. Augmentation was diagnosed retrospectively based on the Max Plank Institute criteria by expert panels. Clinical significance of augmentation was evaluated from clinical course as assessed by IRLS, Augmentation Severity Rating Scale (ASRS) and SF-36 scores. Results: 133 patients (72%) completed and 52 patients (28%) prematurely
discontinued the trial. Change of IRLS total score from the baseline in the phase 2b trial to the end of treatment was -15.4, and 134 patients (73%) were judged as treatment responder (50% or more of IRLS reduction from the baseline). The clinically significant persistent augmentation was observed in 5 patients (2.7%). The first episode of augmentation occurred between Week 16 and Week 24 in these patients. Doses at the onset of episode were 3 mg/24h (4 patients) and 1 mg/24h (1 patient). The other common adverse events in this trial were application site reaction (52.4%), nausea (28.6%), somnolence (15.7%) and headache (13.5%). Conclusion: Long-term treatment with rotigotine improved RLS symptoms in Japanese patients with RLS, with an acceptable safety profile.
T-L-105
STUDY OF RESTLESS LEG SYNDROME IN RUNNERS
Sayonara Beatriz Ranciaro Fagundes, Derlei João Leite Fagundes, Andre L.L. Bachi, Lucila Bizari Fernandes Prado, João Eduardo Coin Carvalho, Luciane Bizari Coin Carvalho, Mauro Vaisberg, Gilmar Fernandes Prado. UNIFESP, Brazil Introduction and Objectives: Long distance running is emerging as a popular sport in Western industrialized countries. It also has beneficial effects such as preventing diabetes, obesityand cardiovascular disease,but it does have adverse effects such as cramping and gastrointestinal bleeding. Objective The purpose of this study was to determine the relationship between Restless Legs Syndrome (RLS) and hematological-biochemical parameters in marathon runners; to estimate the prevalence of RLS in runners and if was associated with alterations in serum biochemical parameters. Materials and Methods: We investigated the biochemical pre race, immediate and post 72 hour in 73 recreational runners participating in 3 marathons (42.195Km) (São Paulo, Porto Alegre and Florianopolis), who finished the race. We excluded 7 (3 m hypertensive, 1 m and 2 f with hypertension and diabetics and 1 m refused to participate). We compared with presence or no of restless leg syndrome. Iron deficiency was defined as a plasma ferritin (PF) concentration <15μmol/l (iron depletion). Results: RLS was found in 22.45% of runners who finished the marathon in less than 4 h. There were 1.5% of runners had iron <50 mcg/dl and the remaining had normal values, (mean basal = 97.12 (SD 35.79) pos = 109.62 (SD 34.15) 72h = 86.70 (SD 26.83) and 1.5% had ferritin concentration <15 mcg/dl (mean basal = 119.64 (SD 79.41) Pos = 148.18 (SD 89.72) 72h = 139.41 (SD 87.58) in the group with RLS. The marathon runners loss iron during the race, but maintain normal values. The mucoprotein was abnormal in 27.27% in runners without RSL and in 12.12% with RLS. Conclusion: The incidence of RLS in marathon runners is higher than expected for the Brazilian general population and it is not linked to iron depletion. This sample related worsening of symptoms after long aerobic work. The relationship of long aerobic effort and RLS was demonstrated. Further studies would be necessary to better understand mechanism of RLS Acknowledgements: The authors gratefully acknowledge the athletes for their patience as well as Gianni M.S. dos Santos for help with statistic analysis and FAPESP who sponsor these study.
T-L-106
THALAMIC MR SPECTROSCOPY EVALUATION OF RESTLESS LEGS SYNDROME
Richard Allen, Peter Barker, Alena Horskå, Christopher Earley. Johns Hopkins University, United States Introduction and Objectives: Evaluate thalamic neurochemistry of restless legs syndrome (RLS) in relation to controls and polysomnographic (PSG) sleep. RLS produces a profound increased arousal (hyperarousal) with both significant wake during sleep times and wakefulness reducing expected daytime sleepiness. Dopamine treatments reduce periodic limb movements in sleep (PLMS) and RLS sensory symptoms but fail to correct sleep loss. A non-dopaminergic abnormality may contribute to RLS sleep problems. Materials and Methods: Thalamic MR spectroscopy glutamate and glutamine (Glx) measures relative to creatine (Cr) were obtained in 28 primary RLS patients off RLS medications, and 20 matched controls. Most had two nights of polysomnography. We hypothesized Glx/Cr would be greater for RLS patients and would correlate with wake time during sleep Results: RLS vs. controls did not differ for Cr but showed significantly increased Glx/Cr for RLS (t=2.2, p=0.008). The Glx/Cr correlated significantly with wake during sleep (r=0.61, p=0.007) and with all sleep variables that
Abstracts of 4th International Congress of WASM & 5th Conference of CSS / Sleep Medicine 12, Suppl. 1 (2011) S1–S130
sue from KPS; and to posit that the RLS symptoms are generated in the peripheral sensorial nervous system. Acknowledgements: We are much indebted to Dr Arthur S. Walters, Professor of Neurology Vanderbilt School of Medicine, Nashville, Tennesee, USA, for helpful criticism of the manuscript and kind attention.
T-L-103
RESTLESS LEGS SYNDROME: THE RESPONSE OF RLS TO COMPREHENSIVE VARICOSE VEIN CARE
Jeffrey Gibson, J. Theodore King. Vein Clinics of America, United States Introduction and Objectives: Restless Legs Syndrome (RLS) is a progressive disorder of uncomfortable sensations in the legs that leads to unwanted motor restlessness. Recent research has suggested a correlation between RLS and chronic venous disorders (CVD). The purpose of this study is to determine the effect that comprehensive vein treatment has in relieving RLS symptoms in those patients who have both RLS and CVD. Materials and Methods: This study is a case series report of a physician’s detailed account of 54 consecutive patients (mean age: 46±13 years) who presented to a specialty phlebology practice with CVD (CEAP C1 to C5) and who also had RLS conforming to the International Restless Legs Syndrome Study Group (IRLSSG) diagnostic criteria. The IRLSSG Rating Scale (RLSRS) ten question survey instrument (score: 0-40) was administered to each patient prior to treatment. Each patient was treated with sclerotherapy, with or without endovenous laser treatment, according to the presentation of their CVD. Each patient’s RLS symptoms were subsequently re-evaluated at predetermined intervals within their treatment course, using the RLSRS survey instrument. The study end points were defined as complete RLS symptom relief (score = 0) or completion of vein treatment protocol, whichever came first. No patients were prescribed any other pharmacologic intervention for their RLS. Results: Fifty patients completed the study. Four patients did not complete the study and/or their treatment and were lost to follow-up. The mean RLSRS baseline score was 22±6 (range: 9–36). Forty-eight of the 50 patients (96%) experienced complete relief of their restless legs symptoms (RLSRS = 0, p<0.001). The mean RLSRS score at the end of the study was 0.5±1 (p<0.01). Two patients (4%) experienced significant but incomplete relief. Conclusion: While the pathology of RLS is unclear, treating a patient’s concomitant chronic venous insufficiency provided them with complete or significant relief of their RLS symptoms. Patients having RLS should be evaluated for concomitant CVD and appropriately treated. Acknowledgements: JS Gibson, JT King, RC Guptan, Vein Clinics of America and Venous Research Foundation, IL, USA
T-L-104
SAFETY AND EFFICACY OF LONG-TERM TREATMENT WITH ROTIGOTINE IN JAPANESE PATIENTS WITH RESTLESS LEGS SYNDROME
Yuichi Inoue 1 , Koichi Hirata 2 , Kenichi Hayashida 3 , Diego García-Borreguero 4, Nobutaka Hattori 5 . 1 Department of Somnology, Tokyo Medical University, Japan; 2 Department of Neurology, Dokkyo Medical University, Japan; 3 Sleep & Stress Clinic, Japan; 4 Sleep Research Institute, Spain; 5 Department of Neurology, Juntendo University School of Medicine, Japan Introduction and Objectives: The aims of this trial were to assess safety and efficacy of long-term treatment with rotigotine transdermal patch in patients with restless legs syndrome (RLS), and to investigate incidence of clinically significant persistent augmentation, the most problematic complication of dopaminergic treatment. Materials and Methods: This open-label extension trial consisted of 6-week dose-titration and 48-week dose-maintenance period. Rotigotine was administered to 185 patients enrolled from the preceding double-blind phase 2b trial. The dosage was initiated from 1 mg/24h with a weekly optimal titration up to 3 mg/24h, and dose adjustment was not permitted after optimal dose was determined. Efficacy was evaluated with the severity scale (IRLS) developed by the International Restless Legs Syndrome Study Group. Augmentation was diagnosed retrospectively based on the Max Plank Institute criteria by expert panels. Clinical significance of augmentation was evaluated from clinical course as assessed by IRLS, Augmentation Severity Rating Scale (ASRS) and SF-36 scores. Results: 133 patients (72%) completed and 52 patients (28%) prematurely
discontinued the trial. Change of IRLS total score from the baseline in the phase 2b trial to the end of treatment was -15.4, and 134 patients (73%) were judged as treatment responder (50% or more of IRLS reduction from the baseline). The clinically significant persistent augmentation was observed in 5 patients (2.7%). The first episode of augmentation occurred between Week 16 and Week 24 in these patients. Doses at the onset of episode were 3 mg/24h (4 patients) and 1 mg/24h (1 patient). The other common adverse events in this trial were application site reaction (52.4%), nausea (28.6%), somnolence (15.7%) and headache (13.5%). Conclusion: Long-term treatment with rotigotine improved RLS symptoms in Japanese patients with RLS, with an acceptable safety profile.
T-L-105
STUDY OF RESTLESS LEG SYNDROME IN RUNNERS
Sayonara Beatriz Ranciaro Fagundes, Derlei João Leite Fagundes, Andre L.L. Bachi, Lucila Bizari Fernandes Prado, João Eduardo Coin Carvalho, Luciane Bizari Coin Carvalho, Mauro Vaisberg, Gilmar Fernandes Prado. UNIFESP, Brazil Introduction and Objectives: Long distance running is emerging as a popular sport in Western industrialized countries. It also has beneficial effects such as preventing diabetes, obesityand cardiovascular disease,but it does have adverse effects such as cramping and gastrointestinal bleeding. Objective The purpose of this study was to determine the relationship between Restless Legs Syndrome (RLS) and hematological-biochemical parameters in marathon runners; to estimate the prevalence of RLS in runners and if was associated with alterations in serum biochemical parameters. Materials and Methods: We investigated the biochemical pre race, immediate and post 72 hour in 73 recreational runners participating in 3 marathons (42.195Km) (São Paulo, Porto Alegre and Florianopolis), who finished the race. We excluded 7 (3 m hypertensive, 1 m and 2 f with hypertension and diabetics and 1 m refused to participate). We compared with presence or no of restless leg syndrome. Iron deficiency was defined as a plasma ferritin (PF) concentration <15μmol/l (iron depletion). Results: RLS was found in 22.45% of runners who finished the marathon in less than 4 h. There were 1.5% of runners had iron <50 mcg/dl and the remaining had normal values, (mean basal = 97.12 (SD 35.79) pos = 109.62 (SD 34.15) 72h = 86.70 (SD 26.83) and 1.5% had ferritin concentration <15 mcg/dl (mean basal = 119.64 (SD 79.41) Pos = 148.18 (SD 89.72) 72h = 139.41 (SD 87.58) in the group with RLS. The marathon runners loss iron during the race, but maintain normal values. The mucoprotein was abnormal in 27.27% in runners without RSL and in 12.12% with RLS. Conclusion: The incidence of RLS in marathon runners is higher than expected for the Brazilian general population and it is not linked to iron depletion. This sample related worsening of symptoms after long aerobic work. The relationship of long aerobic effort and RLS was demonstrated. Further studies would be necessary to better understand mechanism of RLS Acknowledgements: The authors gratefully acknowledge the athletes for their patience as well as Gianni M.S. dos Santos for help with statistic analysis and FAPESP who sponsor these study.
T-L-106
THALAMIC MR SPECTROSCOPY EVALUATION OF RESTLESS LEGS SYNDROME
Richard Allen, Peter Barker, Alena Horskå, Christopher Earley. Johns Hopkins University, United States Introduction and Objectives: Evaluate thalamic neurochemistry of restless legs syndrome (RLS) in relation to controls and polysomnographic (PSG) sleep. RLS produces a profound increased arousal (hyperarousal) with both significant wake during sleep times and wakefulness reducing expected daytime sleepiness. Dopamine treatments reduce periodic limb movements in sleep (PLMS) and RLS sensory symptoms but fail to correct sleep loss. A non-dopaminergic abnormality may contribute to RLS sleep problems. Materials and Methods: Thalamic MR spectroscopy glutamate and glutamine (Glx) measures relative to creatine (Cr) were obtained in 28 primary RLS patients off RLS medications, and 20 matched controls. Most had two nights of polysomnography. We hypothesized Glx/Cr would be greater for RLS patients and would correlate with wake time during sleep Results: RLS vs. controls did not differ for Cr but showed significantly increased Glx/Cr for RLS (t=2.2, p=0.008). The Glx/Cr correlated significantly with wake during sleep (r=0.61, p=0.007) and with all sleep variables that