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P0037 Ropinirole treatment improves the symptoms of restless legs syndrome (RLS) within 2 nights of treatment
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2nd WASM World Congress, Bangkok, 4–8 February 2007 / Sleep Medicine 8 Suppl. 1 (2007) S69–S114
as definite RLS and 127 (2.5%) reported 3 diagnostic symptoms, as probable RLS. Four hundred fourteen respondents (8.3%) met the criteria for definite or probable RLS sufferers. The prevalence of RLS was generally approximately higher for women than men (6.8% vs. 4.7% for definite, 9.4% vs. 7.1% for definite plus probable). Fifties is the highest age group in definite RLS and definite or probable RLS sufferers. 57.5% of definite RLS sufferers and 73.2% of the probable RLS sufferers did not have any other related disorders, the primary RLS group. 49.5% of the 287 definite RLS sufferers have sleep disturbance and 43.0% of the definite and probable RLS suffers have sleep disturbance. Over all, 90.6% of the definite RLS group has the symptoms currently, but only 13.6% of the sufferers take medicine now. Conclusion: RLS is common and underdiagnosed in Korean. It also affects sleep considerably. These results are comparable to other countries’. P0035 The efficacy and safety of zolpidem over 12 months in patients with low back pain and chronic insomnia M. Korzh. Sytenko Research Institute, Kharkov, Ukraine Aims: A double-blind placebo-controlled study of zolpidem found significant, sustained improvement in sleep and daytime function. We investigated the treatment of chronic insomnia in patient with low back pain. Methods: Adults (24−61) with low back pain and insomnia who reported sleep duration <6.5 h/night or sleep latency >30 min/night were included. Patient-reported endpoints included sleep and daytime function. Safety and compliance were assessed at monthly clinic visits. The final double-blind month was used as the baseline for efficacy analyses of the open-label period. Results: Patients who were initially randomized to double-blind placebo and then switched to open-label zolpidem (n = 86) significantly reported the following: (1) decreased sleep latency, wake time after sleep onset, and number of awakenings; (2) increased total sleep time and sleep quality; and (3) improved ratings of daytime ability to function, alertness and sense of physical well-being compared to baseline (P 0.0001 all monthly endpoints). There was no evidence of tolerance on any measure in either group. These subjects sustained the double-blind treatment gains for all sleep and daytime parameters, with further significant improvement in a number of measures. Zolpidem was well tolerated in both groups; unpleasant taste was the only undesirable effect reported by >5% of patients. Conclusions: The significant improvements in sleep and daytime function were evident in those switched from double-blind placebo to 6 months of open-label zolpidem therapy and were sustained during the 6 months of open-label treatment for those receiving prior double-blind zolpidem. During 12 months of nightly treatment, zolpidem was well tolerated; tolerance was not observed. Contributed support: Sytenko Research Institute P0036 A case of obstructive sleep apnea syndrome caused by tortuous internal carotid artery S. Kimura. Department of Otorhinolaryngology, Onomichi Municipal Hospital, Japan Anomalies of carotid artery are rarely seen and there are relatively few reports about tortuosity of the carotid artery in the oropharynx. In this report, the first known case of sleep apnea caused by tortuous internal carotid artery (ICA) bulging and partially constricting the oropharyngeal space. A 67-year-old male was referred to our department with a history of loud snoring and apnea. The patient noted progressive daytime somnolence. Flexible fiberscopic laryngoscopy revealed a bulging of the right posterior wall of the oropharynx. A closer and longer inspection showed the pulsating bulge with normal overlying mucosa. An anomaly of the ICA was therefore considered. CT angiography was performed. Sigmoid tortuosity of the right ICA was clearly demonstrated at the tonsil level. No intravascular abnormality or stenosis was observed. Polysomnography demonstrated severe obstructive
sleep apnea syndrome (OSAS). The patient presented with an apnea– hypopnea index (AHI) of 38.6/h and arterial oxygen saturation as low as 77% during sleep. For OSAS, treatment with a nasal continuous positive airway pressure (CPAP) was successfully initiated and relieved obstructive events. Tortuosity can cause a throbbing or occasionally painful sensation, but is usually asymptomatic and is considered a relatively benign condition. No treatment is needed as long as the patient does not have a cerebrovascular ischemic sign, so this patient was told about the diagnosis and no treatment was given. There has been no cerebrovascular symptom for 19 months to date. When surgery of upper airway is performed in the treatment of OSAS, tortuous ICA may cause a fatal hemorrhage during surgical procedures such as tonsillectomy, adenotomy, and UPPP. Surgeons, especially otolaryngologists, must recognize this anomaly to avoid a serious complication and the patient should be made aware of their condition. P0037 Ropinirole treatment improves the symptoms of restless legs syndrome (RLS) within 2 nights of treatment D. Garcia-Borreguero1 , N.L. Earl2 . 1 Sleep Research Institute, Madrid, Spain, 2 GlaxoSmithKline, Research Triangle Park, NC, USA Purpose: RLS is a neurological disorder characterized by an irresistible urge to move the legs. Efficacy and tolerability of ropinirole, the only FDAapproved treatment for moderate-to-severe primary RLS, was evaluated in placebo-controlled clinical trials. Methods: Pooled data from three similarly designed 12-week trials (TREAT RLS 1, 2, and US) were analyzed. At baseline, patients with moderateto-severe primary RLS were randomized to receive ropinirole (n = 465), 0.25–4.0 mg/day, or placebo (n = 469), titrated as needed and tolerated, once daily 1−3 hours before bedtime. Mean change from baseline in International Restless Legs Scale (IRLS) total score (primary endpoint) and the proportion of patients classified as responders (much/very much improved) on the Clinical Global Impression–Improvement (CGI-I) scale were assessed. Results: The first post-baseline assessment was after 2 nights of treatment (Day 2 for TREAT RLS 1&2 and Day 3 for TREAT RLS US). Adjusted mean (2SE) improvements from baseline in IRLS total score for ropinirole vs placebo were as follows: Day 2 OC: −6.3 (0.8) vs −3.9 (0.8) (adjusted mean treatment difference [AMTD]: −2.4; p < 0.001); Day 3 OC: −6.9 (1.0) vs −4.7 (1.0) (AMTD: −2.2; p < 0.01); Week 12 LOCF: −11.9 (0.8) vs −8.7 (0.8) (AMTD: −3.2; p < 0.001). CGI-I responder rates for ropinirole vs placebo were as follows: Day 2 OC: 24% vs 9% (odds ratio [OR]: 3.0; p < 0.001); Day 3 OC: 36% vs 20% (OR: 2.2; p < 0.01); Week 12 LOCF: 63% vs 47% (OR: 2.0; p < 0.001). These ropinirole treatment benefits were maintained at each assessment through 12 weeks. Mean(SD) doses at last visit were 2.0(1.2) mg/day for ropinirole and 2.9(1.3) mg/day for placebo. Conclusion: Ropinirole treatment improves RLS symptoms within 2 nights of treatment. Reflections: The effects of ropinirole on RLS symptoms take place within a few days, allowing rapid relief to patients with moderate-to-severe primary RLS. Contributed support: Study supported by GlaxoSmithKline. Declaration of conflict of interest: Dr Garcia-Borreguero has received payment for consulting and honoraria for lectures from GSK and BI. Dr Earl is an employee of GSK. P0038 Ropinirole improves sensory and motor symptoms in patients with restless legs syndrome who experience periodic leg movements in sleep P.M. Becker1 , N.L. Earl2 . 1 Sleep Medicine Associates of Texas, Dallas, TX, USA, 2 GlaxoSmithKline, Research Triangle Park, NC, USA Purpose: Patients with Restless Legs Syndrome (RLS) often experience sleep disturbance, which may result from sensory and motor RLS symptoms such as periodic leg movements during sleep (PLMS). Ropinirole is FDAapproved for the treatment of moderate-to-severe primary RLS. In a pivotal study of ropinirole, quantitative measures of PLMS (by actigraphy) and subjective measures of RLS symptoms (International Restless Legs Scale
2nd WASM World Congress, Bangkok, 4–8 February 2007 / Sleep Medicine 8 Suppl. 1 (2007) S69–S114
as definite RLS and 127 (2.5%) reported 3 diagnostic symptoms, as probable RLS. Four hundred fourteen respondents (8.3%) met the criteria for definite or probable RLS sufferers. The prevalence of RLS was generally approximately higher for women than men (6.8% vs. 4.7% for definite, 9.4% vs. 7.1% for definite plus probable). Fifties is the highest age group in definite RLS and definite or probable RLS sufferers. 57.5% of definite RLS sufferers and 73.2% of the probable RLS sufferers did not have any other related disorders, the primary RLS group. 49.5% of the 287 definite RLS sufferers have sleep disturbance and 43.0% of the definite and probable RLS suffers have sleep disturbance. Over all, 90.6% of the definite RLS group has the symptoms currently, but only 13.6% of the sufferers take medicine now. Conclusion: RLS is common and underdiagnosed in Korean. It also affects sleep considerably. These results are comparable to other countries’. P0035 The efficacy and safety of zolpidem over 12 months in patients with low back pain and chronic insomnia M. Korzh. Sytenko Research Institute, Kharkov, Ukraine Aims: A double-blind placebo-controlled study of zolpidem found significant, sustained improvement in sleep and daytime function. We investigated the treatment of chronic insomnia in patient with low back pain. Methods: Adults (24−61) with low back pain and insomnia who reported sleep duration <6.5 h/night or sleep latency >30 min/night were included. Patient-reported endpoints included sleep and daytime function. Safety and compliance were assessed at monthly clinic visits. The final double-blind month was used as the baseline for efficacy analyses of the open-label period. Results: Patients who were initially randomized to double-blind placebo and then switched to open-label zolpidem (n = 86) significantly reported the following: (1) decreased sleep latency, wake time after sleep onset, and number of awakenings; (2) increased total sleep time and sleep quality; and (3) improved ratings of daytime ability to function, alertness and sense of physical well-being compared to baseline (P 0.0001 all monthly endpoints). There was no evidence of tolerance on any measure in either group. These subjects sustained the double-blind treatment gains for all sleep and daytime parameters, with further significant improvement in a number of measures. Zolpidem was well tolerated in both groups; unpleasant taste was the only undesirable effect reported by >5% of patients. Conclusions: The significant improvements in sleep and daytime function were evident in those switched from double-blind placebo to 6 months of open-label zolpidem therapy and were sustained during the 6 months of open-label treatment for those receiving prior double-blind zolpidem. During 12 months of nightly treatment, zolpidem was well tolerated; tolerance was not observed. Contributed support: Sytenko Research Institute P0036 A case of obstructive sleep apnea syndrome caused by tortuous internal carotid artery S. Kimura. Department of Otorhinolaryngology, Onomichi Municipal Hospital, Japan Anomalies of carotid artery are rarely seen and there are relatively few reports about tortuosity of the carotid artery in the oropharynx. In this report, the first known case of sleep apnea caused by tortuous internal carotid artery (ICA) bulging and partially constricting the oropharyngeal space. A 67-year-old male was referred to our department with a history of loud snoring and apnea. The patient noted progressive daytime somnolence. Flexible fiberscopic laryngoscopy revealed a bulging of the right posterior wall of the oropharynx. A closer and longer inspection showed the pulsating bulge with normal overlying mucosa. An anomaly of the ICA was therefore considered. CT angiography was performed. Sigmoid tortuosity of the right ICA was clearly demonstrated at the tonsil level. No intravascular abnormality or stenosis was observed. Polysomnography demonstrated severe obstructive
sleep apnea syndrome (OSAS). The patient presented with an apnea– hypopnea index (AHI) of 38.6/h and arterial oxygen saturation as low as 77% during sleep. For OSAS, treatment with a nasal continuous positive airway pressure (CPAP) was successfully initiated and relieved obstructive events. Tortuosity can cause a throbbing or occasionally painful sensation, but is usually asymptomatic and is considered a relatively benign condition. No treatment is needed as long as the patient does not have a cerebrovascular ischemic sign, so this patient was told about the diagnosis and no treatment was given. There has been no cerebrovascular symptom for 19 months to date. When surgery of upper airway is performed in the treatment of OSAS, tortuous ICA may cause a fatal hemorrhage during surgical procedures such as tonsillectomy, adenotomy, and UPPP. Surgeons, especially otolaryngologists, must recognize this anomaly to avoid a serious complication and the patient should be made aware of their condition. P0037 Ropinirole treatment improves the symptoms of restless legs syndrome (RLS) within 2 nights of treatment D. Garcia-Borreguero1 , N.L. Earl2 . 1 Sleep Research Institute, Madrid, Spain, 2 GlaxoSmithKline, Research Triangle Park, NC, USA Purpose: RLS is a neurological disorder characterized by an irresistible urge to move the legs. Efficacy and tolerability of ropinirole, the only FDAapproved treatment for moderate-to-severe primary RLS, was evaluated in placebo-controlled clinical trials. Methods: Pooled data from three similarly designed 12-week trials (TREAT RLS 1, 2, and US) were analyzed. At baseline, patients with moderateto-severe primary RLS were randomized to receive ropinirole (n = 465), 0.25–4.0 mg/day, or placebo (n = 469), titrated as needed and tolerated, once daily 1−3 hours before bedtime. Mean change from baseline in International Restless Legs Scale (IRLS) total score (primary endpoint) and the proportion of patients classified as responders (much/very much improved) on the Clinical Global Impression–Improvement (CGI-I) scale were assessed. Results: The first post-baseline assessment was after 2 nights of treatment (Day 2 for TREAT RLS 1&2 and Day 3 for TREAT RLS US). Adjusted mean (2SE) improvements from baseline in IRLS total score for ropinirole vs placebo were as follows: Day 2 OC: −6.3 (0.8) vs −3.9 (0.8) (adjusted mean treatment difference [AMTD]: −2.4; p < 0.001); Day 3 OC: −6.9 (1.0) vs −4.7 (1.0) (AMTD: −2.2; p < 0.01); Week 12 LOCF: −11.9 (0.8) vs −8.7 (0.8) (AMTD: −3.2; p < 0.001). CGI-I responder rates for ropinirole vs placebo were as follows: Day 2 OC: 24% vs 9% (odds ratio [OR]: 3.0; p < 0.001); Day 3 OC: 36% vs 20% (OR: 2.2; p < 0.01); Week 12 LOCF: 63% vs 47% (OR: 2.0; p < 0.001). These ropinirole treatment benefits were maintained at each assessment through 12 weeks. Mean(SD) doses at last visit were 2.0(1.2) mg/day for ropinirole and 2.9(1.3) mg/day for placebo. Conclusion: Ropinirole treatment improves RLS symptoms within 2 nights of treatment. Reflections: The effects of ropinirole on RLS symptoms take place within a few days, allowing rapid relief to patients with moderate-to-severe primary RLS. Contributed support: Study supported by GlaxoSmithKline. Declaration of conflict of interest: Dr Garcia-Borreguero has received payment for consulting and honoraria for lectures from GSK and BI. Dr Earl is an employee of GSK. P0038 Ropinirole improves sensory and motor symptoms in patients with restless legs syndrome who experience periodic leg movements in sleep P.M. Becker1 , N.L. Earl2 . 1 Sleep Medicine Associates of Texas, Dallas, TX, USA, 2 GlaxoSmithKline, Research Triangle Park, NC, USA Purpose: Patients with Restless Legs Syndrome (RLS) often experience sleep disturbance, which may result from sensory and motor RLS symptoms such as periodic leg movements during sleep (PLMS). Ropinirole is FDAapproved for the treatment of moderate-to-severe primary RLS. In a pivotal study of ropinirole, quantitative measures of PLMS (by actigraphy) and subjective measures of RLS symptoms (International Restless Legs Scale