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1.293 Ropinirole CR improves the symptoms of restless legs syndrome from the first night of treatment
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Monday, 10 December 2007
−5.2 (P = 0.0033) in older patients. Type and frequency of adverse events were similar in both age groups. Conclusion: By IRLS score, the benefit of pramipexole against RLS in patients 65 years old was similar to that in patients <65 and was significantly different from placebo in the larger, younger groups. Adverse event profiles between groups were similar. Disclosure: Supported by Boehringer Ingelheim International GmbH.
1.291 Improvement in activities of daily living among patients receiving pramipexole for restless legs syndrome (RLS) E. Lainey1° , J. Koester USA
1 Ridgefield,
Objective: To assess the impact of pramipexole therapy on daily affairs and QOL in patients with RLS. Method: Randomized, DB 3-, 6-, and 12-week trials of pramipexole taken once daily. Patients met all RLS diagnostic criteria of the International RLS Study Group (baseline score >15 on the IRLS scale). A total of 564 pramipexole and 220 placebo recipients contributed analyzable data. All trials utilized Question 9 of the IRLS (impact of RLS on daily affairs [0 = none to 4 = very severe]). Additionally, 3- and 6-week trials administered the SF-36 test, which includes social functioning; the 12-week trial administered the Johns Hopkins RLS-QOL, measuring daily activities, physical functioning, and vitality. Results: On IRL Question 9, pramipexole recipients improved by a mean of 0.9 (baseline: 1.4), vs placebo, 0.6 (baseline: 1.5). Pramipexole produced significantly greater Wilcoxon–Mann-Whitney change than placebo for the 6- (P = 0.0319) and 12- (P = 0.0294) week trials and overall (P = 0.0009). Of 378 patients with baseline scores 2, 77% pramipexole improved to 1, vs 56% placebo (P0.0001, Cochran–Mantel–Haenszel test). In 3- and 6week trials, SF-36 social functioning improved with pramipexole (adjusted mean 4.8) (n = 82) and 6.0 (n = 222), while placebo worsened by −5.4 (n = 20; P = 0.0026 ANCOVA) and −0.3 (n = 114; P = 0.0027 ANCOVA), respectively. In the 12-week trial, the adjusted mean RLS-QOL score for pramipexole (n = 249) improved 19.9 points (baseline: 69.2), vs placebo, 13.5 points (baseline: 69.1) (n = 82; P < 0.0001 ANCOVA). Conclusion: Daily life of DB pramipexole RLS patients significantly improved by IRLS Question 9, SF-36 social functioning, and RLS-QOL vs placebo. Supported by Boehringer Ingelheim International GmbH.
1.292 Beneficial impact of pramipexole on social functioning in patients with restless legs syndrome T. Zesiewicz1° , J. K¨oster, S. Albrecht, E. Lainey FL, USA
1 Tampa,
Objective: Restless legs syndrome (RLS) can have a profound effect on quality of life (QOL). The nonergot dopamine agonist pramipexole is effective therapy for RLS. In 3 clinical trials, patients evaluated the treatment’s impact on their QOL, including social functioning. Method: Data from 3 double-blind, placebo-controlled trials of pramipexole at doses of 0.125 to 0.75 mg/d were analyzed. Patients met all RLS diagnostic criteria of the International RLS Study Group, with a baseline score >15 on the Group’s RLS severity scale (IRLS). Threeand 6-week trials utilized the SF-36, a generic questionnaire assessing 8 QOL dimensions, including social functioning. The 12-week trial utilized the Johns Hopkins RLS-QOL, an RLS-specific questionnaire assessing 5 dimensions, including social life. Results: In the 3- and 6-week trials, SF-36 data were available for 82 of the 86 and 222 of the 224 pramipexole recipients, respectively, and for 20 of 21 and 114 of 114 placebo recipients. In both trials, most dimensions exhibited minimal changes, but by ANCOVA (adjusting for age and baseline), social functioning showed a significant treatment effect. In the 3-week trial, adjusted mean improvement was +4.8 (±1.4)
among pramipexole recipients, compared with a −5.4 (±2.9) worsening for placebo (P = 0.0026). In the 6-week trial, improvement was +6.0 (±1.2) vs −0.3 (±1.7; P = 0.0027). In the 12-week trial, RLS-QOL data were available for 253 of the 254 pramipexole recipients and 83 of the 85 placebo recipients. Adjusted mean improvement was 19.9 (±0.8) for pramipexole vs 13.5 (±1.4) for placebo (P < 0.0001). Conclusion: In 3 double-blind multinational trials, pramipexole produced a substantial improvement in QOL of patients with RLS, notably in their social functioning, as assessed by a generic rating (SF-36) and an RLSspecific one (RLS-QOL). Supported by Boehringer Ingelheim International GmbH.
1.293 Ropinirole CR improves the symptoms of restless legs syndrome from the first night of treatment R. Bogan1° , M. Castiglia USA
1 Columbia,
Objective: Restless Legs Syndrome (RLS) symptoms can have a negative impact on sleep and quality of life, therefore rapid treatment with sustained efficacy is desirable. Onset of effect of a once-daily, 14-hour extended-release treatment formulation – ropinirole CR – was assessed in patients with moderate-to-severe primary RLS. Method: In a 12-week pivotal study (protocol 101468/205), patients with moderate-to-severe primary RLS were randomized to ropinirole CR (n = 189), 0.5−6 mg/day, or placebo (n = 195), titrated as needed and tolerated, taken once daily (4pm), 1−2 hours before usual RLS symptom onset. Onset of effect was assessed by proportion of responders (rated ‘very much’ or ‘much’ improved) on the Patient Global Improvement (PGI) scale at Days 2−4 and the Clinical Global Impression–Improvement (CGI-I) scale at Week 1 observed case (OC) through to Week 12 last observation carried forward (LOCF; secondary endpoint), and by mean change from baseline in International Restless Legs Scale (IRLS) total score at Week 1 OC through to Week 12 LOCF (primary endpoint). Results: The proportion of PGI scale responders was significantly greater for ropinirole CR versus placebo on Days 2 (30% versus 12%, after the first night of treatment), 3 (35% versus 18%), and 4 (42% versus 24%); all p < 0.001. The proportion of CGI-I scale responders was also significantly greater for ropinirole CR versus placebo at Week 1 OC (adjusted odds ratio [AOR]: 2.6; p < 0.001) through to Week 12 LOCF (AOR: 4.6; p < 0.001). Mean change from baseline in IRLS total score beginning at Week 1 OC through to Week 12 LOCF was significantly greater (improved) for ropinirole CR versus placebo (adjusted mean treatment difference: Week 1 OC, −3.8; Week 12 LOCF, −5.9; both p < 0.001). Conclusion: Ropinirole CR significantly improves RLS symptoms from the first night of treatment compared with placebo and this treatment benefit is sustained through 12 weeks.
1.294 Tolerability with no loss of efficacy after overnight conversion from immediate-release ropinirole to an extended-release formulation – ropinirole CR – in restless legs syndrome S. Isaacson1° , M. Castiglia, R. Hodge Raton, FL, USA
1 Boca
Objective: Many patients with primary Restless Legs Syndrome (RLS) experience symptoms in the late afternoon/early evening and during the night, and may benefit from extended-duration treatment. The tolerability and safety of overnight conversion from ropinirole immediate release (IR) to a 14-hour extended-release formulation, ropinirole CR, was evaluated in patients with moderate-to-severe primary RLS. Method: In a 4-week, randomized, double-blind, double-dummy, threecohort study (protocol 101468/805), patients taking ropinirole IR for RLS entered cohort A, B, or C based on their stable dose of ropinirole IR (1 mg, 2 mg, or 4 mg, respectively). They were then randomized to one of two
Monday, 10 December 2007
−5.2 (P = 0.0033) in older patients. Type and frequency of adverse events were similar in both age groups. Conclusion: By IRLS score, the benefit of pramipexole against RLS in patients 65 years old was similar to that in patients <65 and was significantly different from placebo in the larger, younger groups. Adverse event profiles between groups were similar. Disclosure: Supported by Boehringer Ingelheim International GmbH.
1.291 Improvement in activities of daily living among patients receiving pramipexole for restless legs syndrome (RLS) E. Lainey1° , J. Koester USA
1 Ridgefield,
Objective: To assess the impact of pramipexole therapy on daily affairs and QOL in patients with RLS. Method: Randomized, DB 3-, 6-, and 12-week trials of pramipexole taken once daily. Patients met all RLS diagnostic criteria of the International RLS Study Group (baseline score >15 on the IRLS scale). A total of 564 pramipexole and 220 placebo recipients contributed analyzable data. All trials utilized Question 9 of the IRLS (impact of RLS on daily affairs [0 = none to 4 = very severe]). Additionally, 3- and 6-week trials administered the SF-36 test, which includes social functioning; the 12-week trial administered the Johns Hopkins RLS-QOL, measuring daily activities, physical functioning, and vitality. Results: On IRL Question 9, pramipexole recipients improved by a mean of 0.9 (baseline: 1.4), vs placebo, 0.6 (baseline: 1.5). Pramipexole produced significantly greater Wilcoxon–Mann-Whitney change than placebo for the 6- (P = 0.0319) and 12- (P = 0.0294) week trials and overall (P = 0.0009). Of 378 patients with baseline scores 2, 77% pramipexole improved to 1, vs 56% placebo (P0.0001, Cochran–Mantel–Haenszel test). In 3- and 6week trials, SF-36 social functioning improved with pramipexole (adjusted mean 4.8) (n = 82) and 6.0 (n = 222), while placebo worsened by −5.4 (n = 20; P = 0.0026 ANCOVA) and −0.3 (n = 114; P = 0.0027 ANCOVA), respectively. In the 12-week trial, the adjusted mean RLS-QOL score for pramipexole (n = 249) improved 19.9 points (baseline: 69.2), vs placebo, 13.5 points (baseline: 69.1) (n = 82; P < 0.0001 ANCOVA). Conclusion: Daily life of DB pramipexole RLS patients significantly improved by IRLS Question 9, SF-36 social functioning, and RLS-QOL vs placebo. Supported by Boehringer Ingelheim International GmbH.
1.292 Beneficial impact of pramipexole on social functioning in patients with restless legs syndrome T. Zesiewicz1° , J. K¨oster, S. Albrecht, E. Lainey FL, USA
1 Tampa,
Objective: Restless legs syndrome (RLS) can have a profound effect on quality of life (QOL). The nonergot dopamine agonist pramipexole is effective therapy for RLS. In 3 clinical trials, patients evaluated the treatment’s impact on their QOL, including social functioning. Method: Data from 3 double-blind, placebo-controlled trials of pramipexole at doses of 0.125 to 0.75 mg/d were analyzed. Patients met all RLS diagnostic criteria of the International RLS Study Group, with a baseline score >15 on the Group’s RLS severity scale (IRLS). Threeand 6-week trials utilized the SF-36, a generic questionnaire assessing 8 QOL dimensions, including social functioning. The 12-week trial utilized the Johns Hopkins RLS-QOL, an RLS-specific questionnaire assessing 5 dimensions, including social life. Results: In the 3- and 6-week trials, SF-36 data were available for 82 of the 86 and 222 of the 224 pramipexole recipients, respectively, and for 20 of 21 and 114 of 114 placebo recipients. In both trials, most dimensions exhibited minimal changes, but by ANCOVA (adjusting for age and baseline), social functioning showed a significant treatment effect. In the 3-week trial, adjusted mean improvement was +4.8 (±1.4)
among pramipexole recipients, compared with a −5.4 (±2.9) worsening for placebo (P = 0.0026). In the 6-week trial, improvement was +6.0 (±1.2) vs −0.3 (±1.7; P = 0.0027). In the 12-week trial, RLS-QOL data were available for 253 of the 254 pramipexole recipients and 83 of the 85 placebo recipients. Adjusted mean improvement was 19.9 (±0.8) for pramipexole vs 13.5 (±1.4) for placebo (P < 0.0001). Conclusion: In 3 double-blind multinational trials, pramipexole produced a substantial improvement in QOL of patients with RLS, notably in their social functioning, as assessed by a generic rating (SF-36) and an RLSspecific one (RLS-QOL). Supported by Boehringer Ingelheim International GmbH.
1.293 Ropinirole CR improves the symptoms of restless legs syndrome from the first night of treatment R. Bogan1° , M. Castiglia USA
1 Columbia,
Objective: Restless Legs Syndrome (RLS) symptoms can have a negative impact on sleep and quality of life, therefore rapid treatment with sustained efficacy is desirable. Onset of effect of a once-daily, 14-hour extended-release treatment formulation – ropinirole CR – was assessed in patients with moderate-to-severe primary RLS. Method: In a 12-week pivotal study (protocol 101468/205), patients with moderate-to-severe primary RLS were randomized to ropinirole CR (n = 189), 0.5−6 mg/day, or placebo (n = 195), titrated as needed and tolerated, taken once daily (4pm), 1−2 hours before usual RLS symptom onset. Onset of effect was assessed by proportion of responders (rated ‘very much’ or ‘much’ improved) on the Patient Global Improvement (PGI) scale at Days 2−4 and the Clinical Global Impression–Improvement (CGI-I) scale at Week 1 observed case (OC) through to Week 12 last observation carried forward (LOCF; secondary endpoint), and by mean change from baseline in International Restless Legs Scale (IRLS) total score at Week 1 OC through to Week 12 LOCF (primary endpoint). Results: The proportion of PGI scale responders was significantly greater for ropinirole CR versus placebo on Days 2 (30% versus 12%, after the first night of treatment), 3 (35% versus 18%), and 4 (42% versus 24%); all p < 0.001. The proportion of CGI-I scale responders was also significantly greater for ropinirole CR versus placebo at Week 1 OC (adjusted odds ratio [AOR]: 2.6; p < 0.001) through to Week 12 LOCF (AOR: 4.6; p < 0.001). Mean change from baseline in IRLS total score beginning at Week 1 OC through to Week 12 LOCF was significantly greater (improved) for ropinirole CR versus placebo (adjusted mean treatment difference: Week 1 OC, −3.8; Week 12 LOCF, −5.9; both p < 0.001). Conclusion: Ropinirole CR significantly improves RLS symptoms from the first night of treatment compared with placebo and this treatment benefit is sustained through 12 weeks.
1.294 Tolerability with no loss of efficacy after overnight conversion from immediate-release ropinirole to an extended-release formulation – ropinirole CR – in restless legs syndrome S. Isaacson1° , M. Castiglia, R. Hodge Raton, FL, USA
1 Boca
Objective: Many patients with primary Restless Legs Syndrome (RLS) experience symptoms in the late afternoon/early evening and during the night, and may benefit from extended-duration treatment. The tolerability and safety of overnight conversion from ropinirole immediate release (IR) to a 14-hour extended-release formulation, ropinirole CR, was evaluated in patients with moderate-to-severe primary RLS. Method: In a 4-week, randomized, double-blind, double-dummy, threecohort study (protocol 101468/805), patients taking ropinirole IR for RLS entered cohort A, B, or C based on their stable dose of ropinirole IR (1 mg, 2 mg, or 4 mg, respectively). They were then randomized to one of two