- Email: [email protected]
P2.165 Dose-related decrease in “off” time with ropinirole prolonged release in patients with advanced Parkinson's disease
S134
Poster presentations / Parkinsonism and Related Disorders 15S2 (2009) S29–S199
Objectives: 1. Study frequency and latency of swallow at baseline, during gum chewing, and post gum chewing for participants with PD (stage 2–4) non-symptomatic for dysphagia. 2. Study carryover effect once gum stimulus is removed. Methods: Twenty participants were studied across three tasks each of 5 min duration: baseline, gum chewing, post gum chewing. Respiratory and laryngeal signals, captured by bellows positioned at the chest and larynx, were continuously recorded using PowerLab (v 4.1.1 ADI Instruments, Castle Hill, Australia). Swallow events were determined (indicated by peaks in the laryngeal wave coinciding with flattening of the respiratory wave) from PowerLab recordings. Frequency and latency of swallow events were calculated. Results: Significant differences (ANOVA) are reported for: frequency (p < 0.00001); latency (p < 0.00001). Swallow frequency increased during gum chewing (mean = 14.95±2.17807) compared to baseline (mean = 3.1±1.099) and post gum chewing (mean = 7.0±0.595966). Latency (s) decreased during gum chewing (mean = 3.949±4.8728) increasing with baseline (mean = 131.8±35.408), and post gum chewing (mean = 60.736±13.82403). Post-hoc analysis (t-test) found significant differences in swallow frequency and latency between tasks: baseline versus gum chewing (p < 0.001, p < 0.001); baseline versus post gum chewing (p < 0.011, p < 0009); and gum chewing versus post gum chewing (p < 0.001, p < 0.002) respectively. Conclusions: Modifying sensorimotor input by chewing gum alters frequency and latency of swallowing and may be an effective strategy for secretion management in PD. P2.163 Short and long term benefits of a community-based exercise program for people with Parkinson’s disease D. Spierer1 , Y. Salem2 , R. States2 , C. Neesemann3 . 1 Division of Sports Sciences, 2 Division of Physical Therapy, 3 Brooklyn Parkinson’s Group, Long Island University, Brooklyn, NY, USA Introduction: General exercise has been shown to be beneficial for people with Parkinson’s disease (PD), based mostly on studies of short-term programs conducted in clinical environments. Objective: To extend that research, we investigated the feasibility and efficacy of a community-based exercise program for people with PD, including its short-term (10 weeks) and long-term (11 months) physical training effects. Patients and Methods: Twenty-two people with PD (Hoehn and Yahr stages I to III) were evaluated and eighteen participated in at least one 10-week session of group exercise. Classes were held twice weekly and included aerobic, strength, flexibility and balance exercises. Evaluations were done before and one week after each of three 10-week sessions. PD signs and symptoms were measured with the Unified Parkinson’s Disease Rating Scale – Motor Scale (UPDRS-M). Gait speed, the six-minute walk test (6MWT), the Berg Balance Scale, the “Timed Up & Go” test, and grip strength were used to assess physical function. Results: Paired t-tests comparing pre- to post-test for each participant’s first 10-week session demonstrated improved UPDRS-M, increased 6MWT distance, and higher bilateral grip strength. Paired t-tests were also done for six participants who completed all three sessions (extended over 11 months). Comparison of participants’ initial pre-test to their final post-test demonstrated long-term improvements in UPDRS-M and bilateral grip strength, while other physical function measures were not significantly changed. Conclusion: Community based exercise programming is feasible and results in short-term and long-term functional improvements, providing a promising intervention to improve physical function in people with PD.
P2.164 Ropinirole prolonged release maintains an increase in daily awake time spent “on” in patients with advanced Parkinson’s disease F. Stocchi1 , B. Hunter2 , L. Giorgi3 , B. Hersh4 . 1 Department of Neurology, IRCCS, San Raffaele Roma, Rome, Italy; 2 GlaxoSmithKline, Harlow, 3 GlaxoSmithKline, Greenford, UK; 4 Harvard Vanguard Medical Associates and Harvard Medical School, Boston, MA, USA Objective: To retrospectively analyze the proportions of patients with advanced Parkinson’s disease (PD) not optimally controlled with L-dopa achieving a maintained increase from baseline in “on” time with ropinirole prolonged release, compared with placebo. Methods: Patients were randomized to adjunctive ropinirole prolonged release (2–24 mg/day) or placebo (EASE-PD, study 101468/169). The proportions of patients achieving maintained increases of ≥0.75, ≥1, ≥1.2 or ≥1.5 hours in “on” time from baseline to endpoint present for ≥2 consecutive visits were summarized. Results: Greater proportions of patients receiving ropinirole prolonged release than placebo achieved increases from baseline in “on” time which were then maintained of ≥0.75, ≥1, ≥1.2 or ≥1.5 hours at Week 2 (observed case): 49/197 (25%), 39/197 (20%), 29/197 (15%) and 22/197 (11%) versus 17/189 (9%), 13/189 (7%), 12/189 (6%) and 9/189 (5%), respectively. A maintained increase was also seen at Week 24 (last observation carried forward): 112/201 (56%), 106/201 (53%), 95/201 (47%) and 87/201 (43%) versus 60/190 (32%), 55/190 (29%), 54/190 (28%) and 43/190 (23%), respectively. The mean(SD) dose of ropinirole prolonged release was 18.8(6.3) mg/day. The adjusted mean change in L-dopa dose was −242 mg/day with ropinirole prolonged release versus −137 mg/day with placebo (AMTD: −105.4 mg/day; 95% CI: −137.8, −73.0; p < 0.0001). Conclusions: Greater proportions of PD patients with motor fluctuations not optimally controlled with L-dopa achieved a maintained increase in daily “on” time with ropinirole prolonged release than with placebo. The treatment effect was evident as early as 2 weeks after initiation of ropinirole prolonged release. Study supported by GlaxoSmithKline R&D and SkyePharma. P2.165 Dose-related decrease in “off” time with ropinirole prolonged release in patients with advanced Parkinson’s disease F. Stocchi1 , B. Hunter2 , L. Giorgi3 , R.A. Hauser4 . 1 Department of Neurology, IRCCS, San Raffaele Roma, Rome, Italy; 2 GlaxoSmithKline, Harlow, 3 GlaxoSmithKline, Greenford, UK; 4 University of South Florida, Tampa, FL, USA Objective: To examine the relationship between dose of once-daily ropinirole prolonged release and decrease in “off” time in patients with advanced Parkinson’s disease (PD) not optimally controlled with L-dopa. Methods: Patients were randomized to adjunctive ropinirole prolonged release, 2–24 mg/day titrated to optimal therapeutic dose after an intial forced titration of 2 mg/week for the first 3 weeks (n = 201) or placebo (n = 190) (EASE-PD Adjunct (101468/169). Proportions of patients attaining ≥20%, ≥30%, ≥40% or ≥50% reductions from baseline in “off” time, were analysed post hoc at the first assessment after which patients received a particular dose. Results: The proportion of patients achieving ≥20% reduction in “off” time with ropinirole prolonged release at 4 mg/day, 8 mg/day, 16 mg/day and 24 mg/day were 86/199 (43%), 120/194 (62%), 101/153 (66%) and 75/101 (74%) respectively. In the placebo group, these proportions were 53/188 (28%), 63/181 (35%), 71/159 (45%) and 36/107 (34%) respectively. Similar dose-dependent increases in the proportions of patients achieving reductions in “off” time of ≥30%, ≥40% and ≥50% were seen. A ≥50% reduction in “off” time with ropinirole prolonged release at 4 mg/day, 8 mg/day, 16 mg/day and
Poster presentations / Parkinsonism and Related Disorders 15S2 (2009) S29–S199
24 mg/day was seen in 28/199 (14%), 50/194 (26%), 43/153 (28%) and 36/101 (36%) patients respectively, compared with 12/188 (6%), 17/181 (9%), 27/159 (17%) and 16/107 (15%) receiving placebo. Conclusion: Increasing doses of ropinirole prolonged release allowed greater proportions of patients to achieve reductions in “off” time from baseline of ≥20% to ≥50%. Some patients benefitted at doses as low as 4 mg/day (the lowest recommended dose). Study supported by GlaxoSmithKline R&D and SkyePharma. P2.166 Once-daily ropinirole prolonged release improves activities of daily living and motor symptoms in patients with advanced Parkinson’s disease F. Stocchi1 , L. Giorgi2 , K. Rolfe3 , C.B. Rockett4 . 1 Department of Neurology, IRCCS, San Raffaele Roma, Rome, Italy; 2 GlaxoSmithKline, Greenford, 3 GlaxoSmithKline, Harlow, UK; 4 GlaxoSmithKline, Research Triangle Park, NC, USA Objective: To investigate the effect of once-daily ropinirole prolonged release on the activities of daily living (ADL) and motor symptoms measured with the Unified Parkinson’s Disease Rating Scale (UPDRS) parts II and III in patients with advanced Parkinson’s disease (PD) not optimally controlled with L-dopa. Methods: Patients were randomized to adjunctive ropinirole prolonged release, 2–24 mg/day titrated to optimal therapeutic dose (n = 201) or placebo (n = 190) (EASE-PD Adjunct [101468/169]). Changes in the combined score of parts II (ADL) and III (motor) of the UPDRS (UPDRS II&III) were analysed post-hoc. Motor scores were measured regardless of “off/on” state, mean of “off” and “on” ADL scores were used for analyses. Results: Mean(SD) baseline UPDRS II&III scores were 43.6(17.8) in patients receiving ropinirole prolonged release (n = 196) and 45.0(19.8) in the placebo group (n = 187). Mean(SD) changes from baseline at Week 12 observed case (OC) were −10.3(11.0) and −3.0(10.1) for the ropinirole prolonged release (n = 181) and placebo (n = 156) groups, respectively. At Week 24 OC, changes from baseline were −11.3(11.9) (n = 153) and −4.7(11.3) (n = 123), respectively. At Week 24 last observation carried forward (LOCF), changes from baseline were −9.9(12.4) (n = 193) and −2.8(10.8) (n = 182), respectively. Adjusted (baseline score and country) mean treatment differences were −6.6 (95% CI −9.27, −3.93) at Week 24 OC ( p < 0.0001) and −7.3 (95% CI −9.64, −5.01) at Week 24 LOCF ( p < 0.0001). Conclusion: UPDRS II&III combined scores were significantly improved in patients with advanced PD treated with once-daily ropinirole prolonged release compared with placebo. Study supported by GlaxoSmithKline R&D and SkyePharma. P2.167 Parkinson’s disease drug therapies: medication compliance and persistence M. Tarrants1 , M. Denarie2 , T. Karabas1 , J. Castelli-Haley1 , J. Millard2 , D. Zhang2 . 1 Teva Neuroscience, Kansas City, MO, 2 IMS Health, Philadelphia, PA, USA Background: Previous studies found strong associations between the worsening of Parkinson’s disease (PD) symptoms and suboptimal compliance to PD medications. Objectives: To examine compliance and persistence by drug therapy for PD patients. Methods: Using the IMS Longitudinal Prescription database, a retrospective analysis was done on PD patients receiving a new PD drug between March-May 2007. A patient receiving a new PD drug included those initiating therapy, adding adjunctive therapy or switching therapy. Patients were further divided into naïve therapy (NT) and prior therapy (PT). Patients were active in the database for a 12 month observation and a 12 month look-back period. Compliance was measured by medication possession ratio (MPR). Persistence was the duration of uninterrupted therapy.
S135
Results: 29,682 PD patients receiving a new PD drug were analyzed. 66% were NT, 34% were PT. Overall 54% of PD patients had compliance rates over 80%. Compliance rates were higher for PT patients than NT patients. Rasagiline had higher average MPR (80.8), followed by ropinirole (76.8), carbidopa/ levodopa/entacapone (LCE) (74.9), selegiline (73.9), COMT (73.6), pramipexole (72.9) and carbidopa/levodopa (LC) (71.8). The median number of persistent days for NT was highest for rasagiline (82), followed by LC (69), ropinirole (63), pramipexole (59), LCE (53), selegiline (47) and COMT (34). Conclusions: In this study rasagiline was associated with the highest rates of compliance and persistence. Favorable tolerability profile, symptomatic benefit and once-daily administration of rasagiline may contribute to these results. Further analysis will be necessary to verify subsequent improvement on clinical and economic outcomes. P2.168 Cost-effectiveness of rasagiline compared to other first line treatment options of early Parkinson’s disease in the United States R. Farkouh1 , M. Wilson1 , M. Tarrants2 , J. Castelli-Haley2 , C. Armand3 . 1 RTI Health Solutions, Research Triangle Park, NC, 2 Teva Neuroscience, Kansas City, MO, USA; 3 H. Lundbeck A/S, Paris, France Objectives: We examined whether rasagiline, a once-daily irreversible monoamine oxidase type-B inhibitor indicated for treatment of early Parkinson’s disease, is a cost-effective firstline treatment strategy when compared with ropinirole XL, pramipexole, generic ropinirole, and first-line levodopa. Methods: We developed a 5-year Markov model to examine the cost-effectiveness of initiating early treatment of PD with rasagiline from a United States payer perspective. Rasagiline was followed by either a dopamine agonist (DA) or levodopa. DA was followed by levodopa. Patients on a DA or levodopa could develop dyskinesias. Health state transitions occurred every 6 months. Transition probabilities were from clinical trial data. Drug costs, medical costs and utility weights were from published sources. One-way and probabilistic sensitivity analyses were performed. Costs and outcomes were discounted at 3% per year. Results: Over 5 years, first-line treatment with rasagiline was cost saving and more effective when compared to branded DAs and levodopa. Rasagiline was cost-effective versus generic ropinirole at $1,838 per quality-adjusted life-year (QALY): incremental costs +$239 and incremental QALYs +0.13. After five years compared to a DA, 23% and 50% fewer patients who initiated treatment with rasagiline were taking levodopa and experiencing dyskinesias respectively. Compared to first-line levodopa, 52% and 69% fewer patients starting rasagiline were taking levodopa and experiencing dyskinesias respectively. Conclusions: Initiating treatment with rasagiline delayed treatment with levodopa, reduced dyskinesias, and appears to be cost-savings or cost-effective when compared to initiating therapy with all other first-line therapies. P2.169 Treatment of advanced Parkinson’s disease in the United States: a cost-utility model M. Tarrants1 , H. Groenendaal2 , C. Armand3 . 1 Teva Neuroscience, Kansas City, MO, 2 Vose Consulting, Boulder, CO, USA; 3 H. Lundbeck A/S, Paris, France Objective: To assess the cost-utility of rasagiline or entacapone (COMT) as adjunctive therapies to levodopa (LD) versus carbidopa/ levodopa/entacapone (LCE) versus standard LD monotherapy in patients with advanced PD and motor fluctuations in the US. Background: As PD progresses, patients experience substantial health and economic burdens. Because motor fluctuations are linked to poor quality of life and higher health care costs minimizing
Poster presentations / Parkinsonism and Related Disorders 15S2 (2009) S29–S199
Objectives: 1. Study frequency and latency of swallow at baseline, during gum chewing, and post gum chewing for participants with PD (stage 2–4) non-symptomatic for dysphagia. 2. Study carryover effect once gum stimulus is removed. Methods: Twenty participants were studied across three tasks each of 5 min duration: baseline, gum chewing, post gum chewing. Respiratory and laryngeal signals, captured by bellows positioned at the chest and larynx, were continuously recorded using PowerLab (v 4.1.1 ADI Instruments, Castle Hill, Australia). Swallow events were determined (indicated by peaks in the laryngeal wave coinciding with flattening of the respiratory wave) from PowerLab recordings. Frequency and latency of swallow events were calculated. Results: Significant differences (ANOVA) are reported for: frequency (p < 0.00001); latency (p < 0.00001). Swallow frequency increased during gum chewing (mean = 14.95±2.17807) compared to baseline (mean = 3.1±1.099) and post gum chewing (mean = 7.0±0.595966). Latency (s) decreased during gum chewing (mean = 3.949±4.8728) increasing with baseline (mean = 131.8±35.408), and post gum chewing (mean = 60.736±13.82403). Post-hoc analysis (t-test) found significant differences in swallow frequency and latency between tasks: baseline versus gum chewing (p < 0.001, p < 0.001); baseline versus post gum chewing (p < 0.011, p < 0009); and gum chewing versus post gum chewing (p < 0.001, p < 0.002) respectively. Conclusions: Modifying sensorimotor input by chewing gum alters frequency and latency of swallowing and may be an effective strategy for secretion management in PD. P2.163 Short and long term benefits of a community-based exercise program for people with Parkinson’s disease D. Spierer1 , Y. Salem2 , R. States2 , C. Neesemann3 . 1 Division of Sports Sciences, 2 Division of Physical Therapy, 3 Brooklyn Parkinson’s Group, Long Island University, Brooklyn, NY, USA Introduction: General exercise has been shown to be beneficial for people with Parkinson’s disease (PD), based mostly on studies of short-term programs conducted in clinical environments. Objective: To extend that research, we investigated the feasibility and efficacy of a community-based exercise program for people with PD, including its short-term (10 weeks) and long-term (11 months) physical training effects. Patients and Methods: Twenty-two people with PD (Hoehn and Yahr stages I to III) were evaluated and eighteen participated in at least one 10-week session of group exercise. Classes were held twice weekly and included aerobic, strength, flexibility and balance exercises. Evaluations were done before and one week after each of three 10-week sessions. PD signs and symptoms were measured with the Unified Parkinson’s Disease Rating Scale – Motor Scale (UPDRS-M). Gait speed, the six-minute walk test (6MWT), the Berg Balance Scale, the “Timed Up & Go” test, and grip strength were used to assess physical function. Results: Paired t-tests comparing pre- to post-test for each participant’s first 10-week session demonstrated improved UPDRS-M, increased 6MWT distance, and higher bilateral grip strength. Paired t-tests were also done for six participants who completed all three sessions (extended over 11 months). Comparison of participants’ initial pre-test to their final post-test demonstrated long-term improvements in UPDRS-M and bilateral grip strength, while other physical function measures were not significantly changed. Conclusion: Community based exercise programming is feasible and results in short-term and long-term functional improvements, providing a promising intervention to improve physical function in people with PD.
P2.164 Ropinirole prolonged release maintains an increase in daily awake time spent “on” in patients with advanced Parkinson’s disease F. Stocchi1 , B. Hunter2 , L. Giorgi3 , B. Hersh4 . 1 Department of Neurology, IRCCS, San Raffaele Roma, Rome, Italy; 2 GlaxoSmithKline, Harlow, 3 GlaxoSmithKline, Greenford, UK; 4 Harvard Vanguard Medical Associates and Harvard Medical School, Boston, MA, USA Objective: To retrospectively analyze the proportions of patients with advanced Parkinson’s disease (PD) not optimally controlled with L-dopa achieving a maintained increase from baseline in “on” time with ropinirole prolonged release, compared with placebo. Methods: Patients were randomized to adjunctive ropinirole prolonged release (2–24 mg/day) or placebo (EASE-PD, study 101468/169). The proportions of patients achieving maintained increases of ≥0.75, ≥1, ≥1.2 or ≥1.5 hours in “on” time from baseline to endpoint present for ≥2 consecutive visits were summarized. Results: Greater proportions of patients receiving ropinirole prolonged release than placebo achieved increases from baseline in “on” time which were then maintained of ≥0.75, ≥1, ≥1.2 or ≥1.5 hours at Week 2 (observed case): 49/197 (25%), 39/197 (20%), 29/197 (15%) and 22/197 (11%) versus 17/189 (9%), 13/189 (7%), 12/189 (6%) and 9/189 (5%), respectively. A maintained increase was also seen at Week 24 (last observation carried forward): 112/201 (56%), 106/201 (53%), 95/201 (47%) and 87/201 (43%) versus 60/190 (32%), 55/190 (29%), 54/190 (28%) and 43/190 (23%), respectively. The mean(SD) dose of ropinirole prolonged release was 18.8(6.3) mg/day. The adjusted mean change in L-dopa dose was −242 mg/day with ropinirole prolonged release versus −137 mg/day with placebo (AMTD: −105.4 mg/day; 95% CI: −137.8, −73.0; p < 0.0001). Conclusions: Greater proportions of PD patients with motor fluctuations not optimally controlled with L-dopa achieved a maintained increase in daily “on” time with ropinirole prolonged release than with placebo. The treatment effect was evident as early as 2 weeks after initiation of ropinirole prolonged release. Study supported by GlaxoSmithKline R&D and SkyePharma. P2.165 Dose-related decrease in “off” time with ropinirole prolonged release in patients with advanced Parkinson’s disease F. Stocchi1 , B. Hunter2 , L. Giorgi3 , R.A. Hauser4 . 1 Department of Neurology, IRCCS, San Raffaele Roma, Rome, Italy; 2 GlaxoSmithKline, Harlow, 3 GlaxoSmithKline, Greenford, UK; 4 University of South Florida, Tampa, FL, USA Objective: To examine the relationship between dose of once-daily ropinirole prolonged release and decrease in “off” time in patients with advanced Parkinson’s disease (PD) not optimally controlled with L-dopa. Methods: Patients were randomized to adjunctive ropinirole prolonged release, 2–24 mg/day titrated to optimal therapeutic dose after an intial forced titration of 2 mg/week for the first 3 weeks (n = 201) or placebo (n = 190) (EASE-PD Adjunct (101468/169). Proportions of patients attaining ≥20%, ≥30%, ≥40% or ≥50% reductions from baseline in “off” time, were analysed post hoc at the first assessment after which patients received a particular dose. Results: The proportion of patients achieving ≥20% reduction in “off” time with ropinirole prolonged release at 4 mg/day, 8 mg/day, 16 mg/day and 24 mg/day were 86/199 (43%), 120/194 (62%), 101/153 (66%) and 75/101 (74%) respectively. In the placebo group, these proportions were 53/188 (28%), 63/181 (35%), 71/159 (45%) and 36/107 (34%) respectively. Similar dose-dependent increases in the proportions of patients achieving reductions in “off” time of ≥30%, ≥40% and ≥50% were seen. A ≥50% reduction in “off” time with ropinirole prolonged release at 4 mg/day, 8 mg/day, 16 mg/day and
Poster presentations / Parkinsonism and Related Disorders 15S2 (2009) S29–S199
24 mg/day was seen in 28/199 (14%), 50/194 (26%), 43/153 (28%) and 36/101 (36%) patients respectively, compared with 12/188 (6%), 17/181 (9%), 27/159 (17%) and 16/107 (15%) receiving placebo. Conclusion: Increasing doses of ropinirole prolonged release allowed greater proportions of patients to achieve reductions in “off” time from baseline of ≥20% to ≥50%. Some patients benefitted at doses as low as 4 mg/day (the lowest recommended dose). Study supported by GlaxoSmithKline R&D and SkyePharma. P2.166 Once-daily ropinirole prolonged release improves activities of daily living and motor symptoms in patients with advanced Parkinson’s disease F. Stocchi1 , L. Giorgi2 , K. Rolfe3 , C.B. Rockett4 . 1 Department of Neurology, IRCCS, San Raffaele Roma, Rome, Italy; 2 GlaxoSmithKline, Greenford, 3 GlaxoSmithKline, Harlow, UK; 4 GlaxoSmithKline, Research Triangle Park, NC, USA Objective: To investigate the effect of once-daily ropinirole prolonged release on the activities of daily living (ADL) and motor symptoms measured with the Unified Parkinson’s Disease Rating Scale (UPDRS) parts II and III in patients with advanced Parkinson’s disease (PD) not optimally controlled with L-dopa. Methods: Patients were randomized to adjunctive ropinirole prolonged release, 2–24 mg/day titrated to optimal therapeutic dose (n = 201) or placebo (n = 190) (EASE-PD Adjunct [101468/169]). Changes in the combined score of parts II (ADL) and III (motor) of the UPDRS (UPDRS II&III) were analysed post-hoc. Motor scores were measured regardless of “off/on” state, mean of “off” and “on” ADL scores were used for analyses. Results: Mean(SD) baseline UPDRS II&III scores were 43.6(17.8) in patients receiving ropinirole prolonged release (n = 196) and 45.0(19.8) in the placebo group (n = 187). Mean(SD) changes from baseline at Week 12 observed case (OC) were −10.3(11.0) and −3.0(10.1) for the ropinirole prolonged release (n = 181) and placebo (n = 156) groups, respectively. At Week 24 OC, changes from baseline were −11.3(11.9) (n = 153) and −4.7(11.3) (n = 123), respectively. At Week 24 last observation carried forward (LOCF), changes from baseline were −9.9(12.4) (n = 193) and −2.8(10.8) (n = 182), respectively. Adjusted (baseline score and country) mean treatment differences were −6.6 (95% CI −9.27, −3.93) at Week 24 OC ( p < 0.0001) and −7.3 (95% CI −9.64, −5.01) at Week 24 LOCF ( p < 0.0001). Conclusion: UPDRS II&III combined scores were significantly improved in patients with advanced PD treated with once-daily ropinirole prolonged release compared with placebo. Study supported by GlaxoSmithKline R&D and SkyePharma. P2.167 Parkinson’s disease drug therapies: medication compliance and persistence M. Tarrants1 , M. Denarie2 , T. Karabas1 , J. Castelli-Haley1 , J. Millard2 , D. Zhang2 . 1 Teva Neuroscience, Kansas City, MO, 2 IMS Health, Philadelphia, PA, USA Background: Previous studies found strong associations between the worsening of Parkinson’s disease (PD) symptoms and suboptimal compliance to PD medications. Objectives: To examine compliance and persistence by drug therapy for PD patients. Methods: Using the IMS Longitudinal Prescription database, a retrospective analysis was done on PD patients receiving a new PD drug between March-May 2007. A patient receiving a new PD drug included those initiating therapy, adding adjunctive therapy or switching therapy. Patients were further divided into naïve therapy (NT) and prior therapy (PT). Patients were active in the database for a 12 month observation and a 12 month look-back period. Compliance was measured by medication possession ratio (MPR). Persistence was the duration of uninterrupted therapy.
S135
Results: 29,682 PD patients receiving a new PD drug were analyzed. 66% were NT, 34% were PT. Overall 54% of PD patients had compliance rates over 80%. Compliance rates were higher for PT patients than NT patients. Rasagiline had higher average MPR (80.8), followed by ropinirole (76.8), carbidopa/ levodopa/entacapone (LCE) (74.9), selegiline (73.9), COMT (73.6), pramipexole (72.9) and carbidopa/levodopa (LC) (71.8). The median number of persistent days for NT was highest for rasagiline (82), followed by LC (69), ropinirole (63), pramipexole (59), LCE (53), selegiline (47) and COMT (34). Conclusions: In this study rasagiline was associated with the highest rates of compliance and persistence. Favorable tolerability profile, symptomatic benefit and once-daily administration of rasagiline may contribute to these results. Further analysis will be necessary to verify subsequent improvement on clinical and economic outcomes. P2.168 Cost-effectiveness of rasagiline compared to other first line treatment options of early Parkinson’s disease in the United States R. Farkouh1 , M. Wilson1 , M. Tarrants2 , J. Castelli-Haley2 , C. Armand3 . 1 RTI Health Solutions, Research Triangle Park, NC, 2 Teva Neuroscience, Kansas City, MO, USA; 3 H. Lundbeck A/S, Paris, France Objectives: We examined whether rasagiline, a once-daily irreversible monoamine oxidase type-B inhibitor indicated for treatment of early Parkinson’s disease, is a cost-effective firstline treatment strategy when compared with ropinirole XL, pramipexole, generic ropinirole, and first-line levodopa. Methods: We developed a 5-year Markov model to examine the cost-effectiveness of initiating early treatment of PD with rasagiline from a United States payer perspective. Rasagiline was followed by either a dopamine agonist (DA) or levodopa. DA was followed by levodopa. Patients on a DA or levodopa could develop dyskinesias. Health state transitions occurred every 6 months. Transition probabilities were from clinical trial data. Drug costs, medical costs and utility weights were from published sources. One-way and probabilistic sensitivity analyses were performed. Costs and outcomes were discounted at 3% per year. Results: Over 5 years, first-line treatment with rasagiline was cost saving and more effective when compared to branded DAs and levodopa. Rasagiline was cost-effective versus generic ropinirole at $1,838 per quality-adjusted life-year (QALY): incremental costs +$239 and incremental QALYs +0.13. After five years compared to a DA, 23% and 50% fewer patients who initiated treatment with rasagiline were taking levodopa and experiencing dyskinesias respectively. Compared to first-line levodopa, 52% and 69% fewer patients starting rasagiline were taking levodopa and experiencing dyskinesias respectively. Conclusions: Initiating treatment with rasagiline delayed treatment with levodopa, reduced dyskinesias, and appears to be cost-savings or cost-effective when compared to initiating therapy with all other first-line therapies. P2.169 Treatment of advanced Parkinson’s disease in the United States: a cost-utility model M. Tarrants1 , H. Groenendaal2 , C. Armand3 . 1 Teva Neuroscience, Kansas City, MO, 2 Vose Consulting, Boulder, CO, USA; 3 H. Lundbeck A/S, Paris, France Objective: To assess the cost-utility of rasagiline or entacapone (COMT) as adjunctive therapies to levodopa (LD) versus carbidopa/ levodopa/entacapone (LCE) versus standard LD monotherapy in patients with advanced PD and motor fluctuations in the US. Background: As PD progresses, patients experience substantial health and economic burdens. Because motor fluctuations are linked to poor quality of life and higher health care costs minimizing