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2.232 Effects of dopamine agonist pramipexole on sleep disturbances in Parkinson's disease
S106
Tuesday, 11 December 2007
2.230 Pramipexole monotherapy in the treatment of early Parkinson’s disease: Results of a 3 year follow up of a randomized controlled study N. Oztekin1° , M.F. Oztekin, R. Sarl-Polat, G. Orhan, S. Bilen, F. Ak Turkey
1 Ankara,
Objective: The aim of the study is to determine the effectiveness of pramipexole monotherapy in providing symptomatic relief in patients with early PD Method: The efficacy and tolerability of pramipexole is evaluated in a double blind, randomized, 3 year trial versus placebo. Patients with a diagnosis of idiopathic PD, with a modified Hoehn & Yahr score I−III, and a score more than 14 points in UPDRS part III at baseline were enrolled to the study. There were 20 patients in the treatment arm (mean age 61.7 yrs) and 20 age matched patients in the placebo group. The primary endpoint-the mean reduction in the Unified Parkinson’s disease Rating Scale (UPDRS) total motor score and change in Global Clinical Impression Scale (GCIS). Results: Patient characteristics were similar in the two groups at the beginning of the study. The pramipexole group showed a significantly important percent of responders (defined as a −40% decrease in UPDRS part III score at end point) compared to placebo (65% versus 11%; p < 0.005). Pramipexole treated group have a significantly greater improvement than placebo treated patients (p < 0.0001) in UPDRS and GCIS. At the end of 3 years the mean pramipexole dose was 4.7 mg/day.12 patients in the placebo group were significantly disabled at the end of 2.8 years and were started either an agonist or levodopa at the end of the trial period (3 years). 19 patients in the pramipexole group are still taking pramipexole monotherapy, although some required dose adjustments. One patient in the pramipexole group required levodopa at the end of the trial. Side effects were mild, becouse all the patients used domperidon started at the beginning of the trial. There were no drop outs due to the side effects of the treatment. Conclusion: The results of this study reveals that pramipexole monotherapy can be considered as an effective and well tolerated first line treatment in patients with early PD
2.231 Maintained pramipexole monotherapy treatment results in significantly lower dyskinesia rates in early Parkinson’s disease: A result of the CALM-PD study after 4 years A. Corbin1° , J. K¨oster CT, USA
1 Ridgefield,
Objective: To determine rate of dyskinesia in the pramipexole monotherapy group as compared to patients receiving supplemental levodopa over the 4-year CALM-PD trial. Method: The CALM-PD trial evaluated the development of motor complications in 301 subjects with early Parkinson’s disease (PD) randomized to initial pramipexole or levodopa treatment and titrated to one of three dosage levels over a period of 10 weeks depending on need. Open-label levodopa could be added after 10 weeks, if needed, to treat emerging motor symptoms. Analyses of the data collected from the item “Have you experienced any involuntary movements?” and of dyskinesia reported as an adverse event (AE) were compared for the levodopa (n = 150) and pramipexole (n = 151) treatment groups. The pramipexole group was subdivided into those adding supplemental levodopa (n = 107), and those that did not (monotherapy group; n = 44). Occurrence of dyskinesia after adding supplemental levodopa was evaluated. Results: Of the 150 subjects initially randomized to levodopa, dyskinesia was reported as an AE in 23 (15.3%) patients, while 81 (54%) experienced any involuntary movement. Of the 44 patients who maintained pramipexole monotherapy, no dyskinesia was reported as an AE (0%), while 2 (4.5%) patients experienced any involuntary movement. Dyskinesia was reported as an AE in 6 of 107 (5.6%) patients randomized to pramipexole receiving supplemental levodopa, while 35 (32.7%) experienced any involuntary
movement; no patient reported an AE of dyskinesia prior to adding levodopa. Conclusion: Dyskinesia was not reported as an AE in early PD patients maintaining pramipexole monotherapy over the 4-year CALM-PD trial. Adding supplemental levodopa resulted in increased dyskinesia AEs and reports of involuntary movement, but substantially less than dyskinesia AEs reported in the levodopa group. If pramipexole monotherapy can be maintained without adding levodopa, PD patients may have a greatly reduced risk for developing dyskinesia as disease progresses.
2.232 Effects of dopamine agonist pramipexole on sleep disturbances in Parkinson’s disease M. Nodel1° , N. Yakhno Russia
1 Moscow,
Objective: To better recognize the main PD-related symptoms causing disorders of initiation and maintenance of sleep (DIMS), to evaluate the effects of the dopamine agonist pramipexole therapy on the DIMS in PD. Method: 30 PD patients (mean age: 56.2±6.02 years; mean duration of disease: 4.92±2.16 years) were enrolled in the study. Pramipexole was added to the other antiparkinsonian medication; mean daily dose: 2.90±0.96 mg. Clinical assessments were carried out at baseline before pramipexole administration and two months later. The therapeutic outcomes were assessed using the UPDRS, “Scale of Motor Fluctuations and Dyskinesias”; PD Sleep Scale (PDSS) and self-developed patients sleep questionnaire (PSQ), focused on the symptom revelation most likely caused DIMS. Results: Among 30 patients the impairment of sleep initiation was detected in 65% patients, frequent night awakenings (more than 2 times per night) were reported in 44% cases and early morning awakenings were revealed in 67% patients. The sense of muscle stiffness, painful/troublesome sensations in the body, restlessness in the legs and nocturia were regarded as frequent (more than 25% of the patients) causes of sleep initiation impairment. The difficulties to turn over in bed, vivid dreams, and painful posturing/cramps in the arms proved to be the main reasons for night awakenings. Pramipexole treatment significantly improved overall quality of sleep, decreased early morning dystonia and nocturia according to PDSS outcomes and reduced pain/troublesome sensations that was demonstrated by PSQ. The changes of the item “quality of sleep” positively correlated with the decrease of night hypokinesia. Conclusion: Over 65% of PD patients suffer from sleep initiation and maintenance disorders. In accordance with previous investigations dopamine agonists have a variable and dose dependent effects on sleep. In our study the Pramipexole therapy improves the quality of sleep in PD patients. We speculate that the above effects are caused by the decrease of nocturnal PD motor (hypokinesia, dystonia) and nonmotor (nocturia, sensor disturbances) symptoms.
2.233 The effectiveness of pramipexole and cabergoline as an adjunct to levodopa in Parkinson’s disease N. Oztekin1° , M.F. Oztekin, R. Sarl-Polat, G. Orhan, F. Ak Turkey
1 Ankara,
Objective: The aim of this double blind study is to compare the efficacy and safety of adjunct pramipexole therapy versus cabergoline in patients with Parkinson’s disease suffering from the complications of levodopa therapy. Method: 40 patients with PD and motor complications using levodopa (mean dose 975 mg), disease duration 5−7 years, Hoehn & Yahr stage II−IV were enrolled to the study and were divided into 2 groups, each group consisting of 20 patients who were evaluated by a blinded physician every week for the first month, and monthly thereafter for 12 months after initiation of the adjunct therapy. The patients were evaluated according to UPDRS, Global Clinical Impression scale (GCIS). The primary end point
Tuesday, 11 December 2007
2.230 Pramipexole monotherapy in the treatment of early Parkinson’s disease: Results of a 3 year follow up of a randomized controlled study N. Oztekin1° , M.F. Oztekin, R. Sarl-Polat, G. Orhan, S. Bilen, F. Ak Turkey
1 Ankara,
Objective: The aim of the study is to determine the effectiveness of pramipexole monotherapy in providing symptomatic relief in patients with early PD Method: The efficacy and tolerability of pramipexole is evaluated in a double blind, randomized, 3 year trial versus placebo. Patients with a diagnosis of idiopathic PD, with a modified Hoehn & Yahr score I−III, and a score more than 14 points in UPDRS part III at baseline were enrolled to the study. There were 20 patients in the treatment arm (mean age 61.7 yrs) and 20 age matched patients in the placebo group. The primary endpoint-the mean reduction in the Unified Parkinson’s disease Rating Scale (UPDRS) total motor score and change in Global Clinical Impression Scale (GCIS). Results: Patient characteristics were similar in the two groups at the beginning of the study. The pramipexole group showed a significantly important percent of responders (defined as a −40% decrease in UPDRS part III score at end point) compared to placebo (65% versus 11%; p < 0.005). Pramipexole treated group have a significantly greater improvement than placebo treated patients (p < 0.0001) in UPDRS and GCIS. At the end of 3 years the mean pramipexole dose was 4.7 mg/day.12 patients in the placebo group were significantly disabled at the end of 2.8 years and were started either an agonist or levodopa at the end of the trial period (3 years). 19 patients in the pramipexole group are still taking pramipexole monotherapy, although some required dose adjustments. One patient in the pramipexole group required levodopa at the end of the trial. Side effects were mild, becouse all the patients used domperidon started at the beginning of the trial. There were no drop outs due to the side effects of the treatment. Conclusion: The results of this study reveals that pramipexole monotherapy can be considered as an effective and well tolerated first line treatment in patients with early PD
2.231 Maintained pramipexole monotherapy treatment results in significantly lower dyskinesia rates in early Parkinson’s disease: A result of the CALM-PD study after 4 years A. Corbin1° , J. K¨oster CT, USA
1 Ridgefield,
Objective: To determine rate of dyskinesia in the pramipexole monotherapy group as compared to patients receiving supplemental levodopa over the 4-year CALM-PD trial. Method: The CALM-PD trial evaluated the development of motor complications in 301 subjects with early Parkinson’s disease (PD) randomized to initial pramipexole or levodopa treatment and titrated to one of three dosage levels over a period of 10 weeks depending on need. Open-label levodopa could be added after 10 weeks, if needed, to treat emerging motor symptoms. Analyses of the data collected from the item “Have you experienced any involuntary movements?” and of dyskinesia reported as an adverse event (AE) were compared for the levodopa (n = 150) and pramipexole (n = 151) treatment groups. The pramipexole group was subdivided into those adding supplemental levodopa (n = 107), and those that did not (monotherapy group; n = 44). Occurrence of dyskinesia after adding supplemental levodopa was evaluated. Results: Of the 150 subjects initially randomized to levodopa, dyskinesia was reported as an AE in 23 (15.3%) patients, while 81 (54%) experienced any involuntary movement. Of the 44 patients who maintained pramipexole monotherapy, no dyskinesia was reported as an AE (0%), while 2 (4.5%) patients experienced any involuntary movement. Dyskinesia was reported as an AE in 6 of 107 (5.6%) patients randomized to pramipexole receiving supplemental levodopa, while 35 (32.7%) experienced any involuntary
movement; no patient reported an AE of dyskinesia prior to adding levodopa. Conclusion: Dyskinesia was not reported as an AE in early PD patients maintaining pramipexole monotherapy over the 4-year CALM-PD trial. Adding supplemental levodopa resulted in increased dyskinesia AEs and reports of involuntary movement, but substantially less than dyskinesia AEs reported in the levodopa group. If pramipexole monotherapy can be maintained without adding levodopa, PD patients may have a greatly reduced risk for developing dyskinesia as disease progresses.
2.232 Effects of dopamine agonist pramipexole on sleep disturbances in Parkinson’s disease M. Nodel1° , N. Yakhno Russia
1 Moscow,
Objective: To better recognize the main PD-related symptoms causing disorders of initiation and maintenance of sleep (DIMS), to evaluate the effects of the dopamine agonist pramipexole therapy on the DIMS in PD. Method: 30 PD patients (mean age: 56.2±6.02 years; mean duration of disease: 4.92±2.16 years) were enrolled in the study. Pramipexole was added to the other antiparkinsonian medication; mean daily dose: 2.90±0.96 mg. Clinical assessments were carried out at baseline before pramipexole administration and two months later. The therapeutic outcomes were assessed using the UPDRS, “Scale of Motor Fluctuations and Dyskinesias”; PD Sleep Scale (PDSS) and self-developed patients sleep questionnaire (PSQ), focused on the symptom revelation most likely caused DIMS. Results: Among 30 patients the impairment of sleep initiation was detected in 65% patients, frequent night awakenings (more than 2 times per night) were reported in 44% cases and early morning awakenings were revealed in 67% patients. The sense of muscle stiffness, painful/troublesome sensations in the body, restlessness in the legs and nocturia were regarded as frequent (more than 25% of the patients) causes of sleep initiation impairment. The difficulties to turn over in bed, vivid dreams, and painful posturing/cramps in the arms proved to be the main reasons for night awakenings. Pramipexole treatment significantly improved overall quality of sleep, decreased early morning dystonia and nocturia according to PDSS outcomes and reduced pain/troublesome sensations that was demonstrated by PSQ. The changes of the item “quality of sleep” positively correlated with the decrease of night hypokinesia. Conclusion: Over 65% of PD patients suffer from sleep initiation and maintenance disorders. In accordance with previous investigations dopamine agonists have a variable and dose dependent effects on sleep. In our study the Pramipexole therapy improves the quality of sleep in PD patients. We speculate that the above effects are caused by the decrease of nocturnal PD motor (hypokinesia, dystonia) and nonmotor (nocturia, sensor disturbances) symptoms.
2.233 The effectiveness of pramipexole and cabergoline as an adjunct to levodopa in Parkinson’s disease N. Oztekin1° , M.F. Oztekin, R. Sarl-Polat, G. Orhan, F. Ak Turkey
1 Ankara,
Objective: The aim of this double blind study is to compare the efficacy and safety of adjunct pramipexole therapy versus cabergoline in patients with Parkinson’s disease suffering from the complications of levodopa therapy. Method: 40 patients with PD and motor complications using levodopa (mean dose 975 mg), disease duration 5−7 years, Hoehn & Yahr stage II−IV were enrolled to the study and were divided into 2 groups, each group consisting of 20 patients who were evaluated by a blinded physician every week for the first month, and monthly thereafter for 12 months after initiation of the adjunct therapy. The patients were evaluated according to UPDRS, Global Clinical Impression scale (GCIS). The primary end point