1、 Slide 23: Pramipexole Improves Motor Function in Early Disease Initial therapy with pramipexole for patients with early Parkinsons disease (stages I-III, modified Hoehn and Yahr Scale) is shown to enhance motor function. In a randomized, double-blind, 31-week trial, patients (n = 335) were titrated
2、 to the highest tolerated dose (maximum: 4.5 mg/day) during a 7-week dose-escalation phase. Patients were maintained at that dose for a 24-week maintenance phase, during which the mean daily dose was 3.8 mg. Patients could continue other parkinsonian therapy except for levodopa or amantadine. In thi
3、s study, 333 patients were eligible for efficacy analysis (ITT patient population). Primary outcomes were UPDRS II (ADL) and UPDRS III (motor) scores. Significant improvements in motor function were evident as early as Week 3 (not shown); by the end of the study, UPDRS scores improved by 25% from ba
4、seline for pramipexole (4.7 points) compared with placebo, which worsened by 6.9% from baseline (1.3 points) (P0.0001).Reference:Shannon KM, Bennett JP Jr, Friedman JH, for the Pramipexole Study Group. Efficacy of pramipexole, a novel dopamine agonist, as monotherapy in Parkinsons disease. Neurology
5、. 1997;49:724-728.Slide 22: Pramipexole Enhances Functioning in Early Disease Initial therapy with pramipexole for patients with early Parkinsons disease (stages I-III, modified Hoehn and Yahr Scale) was shown to enhance patient functioning.In this randomized, double-blind, 31-week trial, patients (
6、n = 335) were titrated to a maximum of 4.5 mg/day during a 7-week dose-escalation phase. Patients were maintained at that dose for a 24-week maintenance phase. Patients could continue other parkinsonian therapy except for levodopa or amantadine. In this study, 333 patients were eligible for efficacy
7、 analysis (ITT patient population). Primary outcomes were Unified Parkinsons Disease Rating Scale (UPDRS) II (ADL) and UPDRS III (motor) scores. Baseline ADL scores were 8.2 in the pramipexole group and 8.3 in the placebo group. Patients treated with pramipexole showed a statistically significant im
8、provement versus placebo in ADL total score as early as Week 3 of treatment. Significant improvements in motor function were evident as early as Week 3. Statistically significant improvements in both parameters were seen throughout the 24-week maintenance period for patients treated with pramipexole
9、. The most common adverse effects among these patients were nausea and insomnia.Reference:Shannon KM, Bennett JP Jr, Friedman JH, for the Pramipexole Study Group. Efficacy of pramipexole, a novel dopamine agonist, as monotherapy in Parkinsons disease. Neurology. 1997;49:724-728.Slide 26: Pramipexole
10、 as an Adjunct to Levodopa Enhances ADL and Motor Scores In a multicenter, randomized, placebo-controlled trial, patients with advanced Parkinsons disease (N=360; Hoehn and Yahr Stages II to IV) were randomized to treatment with pramipexole plus levodopa or placebo plus levodopa. Following a 7-week,
11、 ascending-dose schedule, subjects entered a 24-week maintenance phase. Patients were treated concomitantly with levodopa and could additionally be taking selegiline, anticholinergics, amantadine, or any combination of these agents. For the primary endpoints, significant improvements in ADL “on” and
12、 “off” and motor scores “on” were observed among pramipexole patients (ITT population; some patients were excluded from analysis) versus those receiving placebo.ADL scores during “off” and “on” times were improved 22% and 4% for pramipexole and placebo, respectively.ADL scores during “on” times were
13、 improved 18% and 1%, respectively.Motor “on” scores were improved 25% and 12%, respectively. For additional secondary ADL endpoints, the average daily “off” time was reduced by 31% among pramipexole-treated patients, and the severity of ADL “off” time was lessened.Reference:Data on file. A double-blind, placebo-controlled, parallel-group comparison to assess the safety, tolerance, and efficacy of pramipexole in advanced Parkinsons disease. TR9158-95-023. October 1995.
