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The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson's disease: a randomized, double-blind, double-dummy, parallel-group study.

Wang Y, Sun S, Zhu S, Liu C, Liu Y, Di Q, Shang H, Ren Y, Lu C, Gordon MF, Juhel N, Chen S - Transl Neurodegener (2014)

Bottom Line: For the primary endpoint, the adjusted mean changes (standard error) of UPDRS Parts II + III at week 18 were -13.81 (0.655) and -13.05 (0.643) for ER and IR formulations, respectively, using ANCOVA adjusted for treatment and centre (fixed effect) and baseline (covariate).The safety profiles of pramipexole ER and IR were similar.These results were based on comparable mean daily doses and durations of treatment for both formulations.

View Article: PubMed Central - HTML - PubMed

Affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.

ABSTRACT

Objective: To evaluate the non-inferiority of pramipexole extended-release (ER) versus immediate-release (IR) in Chinese patients with Parkinson's disease (PD) in a double-blind, randomized, parallel-group study.

Methods: Subjects were Chinese patients with idiopathic PD with diagnosis ≥ 2 years prior to trial, age ≥ 30 years old at diagnosis, and Modified Hoehn and Yahr score 2-4 during 'on'-time. Subjects received treatment with pramipexole ER (n=234) or IR (n=239). Non-inferiority was based on the primary endpoint, the change from baseline to end of maintenance (week 18) in the UPDRS (Parts II + III) total score.

Results: For the primary endpoint, the adjusted mean changes (standard error) of UPDRS Parts II + III at week 18 were -13.81 (0.655) and -13.05 (0.643) for ER and IR formulations, respectively, using ANCOVA adjusted for treatment and centre (fixed effect) and baseline (covariate). The adjusted mean between group difference was 0.8 for the 2-sided 95% CI (-1.047, 2.566). Since the lower limit of the 2-sided 95% CI (-1.047) for treatment difference was higher than the non-inferiority margin of -4, non-inferiority between pramipexole ER and IR was demonstrated. The incidence of adverse events (AEs) was 68.8% in the ER arm and 73.6% in the IR arm with few severe AEs (ER: 2.1%; IR: 3.8%).

Conclusion: Based on the UPDRS II + III score, pramipexole ER was non-inferior to pramipexole IR. The safety profiles of pramipexole ER and IR were similar. These results were based on comparable mean daily doses and durations of treatment for both formulations.

No MeSH data available.


Related in: MedlinePlus

Reduction of ‘off’-time in advanced PD patients. (A) Adjusted mean change in the percentage of ‘off’-time over time in patients with advanced Parkinson disease (PD), full analysis set (FAS) (last observation carried forward, LOCF); (B) Adjusted mean duration (±SE) of ‘off’-time. For A and B: No difference was observed in the adjusted mean percentage ‘off’-time or duration between the two arms at any study visit (ANCOVA).
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Figure 2: Reduction of ‘off’-time in advanced PD patients. (A) Adjusted mean change in the percentage of ‘off’-time over time in patients with advanced Parkinson disease (PD), full analysis set (FAS) (last observation carried forward, LOCF); (B) Adjusted mean duration (±SE) of ‘off’-time. For A and B: No difference was observed in the adjusted mean percentage ‘off’-time or duration between the two arms at any study visit (ANCOVA).

Mentions: The mean (SE) ‘off’-time percentage during waking hours at baseline for advanced PD patients was 27.78 (0.81) for ER and 30.80 (1.21) for IR, and decreased to 21.68 (1.53) at week 18 for ER and 22.46 (1.61) for IR, respectively (no statistical difference for superiority). The adjusted mean change (ANCOVA) from baseline was -6.96 (1.51) for ER and -7.4 (1.54) for IR. The adjusted mean change (ANCOVA) from baseline in the mean duration of ‘off’-time was comparable between the two arms (ER: -1.0 (0.23) h; IR: -1.1 (0.23) h). Furthermore, the two arms revealed a similar response with most of the improvement having occurred after approximately 6 weeks of treatment (Figure 2). No difference was observed in the mean ‘off’-time percentage or duration between the two arms at any study visit (ANCOVA). Additionally, a similar response rate for ‘off’-time was observed in the ER and IR arms after 18 weeks (52.7% vs. 55.7%).


The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson's disease: a randomized, double-blind, double-dummy, parallel-group study.

Wang Y, Sun S, Zhu S, Liu C, Liu Y, Di Q, Shang H, Ren Y, Lu C, Gordon MF, Juhel N, Chen S - Transl Neurodegener (2014)

Reduction of ‘off’-time in advanced PD patients. (A) Adjusted mean change in the percentage of ‘off’-time over time in patients with advanced Parkinson disease (PD), full analysis set (FAS) (last observation carried forward, LOCF); (B) Adjusted mean duration (±SE) of ‘off’-time. For A and B: No difference was observed in the adjusted mean percentage ‘off’-time or duration between the two arms at any study visit (ANCOVA).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4128609&req=5

Figure 2: Reduction of ‘off’-time in advanced PD patients. (A) Adjusted mean change in the percentage of ‘off’-time over time in patients with advanced Parkinson disease (PD), full analysis set (FAS) (last observation carried forward, LOCF); (B) Adjusted mean duration (±SE) of ‘off’-time. For A and B: No difference was observed in the adjusted mean percentage ‘off’-time or duration between the two arms at any study visit (ANCOVA).
Mentions: The mean (SE) ‘off’-time percentage during waking hours at baseline for advanced PD patients was 27.78 (0.81) for ER and 30.80 (1.21) for IR, and decreased to 21.68 (1.53) at week 18 for ER and 22.46 (1.61) for IR, respectively (no statistical difference for superiority). The adjusted mean change (ANCOVA) from baseline was -6.96 (1.51) for ER and -7.4 (1.54) for IR. The adjusted mean change (ANCOVA) from baseline in the mean duration of ‘off’-time was comparable between the two arms (ER: -1.0 (0.23) h; IR: -1.1 (0.23) h). Furthermore, the two arms revealed a similar response with most of the improvement having occurred after approximately 6 weeks of treatment (Figure 2). No difference was observed in the mean ‘off’-time percentage or duration between the two arms at any study visit (ANCOVA). Additionally, a similar response rate for ‘off’-time was observed in the ER and IR arms after 18 weeks (52.7% vs. 55.7%).

Bottom Line: For the primary endpoint, the adjusted mean changes (standard error) of UPDRS Parts II + III at week 18 were -13.81 (0.655) and -13.05 (0.643) for ER and IR formulations, respectively, using ANCOVA adjusted for treatment and centre (fixed effect) and baseline (covariate).The safety profiles of pramipexole ER and IR were similar.These results were based on comparable mean daily doses and durations of treatment for both formulations.

View Article: PubMed Central - HTML - PubMed

Affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.

ABSTRACT

Objective: To evaluate the non-inferiority of pramipexole extended-release (ER) versus immediate-release (IR) in Chinese patients with Parkinson's disease (PD) in a double-blind, randomized, parallel-group study.

Methods: Subjects were Chinese patients with idiopathic PD with diagnosis ≥ 2 years prior to trial, age ≥ 30 years old at diagnosis, and Modified Hoehn and Yahr score 2-4 during 'on'-time. Subjects received treatment with pramipexole ER (n=234) or IR (n=239). Non-inferiority was based on the primary endpoint, the change from baseline to end of maintenance (week 18) in the UPDRS (Parts II + III) total score.

Results: For the primary endpoint, the adjusted mean changes (standard error) of UPDRS Parts II + III at week 18 were -13.81 (0.655) and -13.05 (0.643) for ER and IR formulations, respectively, using ANCOVA adjusted for treatment and centre (fixed effect) and baseline (covariate). The adjusted mean between group difference was 0.8 for the 2-sided 95% CI (-1.047, 2.566). Since the lower limit of the 2-sided 95% CI (-1.047) for treatment difference was higher than the non-inferiority margin of -4, non-inferiority between pramipexole ER and IR was demonstrated. The incidence of adverse events (AEs) was 68.8% in the ER arm and 73.6% in the IR arm with few severe AEs (ER: 2.1%; IR: 3.8%).

Conclusion: Based on the UPDRS II + III score, pramipexole ER was non-inferior to pramipexole IR. The safety profiles of pramipexole ER and IR were similar. These results were based on comparable mean daily doses and durations of treatment for both formulations.

No MeSH data available.


Related in: MedlinePlus