课件：普拉克索缓释片的临床应用.pptVIP

Four patients switched from pramipexole immediate release (IR) to pramipexole sustained release (SR) withdrew prematurely from the study and 3 of those remained on IR. A large majority of patients (87/103, 84.5%) successfully switched to SR, although non-inferiority could not be formally demonstrated vs. IR, as the lower bound of the 95% CI (-18.8%) was lower than the conventionally predefined non-inferiority margin of -15% (between group difference -9.76%, 95% CI [-18.81, 1.66]).1 Reference Rascol O, Barone P, Debieuvre C, et al. Easy switching from immediate- to extended-release pramipexole in early Parkinson’s disease at the same daily dosage. Poster presented at the Movement Disorder Society 13th International Congress, Paris , France, June 7-11, 2009, P-255. While a large majority of patients (87/103, 84.5%) successfully switched overnight to SR (with possible dose adaptation), non-inferiority could not be formally demonstrated vs. IR (94.2%, between-group difference, -9.76%; 95% CI [-18.81, +1.66])1. Reference Rascol O, Barone P, Debieuvre C, et al. Easy switching from immediate- to extended-release pramipexole in early Parkinson’s disease at the same daily dosage. Poster presented at the Movement Disorder Society 13th International Congress, Paris, France, June 7-11, 2009, Th-255. Of the 87 patients successfully switched to pramipexole sustained release (SR) , 72 (82.8%) did not require dose adjustment. In the ER group overall (n = 103), mean SR dosage was only marginally increased by 0.12 mg/d (from 2.63 to 2.75), for a ratio of 1:1.05. In the immediate-release (IR) group overall (n = 52), the increase was 0.09 mg/d (from 2.74 to 2.83), for a ratio of 1:1.03. Based on these data, a 1:1 mg overnight switch from pramipexole IR to SR can be recommended. However, a small proportion of patients may require some dose modification following switching1. Reference Rascol O, Barone P, Debieuvre C, et al. Easy switching from immediate- to extended-release pramipex