期刊
MOVEMENT DISORDERS
卷 24, 期 9, 页码 1319-1324出版社
WILEY-LISS
DOI: 10.1002/mds.22587
关键词
Parkinson's disease; levodopa; entacapone; pharmacokinetics; pharmacodynamics; motor fluctuation
资金
- Novartis Phannaceutical Corporation
Controlled-release carbidopa and levodopa (CL-CR) and the combination of carbidopa, levodopa, and entacapone (CLE) are used for extending levodopa (L-dopa) effects. In a randomized, open-label crossover study of 17 PD subjects with wearing-off responses, we compared 8-hour L-dopa pharmacokinetics (PK) and clinical effects after two doses of CL-CR (50 and 200 mg, respectively) and CLE (37.7, 150, 200 mg, respectively). PK analysis revealed the anticipated near-equivalent mean L-dopa area-under-the-concentration-curve values (639,490 ng min/mL for two doses of CLE, and 662,577 for CL-CR, P = 0.86). The mean hourly fluctuation index for L-dopa concentration was 235% for CLE and 196% for CL-CR (P = 0.004). The mean maximal concentration for the first CLE dose was 1,926 +/- 760 ng/mL and for CL-CR, 1,840 +/- 889 (P = 0.33). During the PK studies, the mean time that L-dopa concentration was >= 1,000 ng/mL for CLE was 291 88 minutes and for CL-CR, 306 +/- 86 (P = 0.33). The mean percent-time in off state was 18% for CLE and 28% for CL-CR (P = 0.017), on state without dyskinesia was 64% for CLE and 65% for CL-CR (P = 0.803), and on state with nontroublesome dyskinesia was 18% for CLE and 7% for CL-CR (P = 0.03). Despite less off time with CLE, both formulations demonstrated similar mean PK values and marked intersubject PK variability. (C) 2009 Movement Disorder Society
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