Long‐term safety and efficacy of levodopa‐carbidopa intestinal gel in advanced Parkinson's disease
ABSTRACT Background: Levodopa‐carbidopa intestinal gel (designated as carbidopa‐levodopa enteral suspension in the United States) provides stable plasma levodopa concentrations and reduces motor fluctuations in advanced Parkinson's disease patients through continuous delivery of levodopa via pe...
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| Published in: | Movement disorders Vol. 33; no. 6; pp. 928 - 936 |
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| Main Authors: | , , , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
01.07.2018
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| Subjects: | |
| ISSN: | 0885-3185, 1531-8257, 1531-8257 |
| Online Access: | Get full text |
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| Summary: | ABSTRACT
Background: Levodopa‐carbidopa intestinal gel (designated as carbidopa‐levodopa enteral suspension in the United States) provides stable plasma levodopa concentrations and reduces motor fluctuations in advanced Parkinson's disease patients through continuous delivery of levodopa via percutaneous endoscopic gastrojejunostomy. We report long‐term safety and efficacy outcomes from an open‐label phase 3 treatment program.
Methods: PD patients (n = 262) who completed a 12‐week double‐blind study and its 52‐week open‐label extension or a separate 54‐week open‐label study were enrolled in this ongoing phase 3 open‐label, multinational study (NCT00660673). Safety and efficacy assessments were collected every 6 months.
Results: Mean total duration of exposure to levodopa‐carbidopa intestinal gel was 4.1 years (range, 1.2 to 6.9 years). The overall discontinuation rate was 34% (average annual discontinuation rate, 10%). Although most patients (94%) reported an adverse event, the rate of adverse events decreased over time; 53% experienced a serious adverse event. Of patients in this extension study, 54% required jejunal tube replacement during the study, and 37% required percutaneous endoscopic gastrostomy tube replacement. Most patients were on levodopa monotherapy. Patients maintained reductions in “off” time and increases in mean “on” time without dyskinesia from initial levodopa‐carbidopa intestinal gel infusion to he study end point (P < 0.001; n = 81). Activities of daily living and quality‐of‐life assessments demonstrated significant improvements that persisted through the study.
Conclusions: This long‐term study demonstrates sustained and clinically meaningful benefits from levodopa‐carbidopa intestinal gel in advanced PD patients. Although adverse event rates decreased over time, vigilance is required for device‐related complications and adverse events. © 2018 International Parkinson and Movement Disorder Society |
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| Bibliography: | Correction added on November 1, 2018, after first print and online publication: Open access has been removed and updated in the online text and PDF versions of this article to reflect the correct citation. Relevant conflicts of interest/financial disclosures Funding agencies H.H.F. has received research support from and has served as consultant/scientific adviser and lecturer for AbbVie. J.T.B. has received research support from and has served as a consultant/scientific adviser for AbbVie. V.S.C.F. has received research support from AbbVie. M.F.L. has received research support from and has served as a consultant, adviser, and/or lecturer for AbbVie. R.L.R. has received research support from AbbVie and honoraria from AbbVie for an educational symposium. J.T.S. has received research support from and has served as an adviser for AbbVie. D.G.S. is an investigator in studies funded by AbbVie and has served as a consultant or received honoraria from AbbVie; honoraria paid by AbbVie were for activities unrelated to authorship. C.Z. has received educational grants from and has served as an adviser for AbbVie. A.D.V. has received compensation from AbbVie for consultancy and advisory board services. C.H., W.Z.R., M.F.F., and J.B. are employees of AbbVie, and hold AbbVie stock and/or stock options. K.C. and S.E. are former employees of AbbVie. A.J.E. has received compensation as a consultant/scientific advisory board member from AbbVie. This study was funded by AbbVie Inc. AbbVie participated in the study design, research, data collection, analysis, and interpretation of data, writing, reviewing, and approving this manuscript for publication. ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 |
| ISSN: | 0885-3185 1531-8257 1531-8257 |
| DOI: | 10.1002/mds.27338 |