Abstract
Data concerning efficacy, safety, and patient satisfaction of levodopa/carbidopa intestinal gel (LCIG, Duodopa, AbbVie, Wavre, Belgium) infusion in routine clinical practice were needed to maintain reimbursement of the drug in Belgium. Patients with advanced Parkinson’s disease in 27 neurology centers across Belgium were included. Of 100 patients who underwent naso-intestinal (NI) evaluation with LCIG, 67 received permanent treatment with LCIG via percutaneous endoscopic gastrostomy and jejunal tube (PEG/J). Efficacy was evaluated at baseline (on levodopa) and during a follow-up (FU) visit (on LCIG) using the Unified Parkinson’s Disease Rating Scale (UPDRS) IV. Patient appraisal of the Duodopa system was evaluated using a visual analog scale for therapy compliance, user-friendliness, and global appreciation. Safety was assessed by reporting suspected adverse drug reactions (ADRs) and medical device-related complaints. FU evaluations were conducted in 37 patients. Significant improvement at FU was observed for motor complications (UPDRS IV) as the mean change from baseline to FU was −6.3 (95 % CI −8.1 to −4.5). Patient appraisal showed high scores for hospital delivery, user-friendliness, and patient global appreciation, as well as family appreciation of the system on daily life. Few ADRs and system malfunctions were reported, with no unexpected ADRs. In conclusion, the symptoms and impact of Parkinsonism improved markedly when LCIG PEG/J was initiated.
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Acknowledgments
This Belgian observational study was sponsored by AbbVie sa/nv, Wavre, Belgium. AbbVie contributed to study design, research, and interpretation of data, writing, reviewing, and approving the publication.The authors are grateful to all neurologists who participated as investigators in the Belgian Duodopa Study: Algoed L. Gent; Bourgeois Ph. Roeselare; Bourgeois P. Kortrijk; Cras P. Antwerpen; Daems P. Oostende; Delvaux V. Liège; De Quick M. Tienen; Flamez A. Brussel; Geens K. Brasschaat; Goethals M. Torhout; Leenders J. Geel; Pals Ph. Duffel; Soeur M. Bruxelles; Strauven T. Wilrijk; Tack Ph. Tielt; Van den Abeele K. Waregem; Vandenberghe W. Leuven; Van den kerchove M. Antwerpen; Van Landegem W. Wilrijk; Van Zandijcke M. Brugge; Vercruyssen A. Sint Niklaas; Verhalle D. Oostende; Viaene M.K. Geel; Viaene P. Genk.
Conflict of interest
Barbara Pickut received honoraria from AbbVie and St Jude Medical. Chris van der Linden and Sophie Dethy attest that they have no relevant financial disclosures or relationships with people/organizations that may have inappropriately influenced the outcome/results of this study. Hilde Van De Maele is an employee of AbbVie SA/NV, Wavre, Belgium. Diederik Zegers de Beyl received honoraria and travel expenses from AbbVie.
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For the Belgian Duodopa Study Group.
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Pickut, B.A., van der Linden, C., Dethy, S. et al. Intestinal levodopa infusion: the Belgian experience. Neurol Sci 35, 861–866 (2014). https://doi.org/10.1007/s10072-013-1612-5
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DOI: https://doi.org/10.1007/s10072-013-1612-5