Objective: To investigate efficacy, tolerability, and safety of levodopa-entacapone-carbidopa intestinal gel (LECIG) in Parkinson’s disease.
Background: LECIG was introduced in 2019. The approval was based on one pharmacokinetic trial [1], which implies a knowledge gap regarding long-term efficacy and safety. Furthermore, only one study from a single center on real-life experience of LECIG was found [2].
Method: All patients treated with LECIG in Sweden from 2019 until September 2022 had the possibility to be included in the Swedish national register of Parkinson’s disease, ParkReg. The register includes prospectively collected data such as baseline characteristics, Parkinson KinetiGraph’s (PKG) data, Parkinson’s disease questionnaire-8 (PDQ-8), EuroQol five dimensions questionnaire (EQ5D) and plasma levels of homocysteine (p-Hcy). Data before and during LECIG treatment was collected.
Results: All eligible patients in ParkReg were included (n=150). Sixty-one (41%) of 150 patients were females. Median (range) age in years was 73 (43-86). Median (IQR) duration since motor symptoms onset in years was 17 (9). Twenty (13.3%) of 150 patients discontinued LECIG. Eleven (7.3%) of 150 patients died while on LECIG. Reported complications were mainly related to PEG-J tube and stoma (30% of 150 patients). The median (IQR) PKG scores for 53 patients during LECIG were as follows: bradykinesia score (BKS) was 23.3 (7.5), dyskinesia score (DKS) was 8.3 (10), fluctuation dyskinesia score (FDS) was 10.3 (6.8), percent time immobility score (PTI) was 3.5 (6.7) and percent time tremor score (PTT) was 0.7 (1.4). The median (IQR) p-Hcy during LECIG was 12 (4.6) µmol/L (n=44). Median (IQR) PDQ8-SI during LECIG was 31 (17) (n=52). Median (IQR) EQ5D-SI during LECIG was 0.62 (0.32) (n=41). In patients with data from before and during LECIG median PKG-FDS decreased from 11.6 to 10 (n=25, p=0.043) and mean PDQ8-SI improved from 40 to 36 (n=33, p=0.018).
Conclusion: With more than 3 years of clinical experience with LECIG in 150 patients, we conclude that LECIG is a viable alternative for the management of advanced PD. Long-term efficacy and tolerability of LECIG need to be further investigated.
A previous version of this abstract is accepted for presentation at the AD/PD conference in Gothenburg, Sweden, April 2023.
References: [1] Senek et al. Levodopa-entacapone-carbidopa intestinal gel in Parkinson’s disease: A randomized crossover study. Mov Disord. 2017 Feb;32(2):283-286.
[2] Öthman et al. Initial Experience of the Levodopa-Entacapone-Carbidopa Intestinal Gel in Clinical Practice. J Pers Med. 2021 Mar 31;11(4):254.
To cite this abstract in AMA style:
M. öthman, P. Odin, F. Bergquist, A. Johansson, R. Constantinescu, M. Scharfenort, H. Widner, D. Nyholm. Levodopa-entacapone-carbidopa intestinal gel infusion for Parkinson’s disease: An analysis of data collected from the Swedish national register of Parkinson’s disease. [abstract]. Mov Disord. 2023; 38 (suppl 1). https://www.mdsabstracts.org/abstract/levodopa-entacapone-carbidopa-intestinal-gel-infusion-for-parkinsons-disease-an-analysis-of-data-collected-from-the-swedish-national-register-of-parkinsons-disease/. Accessed November 24, 2024.« Back to 2023 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/levodopa-entacapone-carbidopa-intestinal-gel-infusion-for-parkinsons-disease-an-analysis-of-data-collected-from-the-swedish-national-register-of-parkinsons-disease/