Levodopa-Entacapone-Carbidopa Intestinal Gel Shows Minimal Benefits Over Traditional Parkinson Therapies

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Apart from the small pump system, which was preferred by the patients, the study found no clear advantage of levodopa-entacapone-carbidopa to levodopa-carbidopa intestinal gel.

Vili Viljaharju MD, neurologist at Helsinki University Hospital

Vili Viljaharju MD

In a single-center study of levodopa-entacapone-carbidopa intestinal gel (LECIG), a Parkinson disease (PD) therapy available in Finland since 2020, data showed an increase in levodopa equivalent daily dose (LEDD) over the first months of treatment, with a smaller pump size as the only clear advantage over levodopa-carbidopa intestinal gel (LCIG).1

Published in Movement Disorders, the retrospective longitudinal observational study comprised of 30 patients with advanced PD who received LECIG treatment between August 2020 and December 2022. LECIG treatment was initiated through PEG-J tube either after NJT test phase, directly after a positive LCT, or directly switching from LCIG to LECIG. Three patients were discarded during the NJT test phase while 7 discontinued treatment before the 6 month follow-up and 1 moved to another region, leaving 19 patients who completed 6 months of follow-up.

All patients were eligible for both LCIG and LECIG treatments but chose LECIG because of its smaller pump system. All patients used LECIG for 16 hours daily during the follow-up. Led by Vili Viljaharju, MD, neurologist at Helsinki University Hospital, the study showed a significant increase in LEDD after 6 months of treatment (1230 mg vs 1570 mg; P = .001). Similarly, there was a rise in the daily levodopa dose (891 mg vs 1096 mg; P = .03) during the same follow-up period.

"Apart from the small pump system, which the patients prefer, no clear advantage of LECIG compared to LCIG can be established," the study investigators wrote. "However, long-term data are lacking. Further research with larger patient groups and longer follow-up is needed to examine the safety and efficacy of LECIG treatment."

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As patients’ LEDD and daily levodopa dose increased while on therapy, the mean entacapone dose did not change (1075 mg vs 1018 mg; P = 64; n = 16) between baseline before LECIG initiation (or entacapone) and 6-month follow-up (LECIG-infusion). Entacapone was tolerated without any adverse events (AEs), with 83% of patients reported using the therapy at baseline prior to LECIG initiation.

The discontinuation rate during the first 6 months of LECIG treatment was 26% and 1 patient died of reasons unrelated to the study drug. During the NJT test phase, 2 of the 3 discontinuations were because of neuropsychiatric problems (delirium and hallucinations) and 1 because of difficulties using the pump system. Throughout the study, 2 patients discontinued treatment due to difficulty in finding a suitable infusion rate and 2 because of neuropsychiatric issues. One patient, who had trouble with finding an optimal infusion rate at the start of LECIG treatment, later developed rhabdomyolysis because of severe dyskinesia and thus discontinued treatment.

In the study, 3 patients who had difficulties in finding suitable infusion rates were below the average baseline weight of 67 kg at the 6-month follow-up. On average, there was no significant change in weight over this time in the total cohort (67 kg vs 66 kg; P =.43); however, there were 2 cases of significant weight loss, of which the other was considered as treatment-related.

REFERENCE
1. Viljaharju V, Mertsalmi T, Pauls KAM, et al. Levodopa-entacapone-carbidopa intestinal gel treatment in advanced Parkinson’s disease: a single-center study of 30 patients. Mov Disord. Published online November 15, 2023. doi:10.1002/mdc3.13926
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