Levodopa–Carbidopa–Entacapone Intestinal Gel in Advanced Parkinson Disease: A Multicenter Real-Life Experience

Abstract

Background: For Parkinson disease (PD) patients who have been diagnosed with advanced disease that can no longer be effectively controlled with optimized oral or transdermal medications, a range of device-aided therapies (DAT) are available, comprising either deep brain stimulation or infusion therapies providing continuous dopaminergic stimulation. Levodopa–entacapone–carbidopa intestinal gel (LECIG) infusion is the latest DAT for advanced PD (APD) that was approved in Romania in 2021. Study Question: What is the experience to date in real-world clinical practice in Romania regarding the efficacy and tolerability of LECIG in APD? Study Design: A retrospective evaluation of 74 APD patients treated with LECIG at 12 specialized APD centers in Romania. Measures and Outcomes: Demographic data and various clinical parameters were recorded, including Mini Mental State Evaluation score or Montreal Cognitive Assessment Test score. Levodopa-equivalent daily dose and the administered doses of levodopa and other PD medications were evaluated at baseline and after starting LECIG treatment. The efficacy of LECIG in reducing daily hours of off time, motor fluctuations, and dyskinesias were assessed. Any percutaneous endoscopic gastrojejunostomy system or device complications after starting LECIG treatment were noted. Results: At baseline, patients were taking oral levodopa for a mean of 5.3 times per day, with a high proportion also taking concomitant add-on therapies (dopamine agonists, 86%, monoamine oxidase type-B inhibitors, 53%; catechol-O-methyltransferase inhibitors, 64%). LECIG treatment significantly reduced daily off time versus baseline from 5.7 h/d to 1.7 hours per day (P < 0.01). Duration and severity of dyskinesias was also significantly reduced versus baseline, and improvements were observed in Hoehn and Yahr Scale scores. LECIG treatment also allowed a significant reduction in the use of concomitant oral medications. Conclusions: These findings suggest that LECIG treatment is an effective DAT option in APD that can simplify the treatment regimen.

Levodopa–Entacapone–Carbidopa Intestinal Gel in the Treatment of Advanced Parkinson’s Disease: A Single Center Real-World Experience

“…As the experience using LECIG was limited when it became available in our country, we selected for initiation mostly patients who previously also had entacapone therapy. In a recently published retrospective evaluation of 74 APD patients treated with LECIG at 12 specialized APD centers in Romania, we showed that during the titration period as well as the post-PEG adjustment period, we did not encounter any significant adverse effects compared to those mentioned in the literature regarding the PEG insertion procedure [ 56 ]. We would like to point out that in the present evaluation, none of the entacapone-naive patients experienced gastrointestinal adverse effects; furthermore, none of the patients showed modified laboratory results on further testing.…”