Advanced Parkinson's Disease Treatment Simplification and Long-Term Outcomes with Levodopa Carbidopa Intestinal Gel: COSMOS Romanian Subanalysis.

Mihaela Adriana Simu,József Attila Szász,Juan Carlos Parra,Diana Popescu,Viorelia Adelina Constantin,Adriana Octaviana Dulamea,Dragoș Cătălin Jianu

doi:10.3390/brainsci11121566

Abstract

The aim of the COmedication Study assessing Mono- and cOmbination therapy with levodopa-carbidopa inteStinal gel (COSMOS) was to assess the use of levodopa/carbidopa intestinal gel (LCIG) as monotherapy in patients with advanced Parkinson’s disease (APD) in routine clinical practice. COSMOS was an international observational study with one cross-sectional visit and retrospective data collection. In Romania, 95 adult patients with APD on LCIG treatment for at least 12 months were enrolled and stratified according to their LCIG therapy after 12 months: monotherapy (without any add-on PD medication), monotherapy with night PD medication and LCIG + add-on medication. Compared to the moment of LCIG initiation, the percentage of patients on monotherapy increased at three months after LCIG initiation and remained constant up to 12 months, when 30.5% of the patients were on LCIG monotherapy and 11.6% were on monotherapy with night medication. “Off” time and “On” time with dyskinesia decreased from LCIG initiation to patient visit in all groups. LCIG monotherapy with or without night medication may provide a simplified treatment option for selected APD patients, with long-term efficacy similar to that of LCIG plus add-on medication.

Highlights

Levodopa, a precursor of dopamine, is currently considered the most efficient therapy for Parkinson’s disease (PD) [1]
The mean number of PD and advanced Parkinson’s disease (APD) patients treated per year by these investigators was
In the current analysis of the COSMOS study, only four ADRs were reported, one in the levodopa/carbidopa intestinal gel (LCIG) initiation phase and three during the maintenance therapy. This low number should be interpreted with caution as ADRs were collected retrospectively and, an under-reporting or lack of recording in medical charts may have occurred. In this analysis of the COSMOS results, LCIG monotherapy was associated with improvements in patient-reported outcomes comparable to the ones reported by patients on LCIG with add-on medication

Summary

Introduction

A precursor of dopamine, is currently considered the most efficient therapy for Parkinson’s disease (PD) [1]. Long-term use of levodopa is associated with the development of motor fluctuations with alternating periods of good and poor symptom control and dyskinesia [2]. Possible causes of these motor fluctuations include progressive degeneration of the dopaminergic neurons involved in the conversion of levodopa to dopamine, pulsatile stimulation of receptors after oral levodopa administration [3,4,5], and gastrointestinal dysfunction with variable gastric emptying rates, as well as impaired intestinal absorption, a symptom developed in many patients over the course of the disease [6]. Clinical trials and post-marketing observational studies on the use of LCIG in routine care conditions have demonstrated LCIG efficacy and safety [10,11,12,13,14,15] and long-term improvements in motor symptoms and quality of life in patients with advanced PD (APD) [7,16,17,18]

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Results

Discussion

Conclusion