Levodopa–carbidopa intestinal gel in advanced Parkinson’s disease: long-term results from COSMOS

Abstract

Background While immediate benefits of levodopa–carbidopa intestinal gel (LCIG) are evident in patients with Parkinson’s disease (PD), long-term LCIG effects require further study. Objectives We explored long-term LCIG on motor symptoms, nonmotor symptoms (NMS), and LCIG treatment settings in patients with advanced PD (APD). Methods Data were obtained (medical records and patient visit) from COSMOS, a multinational, retrospective, cross-sectional post-marketing observational study in patients with APD. Patients were stratified into 5 groups based on LCIG treatment duration at the patient visit, from 1–2 to > 5 years LCIG. Between-group differences were assessed for changes from baseline in LCIG settings, motor symptoms, NMS, add-on medications, and safety. Results Out of 387 patients, the number of patients per LCIG group was: > 1– ≤ 2 years LCIG (n = 156); > 2– ≤ 3 years LCIG (n = 80); > 3– ≤ 4 years LCIG (n = 61); > 4– ≤ 5 years LCIG (n = 30); > 5 years LCIG (n = 60). Baseline values were similar; data reported are changes from the baseline. There were reductions in “off” time, dyskinesia duration, and severity across LCIG groups. Prevalence, severity, and frequency of many individual motor symptoms and some NMS were reduced amongst all LCIG groups, with few differences between groups. Doses for LCIG, LEDD and LEDD for add-on medications were similar across groups both at LCIG initiation and patient visit. Adverse events were similar across all LCIG groups and consistent with the established safety profile of LCIG. Conclusions LCIG may provide sustained, long-term symptom control, while potentially avoiding increases in add-on medication dosages. Trial registration ClinicalTrials.gov Identifier: NCT03362879. Number and date: P16-831, November 30, 2017.

Nationwide Retrospective Analysis of Combinations of Advanced Therapies in Patients With Parkinson Disease

“…Clinical benefit for more than 15 years is documented in some patients for DBS 19 and for more than 5 years for LCIG. 43 CSAI, although being clinically effective for more than 3 years, is often used as a bridging therapy because of its less-invasive procedures 10 and is characterized by a relevant dropout in studies because of side effects (mainly neuropsychiatric and cutaneous), 10,41 thereby resulting in the shortest time of use of all 3 ATs.…”

“…Clinical benefit for more than 15 years is documented in some patients for DBS 19 and for more than 5 years for LCIG. 43 CSAI, although being clinically effective for more than 3 years, is often used as a bridging therapy because of its less-invasive procedures 10 and is characterized by a relevant dropout in studies because of side effects (mainly neuropsychiatric and cutaneous), 10,41 44 Cost reduction efforts need to be discussed for AT combinations because an addition of costs in AT combinations is expected (devices, surgery, hospitalization, and continuous drug provision). No data so far exist concerning real-life costs of combined ATs, compared with best medical treatment, however.…”

Levodopa infusion therapies for Parkinson disease

“…DUOGLOBE demonstrated that benefits with respect to off time and other parameters persist for at least 3 years [4 ▪ ]. COSMOS reported continued efficacy in patients treated for 5 years or more [14]. A recent report from Canada described patients treated for 5 years or more, with persistent improvement in off time (mean 3.3 h) and no worsening of dyskinesia [15].…”

Low intensity focused ultrasound: a new prospect for the treatment of Parkinson’s disease

“…Currently, surgical methods available for the treatment of PD include deep brain stimulation (DBS) [ 10 , 11 ], levodopa carbidopa intestinal gel therapy [ 12 ], HIFU ablation of the subthalamic nucleus [ 13 ], and other methods, but these methods are highly invasive. At present, HIFU is mainly used clinically for PD, such as MRgFUS (unilateral [ 14–16 ] or bilateral [ 17 , 18 ]), and unilateral FUS-STN [ 19 ].The clinical efficacy of non-incisional transcranial MRgFUS will ultimately rest in appropriate target selection and optimized thermolesional coverage of the target [ 16 , 20 ].…”