Dataset Information

Levodopa-Carbidopa Intestinal Gel Monotherapy: GLORIA Registry Demographics, Efficacy, and Safety.

ABSTRACT:

Background

Continuous delivery of levodopa-carbidopa intestinal gel (LCIG) provides stable plasma levodopa concentrations and reduces motor fluctuations in advanced Parkinson's disease (PD) patients.

Objective

To compare the effectiveness and safety of LCIG monotherapy vs polytherapy in patients in the GLORIA registry.

Methods

This was a post hoc analysis of a 24-month, multinational observational registry where advanced PD patients with persistent motor complications received LCIG (with adjunctive PD treatment, as necessary). Patients were categorized retrospectively into three stable treatment groups: LCIG monotherapy, LCIG in combination with oral levodopa only ("levodopa monotherapy" [including nighttime oral levodopa]), or LCIG in combination with any other antiparkinsonian medication ("LCIG polytherapy").

Results

Of 356 patients, 208 were on stable regimens (LCIG monotherapy n?=?80; levodopa monotherapy n?=?47; LCIG polytherapy n?=?81). Baseline characteristics were similar across groups. LCIG monotherapy showed significant improvements until month 18 in activities of daily living and quality of life, and until month 24 for Unified Parkinson's Disease Rating Scale (UPDRS) motor examination (p?ConclusionsThese data demonstrate that LCIG monotherapy is an effective treatment option in appropriate advanced PD patients; however, definitive baseline clinical predictors identifying patients who can discontinue concomitant oral therapy have not yet been defined.

SUBMITTER: Poewe W

PROVIDER: S-EPMC6700622 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Publications

Levodopa-Carbidopa Intestinal Gel Monotherapy: GLORIA Registry Demographics, Efficacy, and Safety.

Poewe Werner W Bergmann Lars L Kukreja Pavnit P Robieson Weining Z WZ Antonini Angelo A

Journal of Parkinson's disease 20190101 3

<h4>Background</h4>Continuous delivery of levodopa-carbidopa intestinal gel (LCIG) provides stable plasma levodopa concentrations and reduces motor fluctuations in advanced Parkinson's disease (PD) patients.<h4>Objective</h4>To compare the effectiveness and safety of LCIG monotherapy vs polytherapy in patients in the GLORIA registry.<h4>Methods</h4>This was a post hoc analysis of a 24-month, multinational observational registry where advanced PD patients with persistent motor complications recei ...[more]

PMID: 31282424

Similar Datasets

Project description:BackgroundContinuous administration of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) through a percutaneous endoscopic gastrojejunostomy is a treatment option for advanced Parkinson disease (PD) patients with motor fluctuations resistant to standard oral medications. Safety data from 4 prospective studies were integrated to assess the safety of this therapy.MethodsSafety data from 4 studies were summarized using 2 overlapping data sets, permitting the separation of procedure/device-associated (n = 395) from non-procedure/device adverse events (n = 412).ResultsAt the data cutoff, median exposure to levodopa-carbidopa intestinal gel was 911 days (range, 1-1980 days) with 963 total patient-years of exposure. Procedure/device adverse events occurred in 300 patients (76%), and serious adverse events occurred in 68 (17%); most frequently reported procedure/device adverse events and serious adverse events were complications of device insertion (41% and 8%, respectively) and abdominal pain (36% and 4%, respectively). Non-procedure/device adverse events occurred in 92% (379), with most frequently reported being insomnia (23%) and falls (23%); 42% (171) had non-procedure/device serious adverse events, with most frequently reported being pneumonia (5%) and PD symptoms (2%). Adverse events led to discontinuation in 17% (72), most frequently because of complication of device insertion (2.4%). There were 34 treatment-emergent deaths (8.3%) in the overlapping data sets, 2 of which (0.5%) were considered "possibly related" to the treatment system.ConclusionIn the largest collection of levodopa-carbidopa intestinal gel safety data from prospective clinical studies, procedure/device events were frequently reported and occasionally life threatening. Most non-procedure/device events were typical for levodopa treatment and an elderly population. These factors combined with high treatment efficacy led to a relatively low discontinuation rate in advanced PD patients.

Dataset Information

Levodopa-Carbidopa Intestinal Gel Monotherapy: GLORIA Registry Demographics, Efficacy, and Safety.

Background

Objective

Methods

Results

Publications

Levodopa-Carbidopa Intestinal Gel Monotherapy: GLORIA Registry Demographics, Efficacy, and Safety.

Similar Datasets

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