Dataset Information

Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients.

ABSTRACT:

Objective

The purpose of this study was to assess the effect of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) in advanced Parkinson's disease patients with troublesome dyskinesia.

Methods

Post hoc analyses of patient data from a 12-week, randomized, double-blind study and a 54-week open-label study were performed. Efficacy was assessed in the subgroup of patients defined by ?1 hour of "on" time with troublesome dyskinesia at baseline as recorded in Parkinson's disease symptom diaries (double blind: n?=?11 levodopa-carbidopa intestinal gel, n?=?12 oral levodopa-carbidopa; open label: n?=?144 levodopa-carbidopa intestinal gel). The changes in "off" time, "on" time with and without troublesome dyskinesia, and the overall safety and tolerability of levodopa-carbidopa intestinal gel were analyzed.

Results

Although not significantly different from oral levodopa treatment (P?>?.05) in the double-blind study, levodopa-carbidopa intestinal gel treatment resulted in a reduction from baseline in "on" time with troublesome dyskinesia (mean [standard deviation] hours: baseline?=?3.1 [1.7], change from baseline to final?=?-1.8 [1.8], P?=?.014), increase in "on" time without troublesome dyskinesia (baseline?=?7.4 [2.2], change?=?4.4 [3.6], P?=?.004), and decrease in "off" time (baseline?=?5.5 [1.3], change?=?-2.7 [2.8], P?=?.015). Similar trends were found in the open-label study. An increase in levodopa-carbidopa intestinal gel dose was not significantly correlated with increased "on" time with troublesome dyskinesia in either study (double blind: r?=?-.073, P?=?.842; open label: r?=?-0.001, P?=?.992). Adverse events were usually mild to moderate in severity and related to the gastrointestinal procedure.

Conclusion

Our exploratory analyses suggest that optimizing levodopa delivery with levodopa-carbidopa intestinal gel may reduce troublesome dyskinesia in advanced Parkinson's disease.

SUBMITTER: Antonini A

PROVIDER: S-EPMC5066747 | biostudies-literature | 2016 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients.

Antonini Angelo A Fung Victor S C VS Boyd James T JT Slevin John T JT Hall Coleen C Chatamra Krai K Eaton Susan S Benesh Janet A JA

Movement disorders : official journal of the Movement Disorder Society 20160128 4

<h4>Objective</h4>The purpose of this study was to assess the effect of levodopa-carbidopa intestinal gel (carbidopa-levodopa enteral suspension) in advanced Parkinson's disease patients with troublesome dyskinesia.<h4>Methods</h4>Post hoc analyses of patient data from a 12-week, randomized, double-blind study and a 54-week open-label study were performed. Efficacy was assessed in the subgroup of patients defined by ≥1 hour of "on" time with troublesome dyskinesia at baseline as recorded in Park ...[more]

PMID: 26817533

Similar Datasets

Project description:Levodopa-carbidopa intestinal gel (LCIG) has shown to be efficacious in motor and non-motor symptoms (NMS). Nevertheless, studies with patient Quality of Life (QoL) as a primary endpoint are scarce. To assess the effect of LCIG on Advanced Parkinson's Disease (APD) patients QoL. Secondarily, the impact on motor symptoms and NMS, emotional well-being, treatment satisfaction, and caregiver QoL, stress, disease burden, anxiety, depression, and work impairment were also investigated. In this prospective, 6-month multicenter postmarketing observational study, LCIG was administered to 59 patients with APD. Endpoints were assessed using validated scales and questionnaires. LCIG significantly improved patient QoL (PDQ-39 mean change ± standard deviation from baseline, -12.8 ± 14.6; P < 0.0001), motor symptoms (UPDRS-III in "On," -6.5 ± 11.8; P = 0.0002), NMS (NMSS, -35.7 ± 31.1; P < 0.0001), mood (Norris/Bond-Lader VAS, -6.6 ± 21.1; P = 0.0297), fatigue (PFS-16, -0.6 ± 1.0; P = 0.0003), depression (BDI-II, -5.1 ± 9.4; P = 0.0002), anxiety (BAI, -6.2 ± 9.6; P < 0.0001), and patient treatment satisfaction (SATMED-Q, 16.1 ± 16.8; P < 0.0001). There were significant correlations between the change from baseline to 6 months between PDQ-39 and UPDRS-IV, NMSS, BAI, BDI-II, AS, and PFS-16 scores, and Norris/Bond-Lader alertness/sedation factor. Caregiver anxiety also improved (Goldberg anxiety scale, -1.1 ± 1.0; P = 0.0234), but the clinical relevance of this finding is questionable. The serious adverse events reported were similar to those previously described for LCIG. In patients with APD, LCIG improves QoL, motor symptoms and NMS, emotional well-being, and satisfaction with the treatment. Improvement in patient QoL is associated with improvements in motor complications, NMS, anxiety, depression, apathy and fatigue. Improvements in patients' QoL does not correspond with improvements in caregivers' QoL or burden.

Dataset Information

Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients.

Objective

Methods

Results

Conclusion

Publications

Effect of levodopa-carbidopa intestinal gel on dyskinesia in advanced Parkinson's disease patients.

Similar Datasets

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