Dataset Information

Rescue levodopa-carbidopa intestinal gel (LCIG) therapy in Parkinson's disease patients with suboptimal response to deep brain stimulation.

ABSTRACT:

Objective

To evaluate the effectiveness of levodopa-carbidopa intestinal gel (LCIG) as an add-on rescue therapy following deep brain stimulation (DBS) for treatment of motor fluctuations.

Background

Both DBS and LCIG are FDA-approved therapies for treatment of motor fluctuations in advanced PD. Few studies have examined dual therapy for refractory motor fluctuations and it is unknown what the effect on quality of life will be in advanced PD.

Methods

We conducted a retrospective study using a large database of all medical and surgical PD cases at the University of Florida. Six patients were identified with DBS who subsequently received rescue LCIG therapy. The clinical histories, indications for intervention and outcomes were reviewed.

Results

All patients were managed initially with DBS (bilateral STN DBS (n = 3), bilateral GPi DBS (n = 1), unilateral GPI DBS (n = 2)). Patients with well-placed (n = 3) and suboptimally placed DBS leads (n = 3) had significant reduction in their motor fluctuations with improvement in the off-medication time after rescue LCIG therapy. Improvement in quality of life scores (PDQ-39) was appreciated in four DBS patients following the addition of LCIG therapy.

Conclusions

LCIG is a promising add-on rescue therapy for select patients with existing DBS devices. The LCIG may possibly reduce motor fluctuations and improve quality of life in advanced PD irrespective of the DBS target or the accuracy of lead placement. Dual therapy may also be ideal for patients who are considered high risk for additional DBS surgeries.

SUBMITTER: Elkouzi A

PROVIDER: S-EPMC6801178 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Publications

Rescue levodopa-carbidopa intestinal gel (LCIG) therapy in Parkinson's disease patients with suboptimal response to deep brain stimulation.

Elkouzi Ahmad A Ramirez-Zamora Adolfo A Zeilman Pam P Barabas Matthew M Eisinger Robert S RS Malaty Irene A IA Okun Michael S MS Almeida Leonardo L

Annals of clinical and translational neurology 20190913 10

<h4>Objective</h4>To evaluate the effectiveness of levodopa-carbidopa intestinal gel (LCIG) as an add-on rescue therapy following deep brain stimulation (DBS) for treatment of motor fluctuations.<h4>Background</h4>Both DBS and LCIG are FDA-approved therapies for treatment of motor fluctuations in advanced PD. Few studies have examined dual therapy for refractory motor fluctuations and it is unknown what the effect on quality of life will be in advanced PD.<h4>Methods</h4>We conducted a retrospec ...[more]

PMID: 31518070

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Project description:Background: Currently, some advanced treatments such as Levodopa-Carbidopa intestinal gel infusion (LCIG), deep-brain stimulation (DBS), and subcutaneous apomorphine infusion have become alternative strategies for advanced Parkinson's disease (PD). However, which treatment is better for individual patients remains unclear. This review aims to compare therapeutic effects of motor and/or non-motor symptoms of advanced PD patients between LCIG and DBS. Methods: We manually searched electronic databases (PubMed, Embase, Cochrane Library) and reference lists of included articles published until April 04, 2019 using related terms, without language restriction. We included case-controlled cohort studies and randomized-controlled trials, which directly compared differences between LCIG and DBS. The Newcastle-Ottawa scale (NOS), proposed by the Cochrane Collaboration, was utilized to assess the quality of the included studies. Two investigators independently extracted data from each trial. Pooled standard-mean differences (SMDs) and relative risks (RRs) with 95% confidence intervals (CIs) were calculated by meta-analysis. Outcomes were grouped according to the part III and part IV of the Unified Parkinson Disease Rating Scale (UPDRS) and adverse events. We also descriptively reviewed some data, which were unavailable for statistical analysis. Results: This review included five cohort trials of 257 patients for meta-analysis. There were no significant differences between LCIG and subthalamic nucleus deep-brain stimulation (STN-DBS) on UPDRS-III and adverse events comparisons: UPDRS-III (pooled SMDs = 0.200, 95% CI: -0.126-0.527, P = 0.230), total adverse events (pooled RRs = 1.279, 95% CI: 0.983-1.664, P = 0.067), serious adverse events (pooled RRs = 1.539, 95% CI: 0.664-3.566, P = 0.315). Notably, the improvement of UPDRS-IV was more significant in STN-DBS groups: pooled SMDs = 0.857, 95% CI: 0.130-1.584, P = 0.021. However, the heterogeneity was moderate for UPDRS-IV (I 2 = 73.8%). Conclusion: LCIG has comparable effects to STN-DBS on motor function for advanced PD, with acceptable tolerability. More large, well-designed trials are needed to assess the comparability of LCIG and STN-DBS in the future.

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

Rescue levodopa-carbidopa intestinal gel (LCIG) therapy in Parkinson's disease patients with suboptimal response to deep brain stimulation.

Objective

Background

Methods

Results

Conclusions

Publications

Rescue levodopa-carbidopa intestinal gel (LCIG) therapy in Parkinson's disease patients with suboptimal response to deep brain stimulation.

Similar Datasets

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