Efficacy, safety and patient’s quality of life of long-term treatment with levodopa-carbidopa intestinal gel in advanced Parkinson’s disease in Romania: Results from GLORIA observational study

Abstract

Objectives. The aim of the Global Long-Term Registry on Efficacy and Safety of DUODOPA in Patients with Advanced Parkinson’s Disease in Routine Care (GLORIA) was to document 24-month efficacy, safety and the effect on patient’s quality of life (QoL) of long-term treatment with levodopa-carbidopa intestinal gel (LCIG) in advanced Parkinson’s disease (PD) in routine clinical care. Here we present the results for the patients enrolled in Romania in the GLORIA registry. Material and methods. GLORIA registry is a multicenter, international, observational registry conducted between June 2010 and June 2015. In Romania, 39 patients with an indication for LCIG therapy were enrolled and followed for up to 24 months. Outcomes. During the study period LCIG led to significant improvements in “Off” time, “On” time with dyskinesia, activities of daily living (ADLs), motor examination, non-motor symptoms, and QoL which maintained up to the end of follow-up. At 24 months, “Off” time had a mean reduction of -5.2±3.1 hours/day vs. baseline (p < 0.0001) and “On” time with dyskinesia had a mean reduction of -3.5±3.3 hours/day vs. baseline (p < 0.0001). Both ADLs and motor examination “On” scores showed a maximum improvement at 6 months and 12 months (p < 0.0001) and remained significantly lower vs. baseline at 24 months (ADLs -6.6±8.7, p = 0.0023; motor examination -6.4±7.3, p = 0.0007). Non-motor symptoms scale (NMSS) total score had a mean reduction at 24 months of -18.29 as compared to baseline (p = 0.0011). QoL, as assessed by PDQ-8 significantly improved at 6 months as compared to baseline (p = 0.0141) and maintained its statistical significance until the 12 months evaluation (p = 0.0076). Adverse drug reactions possibly or probably related to the LCIG therapy were reported for 2.9% (1/35) of the patients during the temporary nasojejunal tube therapy and for 60.0% (21/35) of the patients during permanent tube phase. Conclusions. LCIG treatment showed significant and clinically relevant long-term improvements in motor symptoms and QoL in advanced PD patients. The safety/tolerability data confirmed the established safety profile.

Keywords

• parkinson’s disease
• levodopa-carbidopa intestinal gel
• efficacy
• safety
• quality of life