DUOGLOBE: One-Year Outcomes in a Real-World Study of Levodopa Carbidopa Intestinal Gel for Parkinson's Disease.

BACKGROUND

Levodopa-carbidopa intestinal gel (LCIG) is an established treatment for improving motor and some non-motor symptoms (NMS) in patients with advanced Parkinson's disease (PD). Prospective long-term data in routine clinical practice are limited.

OBJECTIVE

Assess LCIG effectiveness and safety in patients with advanced PD after 12 months during real-world routine clinical practice.

METHODS

Duodopa/Duopa in patients with advanced Parkinson's disease-a global observational study evaluating long-term effectiveness (DUOGLOBE) (NCT02611713) is an ongoing, prospective, multinational, observational study of LCIG-naïve patients treated as part of routine clinical practice; 3 years of follow-up are planned. The primary outcome is the change in patient-reported time. Other assessments include the Unified Dyskinesia Rating Scale (UDysRS), Non-Motor Symptoms Scale (NMSS), Parkinson's Disease Sleep scale (PDSS-2), Epworth Sleepiness Scale (ESS), health-related quality of life (HR-QoL), caregiver burden, and serious adverse events (SAEs). Outcomes from baseline to month (M) 12 are presented.

RESULTS

In this 12-month follow-up, patients (N = 195) had baseline characteristics similar to other LCIG studies. Significant improvements (mean change to M12) were observed in time (-3.9 ± 3.6 hr/day,  < 0.001), dyskinesia assessed using the UDysRS (-9.6 ± 22.5,  < 0.001), NMSS (-23.1 ± 41.4,  < 0.001), sleep and sleepiness symptoms on the PDSS-2 (-6.5 ± 12.2,  < 0.001) and ESS (-1.0 ± 5.7,  < 0.05), HR-QoL (-9.0 ± 21.6,  < 0.001), and caregiver burden (-1.9 ± 6.7,  = 0.008). Overall, 40.5% (n = 79) of patients experienced SAEs; fall (n = 6; 3.1%) and urinary tract infection (n = 6; 3.1%) were SAEs reported in ≥3% of patients.

CONCLUSIONS

These 12-month outcome data show sustained, long-term improvements and support the real-world effectiveness of LCIG in patients with advanced PD. Safety was consistent with previous studies.