Details

Autor(en) / Beteiligte

• Standaert, David G.
• Aldred, Jason
• Anca‐Herschkovitsch, Marieta
• Bourgeois, Paul
• Cubo, Esther
• Davis, Thomas L.
• Iansek, Robert
• Kovács, Norbert
• Pontieri, Francesco E.
• Siddiqui, Mustafa S.
• Simu, Mihaela
• Bergmann, Lars
• Kukreja, Pavnit
• Robieson, Weining Z.
• Chaudhuri, K. Ray

Titel

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

Ist Teil von

• Movement disorders clinical practice (Hoboken, N.J.), 2021-10, Vol.8 (7), p.1061-1074

Ort / Verlag

Hoboken, USA: John Wiley & Sons, Inc

Erscheinungsjahr

2021

Quelle

Wiley Online Library - AutoHoldings Journals

Beschreibungen/Notizen

• ABSTRACT 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 off 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 off time (−3.9 ± 3.6 hr/day, P < 0.001), dyskinesia assessed using the UDysRS (−9.6 ± 22.5, P < 0.001), NMSS (−23.1 ± 41.4, P < 0.001), sleep and sleepiness symptoms on the PDSS‐2 (−6.5 ± 12.2, P < 0.001) and ESS (−1.0 ± 5.7, P < 0.05), HR‐QoL (−9.0 ± 21.6, P < 0.001), and caregiver burden (−1.9 ± 6.7, P = 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.