| Title: |
Trial of Lixisenatide in Early Parkinson’s Disease ; N Engl J Med |
| Authors: |
MEISSNER, Wassilios; REMY, Philippe; GIORDANA, Caroline; MALTETE, David; DERKINDEREN, Pascal; HOUETO, Jean-Luc; ANHEIM, Mathieu; BENATRU, Isabelle; BORAUD, Thomas; BREFEL-COURBON, Christine; CARRIERE, Nicolas; CATALA, Helene; COLIN, Olivier; CORVOL, Jean-Christophe; DAMIER, Philippe; DELLAPINA, Estelle; DEVOS, David; DRAPIER, Sophie; FABBRI, Margherita; FERRIER, Vanessa; SAMIER FOUBERT, Alexandra; FRISMAND-KRYLOFF, Solene; GEORGET, Aurore; GERMAIN, Christine; GRIMALDI, Stephane; HARDY, Clemence; HOPES, Lucie; KRYSTKOWIAK, Pierre; LAURENS, Brice; LEFAUCHEUR, Romain; MARIANI, Louise-Laure; MARQUES, Ana; MARSE, Claire; ORY-MAGNE, Fabienne; RIGALLEAU, Vincent; SALHI, Hayet; SAUBION, Amandine; STOTT, Simon R. W.; THALAMAS, Claire; THIRIEZ, Claire; TIR, Melissa; WYSE, Richard K.; BENARD, Antoine; RASCOL, Olivier; GROUP, Lixipark Study |
| Publication Year: |
2024 |
| Subject Terms: |
Sciences du Vivant [q-bio]/Santé publique et épidémiologie |
| Description: |
Background Lixisenatide, a glucagon-like peptide-1 receptor agonist used for the treatment of diabetes, has shown neuroprotective properties in a mouse model of Parkinson's disease.Methods In this phase 2, double-blind, randomized, placebo-controlled trial, we assessed the effect of lixisenatide on the progression of motor disability in persons with Parkinson's disease. Participants in whom Parkinson's disease was diagnosed less than 3 years earlier, who were receiving a stable dose of medications to treat symptoms, and who did not have motor complications were randomly assigned in a 1:1 ratio to daily subcutaneous lixisenatide or placebo for 12 months, followed by a 2-month washout period. The primary end point was the change from baseline in scores on the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (range, 0 to 132, with higher scores indicating greater motor disability), which was assessed in patients in the on-medication state at 12 months. Secondary end points included other MDS-UPDRS subscores at 6, 12, and 14 months and doses of levodopa equivalent.Results A total of 156 persons were enrolled, with 78 assigned to each group. MDS-UPDRS part III scores at baseline were approximately 15 in both groups. At 12 months, scores on the MDS-UPDRS part III had changed by -0.04 points (indicating improvement) in the lixisenatide group and 3.04 points (indicating worsening disability) in the placebo group (difference, 3.08; 95% confidence interval, 0.86 to 5.30; P=0.007). At 14 months, after a 2-month washout period, the mean MDS-UPDRS motor scores in the off-medication state were 17.7 (95% CI, 15.7 to 19.7) with lixisenatide and 20.6 (95% CI, 18.5 to 22.8) with placebo. Other results relative to the secondary end points did not differ substantially between the groups. Nausea occurred in 46% of participants receiving lixisenatide, and vomiting occurred in 13%.Conclusions In participants with early Parkinson's disease, lixisenatide therapy resulted in less progression of ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1056/NEJMoa2312323 |
| Availability: |
https://oskar-bordeaux.fr/handle/20.500.12278/201231; https://hdl.handle.net/20.500.12278/201231; https://doi.org/10.1056/NEJMoa2312323 |
| Rights: |
open ; Pas de Licence CC |
| Accession Number: |
edsbas.634CA35D |
| Database: |
BASE |