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Article Dans Une Revue New England Journal of Medicine Année : 2024

Trial of Lixisenatide in Early Parkinson’s Disease

1 IMN - Institut des Maladies Neurodégénératives [Bordeaux]
2 CHU Henri Mondor [Créteil]
3 Hôpital Henri Mondor
4 IMRB - Institut Mondor de Recherche Biomédicale
5 Service de Neurologie [CHU Nice]
6 GPMCND - Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques
7 TENS - The Enteric Nervous System in gut and brain disorders [U1235]
8 CIC 0004 - Nantes - Centre d'investigation clinique (CIC) de Nantes -CIC Plurithématique
9 CHU Limoges
10 Hôpital de Hautepierre [Strasbourg]
11 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
12 ICHN - Imagerie cérébrale et handicaps neurologiques
13 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
14 ICM - Institut du Cerveau = Paris Brain Institute
15 CIC Nantes - Centre d’Investigation Clinique de Nantes
16 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
17 UT3 - Université Toulouse III - Paul Sabatier
18 CIC 1436 - Centre d'investigation clinique de Toulouse
19 LNFP - Laboratoire de Neurosciences Fonctionnelles et Pathologies - UR UPJV 4559
20 CIC - Centre d'Investigation Clinique [Rennes]
21 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
22 EPV - Emergence des Pathologies Virales
23 Service de neurologie [Amiens]
24 CHIMERE - CHirurgie, IMagerie et REgénération tissulaire de l’extrémité céphalique - Caractérisation morphologique et fonctionnelle - UR UPJV 7516
Jean-Luc Houéto
  • Fonction : Auteur
Hélène Catala
  • Fonction : Auteur
Olivier Colin
  • Fonction : Auteur
Alexandra Foubert-Samier
  • Fonction : Auteur
Solène Frismand-Kryloff
  • Fonction : Auteur
Aurore Georget
  • Fonction : Auteur
Christine Germain
  • Fonction : Auteur
Stéphane Grimaldi
Clémence Hardy
  • Fonction : Auteur
Lucie Hopes
  • Fonction : Auteur
Brice Laurens
  • Fonction : Auteur
Romain Lefaucheur
  • Fonction : Auteur
Louise-Laure Mariani
  • Fonction : Auteur
Ana Marques
  • Fonction : Auteur
Claire Marse
  • Fonction : Auteur
Fabienne Ory-Magne
  • Fonction : Auteur
Vincent Rigalleau
  • Fonction : Auteur
Hayet Salhi
  • Fonction : Auteur
Amandine Saubion
  • Fonction : Auteur
Simon Stott
  • Fonction : Auteur
Claire Thalamas
  • Fonction : Auteur
Claire Thiriez
  • Fonction : Auteur
Richard Wyse
Antoine Benard
  • Fonction : Auteur
Olivier Rascol
  • Fonction : Auteur

Résumé

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 motor disability than placebo at 12 months in a phase 2 trial but was associated with gastrointestinal side effects. Longer and larger trials are needed to determine the effects and safety of lixisenatide in persons with Parkinson's disease.
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Dates et versions

hal-04552147 , version 1 (19-04-2024)

Identifiants

Citer

Wassilios Meissner, Philippe Remy, Caroline Giordana, David Maltête, Pascal Derkinderen, et al.. Trial of Lixisenatide in Early Parkinson’s Disease. New England Journal of Medicine, 2024, 390 (13), pp.1176-1185. ⟨10.1056/NEJMoa2312323⟩. ⟨hal-04552147⟩
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