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Trial of Lixisenatide in Early Parkinson’s Disease

dc.rights.licenseopenen_US
hal.structure.identifierInstitut des Maladies Neurodégénératives [Bordeaux] [IMN]
dc.contributor.authorMEISSNER, Wassilios
dc.contributor.authorREMY, Philippe
dc.contributor.authorGIORDANA, Caroline
dc.contributor.authorMALTETE, David
dc.contributor.authorDERKINDEREN, Pascal
dc.contributor.authorHOUETO, Jean-Luc
dc.contributor.authorANHEIM, Mathieu
dc.contributor.authorBENATRU, Isabelle
hal.structure.identifierInstitut des Maladies Neurodégénératives [Bordeaux] [IMN]
dc.contributor.authorBORAUD, Thomas
dc.contributor.authorBREFEL-COURBON, Christine
dc.contributor.authorCARRIERE, Nicolas
dc.contributor.authorCATALA, Helene
dc.contributor.authorCOLIN, Olivier
dc.contributor.authorCORVOL, Jean-Christophe
dc.contributor.authorDAMIER, Philippe
dc.contributor.authorDELLAPINA, Estelle
dc.contributor.authorDEVOS, David
dc.contributor.authorDRAPIER, Sophie
dc.contributor.authorFABBRI, Margherita
dc.contributor.authorFERRIER, Vanessa
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSAMIER FOUBERT, Alexandra
dc.contributor.authorFRISMAND-KRYLOFF, Solene
dc.contributor.authorGEORGET, Aurore
dc.contributor.authorGERMAIN, Christine
dc.contributor.authorGRIMALDI, Stephane
dc.contributor.authorHARDY, Clemence
dc.contributor.authorHOPES, Lucie
dc.contributor.authorKRYSTKOWIAK, Pierre
dc.contributor.authorLAURENS, Brice
dc.contributor.authorLEFAUCHEUR, Romain
dc.contributor.authorMARIANI, Louise-Laure
dc.contributor.authorMARQUES, Ana
dc.contributor.authorMARSE, Claire
dc.contributor.authorORY-MAGNE, Fabienne
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorRIGALLEAU, Vincent
dc.contributor.authorSALHI, Hayet
dc.contributor.authorSAUBION, Amandine
dc.contributor.authorSTOTT, Simon R. W.
dc.contributor.authorTHALAMAS, Claire
dc.contributor.authorTHIRIEZ, Claire
dc.contributor.authorTIR, Melissa
dc.contributor.authorWYSE, Richard K.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBENARD, Antoine
dc.contributor.authorRASCOL, Olivier
dc.contributor.authorGROUP, Lixipark Study
dc.date.accessioned2024-08-21T11:59:35Z
dc.date.available2024-08-21T11:59:35Z
dc.date.issued2024-04-04
dc.identifier.issn1533-4406en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/201231
dc.description.abstractEnBackground 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. (Funded by the French Ministry of Health and others; LIXIPARK ClinicalTrials.gov number, NCT03439943.) In a placebo-controlled trial involving persons with Parkinson's disease, the subcutaneous GLP-1 receptor agonist lixisenatide was associated with reduced motor disability over a period of 12 months.
dc.language.isoENen_US
dc.title.enTrial of Lixisenatide in Early Parkinson’s Disease
dc.title.alternativeN Engl J Meden_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1056/NEJMoa2312323en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed38598572en_US
bordeaux.journalNew England Journal of Medicineen_US
bordeaux.page1176-1185en_US
bordeaux.volume390en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue13en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.institutionCNRS
bordeaux.teamACTIVE_BPHen_US
bordeaux.teamPHARES_BPHen_US
bordeaux.teamLEHA_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exportfalse
dc.rights.ccPas de Licence CCen_US
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