Lixisenatide Shows Benefits in Early Parkinson’s Disease

 

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Lixisenatide Shows Benefits in Early Parkinson’s Disease

VIRTUAL -- August 28, 2023 -- Lixisenatide, a glucagon-like peptide 1 receptor (GLP1-R) agonist approved for the treatment of type 2 diabetes shows disease-modifying effects in the slowing of motor function loss in people with early Parkinson’s disease, according to a study

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Rami Komrokji, MD

1.0 CME / MOC / CC

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presented at the 2023 International Congress of Parkinson’s Disease and Movement Disorders (MDS).

"Lixisenatide had beneficial effects on motor progression in patients with early Parkinson’s disease, supporting a disease-modifying effect that warrants further investigation," reported Wassilios G. Meissner, MD, University of Bordeaux, Bordeaux, France.

The study included 156 patients at 21 centres in France with early Parkinson’s disease, defined as less than 3 years since diagnosis. Patients were randomised to receive either subcutaneous lixisenatide 20 µg or placebo once daily for 12 months, followed by a 2-month wash-out period.

The patients had a mean age of 60 years and an average time from diagnosis of 1.4 years. Their average Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) score was 15 and mean levodopa equivalent daily dosage (LEDD) was 330 mg per day.

All patients were also on stable symptomatic medications without motor complications.

After 12 months, the average MDS-UPDRS III score had increased significantly less in the lixisenatide group (0.0) compared with the placebo group (+3.0; P = .0068).

At month-14, the mean MDS-UPDRS III score during OFF times, when patients are not under the effects of other medications, was significantly lower in the lixisenatide group (17.7) compared with the placebo group (20.6; P = .0445).

There were no significant differences between the groups in terms of other secondary outcomes, including LEDD.

The drop-out rate in the study was low, at just 4.5%, and safety was consistent with that observed with treatment of lixisenatide among those with diabetes, with more frequent nausea reported among those on lixisenatide, the authors reported.

The authors noted that the improvements in the lixisenatide group observed in the ON and OFF states suggest an improvement in the underlying disease state and not just a pharmacologic effect that is amplified by drugs already being used.    

"The study design is innovative, because it examines drug effects in both ON and OFF phases," commented Christopher Goetz, Rush University, Chicago, Illinois, who was not part of the study. "Further, the high retention rates bespeak an impressive, centralised organisation across the French centres conducting the research program. Larger international studies will definitively define this drug’s place in our treatment portfolio, but disease-modifying therapies are a goal that would open the prospect of treating the underlying disease as well as ameliorating symptoms."

[Presentation title: Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Proof-of-Concept Study of Lixisenatide in Patients With Early Parkinson’s Disease (PD): The LIXIPARK trial (NCT03439943). Abstract 94]