Evidence map›Paper›PMID 36201116›Full record

ArticleActa neurologica Belgica2023

Effectiveness and safety of safinamide in routine clinical practice in a Belgian Parkinson's disease population: an open-label, levodopa add-on study.

Belgian Safinamide Study Group, Bruno Bergmans, Philip Bourgeois, Patrick Cras, Sophie Dethy, Nina De Klippel, Gianni Franco, Gaëtan Garraux, Karine Geens, Philippe Jacquerye and 4 more

Open access · hybridAbstract readMulticenter Study
In one paragraph

Article in Acta neurologica Belgica, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.2field-weighted citation impact, top 43% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 1 country.

Belgian Safinamide Study Group
Bruno BergmansDepartment of Neurology, AZ St-Jan Brugge-Oostende AV, Campus Brugge, Brugge, Belgium.
Philip BourgeoisDepartment of Neurology, AZ Delta, Roeselare, Belgium.
Patrick CrasDepartement of Neurology, Born Bunge Institute, Faculty of Medicine and Health Sciences, Antwerp University Hospital, University of Antwerp, Universiteitsplein 1, 2610, Wilrijk, Belgium.
Sophie DethyDepartment of Neurology, CHU-Tivoli, La Louvière, Belgium.
Nina De KlippelDepartment of Neurology, Jessa Hospital, Hasselt, Belgium.
Gianni FrancoDepartment of Neurology, CHU UCL Namur Dinant, Collaborator ULiège, Dinant, Belgium.
Gaëtan GarrauxMoVeRe Group, Cyclotron Research Center, University of Liege, Liège, Belgium.
Karine GeensDepartment of Neurology, AZ Klina, Brasschaat, Belgium.
Philippe JacqueryeDepartment of Neurology, La Louvière, Belgium.
Anne JeanjeanDepartment of Neurology, Saint Luc University Hospital, UCLouvain, Brussels, Belgium.
Frédéric SupiotDepartment of Neurology, Erasme Academic Hospital, Anderlecht, Belgium.
Chris Van der LindenDepartment of Neurology, AZ Sint-Lucas Hospital, Ghent, Belgium.
Claude KrygierMedical Department, Zambon Belgium, Brussels, Belgium. claude.krygier@zambongroup.com.ORCID http://orcid.org/0000-0002-7857-4544
University of Liège · BECliniques Universitaires Saint-Luc · BEGhent University Hospital · BEUniversity of Antwerp · BEZambon (Belgium) · BEAZ Klina · BEAZ Sint-Lucas · BEJessa Hospital · BE

Funding

Zambon S.p.A. funded the study
6 · The paper itself

Abstract

backgroundSafinamide is a recent multimodal antiparkinsonian drug that inhibits monoamine oxidase B and modulates the glutamatergic system with positive effects on motor and nonmotor symptoms of Parkinson's disease (PD). This post-hoc analysis of the European SYNAPSES study provides first-time data on the use of safinamide in routine clinical practice in Belgium.

objectiveTo describe the efficacy and safety of safinamide in Belgian PD patients in real-life conditions.

methodsPost-hoc analysis of the Belgian cohort from the European SYNAPSES trial, which was an observational, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months. Analyses were performed in the overall population and according to different criteria such as the age limit (> 75 years), presence or absence of relevant comorbidities, presence or absence of psychiatric conditions such as depression and anxiety, patients on levodopa monotherapy or levodopa in combination with other treatments, patients on rasagiline before inclusion or not.

resultsOf the 172 patients included, 29.2% were > 75 years, 58.9% had relevant comorbidities and 32.7% had psychiatric conditions. Almost all the patients reported motor (98.8%) or non-motor (86.3%) symptoms. During the study, 36.3% of patients reported drug-related reactions. The adverse drug reactions were those already described in the patients' information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroups of patients. Almost 35% of the patients demonstrated a clinically significant improvement in the UPDRS and 50% of the patients with wearing-off at baseline, did not report wearing-off anymore after one year of treatment. Patients under levodopa monotherapy compared to patients receiving levodopa combined with other antiparkinsonian treatments benefit more from safinamide treatment. Patients switched from rasagiline to safinamide seemed also to benefit more from safinamide treatment.

conclusionThe study confirms the excellent safety and efficacy profile of safinamide, particularly in more vulnerable groups of patients such as the elderly and patients with significant comorbidities or psychiatric conditions such as depression or anxiety.

Indexed as

Drug-Related Side Effects and Adverse ReactionsParkinson DiseaseAgedAlanineAntiparkinson AgentsBelgiumBenzylaminesHumansIndansLevodopaProspective StudiesRetrospective StudiesAlanineAntiparkinson AgentsBenzylaminesIndansLevodoparasagilinesafinamideBelgiumEffectivenessFluctuationLevodopaMAO-B inhibitorParkinson’s diseaseReal-life evaluationSafetySafinamide

Identifiers

PMID36201116
PMCPMC10238295
OpenAlexW4302763295

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.