Evidence map›Paper›PMID 33104040›Full record

Observational studyJournal of Parkinson's disease2021

A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial.

Giovanni Abbruzzese, Jaime Kulisevsky, Bruno Bergmans, Juan C Gomez-Esteban, Georg Kägi, Jason Raw, Alessandro Stefani, Tobias Warnecke, Wolfgang H Jost, SYNAPSES Study Investigators Group

Erratum issuedOpen access · hybridAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Journal of Parkinson's disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 6% 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

35 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Observational
  17. Review
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 6 countries.

Giovanni AbbruzzeseDINOGMI, University of Genoa, Genova, Italy.
Jaime KulisevskySant Pau Hospital, Universitat Autònoma de Barcelona, CIBERNED, Barcelona, Spain.
Bruno BergmansDepartment of Neurology, AZ St-Jan Brugge-Oostende AV, Campus Brugge, Brugge & Ghent University Hospital, Ghent, Belgium.
Juan C Gomez-EstebanBiocruces Research Institute, Barakaldo, Spain.
Georg KägiDepartment of Neurology, Cantonal Hospital St.Gallen, Switzerland.
Jason RawFairfield General Hospital, Bury, Greater Manchester, UK.
Alessandro StefaniParkinson Center, University Policlinico Tor Vergata, Roma, Italy.
Tobias WarneckeDepartment of Neurology, University of Muenster, Muenster, Germany.
Wolfgang H JostParkinson-Klinik Ortenau, University of Freiburg, Wolfach, Germany.
SYNAPSES Study Investigators Group
Universitat Autònoma de Barcelona · ESUniversity of Freiburg · DEUniversity of St.Gallen · CHFairfield General Hospital · GBGhent University Hospital · BEUniversity of Genoa · ITUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSafinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson's disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency.

objectiveTo describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions.

methodsThe SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions.

resultsOf the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events 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 subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in ≥40% of patients, according to the criteria developed by Shulman et al.Conclusion:The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term.

Indexed as

Outcome Assessment, Health CareAgedAged, 80 and overAlanineBenzylaminesComorbidityDrug-Related Side Effects and Adverse ReactionsEuropeFemaleFollow-Up StudiesHumansMaleMental DisordersMiddle AgedMonoamine Oxidase InhibitorsParkinson DiseaseAlanineBenzylaminesMonoamine Oxidase InhibitorssafinamideMAO-B inhibitorParkinson’s diseasereal-life evaluationsafinamide

Identifiers

PMID33104040
PMCPMC7990425
OpenAlexW3094227256

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.