490
Views
1
CrossRef citations to date
0
Altmetric
Real-World Evidence and Medical Affairs

Real world data of a German Parkinson’s disease population: effectiveness and safety of safinamide in routine clinical practice

, , , &
Pages 1621-1628 | Received 13 Apr 2023, Accepted 06 Jul 2023, Published online: 17 Jul 2023

References

  • Deutsche Gesellschaft für Neurologie (DGN). S3 guideline idiopathic parkinson syndrome. 2016 (currently under revision). AWMF Registry no: 030-010. Internet. [cited 2023 Jan 24]. Available from: https://register.awmf.org/de/leitlinien/detail/030-010
  • Nerius M, Fink A, Doblhammer G. Parkinson’s disease in Germany: prevalence and incidence based on health claims data. Acta Neurol Scand. 2017;136(5):386–392. doi: 10.1111/ane.12694.
  • Poewe W, Seppi K, Tanner CM, et al. Parkinson disease. Nat Rev Dis Primers. 2017;3:17013. doi: 10.1038/nrdp.2017.13.
  • Wang J, Wang F, Mai D, et al. Molecular mechanisms of glutamate toxicity in Parkinson’s disease. Front Neurosci. 2020;14:585584. doi: 10.3389/fnins.2020.585584.
  • Titova N, Qamar MA, Chaudhuri KR. The nonmotor features of Parkinson’s disease. Int Rev Neurobiol. 2017;132:33–54.
  • Richter D, Bartig D, Jost W, et al. Dynamics of device-based treatments for Parkinson’s disease in Germany from 2010 to 2017: application of continuous subcutaneous apomorphine, levodopa-carbidopa intestinal gel, and deep brain stimulation. J Neural Transm. 2019;126(7):879–888. doi: 10.1007/s00702-019-02034-8.
  • Nyholm D, Jost WH. Levodopa-entacapone-carbidopa intestinal gel infusion in advanced Parkinson’s disease: real-world experience and practical guidance. Ther Adv Neurol Disord. 2022;15:17562864221108018. doi: 10.1177/17562864221108018.
  • deSouza RM, Schapira A. Safinamide for the treatment of Parkinson’s disease. Expert Opin Pharmacother. 2017;18(9):937–943. doi: 10.1080/14656566.2017.1329819.
  • Blair HA, Dhillon S. Safinamide: a review in Parkinson’s disease. CNS Drugs. 2017;31(2):169–176. doi: 10.1007/s40263-017-0408-1.
  • Muller T. Safinamide in the treatment of Parkinson’s disease. Neurodegener Dis Manag. 2020;10(4):195–204. doi: 10.2217/nmt-2020-0017.
  • Fox SH, Katzenschlager R, Lim SY, et al. International Parkinson and movement disorder society evidence-based medicine review: update on treatments for the motor symptoms of Parkinson’s disease. Mov Disord. 2018;33(8):1248–1266. doi: 10.1002/mds.27372.
  • European Medicines Agency (EMA). Xadago (Safinamide) summary of product characteristics [Internet]. London: EMA; 2015. [cited 2023 Jan 24]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/xadago.
  • Schapira AH, Fox SH, Hauser RA, et al. Assessment of safety and efficacy of safinamide as a levodopa adjunct in patients with Parkinson disease and motor fluctuations: a randomized clinical trial. JAMA Neurol. 2017;74(2):216–224. doi: 10.1001/jamaneurol.2016.4467.
  • Borgohain R, Szasz J, Stanzione P, et al. Randomized trial of safinamide add-on to levodopa in Parkinson’s disease with motor fluctuations. Mov Disord. 2014;29(2):229–237. doi: 10.1002/mds.25751.
  • Cattaneo C, Jost WH, Bonizzoni E. Long-term efficacy of safinamide on symptoms severity and quality of life in fluctuating Parkinson’s disease patients. J Parkinsons Dis. 2020;10(1):89–97. doi: 10.3233/JPD-191765.
  • Borgohain R, Szasz J, Stanzione P, et al. Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson’s disease. Mov Disord. 2014;29(10):1273–1280. doi: 10.1002/mds.25961.
  • Cattaneo C, Barone P, Bonizzoni E, et al. Effects of safinamide on pain in fluctuating Parkinson’s disease patients: a post-hoc analysis. J Parkinsons Dis. 2017;7(1):95–101. doi: 10.3233/JPD-160911.
  • Cattaneo C, Sardina M, Bonizzoni E. Safinamide as add-on therapy to levodopa in mid- to late-stage Parkinson’s disease fluctuating patients: post hoc analyses of studies 016 and SETTLE. J Parkinsons Dis. 2016;6(1):165–173. doi: 10.3233/JPD-150700.
  • Geroin C, Di Vico IA, Squintani G, et al. Effects of safinamide on pain in Parkinson’s disease with motor fluctuations: an exploratory study. J Neural Transm. 2020;127(8):1143–1152. doi: 10.1007/s00702-020-02218-7.
  • Liguori C, Stefani A, Ruffini R, et al. Safinamide effect on sleep disturbances and daytime sleepiness in motor fluctuating Parkinson’s disease patients: a validated questionnaires-controlled study. Parkinsonism Relat Disord. 2018;57:80–81. doi: 10.1016/j.parkreldis.2018.06.033.
  • Jost WH, Kupsch A, Mengs J, et al. Effectiveness and safety of safinamide as add-on to levodopa in patients with Parkinson’s disease: non-interventional study. Fortschr Neurol Psychiatr. 2018;86:624–634.
  • Mofid S, Bolislis WR, Kuhler TC. Real-world data in the postapproval setting as applied by the EMA and the US FDA. Clin Ther. 2022;44(2):306–322. doi: 10.1016/j.clinthera.2021.12.010.
  • Abbruzzese G, Kulisevsky J, Bergmans B, et al. A european observational study to evaluate the safety and the effectiveness of safinamide in routine clinical practice: the SYNAPSES trial. J Parkinsons Dis. 2021;11(1):187–198. doi: 10.3233/JPD-202224.
  • GBD 2016 Parkinson’s Disease Collaborators. Global, regional, and national burden of parkinson’s disease, 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet Neurol. 2018;17:939–953.
  • Shulman LM, Gruber-Baldini AL, Anderson KE, et al. The clinically important difference on the unified Parkinson’s disease rating scale. Arch Neurol. 2010;67(1):64–70. doi: 10.1001/archneurol.2009.295.
  • Cerri S, Mus L, Blandini F. Parkinson’s disease in women and men: what’s the difference? [review]. J Parkinsons Dis. 2019;9(3):501–515. doi: 10.3233/JPD-191683.
  • Fariello RG. Safinamide. Neurotherapeutics. 2007;4(1):110–116. doi: 10.1016/j.nurt.2006.11.011.
  • Onofrj M, Bonanni L, Thomas A. An expert opinion on safinamide in Parkinson’s disease. Expert Opin Investig Drugs. 2008;17(7):1115–1125. doi: 10.1517/13543784.17.7.1115.
  • Poewe W, Mahlknecht P. The clinical progression of Parkinson’s disease. Parkinsonism Relat Disord. 2009;15(Suppl 4): S28–S32. doi: 10.1016/S1353-8020(09)70831-4.
  • Schrag A, Dodel R, Spottke A, et al. Rate of clinical progression in Parkinson’s disease. A prospective study. Mov Disord. 2007;22(7):938–945. doi: 10.1002/mds.21429.
  • Delgado-Rodriguez M, Llorca J. Bias. J Epidemiol Community Health. 2004;58(8):635–641. doi: 10.1136/jech.2003.008466.
  • van Onzenoort HA, Menger FE, Neef C, et al. Participation in a clinical trial enhances adherence and persistence to treatment: a retrospective cohort study. Hypertension. 2011;58(4):573–578. doi: 10.1161/HYPERTENSIONAHA.111.171074.
  • Onakpoya IJ. Rare adverse events in clinical trials: understanding the rule of three. BMJ Evid Based Med. 2018;23(1):6. doi: 10.1136/ebmed-2017-110885.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.