Wirksamkeit und Sicherheit von Safinamid als Zusatztherapie zu Levodopa bei Parkinson-Patienten: eine nicht-interventionelle Beobachtungsstudie

Jost, Wolfgang H.; Kupsch, Andreas; Mengs, Jörg; Delf, Martin; Bosse, Dietrich

doi:10.1055/a-0665-4667

Cited by 5 publications

(6 citation statements)

References 25 publications

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“…This is the first observational multicenter Spanish study describing the effectiveness, tolerability and safety of safinamide in real clinical practice. Our results are consistent with previous studies, and confirm that safinamide can be considered an effective and safe add-on therapy for symptomatic PD treatment [9,10,11,16,17,19,20]. In general, safinamide was well tolerated with a dropout rate (DR) of 16.4%, which was even lower when considering only the AE-related DR (11.2%).…”

Section: Discussionsupporting

confidence: 91%

“…This benefit was independent of the safinamide final dose after adjustment for confounding factors. These results confirm and extend previous data from randomized controlled trials and also those obtained in several open-label studies in which the addition of safinamide to conventional levodopa was followed by a significant improvement in motor and NMS as well as in the quality of life [16,19,20]. More importantly, our results indicate that the clinical benefit reported in controlled trials can be replicated in daily clinical practice.…”

Section: Discussionsupporting

confidence: 90%

“…Previous studies have reported very variable DR after starting safinamide, and this inconsistency is probably due to methodological differences in the study design (length of observation period, total or EA-related DR, etc.) [9,16,19]. For instance, in our cohort, the patients who withdrew from safinamide showed a more advanced stage of the disease (higher mH&Y scores, higher LEDD, cognitive impairment and a trend to be older) than those that continued safinamide treatment.…”

Section: Discussionmentioning

confidence: 65%

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Safinamide in Clinical Practice: A Spanish Multicenter Cohort Study

et al. 2019

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Background: Safinamide is an approved drug for the treatment of motor fluctuations of Parkinson’s Disease (PD) patients with a potential benefit on non-motor symptoms (NMS). Methods: A retrospective multicenter cohort study was conducted, in which the clinical effect of safinamide on both motor and NMS was assessed by the Clinical Global Impression of Change scale. Furthermore, we assessed the appearance of adverse events (AEs) and its effect on dyskinesia, that were also recorded in non-fluctuating PD patients and in those previously treated with rasagiline. Results: We included 213 PD patients who received safinamide in addition to their regular levodopa therapy. Thirty-five withdrew prematurely from safinamide, mainly because of AEs. Out of 178, clinical improvement on motor and NMS was found in 76.4% and 26.2%, respectively. A total of 44 reported AEs of mild intensity. We did not find a difference concerning the clinical benefit or AEs when comparing either patients who had or had not been taking Monoamine Oxidase B Inhibitor (MAOB-I) previously or between patients with and without motor complications. Conclusions: Safinamide is an effective and safe add-on to levodopa drug for PD patients. Moreover, safinamide could elicit an additional clinical improvement in PD patients previously treated with other MAOB-I and in non- fluctuating patients with suboptimal motor control.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 65%

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Safinamide in Clinical Practice: A Spanish Multicenter Cohort Study

et al. 2019

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“…Box 1: Exemplary questions to probe for motor fluctuations in PD patients (Jost et al 2022 ). Have you noticed that the effect of your medication does not last until the next dosing?…”

Section: Motor Fluctuations In Parkinson’s Diseasementioning

confidence: 99%

Clinical benefit of MAO-B and COMT inhibition in Parkinson’s disease: practical considerations

Regensburger

Kohl

et al. 2023

J Neural Transm

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Inhibitors of monoamine oxidase B (MAO-B) and catechol-O-methyltransferase (COMT) are major strategies to reduce levodopa degradation and thus to increase and prolong its effect in striatal dopaminergic neurotransmission in Parkinson’s disease patients. While selegiline/rasagiline and tolcapone/entacapone have been available on the market for more than one decade, safinamide and opicapone have been approved in 2015 and 2016, respectively. Meanwhile, comprehensive data from several post-authorization studies have described the use and specific characteristics of the individual substances in clinical practice under real-life conditions. Here, we summarize current knowledge on both medication classes, with a focus on the added clinical value in Parkinson’s disease. Furthermore, we outline practical considerations in the treatment of motor fluctuations and provide an outlook on ongoing studies with MAO-B and COMT inhibitors.

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“…The X-TRA study (Jost et al 2018 ) observed 297 patients between 2015 and 2017 under everyday conditions ("real life") exclusively in Germany and thus constitutes the largest completed study of its kind on safinamide. The motor and non-motor symptoms as well as the quality of life improved while unknown adverse side effects have not yet been observed.…”

Section: Safinamidementioning

confidence: 99%

A critical appraisal of MAO-B inhibitors in the treatment of Parkinson’s disease

Jost

2022

J Neural Transm

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Since the 1980s, the MAO-B inhibitors have gained considerable status in the therapy of the Parkinson’s disease. In addition to the symptomatic effect in mono- and combination therapies, a neuroprotective effect has repeatedly been a matter of some discussion, which has unfortunately led to a good many misunderstandings. Due to potential interactions, selegiline has declined in significance in the field. For the MAO-B inhibitor safinamide, recently introduced to the market, an additional inhibition of pathological release of glutamate has been postulated. At present, rasagiline and selegiline are being administered in early therapy as well as in combination with levodopa. Safinamide has been approved only for combination therapy with levodopa when motor fluctuations have occurred. MAO-B inhibitors are a significant therapeutic option for Parkinson’s disease, an option which is too often not appreciated properly.

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Wirksamkeit und Sicherheit von Safinamid als Zusatztherapie zu Levodopa bei Parkinson-Patienten: eine nicht-interventionelle Beobachtungsstudie

Abstract: Safinamide therapy improved the motor and non-motor symptoms as well as the quality of life in PD. Most patients tolerated the therapy well. The only side effects that occurred are those described in the patient information leaflet.

Cited by 5 publications

References 25 publications

Safinamide in Clinical Practice: A Spanish Multicenter Cohort Study

Safinamide in Clinical Practice: A Spanish Multicenter Cohort Study

Clinical benefit of MAO-B and COMT inhibition in Parkinson’s disease: practical considerations

A critical appraisal of MAO-B inhibitors in the treatment of Parkinson’s disease

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