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Solriamfetol real world experience study (SURWEY): Initiation, titration, safety, effectiveness, and experience during follow-up for patients with narcolepsy from Germany.
Winter, Yaroslav; Mayer, Geert; Kotterba, Sylvia; Benes, Heike; Burghaus, Lothar; Koch, Andreas; Girfoglio, Daniela; Setanoians, Melinda; Kallweit, Ulf.
Afiliação
  • Winter Y; Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Langenbeckstraße 1, 55131, Mainz, Germany; Department of Neurology, Philipps-University, Biegenstraße 10, 35037, Marburg, Germany. Electronic address: yaroslav.winter@unimedizin-mainz.de.
  • Mayer G; Hephata Klinik, Schimmelpfengstraße 6, 34613, Schwalmstadt, Germany; Philipps University, Biegenstraße 10, 35037, Marburg, Germany.
  • Kotterba S; Klinikum Leer gGmbH, Augustenstraße 35, 26789, Leer (Ostfriesland), Lower Saxony, Germany.
  • Benes H; Somni bene GmbH Institut für Medizinische Forschung and Schlafmedizin Schwerin GmbH, Goethestraße 1, 19053, Schwerin, Germany.
  • Burghaus L; Department of Neurology, Heilig Geist-Hospital, Graseggerstr. 105, 50737, Cologne-Longerich, Germany.
  • Koch A; Jazz Pharmaceuticals, Einsteinstrasse 174, 81677, München, Munich, Germany.
  • Girfoglio D; Jazz Pharmaceuticals, Wing B, Building 5700, Spires House, John Smith Drive, Oxford Business Park South, Oxford, OX4 2RW, United Kingdom.
  • Setanoians M; Jazz Pharmaceuticals, Wing B, Building 5700, Spires House, John Smith Drive, Oxford Business Park South, Oxford, OX4 2RW, United Kingdom.
  • Kallweit U; Institute of Immunology and Center for Biomedical Education and Research, University Witten/Herdecke, Stockumer Str. 10, 58453, Witten, Germany.
Sleep Med ; 103: 138-143, 2023 03.
Article em En | MEDLINE | ID: mdl-36796288
ABSTRACT

BACKGROUND:

Excessive daytime sleepiness (EDS) is a core narcolepsy symptom, for which solriamfetol (Sunosi®) was recently approved in the European Union. SURWEY characterises real-world strategies used by physicians when initiating solriamfetol, and patient outcomes after follow-up.

METHODS:

SURWEY is an ongoing retrospective chart review conducted by physicians in Germany/France/Italy. Here, data are reported from 70 German patients with EDS and narcolepsy. Eligibility included age ≥18 years, reached a stable solriamfetol dose, and completed ≥6 weeks of treatment. Patients were classified (based on existing EDS treatment) into changeover, add-on, or new-to-therapy subgroups.

RESULTS:

Patients' mean ± SD age was 36.9 ± 13.9 years. Changeover from prior EDS medication was the most common initiation strategy. Initial solriamfetol dose was typically 75 mg/day (69%). In 30 patients (43%), solriamfetol was titrated; 27/30 (90%) completed titration as prescribed, most within 7 days. Mean ± SD Epworth Sleepiness Scale (ESS) score was 17.6 ± 3.1 at initiation (n = 61) and 13.6 ± 3.8 at follow-up (n = 51). Slight/strong improvements in EDS were perceived for >90% of patients (patient and physician report). Sixty-two percent reported an effect duration of 6 to <10 h; 72% reported no change in perceived nighttime sleep quality. Common adverse events included headache (9%), decreased appetite (6%), and insomnia (6%); no cardiovascular events were reported.

CONCLUSIONS:

Most patients in this study were switched from a prior EDS medication to solriamfetol. Solriamfetol was typically initiated at 75 mg/day; titration was common. ESS scores improved after initiation, and most patients perceived improvement in EDS. Common adverse events were consistent with those reported in clinical trials. GOV REGISTRATION N/A.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Distúrbios do Sono por Sonolência Excessiva / Narcolepsia Tipo de estudo: Observational_studies / Prognostic_studies Limite: Adolescent / Adult / Humans / Middle aged País como assunto: Europa Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Distúrbios do Sono por Sonolência Excessiva / Narcolepsia Tipo de estudo: Observational_studies / Prognostic_studies Limite: Adolescent / Adult / Humans / Middle aged País como assunto: Europa Idioma: En Ano de publicação: 2023 Tipo de documento: Article