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039 Solriamfetol real world experience study (SURWEY): safety and effectiveness for patients with narcolepsy from Germany
  1. Ulf Kallweit1,
  2. Yaroslav Winter2,
  3. Sylvia Kotterba3,
  4. Heike Benes4,
  5. Lothar Burghaus5,
  6. Andreas Koch6,
  7. Daniela Girfoglio7,
  8. Melinda Setanoians7,
  9. Geert Mayer8
  1. 1Center for Biomedical Education and Research, University Witten/Herdecke, Witten, Germany
  2. 2Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg
  3. 3Klinikum Leer gGmbH, Leer, Lower Saxony, Germany
  4. 4Somni bene GmbH Institut für Medizinische Forschung and Schlafmedizin Schwerin GmbH, Schwerin, Germany
  5. 5Department of Neurology, Heilig Geist-Hospital, Cologne, Germany
  6. 6Jazz Pharmaceuticals, Munich, Germany
  7. 7Jazz Pharmaceuticals, Oxford, UK
  8. 8Hephata Klinik, Schwalmstadt, Germany and Philipps University Marburg, Marburg, Germany

Abstract

Introduction Solriamfetol is a dopamine/norepinephrine reuptake inhibitor approved in the EU for excessive daytime sleepiness (EDS) associated with narcolepsy. This real-world study characterises outcomes following solriamfetol initiation.

Methods SURWEY is an ongoing retrospective chart review (Germany, France, Italy). Patients (≥18 years old, EDS due to narcolepsy, stable solriamfetol dose, ≥6 weeks of treatment) were classified by solriamfe- tol initiation: changeover (from existing EDS medications), add-on (to current EDS medication), or new- to-therapy (no current/prior EDS medication). Epworth Sleepiness Scale (ESS) scores, patient/physician impressions of improvement, and adverse events (AEs) were assessed.

Results Among 78 German patients (36.9±13.9 years old; 56% female, 57% with cataplexy), changeo- ver was most common (n=43), followed by add-on (n=19) and new-to-therapy (n=8). Final follow-up was 15.9±7.0 weeks after initiation. Overall, ESS scores were 17.6±3.1 (n=61) at initiation and 13.6±3.8 at follow-up (n=51), indicating improvement of EDS (improvements similar across subgroups). Most patients perceived slight/strong improvements in their condition (physician report, 94%; patient report, 91%; results similar across subgroups). Common AEs: headache (9%), decreased appetite (6%), insomnia (6%).

Conclusion In this real-world cohort of German patients with narcolepsy, EDS improved across all subgroups with solriamfetol treatment. AEs were consistent with those reported in clinical trials.

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