Dosing and transition characteristics in people with narcolepsy transitioning from sodium oxybate to low-sodium oxybate: Data from the real-world TENOR study.

Autor: Husain AM; Duke University Medical Center, Durham, NC, USA. Electronic address: aatif.husain@duke.edu., Zee PC; Northwestern University, Feinberg School of Medicine, Chicago, IL, USA., Leary EB; Jazz Pharmaceuticals, Palo Alto, CA, USA., Fuller DS; Jazz Pharmaceuticals, Philadelphia, PA, USA., Macfadden W; Jazz Pharmaceuticals, Philadelphia, PA, USA., Candler S; Jazz Pharmaceuticals, Philadelphia, PA, USA., Whalen M; Jazz Pharmaceuticals, Philadelphia, PA, USA., Bae CJ; Penn Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Jazyk: angličtina
Zdroj: Sleep medicine [Sleep Med] 2024 Jan; Vol. 113, pp. 328-337. Date of Electronic Publication: 2023 Nov 25.
DOI: 10.1016/j.sleep.2023.11.022
Abstrakt: Objective: The Transition Experience of persons with Narcolepsy taking Oxybate in the Real-world (TENOR) study assessed the real-world experience of people with narcolepsy switching from sodium oxybate (SXB) to low-sodium oxybate (LXB; 92 % less sodium than SXB).
Methods: TENOR is a patient-centric, prospective, observational, virtual-format study. Eligible participants included US adults with narcolepsy transitioning from SXB to LXB (±7 days from LXB initiation). Longitudinal data were collected from baseline (taking SXB) through 21 weeks post-transition.
Results: TENOR included 85 participants with narcolepsy (type 1, n = 45; type 2, n = 40). Mean (SD) age was 40.3 (13.0) years; the majority (73 %) were female and White (87 %). At study completion, wake-promoting agents were the most common concomitant medications (47 %). Mean (SD) SXB treatment duration was 57.8 (52.1) months; 96 % took SXB twice nightly. After transitioning, 97 % continued on twice-nightly regimens. Mean (SD) dose of both total nightly SXB (n = 85) and baseline LXB (n = 84) was 7.7 (1.5) g; SXB-LXB dose conversions at baseline were gram-for-gram in 87 % of participants. The mean final total nightly dose of LXB was 7.9 g. The most common participant-reported reasons for transitioning included lower sodium content for improved long-term health (93 %), physician recommendation (47 %), to avoid cardiovascular issues (39 %), to avoid side effects (31 %), and to improve control of narcolepsy symptoms (18 %).
Conclusion: Most participants transitioned from SXB to LXB using a gram-for-gram strategy. The most commonly cited reason for transition was long-term health benefits due to lower sodium.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Wayne Macfadden reports financial support, administrative support, and writing assistance were provided by Jazz Pharmaceuticals. Aatif M. Husain reports financial support, administrative support, and writing assistance were provided by Jazz Pharmaceuticals. Phyllis C. Zee reports financial support, administrative support, and writing assistance were provided by Jazz Pharmaceuticals. Eileen B. Leary reports financial support, administrative support, and writing assistance were provided by Jazz Pharmaceuticals. Douglas S. Fuller reports financial support, administrative support, and writing assistance were provided by Jazz Pharmaceuticals. Shawn Candler reports financial support, administrative support, and writing assistance were provided by Jazz Pharmaceuticals. Marisa Whalen reports financial support, administrative support, and writing assistance were provided by Jazz Pharmaceuticals. Charles J. Bae reports financial support, administrative support, and writing assistance were provided by Jazz Pharmaceuticals. Wayne Macfadden reports a relationship with Jazz Pharmaceuticals that includes: employment and equity or stocks. Douglas S. Fuller reports a relationship with Jazz Pharmaceuticals that includes: employment and equity or stocks. Shawn Candler reports a relationship with Jazz Pharmaceuticals that includes: employment and equity or stocks. Marisa Whalen reports a relationship with Jazz Pharmaceuticals that includes: employment and equity or stocks. Eileen B. Leary reports a relationship with Jazz Pharmaceuticals that includes: employment and equity or stocks. Aatif M. Husain reports a relationship with Jazz Pharmaceuticals that includes: consulting or advisory and funding grants. Aatif M. Husain reports a relationship with UCB that includes: consulting or advisory and funding grants. Aatif M. Husain reports a relationship with BlackThorn that includes: consulting or advisory and funding grants. Aatif M. Husain reports a relationship with Sage that includes: consulting or advisory and funding grants. Aatif M. Husain reports a relationship with Eisai that includes: consulting or advisory and funding grants. Aatif M. Husain reports a relationship with Marinus that includes: consulting or advisory and funding grants. Aatif M. Husain reports a relationship with Neurelis that includes: consulting or advisory and funding grants. Aatif M. Husain reports a relationship with Springer that includes: equity or stocks. Aatif M. Husain reports a relationship with Demos Medical that includes: equity or stocks. Aatif M. Husain reports a relationship with Walters Kluwer that includes: equity or stocks. Phyllis C. Zee reports a relationship with Jazz Pharmaceuticals that includes: consulting or advisory. Phyllis C. Zee reports a relationship with Eisai that includes: consulting or advisory. Phyllis C. Zee reports a relationship with Harmony Biosciences that includes: consulting or advisory. Phyllis C. Zee reports a relationship with CVS Caremark that includes: consulting or advisory. Phyllis C. Zee reports a relationship with Teva that includes: equity or stocks. Charles J. Bae reports a relationship with Jazz Pharmaceuticals that includes: consulting or advisory. AM Husain has received consultancy fees and/or research funding from Jazz Pharmaceuticals, UCB, BlackThorn, Sage, Eisai, Marinus, and Neurelis, as well as royalties from Springer, Demos Medical, and Wolters Kluwer, and holds an editorship role with Wolters Kluwer. EB Leary is a former full-time employee of Jazz Pharmaceuticals who, in the course of this employment, received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, plc. DS Fuller, W Macfadden, S Candler, and M Whalen are full-time employees of Jazz Pharmaceuticals who, in the course of this employment, have received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, plc. PC Zee serves on scientific advisory boards for Jazz Pharmaceuticals, Eisai, and Harmony Biosciences, is a consultant for CVS Caremark, and owns stock in Teva. CJ Bae participated in an advisory board for Jazz Pharmaceuticals.
(Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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