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Time to response with sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.
J Clin Sleep Med. 2015 Apr 15; 11(4):427-32.JC

Abstract

STUDY OBJECTIVES

This post hoc analysis evaluated the time to response that can be expected with sodium oxybate (SXB) for treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy.

METHODS

Data were from a 4-week, double-blind, randomized, placebo-controlled trial (GHB-2; N = 136) of oral SXB 3 g, 6 g, and 9 g nightly, and its 12-month open-label extension (GHB-3). Two response definitions were utilized: ≥ 20% improvement in Epworth Sleepiness Scale (ESS) score (EDS responders), and ≥ 50% reduction in weekly cataplexy attacks (cataplexy responders). These thresholds were previously determined to be clinically relevant based on analysis of the relationship of Clinical Global Impression of Change with ESS and number of cataplexy attacks. Kaplan-Meier curves and median times to first response, based on above criteria, and to maximum response were estimated.

RESULTS

Among 86 patients randomized to SXB in GHB-2 and continued into GHB-3, 77.6% and 90.7% were EDS and cataplexy responders, respectively. The median (95% CI) times to first response were 37 (31-50) days for EDS and 25 (17-29) days for cataplexy, and median times to maximum response were 106 (85-164) days for EDS and 213 (94-279) days for cataplexy. GHB-3 results among 31 patients initially randomized to placebo were consistent with those treated with SXB throughout, but with longer times to maximum response.

CONCLUSIONS

Response onset, assessed as clinically meaningful improvements in EDS and cataplexy, was observed in most patients within 2 months; a longer period is needed to achieve maximum response. Clinicians should recognize that time to initial and maximum response may take weeks to months.

Authors+Show Affiliations

University of South Carolina School of Medicine, Columbia, SC.Sleep Disorders and Research Center, Henry Ford Hospital, Detroit, MI.University of Oklahoma Health Services Center, Oklahoma City, OK.Jazz Pharmaceuticals, Inc., Palo Alto, CA.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25580605

Citation

Bogan, Richard K., et al. "Time to Response With Sodium Oxybate for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy." Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine, vol. 11, no. 4, 2015, pp. 427-32.
Bogan RK, Roth T, Schwartz J, et al. Time to response with sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. J Clin Sleep Med. 2015;11(4):427-32.
Bogan, R. K., Roth, T., Schwartz, J., & Miloslavsky, M. (2015). Time to response with sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine, 11(4), 427-32. https://doi.org/10.5664/jcsm.4598
Bogan RK, et al. Time to Response With Sodium Oxybate for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Patients With Narcolepsy. J Clin Sleep Med. 2015 Apr 15;11(4):427-32. PubMed PMID: 25580605.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Time to response with sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. AU - Bogan,Richard K, AU - Roth,Thomas, AU - Schwartz,Jonathan, AU - Miloslavsky,Maja, Y1 - 2015/04/15/ PY - 2014/09/16/received PY - 2014/11/20/accepted PY - 2015/1/13/entrez PY - 2015/1/13/pubmed PY - 2016/4/12/medline KW - cataplexy KW - excessive daytime sleepiness KW - narcolepsy KW - sodium oxybate KW - time to response SP - 427 EP - 32 JF - Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine JO - J Clin Sleep Med VL - 11 IS - 4 N2 - STUDY OBJECTIVES: This post hoc analysis evaluated the time to response that can be expected with sodium oxybate (SXB) for treatment of excessive daytime sleepiness (EDS) and cataplexy in patients with narcolepsy. METHODS: Data were from a 4-week, double-blind, randomized, placebo-controlled trial (GHB-2; N = 136) of oral SXB 3 g, 6 g, and 9 g nightly, and its 12-month open-label extension (GHB-3). Two response definitions were utilized: ≥ 20% improvement in Epworth Sleepiness Scale (ESS) score (EDS responders), and ≥ 50% reduction in weekly cataplexy attacks (cataplexy responders). These thresholds were previously determined to be clinically relevant based on analysis of the relationship of Clinical Global Impression of Change with ESS and number of cataplexy attacks. Kaplan-Meier curves and median times to first response, based on above criteria, and to maximum response were estimated. RESULTS: Among 86 patients randomized to SXB in GHB-2 and continued into GHB-3, 77.6% and 90.7% were EDS and cataplexy responders, respectively. The median (95% CI) times to first response were 37 (31-50) days for EDS and 25 (17-29) days for cataplexy, and median times to maximum response were 106 (85-164) days for EDS and 213 (94-279) days for cataplexy. GHB-3 results among 31 patients initially randomized to placebo were consistent with those treated with SXB throughout, but with longer times to maximum response. CONCLUSIONS: Response onset, assessed as clinically meaningful improvements in EDS and cataplexy, was observed in most patients within 2 months; a longer period is needed to achieve maximum response. Clinicians should recognize that time to initial and maximum response may take weeks to months. SN - 1550-9397 UR - https://www.unboundmedicine.com/medline/citation/25580605/Time_to_response_with_sodium_oxybate_for_the_treatment_of_excessive_daytime_sleepiness_and_cataplexy_in_patients_with_narcolepsy_ L2 - https://doi.org/10.5664/jcsm.4598 DB - PRIME DP - Unbound Medicine ER -