Discussion
cataplexy, narcolepsy, EDS, sleepiness, Adverse drug reactions
NARCOLEPSY, SECONDARY, CATAPLEXY, ADVERSE DRUG REACTION
This post hoc analysis of data from REST-ON assessed efficacy endpoints in NT1 and NT2 subgroups separately and provides further insight into baseline measures of EDS and DNS in each narcolepsy type. Although patients with either NT1 or NT2 experience pathologic sleepiness [A diagnosis of NT1 can be made based on findings from CSF, however, lumbar puncture is rarely performed in the United States [When immediate-release SXB was initially approved by the FDA in 2002, the indication was limited to the treatment of cataplexy in narcolepsy. In 2005, the indication was expanded to include EDS in narcolepsy. In practice, some clinicians may reserve the use of oxybates for NT1, despite the approved indication [Overall, efficacy benefits with ON-SXB vs placebo were consistent between patients with NT1 and NT2. Although not all endpoints in the NT2 subgroup reached statistical significance, the magnitude of change was clinically significant. The lack of statistical significance in some of the secondary endpoints (ie, refreshing nature of sleep and ESS score) was likely a result of the small sample size of the NT2 subgroup and insufficient power; enrollment of participants with NT2 was limited by the oversampling of the NT1 group in REST-ON [ON-SXB was well tolerated in REST-ON. Adverse drug reactions during treatment with ON-SXB were consistent with the known safety profile of twice-nightly SXB and were generally mild or moderate [