Correction to: Neurol Ther (2023) 12:1805–1820 10.1007/s40120-023-00543-z
In this article Russell Rosenberg is deceased; Chad Ruoff has been denoted as the corresponding author with affiliation ‘Division of Pulmonary Medicine, Mayo Clinic, 13400 East Shea Boulevard, Scottsdale, AZ 85259, USA, e-mail: Ruoff.Chad@mayo.edu’.
In Table 2 of this Commentary article, for the number of sleep stage shifts, number of arousals, and patient-reported sleep quality, the values for the REST-ON trial were inadvertently taken from a subgroup analysis of participants taking stimulants presented in Table 2 of the source article [1], rather than from the modified intent-to-treat (mITT) population (reported in Figs. 1–3 of the source article). Additionally, a minus symbol was missing from the value reported for the number of awakenings for the placebo group corresponding to the 6 g dose for SXB trial 2 and values were adjusted to remove “0” after a decimal place where unnecessary for this trial. Table 2 in our Commentary article has been corrected (see next page) to provide the values for the mITT population for the 3 parameters from the REST-ON trial and add the omitted minus symbol and align the decimal places for SXB trial 2.
Table 2.
Twice-nightly oxybate (SXB) | Once-nightly oxybate (SXB-ER) | ||||
---|---|---|---|---|---|
SXB trial 1 | SXB trial 2 | Pediatric SXB trial | SXB trial 3 | REST-ON trial | |
PSG measures of DNS | Median change from baseline to 8 weeks | Median change from baseline to 4 weeks (6 g) or 8 weeks (9 g) | Median change from baseline to end of study (individual doses) | Mean at 4 weeks (4.5 g), 6 weeks (6 g), 8 weeks (7.5 g), or 10 weeks (9 g) | LSMD vs placebo at week 3 (6 g), week 8 (7.5 g), or week 13 (9 g) |
TST, min |
Increased Placebo: 0.3 SXB 4.5 g: 0 SXB 6 g: 13.0 SXB 9 g: 18.0† |
Not significant Placebo: − 5.5 SXB 6 g: − 5 Placebo: − 0.5 SXB 9 g: − 4.5 |
– |
Not significant (4.5 g decreased) Baseline: 383.4 SXB 4.5 g: 364.8* SXB 6 g: 363.0 SXB 7.5 g: 374.1 SXB 9 g: 380.8 |
– |
WASO, min |
Decreased Placebo: 2.0 SXB 4.5 g: − 5.8 SXB 6 g: − 3.8 SXB 9 g: − 22.0† |
– | – | – | – |
N1, min (except pediatric data) |
Decreased Placebo: − 2.3 SXB 4.5 g: − 9.5 SXB 6 g: − 13.5††† SXB 9 g: − 22.5††† |
Decreased Placebo: 3.25 SXB 6 g: − 9.5 Placebo: 1.5 SXB 9 g: − 16††† |
Decreased SXB-naive: − 4.6% Taking SXB at study entry: − 0.6% |
Not significant Baseline: 74.8 SXB 4.5 g: 72.3 SXB 6 g: 68.1 SXB 7.5 g: 69.4 SXB 9 g: 62.6 |
Decreased SXB-ER 6 g: − 5.9† SXB-ER 7.5 g: − 11.0††† SXB-ER 9 g: − 13.4††† |
N2, min |
Not significant Placebo: 3.5 SXB 4.5 g: 9.5 SXB 6 g: 13.0 SXB 9 g: 31.5 |
Not significant Placebo: − 5.25 SXB 6 g: 0.5 Placebo: − 8.25 SXB 9 g: 3.5 |
No change Values not reported |
Not significant Baseline: 217.8 SXB 4.5 g: 216.9 SXB 6 g: 216.9 SXB 7.5 g: 224.1 SXB 9 g: 238.0 |
Not significant SXB-ER 6 g: − 6.6 SXB-ER 7.5 g: 3.6 SXB-ER 9 g: − 13.5 |
SWS, min (except pediatric data) |
Increased Placebo: 0 SXB 4.5 g: 3.0† SXB 6 g: 21.0††† SXB 9 g: 52.5††† |
Increased Placebo: 0 SXB 6 g: 11† Placebo: 0 SXB 9 g: 43.5††† |
Increased SXB-naive: 12.6% Taking SXB at study entry: − 1.0% |
Increased Baseline: 3.0 (1st half), 0.6 (2nd half) SXB 4.5 g: 3.5 (1st half), 0.7 (2nd half) SXB 6 g: 5.5 (1st half), 4.5 (2nd half) SXB 7.5 g: 9.8 (1st half), 4.5* (2nd half) SXB 9 g: 14.2 (1st half), 12.6* (2nd half) |
Increased SXB-ER 6 g: 22.1††† SXB-ER 7.5 g: 26.8††† SXB-ER 9 g: 38.4††† |
REM, min (except pediatric data) |
Decreased Placebo: − 1.0 SXB 4.5 g: − 6.0 SXB 6 g: − 7.0 SXB 9 g: − 22.0† |
Decreased Placebo: 6.25 SXB 6 g: − 14.5†† Placebo: 10 SXB 9 g: − 38.5††† |
Decreased SXB-naive: − 6.0% Taking SXB at study entry: not reported |
Decreased Baseline: 31.2 (1st half), 56.0 (2nd half) SXB 4.5 g: 29.7 (1st half), 43.5* (2nd half) SXB 6 g: 26.3 (1st half), 42.7*** (2nd half) SXB 7.5 g: 31.3 (1st half), 34.9*** (2nd half) SXB 9 g: 22.9 (1st half), 30.5*** (2nd half) |
Decreased SXB-ER 6 g: − 16.7††† SXB-ER 7.5 g: − 27.2††† SXB-ER 9 g: − 24.5††† |
Shifts from N2/N3/REM to N1/wake |
Decreased (LSM change from baseline in shifts per hour) Placebo: − 0.8 SXB 4.5 g: − 1.7 SXB 6 g: − 2.7† SXB 9 g: − 4.4††† |
Decreased (LSM change from baseline in shifts per night) Placebo: − 0.6 SXB 9 g: − 16.5††† |
– | – |
Decreased (LSMD change from baseline in shifts per night to wake or N1 from N1, N2, N3, and REM) SXB-ER 6 g: − 11.0††† SXB-ER 7.5 g: − 17.7††† SXB-ER 9 g: − 22.6††† |
Shifts from N2/N3 to N1/wake |
Decreased (LSM change from baseline in shifts per hour) Placebo: − 0.3 SXB 4.5 g: − 0.9 SXB 6 g: − 1.7† SXB 9 g: − 3.1††† |
– | – | – | |
Shifts from REM to N1/wake |
Decreased (LSM change from baseline in shifts per hour) Placebo: − 1.9 SXB 4.5 g: − 3.8 SXB 6 g: − 5.0 SXB 9 g: − 7.6† |
Decreased (LSM change from baseline in shifts per night) Placebo: − 0.6 SXB 9 g: − 6.0††† |
– | – | |
Arousals | – | – |
Decreased SXB-naive: − 43.0 Taking SXB at study entry: − 1.0 |
– |
Decreased SXB-ER 6 g: − 11.3† SXB-ER 7.5 g: − 19.4††† SXB-ER 9 g: − 23.7††† |
Awakenings |
Decreased Placebo: − 0.5 SXB 4.5 g: − 5.0 SXB 6 g: − 8.0†† SXB 9 g: − 12.0†† |
Decreased Placebo: − 0.5 SXB 6 g: − 1 Placebo: − 0.5 SXB 9 g: − 6†† |
No change SXB-naive: − 4.0 awakenings Taking SXB at study entry: 1.5 awakenings |
Decreased Baseline: 50.2 SXB 4.5 g: 50.0 SXB 6 g: 45.1 SXB 7.5 g: 37.3*** SXB 9 g: 37.8** |
– |
Patient-reported sleep quality |
Improved (4-point Likert scale)a Placebo: − 0.10 SXB 4.5 g: − 0.41† SXB 6 g: − 0.31† SXB 9 g: − 0.46††† |
Improved (LSM change from baseline on question 6 of the PSQI) Placebo: − 0.07 SXB 9 g: − 0.52††† |
– |
Improved (Self-reported degree of change) Baseline: 0% (much), 14% (somewhat) SXB 4.5 g: 19% (much), 57% (somewhat) SXB 6 g: 24% (much), 67% (somewhat) SXB 7.5 g: 24% (much), 62% (somewhat) SXB 9 g: 24% (much), 57% (somewhat) |
Improved (Visual analog scale from 0–100)b SXB-ER 6 g: 7.0††† SXB-ER 7.5 g: 9.9††† SXB-ER 9 g: 10.4††† |
DNS disrupted nighttime sleep, LSM least squared mean, LSMD least squared mean difference, N1/2 stage 1/2 non-rapid eye movement sleep, ns not significant, PSG polysomnography, REM rapid eye movement, S3/S4 stage 3/4, SWS slow-wave sleep, SXB sodium oxybate, SXB-ER sodium oxybate for extended release, TST total sleep time, WASO wake after sleep onset
aAssessed with 4-point Likert-type scale (0, excellent; 1, good; 2, fair; 3, poor)
bBaseline scores were 53.8 and 55.9 in ON-SXB and placebo groups, respectively
†P < 0.05 vs placebo. ††P < 0.01 vs placebo. †††P < 0.001 vs placebo. *P < 0.05 vs baseline. **P < 0.01 vs baseline. ***P < 0.005 vs baseline. – denotes a variable not assessed in this trial. No statistical testing was performed in the pediatric trial
Similarly, in the section “Both Twice-Nightly and Once-Nightly Oxybate Regimens Improve PSG Measures of DNS, With a Similar Magnitude of Effect” of this article, the number of stage shifts was incorrectly given as − 19.6 (the value for the subgroup analysis) instead of − 20.5 (the value for the modified intent-to-treat population). The corrected sentence is as follows: “Following 13 weeks of SXB-ER treatment (titrated to 9 g), total shifts per night from N1/2/3/REM to wake and N2/3/REM to N1 decreased significantly from baseline (LSM, − 20.5); this trial did not report stage shifts broken down by sleep stage as were reported in SXB trials 1 and 2 [20].”
These corrections do not impact the conclusions of this Commentary article.
The original article has been corrected.
Footnotes
Russell Rosenberg passed away after the publication of the commentary.
Rogelio Braceras and Wayne Macfadden are former employees of Jazz Pharmaceuticals.
Reference
- 1.Roth T, Dauvilliers Y, Thorpy MJ, et al. Effect of FT218, a once-nightly sodium oxybate formulation, on disrupted nighttime sleep in patients with narcolepsy: results from the randomized phase III REST-ON trial. CNS Drugs. 2022;36(4):377–87. 10.1007/s40263-022-00904-6 [DOI] [PMC free article] [PubMed] [Google Scholar]