Switching from high-sodium to low-sodium oxybate for narcolepsy treatment

A recent prospective study, SEGUE, published in the Journal of Clinical Sleep Medicine, has shown that patients with narcolepsy can safely transition from a high-sodium oxybate (SXB) to a low-sodium oxybate (LXB) regimen, without experiencing any reduction in the efficacy of their treatment.

Overview of Oxybate Treatment for Narcolepsy

Narcolepsy is a chronic neurological disorder that affects the sleep-wake cycle and leads to excessive daytime sleepiness, as well as other symptoms such as cataplexy, hallucinations, and sleep paralysis. Oral SXB was approved by the FDA in 2017 as a treatment for narcolepsy, making it the first generic medication indicated for this patient population. However, due to its association with severe adverse effects, SXB was subjected to a Risk Evaluation and Mitigation Strategy (REMS) program as a part of its approval. LXB became the first FDA-approved drug for the treatment of idiopathic hypersomnia in August 2021. Both SXB and LXB contain gamma-hydroxybutyrate (GHB), which is a Schedule 1 controlled substance that can drastically impair one’s alertness and respiratory function.

Study Details

The SEGUE study was conducted by researchers to investigate the transition of patients with narcolepsy from a SXB to an LXB dosage regimen. Participants included patients aged 18-80 years diagnosed with narcolepsy type 1 or 2 and who followed a steady SXB dosing regimen. For the first two weeks of the study, they continued their usual SXB dose before transitioning to an equal LXB dose for the next six weeks. To measure their experiences and adjustment to the new medication, researchers utilized the Epworth Sleepiness Scale (ESS), ease of switching medication scale (EOSMS), Patient Global Impression of Change (PGIc), and the forced preference questionnaire (FPQ).

Results

A total of 54 of the 62 participants completed the study, and no additional tolerability or safety concerns arose during the SXB to LXB transition. On average, the initial and end doses of LXB were 8.0 g/night, and ESS scores were 9.4 and 8.8, respectively. In 45% of participant responses to the PGIc, noticeable improvements were reported, while 48% reported no changes in their symptoms. Furthermore, results from the EOSMS revealed that 93% of participants found the transition from SXB to LXB “easy,” and the FPQ demonstrated that 79% of participants favored LXB over SXB, largely due to the reduced sodium content.

Importance of Low-Sodium Regimens

Because patients with narcolepsy carry an increased risk for cardiovascular issues, the present authors expressed how effective lower-sodium regimens are for improving cardiovascular morbidity outcomes. LXB contains 92% less sodium than SXB, highlighting its potential superiority in cases of elevated cardiovascular risk. Therefore, the results of the SEGUE study further support the use of LXB in narcolepsy treatment.

Conclusion

In conclusion, the SEGUE study confirms that patients with narcolepsy can safely switch from a high-sodium oxybate (SXB) to a low-sodium oxybate (LXB) regimen for the management of their symptoms. Most participants were able to transition from SXB to LXB without the need for much modification to their dosing or routine, and this process was largely seamless. The efficacy of their oxybate treatment was unaffected and maintained during this transition. The study’s results highlight the potential of LXB for improving cardiovascular morbidity outcomes and provide further evidence supporting its use in narcolepsy treatment.

Related Keywords

Narcolepsy
Low-sodium oxybate
High-sodium oxybate
Schedule 1 controlled substance
Risk Evaluation and Mitigation Strategy (REMS)
Idiopathic Hypersomnia
Gamma-hydroxybutyrate (GHB)
Epworth Sleepiness Scale (ESS)
Patient Global Impression of Change (PGIc)
Forced preference questionnaire (FPQ)
Cardiovascular morbidity outcomes

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Low-Sodium Oxybate: An Equally Effective but Safer Alternative to High-Sodium Oxybate for…