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A recent poster presentation at the 38th annual meeting of the Associated Professional Sleep Societies June 1-5 2024, Houston, TX, titled “Design Elements for a Switch Study from High to Low-Sodium Oxybate Evaluating Blood Pressure in Narcolepsy (XYLO)”, showcased the effects of switching from high-sodium to low-sodium oxybate on blood pressure in narcolepsy patients, addressing the cardiovascular risks associated with high sodium intake while maintaining treatment efficacy
Narcolepsy is a disorder characterized by disrupted nighttime sleep, with oxybate therapy being one of its treatment options.
There is an alternative oxybate formulation that does not have a high salt load. The question is whether the salt content of Xyrem significantly raises blood pressure and if switching patients to an equivalent low-salt oxybate would lower blood pressure, added study investigator Virend Somers from Mayo Clinic in Rochester, MN.
“The point of this study is to assess individuals currently using the high-salt oxybate Xyrem, with systolic blood pressures between 130 and 155 mmHg. Participants are switched to the low-salt oxybate Xywav, to observe the changes in their blood pressure over a 6-week period of reduced salt intake” added Somers.
Objective
The XYLO study aims to investigate the effects of switching from high-sodium to low-sodium oxybate on blood pressure in narcolepsy patients, addressing cardiovascular risks associated with high sodium intake while maintaining treatment efficacy.
Background
Narcolepsy is a disorder characterized by disrupted nocturnal sleep and excessive daytime sleepiness. Oxybate therapy is a common treatment, effective in managing symptoms but associated with high sodium intake, which can increase cardiovascular risks. The development of low-sodium oxybate aims to reduce these risks.
Study Design
The study is an open-label, multicenter switch trial involving narcolepsy patients currently on high-sodium oxybate. Participants will transition to low-sodium oxybate, with regular monitoring of blood pressure, narcolepsy symptoms, and adverse events to assess safety and efficacy.
Endpoints
Methods
Blood pressure will be monitored regularly, narcolepsy symptoms assessed using standardized scales and patient diaries, and adverse events systematically recorded.
Expected Outcomes
The study anticipates a reduction in blood pressure due to lower sodium intake while maintaining the therapeutic efficacy of oxybate for narcolepsy symptoms. Safety and tolerability of the low-sodium formulation will also be evaluated.
Conclusion
The XYLO study could demonstrate significant cardiovascular benefits of low-sodium oxybate, supporting its broader adoption in clinical practice to enhance patient safety without compromising efficacy.
This synopsis highlights the critical aspects and potential implications of the XYLO study, aiming to provide a safer treatment alternative for narcolepsy patients
To view full research click here
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Writer: Chris Vu, ASBA