Increased Risk of Hypertension Onset among Patients with Narcolepsy Newly Treated with High-Sodium Oxybate

Objective: This study compared intermediate-term risk (≤180 days) of new-onset hypertension among normotensive patients with narcolepsy initiating high-sodium oxybate (SXB cohort) with those not initiating high-sodium oxybate (controls). Background: High-sodium oxybate, a recommended narcolepsy treatment, contains a high-sodium content warning in its US Food and Drug Administration–approved labeling. The sodium-hypertension relationship is well established. Design/Methods: MarketScan® claims (1/2014 to 2/2020) were analyzed. Eligible adults had continuous enrollment and ≥1 narcolepsy claim or prescription for sodium oxybate. Patients with a history of hypertension, use of antihypertensives, and prior use of sodium oxybate were excluded. In a sensitivity analysis, patients with a history of cardiovascular disease (CVD) were also excluded. Two endpoints were assessed: 1) a composite of new-onset hypertension diagnosis or initiation of antihypertensive medication and 2) new-onset hypertension diagnosis alone. Propensity-score 1:2 matching was applied to balance baseline characteristics. Risk per 100 patients and adjusted odds ratios (ORs) were reported with 95% confidence intervals (CIs). Results: A total of 954 and 1906 patients were included in the SXB and control cohorts, respectively. Risk of the composite endpoint per 100 patients was higher in SXB (6.60) than control (4.20) cohorts (OR=1.61; 95% CI, 1.15–2.27); risk of new-onset hypertension per 100 patients was higher in SXB (0.94) than control (0.52) cohorts (OR=1.81; 95% CI, 0.73–4.46). In the sensitivity analysis, risk of the composite endpoint per 100 patients was higher in SXB (6.22) than control (4.06) cohorts (OR=1.57; 95% CI, 1.10–2.24); risk of new-onset hypertension per 100 patients was higher in SXB (0.89) than control (0.44) cohorts (OR=2.01; 95% CI, 0.75–5.36). Conclusions: This study showed increased risk of new-onset hypertension among normotensive patients with narcolepsy treated with sodium oxybate, even among patients without history of CVD. Clinicians should consider the cardiovascular risk associated with high-sodium oxybate. Disclosure: Dr. Ben-Joseph has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Dr. Ben-Joseph has stock in Jazz Pharmaceuticals. Virend Somers has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz Pharmaceuticals . Virend Somers has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Respicardia. Virend Somers has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bayer . Virend Somers has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Baker Tilly. The institution of Virend Somers has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sleep Number . Virend Somers has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for National Institutes Health . The institution of Virend Somers has received research support from National Institutes Health. The institution of Virend Somers has received research support from Sleep Number . Jed Black, MD has stock in Jazz Pharmaceuticals. Jed Black, MD has stock in . Dr. Dagostino has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz Pharmaceutical . Dr. Dagostino has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Dagostino has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Exelixis. Dr. Dagostino has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MEI Pharma. Dr. Dagostino has received research support from NIH. Mr. Saad has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Mr. Saad has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Evidinno Outcomes Research Inc.. Mr. Saad has received stock or an ownership interest from Jazz Pharmaceuticals. Mat D. Davis has received personal compensation for serving as an employee of Teva pharmaceuticals. Mat D. Davis has received stock or an ownership interest from Teva Pharmaceuticals. Dr. Macfadden has received personal compensation for serving as an employee of Jazz pharma. Dr. Macfadden has stock in Jazz pharma. Dr. Mues has received personal compensation for serving as an employee of Aetion. Ms. Jackson has received personal compensation for serving as an employee of Aetion. Ms. Jackson has stock in Aetion. Dr. Ni has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Dr. Ni has stock in Jazz Pharmaceuticals. Dr. Cook has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Dr. Cook has stock in Jazz Pharmaceuticals. Miss Pitino has received personal compensation for serving as an employee of Aetion, Inc. Miss Pitino has stock in Aetion, Inc. Ms. Latimer has received personal compensation for serving as an employee of Aetion. Ms. Latimer has stock in Aetion. Ms. Dabrowski has received personal compensation for serving as an employee of Aetion, Inc.. Ms. Dabrowski has received stock or an ownership interest from AbbVie Inc.. Ms. Dabrowski has received stock or an ownership interest from BioMarin Pharmaceutical Inc.. Ms. Dabrowski has received stock or an ownership interest from CVS Health Corporation . Ms. Dabrowski has received stock or an ownership interest from Moderna Inc.. Ms. Dabrowski has received stock or an ownership interest from Walgreens Boots Alliance. Dr. White has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for JAZZ Pharmaceuticals.