Increased Risk of Hypertension Onset Among Patients With Narcolepsy Newly Treated With High-Sodium Oxybate
Rami Ben-Joseph1, Virend Somers2, Jed Black1, Ralph D'Agostino3, Ragy Saad1, Mat Davis1, Wayne Macfadden1, Katherine Mues4, Clark Jackson4, Weiyi Ni1, Michael Cook1, Julia Pitino4, Helen Latimer4, Elizabeth Dabrowski4, William White5
1Jazz Pharmaceuticals, 2Mayo Clinic, 3Wake Forest University School of Medicine, 4Aetion, 5University of Connecticut Health Center
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.