Hypertension Onset Among Patients With Narcolepsy Newly Treated With Sodium Oxybate

Abstract: Introduction: Sodium oxybate, a recommended narcolepsy treatment, is a high sodium–containing drug with consequent label warnings. The sodium-hypertension relationship is well established. This exploratory study compared intermediate-term risk (within 180 days) of developing hypertension among normotensive patients with narcolepsy initiating sodium oxybate (SXB) versus those not initiating sodium oxybate (controls). Methods: IBM® MarketScan® claims (1/2014 to 2/2020) were analyzed. Eligible patients were adults with continuous enrollment and ≥1 narcolepsy claim or prescription for sodium oxybate. Patients were excluded for history of hypertension or use of antihypertensive medication or sodium oxybate prior to cohort entry. SXB and control cohorts were 1:2 propensity-score matched. Endpoints were hypertension diagnosis and a composite of hypertension diagnosis or a new antihypertensive drug prescription. Risk per 100 patients was reported and differences were evaluated using odds ratios (ORs) and 95% confidence intervals (CIs). Results: There were 954 and 1906 patients included in the SXB and matched control cohorts, respectively. Mean (SD) age was 35 (12) years; most patients (67%) were female. Risk of incident hypertension diagnosis was numerically higher in SXB (0.94) than control (0.52) cohorts (OR=1.81 [95% CI, 0.73–4.46]). Risk of the composite endpoint of either diagnosis of hypertension or initiation of antihypertensive therapy was higher in SXB (6.60) than control (4.20) cohorts (OR=1.61 [95% CI, 1.15–2.27]). Conclusions: Increased risk of new-onset hypertension in normotensive patients with narcolepsy initiating sodium oxybate was demonstrated, which is consistent with known consequences of excess sodium consumption.Short Description: Hypertension is one of several comorbidities associated with narcolepsy. Sodium oxybate, a recommended standard narcolepsy treatment, contributes 1100–1640 mg of sodium to daily sodium intake at doses of 6–9 g/night. This exploratory study, using IBM® MarketScan® claims data, compared the risk of developing hypertension among normotensive narcolepsy patients initiating sodium oxybate (SXB) with those not initiating sodium oxybate (controls). Increased risk of hypertension was observed for sodium oxybate–treated patients.Name of Sponsoring Organization(s): Jazz Pharmaceuticals