Abstract Details

Title Cardiovascular Burden of Narcolepsy Disease (CV-BOND): a Real-World Evidence Study

Topic Sleep

Presentation(s) S1 - Sleep: Want to Hear the Latest? (2:24 PM-2:36 PM)

Poster/Presentation
Number 008

Objective To estimate the risk of cardiovascular and renal comorbidities in US adults with narcolepsy.

Background Narcolepsy is a rare, central disorder of hypersomnolence that requires long-term treatment and is associated with multiple comorbidities. Many treatments for narcolepsy symptoms have cardiovascular-related warnings and precautions in their labels.

Design/Methods Claims from IBM^® MarketScan^®, an administrative claims database, between January 2014 and June 2019 were analyzed. Eligible patients were ≥18 years of age and had continuous medical and prescription coverage (gaps ≤30 days allowed). The narcolepsy cohort was defined by ≥2 outpatient claims containing a diagnosis of narcolepsy type 1 or type 2 on separate days and no more than 6 months apart, with ≥1 non-diagnostic office visit. Patients without narcolepsy were matched 3:1 to patients with narcolepsy by calendar date of cohort entry, age, gender, US geographic region, and insurance type. Each incidence calculation required a 6-month washout period prior to cohort entry. Differences between cohorts were evaluated using a Cox proportional hazard model adjusted for age, gender, region, insurance type, and relevant morbidities/comorbidities and medications in the baseline period.

Results

Of 54,239,110 adults in the database, 12,816 and 38,441 were included in the narcolepsy and matched non-narcolepsy cohorts. Approximately 67% were female, and mean age was approximately 38 years in both cohorts. Adjusted hazard ratios (HRs), derived from incidence rates, suggested significantly increased risk of the following outcomes in the narcolepsy cohort compared with matched non-narcolepsy controls (nominal P<0.05): any stroke (HR [95% CI]: 1.71 [1.24, 2.34]); edema (1.61 [1.28, 2.03]); heart failure (1.35 [1.03, 1.76]); ischemic stroke (1.67 [1.19, 2.34]); major adverse cardiac event (1.45 [1.20, 1.74]); grouped instances of stroke, atrial fibrillation, or edema (1.48 [1.25, 1.74]); and any cardiovascular disease excluding hypertension (1.30 [1.08, 1.56]).

Conclusions Physicians should consider increased cardiovascular risk when weighing risk modification strategies and treatment options for narcolepsy.

Authors/Disclosures
Rami Ben-Joseph, PhD PRESENTER	Dr. Ben-Joseph has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Dr. Ben-Joseph has stock in Jazz Pharmaceuticals.
Ragy Saad (Jazz Pharmaceuticals)	No disclosure on file
Jed Black, MD (Jazz Pharmaceuticals)	Jed Black, MD has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Jed Black, MD has stock in Jazz Pharmaceuticals. Jed Black, MD has stock in .
	No disclosure on file
	No disclosure on file
	No disclosure on file
Virend Somers	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 $5,000-$9,999 for serving as a Consultant for Lilly. Virend Somers has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axome. Virend Somers has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ApniMed. The institution of Virend Somers has received research support from National Institutes Health.

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