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Introduction A retrospective analysis was conducted to characterize diagnostic sleep testing during the 12 months before diagnosis of idiopathic hypersomnia (IH), a hypersomnolence disorder with no approved treatments. Methods IBM® MarketScan® claims data were analyzed (1/1/14–9/30/19) to identify adults with newly diagnosed IH, defined as ≥2 claims with an IH diagnosis code ≥1 day and ≤180 days apart, and without an IH diagnosis ≤12 months before cohort entry. Demographics, diagnosing physician specialty, and diagnostic sleep disorder testing (identified via claims with procedure codes for multiple sleep latency test/maintenance of wakefulness test [MSLT/MWT], home sleep test, and polysomnography) were summarized. Analyses were performed on patients with IH diagnosis codes recorded in any position on the claims (“overall IH”) and in the primary position (“primary IH”) to understand the effects of applying a more specific definition of IH. Results Of 32,948,986 eligible people, 4,980 (0.015%) newly diagnosed IH patients were identified. Mean age was 43 years and 67% were female; those with primary IH (n=2,205; 44% of overall IH) were younger (mean age, 39 years) and more likely to be female (73%). Long sleep time was documented for 69% of the overall IH group and 67% of the primary IH group. The top 3 diagnosing physicians’ specialties were similar for overall IH/primary IH: pulmonology (23%/26%), neurology (14%/16%), and internal medicine (11%/10%). Few patients (9% overall IH; 7% with primary IH) were diagnosed in family practice. Any sleep testing was performed in 44% of overall IH and 53% of primary IH patients. Polysomnography and MSLT/MWT, the most frequently used sleep tests, were less common in overall IH (39% and 22%) than in primary IH (48% and 32%). Conclusion IH patients were typically diagnosed by specialists, outside of general medical practice. The most common diagnosing physicians were pulmonologists and neurologists for both the overall and primary IH groups. Objective sleep testing was more frequently documented in diagnosis of primary IH but utilization was low regardless of the definition of IH diagnosis. Further research is needed to investigate the utilization of sleep testing by clinicians for diagnosing IH. Support (if any) Jazz Pharmaceuticals

Study Objectives Narcolepsy is associated with cardiovascular risk factors; however, the risk of new-onset cardiovascular events in this population is unknown. This real-world study evaluated the excess risk of new-onset cardiovascular events in US adults with narcolepsy. Methods A retrospective cohort study using IBM ® MarketScan ® administrative claims data (2014–2019) was conducted. A narcolepsy cohort, comprising adults (≥18 years) with at least two outpatient claims containing a narcolepsy diagnosis, of which at least one was non-diagnostic, was matched to a non-narcolepsy control cohort (1:3) based on cohort entry date, age, sex, geographic region, and insurance type. The relative risk of new-onset cardiovascular events was estimated using a multivariable Cox proportional hazards model to compute adjusted hazard ratios (HRs) and 95% confidence intervals (CIs). Results The narcolepsy and matched non-narcolepsy control cohorts included 12,816 and 38,441 individuals, respectively. At baseline, cohort demographics were generally similar; however, patients with narcolepsy had more comorbidities. In adjusted analyses, the risk of new-onset cardiovascular events was higher in the narcolepsy cohort compared with the control cohort: any stroke (HR [95% CI], 1.71 [1.24, 2.34]); heart failure (1.35 [1.03, 1.76]); ischemic stroke (1.67 [1.19, 2.34]); major adverse cardiac event (MACE; 1.45 [1.20, 1.74]); grouped instances of stroke, atrial fibrillation, or edema (1.48 [1.25, 1.74]); and cardiovascular disease (1.30 [1.08, 1.56]). Conclusion Individuals with narcolepsy are at increased risk of new-onset cardiovascular events compared with individuals without narcolepsy. Physicians should consider cardiovascular risk in patients with narcolepsy when weighing treatment options.

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Introduction Narcolepsy is a rare, lifelong disorder that requires long-term treatment and is associated with multiple comorbidities, including cardiovascular conditions. Many available treatments have cardiovascular-related warnings and precautions in their labels. The objective of this study was to estimate the incidence of cardiovascular comorbidities in adult patients with a narcolepsy diagnosis in the US. Methods Claims from IBM® MarketScan®, an administrative claims database, between January 2014 and June 2019 were analyzed. Eligible patients were ≥18 years 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. Non-narcolepsy patients were matched 3:1 to narcolepsy patients by calendar date of cohort entry, age, gender, US geographic region, and insurance type. Each incidence calculation required a 6 month wash-out 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 cohort. Approximately 67% were female patients and mean age was approximately 38 years in both cohorts. Incidence rates (per 1,000 person-years) for newly recorded cardiovascular comorbidities or events in narcolepsy/non-narcolepsy were: CVD without hypertension (13.29/7.99), MACE+ (11.75/6.86), heart failure (5.72/3.41), stroke (4.28/2.17), ischemic stroke (3.69/1.91), edema (9.84/4.22), and a composite of stroke, atrial fibrillation, and edema (17.73/8.88). Conclusion Physicians should consider the increased cardiovascular risk when considering risk modification strategies and treatment options for narcolepsy patients. Further research is needed to understand treatment-specific risks. Support (if any) Jazz Pharmaceuticals