Purpose CPX-351 is dual-drug liposomal encapsulation of daunorubicin and cytarabine at a fixed synergistic 1:5 molar ratio. This study determined current real-world use of CPX-351 versus conventional 7+3 (cytarabine+daunorubicin) therapy and evaluated hospital length of stay (LOS) and supportive care utilization in t-AML and AML-MRC. Patients and Methods This retrospective, observational study utilized the Premier Healthcare Database and included patients who were aged ≥18 years with t-AML or AML-MRC and treated with CPX-351 or 7+3 between August 1, 2017 and February 28, 2019. All patients treated with 7+3 were required to be eligible for CPX-351 based on its FDA-approved indication. Outcome variables were annualized and adjusted for patient, hospital, and clinical confounding factors. The primary outcome was inpatient LOS. Secondary outcomes included use of blood products and use of anti-infectives. Results The study included 195 qualifying patients treated with CPX-351 and 160 patients treated with 7+3 who were eligible for CPX-351. Approximately one-third of the patients treated with CPX-351 were administered therapy in a hospital-based outpatient setting, and all patients treated with 7+3 received it in the inpatient setting. The regression-adjusted annualized inpatient LOS was shorter with CPX-351 than 7+3 (mean of 183.7 vs 197.1 days, p<0.001). The difference in mean-adjusted LOS was most pronounced for t-AML, with a mean-adjusted LOS of 168.9 versus 192.5 days for CPX-351 versus 7+3, respectively (nominal p<0.001). Supportive care utilization, including the number of administrations of red blood cells, the number of administrations of platelets, and the number of days on anti-infectives, was similar between treatment groups. Conclusion CPX-351 was associated with a shorter inpatient LOS than 7+3. Supportive care use, including blood products and anti-infectives, was similar for CPX-351 and 7+3. These findings suggest CPX-351 conveys resource advantages over 7+3 in patients with newly diagnosed t-AML and AML-MRC.

Introduction Idiopathic hypersomnia (IH) is a rare neurologic disorder that can cause debilitating symptoms, including excessive daytime sleepiness, severe sleep inertia, prolonged nighttime sleep, long and unrefreshing naps, and cognitive dysfunction. Limited research has investigated the clinical burden associated with IH. This study compared the clinical profile of patients diagnosed with IH versus matched non-IH controls. Methods MarketScan® administrative claims were analyzed between December 2013 and February 2020. Eligible patients were aged ≥18 years upon cohort entry and had 365 days of continuous medical coverage (gaps ≤30 days allowed) before and after cohort entry. IH cases entered the cohort upon the first medical claim containing an IH diagnosis and without history of cataplexy. Non-IH controls were matched 5:1 to patients with IH on age, sex, region, payer type, and cohort entry date. Prevalence estimates of Clinical Classification System Multilevel (CCSM) categories and comorbid conditions during the 2-year study period were compared between cohorts using logistic regression. Odds ratios (ORs) and 95% confidence intervals (CIs) were reported. Results The final cohorts included 11,428 and 57,138 patients with IH and non-IH controls, respectively. Approximately two-thirds of the sample was female (65.0%); median age was 45 years. Compared with non-IH controls, patients with IH experienced significantly higher prevalence of all CCSM categories. Prevalence estimates of conditions associated with sleep disorders, such as sleep apnea (OR: 26.1 [CI: 24.8, 27.6]), mood disorders (OR: 3.7 [CI: 3.6, 3.9]), and headache/migraine (OR: 2.9 [CI: 2.7, 3.0]), were higher among patients with IH. Similarly, cardiovascular conditions, including cardiovascular disease (OR: 2.2 [CI: 2.1, 2.4]), stroke (OR: 2.2 [CI: 2.0, 2.4]), major adverse cardiovascular events (OR: 2.2 [CI: 2.0, 2.4]), a composite of hypertension diagnosis or use of antihypertensive medications (OR: 2.0 [CI: 2.0, 2.1]), and heart failure (OR: 2.0 [CI: 1.8, 2.3]), were significantly more prevalent among patients with IH. Conclusion Patients with IH experience a significant burden of psychiatric and medical comorbidities, including acute and chronic cardiovascular illnesses. This is consistent with observations in other sleep disorders, namely, narcolepsy. Holistic treatment strategies for IH patients are needed, requiring careful consideration of patients’ overall clinical profile when selecting therapies. Support (if any) Jazz Pharmaceuticals.

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