Emergent reversal of oral factor Xa inhibitors with four-factor prothrombin complex concentrate.

BACKGROUND: Controversy exists regarding first-line use of the recently approved reversal agent andexanet alfa due to limitations of the ANEXXA-4 study, thrombotic risks, and high medication acquisition cost. The purpose of this study was to evaluate the safety and effectiveness of 4F-PCC for the reversal of emergent oral fXa inhibitor-related bleeding. Furthermore, we aimed to evaluate a subgroup using strict ANNEXA-4 patient selection criteria. METHODS: This was a retrospective study conducted utilizing chart review of adult patients that received 4F-PCC for oral fXa inhibitor-related bleeding. The primary endpoint was the rate of clinical success defined as achieving excellent or good hemostatic effectiveness following the administration of 4F-PCC. Secondary endpoints included in-hospital mortality and arterial/venous thromboembolism, and cost compared with andexanet alfa. RESULTS: A total of 119 patients were included, with 83 patients in the ANNEXA-4 criteria subgroup. Eighty-five of the 119 patients (71%) required reversal due to intracranial bleeding. Prior to reversal, 70 patients (59%) were taking apixaban and 49 patients (41%) were taking rivaroxaban. Clinical success was achieved in 106 of 119 patients (89%) and 74 of 83 patients (90%) in the strict criteria subgroup. Three of 119 patients (2.5%) had a thrombotic event during hospital stay and the overall mortality rate was 13%. The average cost increase of andexanet alfa compared to 4F-PCC would have been $29,500 per patient. CONCLUSIONS: Administration of 4F-PCC for the reversal of oral fXa inhibitors was effective with relatively low thrombotic risk. Further direct prospective comparison of 4F-PCC to andexanet alfa is warranted.

Long-Term Outcomes of a Cardiovascular and Diabetes Risk-Reduction Program Initiated by a Self-Insured Employer.

BACKGROUND: Cardiovascular disease remains the leading cause of death in America and poses a significant challenge for self-insured employers attempting to improve employee health and well-being while controlling healthcare costs. Disease state management programs can be an effective means of achieving these outcomes, but the durability and long-term effects of such programs have limited evaluation. OBJECTIVE: To assess the 5-year health, economic, and quality-of-life patient outcomes of an employer-sponsored disease state management program. METHODS: This was a longitudinal, 5-year, quasi-experimental, pre-/postenrollment study. Self-insured health plan members with hypertension, hyperlipidemia, diabetes, or a combination of these conditions met with a pharmacist regularly (monthly for the first year, then varied by participant) to implement lifestyle medicine programs, optimize medication therapy, and facilitate the coordination of care. Biometric markers, lifestyle behaviors, quality of life, and work productivity were assessed on an annual basis. RESULTS: The significant biometric improvements (mean) seen after 5 years of program participation compared with pre-enrollment included decreased low-density lipoprotein cholesterol levels (96.71 mg/dL vs 84.83 mg/dL, respectively), increased high-density lipoprotein cholesterol levels (39.32 mg/dL vs 46.12 mg/dL), and decreased systolic blood pressure (132.04 mm Hg vs 123.63 mm Hg) and diastolic blood pressure (85.75 mm Hg vs 75.83 mm Hg). The average exercise time increased (50 minutes weekly vs 156.04 minutes weekly), as did fruit and vegetable consumption (3.98 servings daily vs 5.27 servings daily). The program participants reported improved general health and a reduced number of unhealthy days. The combined healthcare and productivity return on investment for the program at 5 years was $9.64 for every $1 invested. CONCLUSIONS: Significant changes in employees' health, well-being, and health-related costs are possible through sustained participation in an employer-sponsored disease state management program.