Efficacy and safety of factor Xa inhibitors in low body weight patients.

STUDY OBJECTIVE: The purpose of this study is to provide evidence for the safety and efficacy of factor Xa inhibitors in patients with a weight ≤60 kg or BMI < 18.5 kg/m2 . DESIGN: Multicenter, retrospective, cohort study. SETTING: Twenty-two Ascension Health hospitals. PATIENTS: Low-body-weight adult patients (weight ≤ 60 kg or BMI < 18.5 kg/m2 ) receiving treatment for atrial fibrillation or venous thromboembolism. INTERVENTION: Factor Xa inhibitors (apixaban or rivaroxaban) or warfarin. MEASUREMENTS AND MAIN RESULTS: This study included 2538 patients between the factor Xa inhibitors (n = 1695) and warfarin (n = 843) groups with a mean weight of 53.5 ± 5.5 kg and BMI of 20.7 ± 3.1 kg/m2 . No significant difference in time to major bleeding was noted after controlling for potential confounders (HR 1.03, 95% CI 0.70-1.53, p = 0.87); similar results were seen following propensity score matching. Thromboembolism (5.3% vs. 6.2%, p = 0.38), composite major + clinically relevant nonmajor bleeding (9.8% vs. 11.5%, p = 0.18), and all-cause mortality (10.7% vs. 12.8%, p = 0.12) were similar between patients receiving factor Xa inhibitors versus warfarin. CONCLUSION: No differences in safety or effectiveness were noted between factor Xa inhibitors versus warfarin. These findings provide encouraging evidence to support the use of factor Xa inhibitors in low-body-weight patients.

Caring for Maya: A Family, Pediatrician, and Complex Care Partnership.

Coordinating care to meet the robust needs of children with medical complexity and their families is challenging, especially in the setting of a busy primary care practice. This article describes the experience of one family and pediatrician and highlights specific factors, such as a focus on building relationships, meaningful and structured information-sharing, and partnership with a complex care program, that can positively affect care. [Pediatr Ann. 2020;49(11):e486-e490.].

Calcimimetic Use in Dialysis-Dependent Medicare Fee-for-Service Beneficiaries and Implications for Bundled Payment.

Background: Patients who are dialysis dependent and have secondary hyperparathyroidism (SHPT) may require calcimimetics to reduce parathyroid hormone levels to treatment goals. Medicare currently uses the Transitional Drug Add-on Payment Adjustment (TDAPA) designation under the ESKD Prospective Payment System ("bundled payment") to pay for calcimimetics (the first products eligible for the adjustment); this payment designation for calcimimetics is expected to conclude after 2020. This study explores variability in calcimimetic use across key patient characteristics and its potential effect on policy options for incorporating calcimimetics permanently into the bundle. Methods: This descriptive analysis used the 100% sample of Medicare FFS Part B (outpatient) 2018 claims to describe national-, regional-, and patient-level variation (including race, dual eligibility, and dialysis vintage) in calcimimetic use among beneficiaries who are dialysis dependent. Results: A total of 373,874 beneficiaries were analyzed, 28% had ≥90 days of calcimimetic use during 2018. At the national level, the proportion of patients on dialysis using calcimimetics was roughly 80% higher in Black versus non-Black patients on dialysis, 30% higher in patients on dialysis who were dual eligible versus non-dual eligible, and three times higher in patients with a dialysis vintage ≥3 years versus <3 years (all results unadjusted). Calcimimetic use was similar across census regions, however, substantial variation in calcimimetic use was observed at the facility level. Medicare spending for calcimimetic therapies as a proportion of total Medicare dialysis spending was >10% in approximately 20% of dialysis facilities. Conclusions: Although less than a third of beneficiaries use calcimimetics, certain patient-level characteristics are associated with higher rates of maintenance calcimimetic use. Due to the financial pressure many dialysis facilities face, how calcimimetics are incorporated into the bundle may have a direct effect on facility reimbursement for, and patient access to, therapy. Careful consideration will be required to ensure patients who are vulnerable and require treatment for SHPT do not face barriers to appropriate care.