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A standardized therapeutic range for voriconazole has not been defined. Most available studies recommend trough concentrations of approximately 1-6 microg/mL. Prospective, randomized trials are needed to confirm the correlation between plasma voriconazole concentrations and clinical outcomes.

Although guidelines are inadequate to predict and prevent anthracycline-induced cardiotoxicity, until further research is available, following one of the existing guidelines to monitor for this adverse effect is a practical solution.

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Data comparing the patient characteristics, management and outcomes for dabigatran versus warfarin major bleeding in the practice setting are limited. We performed a retrospective single health system study of atrial fibrillation patients with dabigatran or warfarin major bleeding from October 2010 through September 2012. Patient identification occurred through both an internal adverse event reporting system and a structured stepwise data filtering approach using the International Classification of Diseases diagnosis codes. Thirty-five dabigatran major bleeding patients were identified and compared to 70 warfarin major bleeding patients. Intracranial bleed occurred in 4.3 % of warfarin patients and 8.6 % of dabigatran patients. Dabigatran patients tended to be older (79.9 vs. 76 years) and were more likely to have a creatinine clearance of 15-30 mL/min (40 vs. 18.6 %, p = 0.02). Over one-third of dabigatran patients had an excessive dose based on renal function. More dabigatran patients required a procedure for bleed management (37.1 vs. 17.1 %, p = 0.03) and received a hemostatic agent for reversal (11.4 vs. 1.4 %, p = 0.04). Dabigatran patients were twice as likely to spend time in an ICU (45.7 vs. 27.1 %, p = 0.06), be placed in hospice/comfort care (14.3 vs. 7.1 %, p = 0.24), expire during hospitalization (14.3 vs. 7.1 %, p = 0.24), and expire within 30-days (22.9 vs. 11.4 %, p = 0.28). In a single hospital center practice setting, as compared to warfarin, patients with dabigatran major bleeding were more likely to be older, have renal impairment, require a procedure for bleed management and receive a hemostatic agent. Patients with dabigatran major bleeding had an excessive dose for renal function in more than one-third of cases.

Rivaroxaban, the first oral direct factor Xa inhibitor, was approved for stroke prevention in nonvalvular atrial fibrillation in 2011. Limited data are available regarding major bleeding in a clinical practice setting. The purpose of this study is to describe the patient characteristics, management, and outcomes of major bleeding events in patients receiving rivaroxaban for atrial fibrillation. This retrospective, single health system study identified patients with rivaroxaban having a major bleeding event between July 2011 and June 2014. Patients were identified through adverse event reporting or by cross-referencing rivaroxaban with International Classification of Diseases, Ninth Revision diagnosis codes for atrial fibrillation and hemorrhage, with and without transfusion. A total of 60 patients were identified. The mean age of patients was 80.3 ± 7.4 years. The most common bleed sites were gastrointestinal (63.3%) and intracranial (26.7%). Higher dose than recommended based on renal function was present in 35% of patients and concurrent antiplatelet therapy occurred in 70%. Activated prothrombin complex concentrate was utilized in 30% of patients and recombinant factor VIIa in 6.7%. A procedure or surgery was performed for bleed management in 10 patients. Anticoagulation was held at discharge in 76% of patients. A total of 6 patients died during hospital admission, 5 of whom experienced an intracranial hemorrhage. In conclusion, patients experiencing a rivaroxaban major bleeding event were elderly, often renally impaired, and receiving concurrent antiplatelet therapy. In-hospital mortality was 10%. The majority of patients (76%) had anticoagulation therapy held at discharge.

Patients with major bleeding were elderly and frequently on inappropriate concomitant antiplatelet therapy. The majority of patients were managed with PRBC transfusion. More than half of patients had anticoagulation therapy held at discharge. Concerns with prescribing and patient management were identified leading to recommendations for improving the safe use of apixaban therapy.

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