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PURPOSE: The safety and efficacy of dual antiplatelet therapy (DAPT) with aspirin and clopidogrel in the setting of secondary stroke prevention are reviewed. SUMMARY: Antiplatelet therapy has been shown to reduce the risk of numerous vascular events, especially in the setting of secondary prevention. DAPT with aspirin and another antiplatelet agent such as clopidogrel, prasugrel, or ticagrelor has become the main stay of acute coronary syndrome (ACS) management. The underlying pathophysiologies of ACS, ischemic stroke, and transient ischemic attack (TIA) are similar. In the setting of ACS, DAPT has clearly been shown to improve outcomes over single antiplatelet therapy for up to 12 months after the ischemic event. However, the role for DAPT in the setting of ischemic stroke and TIA is less clear. The MATCH, CHARISMA, and SPS3 studies demonstrated that DAPT was associated with increased bleeding compared with single antiplatelet therapy without an appreciable reduction in ischemic events. Early initiation of DAPT proved beneficial in reducing future ischemic events in the FASTER and CHANCE trials; however, these trials did not provide enough evidence to recommend the routine use of DAPT in secondary stroke prevention, and current guidelines recommend against such therapy. DAPT with aspirin and clopidogrel appears to be effective only for patients with minor stroke or TIA when started within 24 hours of the ischemic event and continued for a maximum of 21 days. CONCLUSION: Currently available evidence does not substantiate the widespread use of long-term aspirin with clopidogrel for the secondary prevention of ischemic stroke or TIA.

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OBJECTIVE: Heart failure (HF) is a leading cause of hospital readmissions adversely affecting resources and hospital reimbursements. The purpose of this study was to optimize medication therapy, provide patient education and facilitate discharge and follow-up through the creation of a pharmacy resident managed HF transition service with the intention of decreasing readmission rates. METHODS: A 6-month prospective, single center pilot study was conducted by a pharmacy resident to decrease readmission rates in patients with HF. Patients were identified through emergency department admission reports and direct requests from discharge nurses. The pharmacy resident provided patients with tailored medication and disease state counseling, ensured obtainment of discharge medications and performed follow up telephone calls for appointment reminders and further counseling. The primary outcome measured was readmission rate at 30 days. Secondary outcomes were number of patients requesting safety net medications, reason for readmission(s), and appointment compliance. RESULTS: Thirty patients were enrolled in the program. The 30-day heart failure readmission rate decreased from 28.1% to 16.6%. Eighty-eight percent of patients attended their follow up appointments. CONCLUSION: A reduction in readmission rate was achieved through this pharmacy resident-run HF transition service. The majority of patients attended follow-up visits and financial appointments after discharge.

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OBJECTIVE: To review the evidence for the use of the direct-acting oral anticoagulants (DOACs) in adult patients with heparin-induced thrombocytopenia (HIT). DATA SOURCE: A PubMed search (1950-February 2015) was collected using the terms heparin-induced thrombocytopenia, with dabigatran, rivaroxaban, or apixaban, or heparin-induced thrombocytopenia and target-specific anticoagulants, or heparin-induced thrombocytopenia and direct-acting oral anticoagulants, or heparin-induced thrombocytopenia and new oral anticoagulants. STUDY SELECTION AND DATA EXTRACTION: All English-language articles were reviewed for inclusion. The references of included articles were reviewed for additional data. DATA SYNTHESIS: HIT is an immune-mediated, prothrombotic adverse reaction that requires not only discontinuation of heparin but also initiation of an alternative nonheparin anticoagulant to counter the effects of the autoimmune cascade. Pharmacotherapeutic management with argatroban is unpredictable and problematic. The DOACs display predictable pharmacokinetic and pharmacodynamic profiles and exhibit no interaction with platelet factor 4. Currently, the DOACs are approved by the Food and Drug Administration for venous thromboembolism, yet have limited evidence in both in vitro and clinical HIT studies. CONCLUSIONS: Though dabigatran, rivaroxaban, and apixaban have been used in case reports, currently data are not yet sufficient to recommend clinical use of these agents in the management of HIT. Future trial results may further substantiate management of HIT with use of the DOACs.

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OBJECTIVE: To evaluate the role of idarucizumab, a humanized monoclonal antibody fragment, as a specific reversal agent for the anticoagulant activity of dabigatran and to review the pharmacology, pharmacokinetic properties, efficacy, and safety of this agent. METHODS: A literature search was conducted consisting of a PubMed database using the MeSH term idarucizumab and the key word dabigatran antidote. Studies evaluating the pharmacology, pharmacokinetics, safety, and efficacy of idarucizumab for the reversal of the anticoagulant activity of dabigatran were included. RESULTS: Idarucizumab represents a novel treatment option as it is the only humanized, monoclonal antibody fragment that specifically binds to dabigatran. Studies evaluating reversal of dabigatran-induced anticoagulation have demonstrated immediate, complete, and sustained effects with idarucizumab. Idarucizumab did not overcorrect thrombin generation. Additionally, evaluations have shown that dabigatran can be safely reinitiated 24 hours after the administration of idarucizumab. The United States Food and Drug Administration granted priority review for the biologic license application and accelerated approval for idarucizumab. CONCLUSION: Idarucizumab represents an encouraging development in the reversal of dabigatran. Its novel mechanism of action, pharmacokinetics, tolerability, and lack of thrombotic events contribute positively to its use in patients who experience bleeding or for those who require emergent surgery or procedures.

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Pharmacist-directed anticoagulation management services (AMSs) have been shown to significantly lower anticoagulation-related mortality, length of hospital stay, bleeding complications, blood transfusion requirements, and cost of therapy. AMSs are only 1 component of an anticoagulation stewardship program. Frequently, stewardship programs are limited to inpatient populations. Incorporating components that facilitate transition to outpatient status will ideally encompass complete care. The purpose of this program was to expand anticoagulation services and standardize care by implementing a full-service stewardship program including a transition of care service. The first component of the study involved medication surveillance for inpatients on anticoagulation therapy. The second component involved transitioning patients on anticoagulation, primarily with venous thromboembolism (VTE) to outpatient management. Finally, the pharmacist identified areas for optimization. Optimization involved developing or updating protocols to reflect updates in the literature as well as updating institution-specific information resources. Interventions made through medication surveillance and utilization of the VTE transition of care services translated into a total cost savings of approximately US$270 320. A postgraduate, first-year pharmacy resident contributed to improving patient outcomes while reducing utilization of hospital services and obtaining substantial cost savings through participation in anticoagulation stewardship services.

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PURPOSE: This study explored the potential financial benefits associated with dose rounding three costly cancer agents: bevacizumab, trastuzumab, and cetuximab. METHODS: Electronic chemotherapy health record software was queried to identify inpatient and outpatient use of bevacizumab, trastuzumab, and cetuximab. Available drug vial sizes were noted. Costs of actual doses prescribed were compared to theoretically reduced doses (5% and 10%) adjusted to the nearest vial size. Only doses resulting in a decrease in the number of vials qualified for dose rounding. New doses were analyzed for potential cost savings considering the percent-change from the original dose. All institutional review board procedures were followed. RESULTS: In all, 425 doses of bevacizumab, trastuzumab, and cetuximab were identified. At a 5% dose reduction, 51 doses (12%) qualified for dose rounding, translating to a potential cost savings of $60,648 ($6,188, $52,640, and $1,820, respectively). Although a 5% limit was set, the average change in dose did not exceed 2.5%. At a 10% dose reduction, 124 doses (29%) qualified for dose rounding, translating to a potential cost savings of $112,585 ($26,520, $80,605, and $5,460, respectively). With the 10% dose reduction, the average change in dose did not surpass 6.1%. Projected annual savings were calculated as $181,944 or $337,755, depending on the rounding limit. CONCLUSION: Consultation with key physicians regarding the proposed percent reduction resulted in a 10% dose reduction for all cases when utilizing these three agents. Implementation of a dose rounding protocol for bevacizumab, trastuzumab, and cetuximab represents a potentially substantial cost savings at this institution.

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PURPOSE: The pharmacology, pharmacokinetics, and clinical efficacy and safety of lomitapide in the management of homozygous familial hypercholesterolemia (HoFH) are reviewed. SUMMARY: Lomitapide (Juxtapid, Aegerion Pharmaceuticals) is an oral microsomal triglyceride transfer protein (MTP) inhibitor indicated for the treatment of patients with HoFH, a rare form of hypercholesterolemia that can lead to premature atherosclerotic disease. In clinical trials, the use of lomitapide alone or in combination with other lipid-lowering modalities reduced plasma concentrations of low-density lipoprotein cholesterol (LDL-C) by a mean of more than 50%. Lomitapide is associated with significant gastrointestinal adverse effects and increases in hepatic fat levels. Lomitapide undergoes hepatic metabolism via cytochrome P-450 (CYP) isoenzyme 3A4 and interacts with CYP3A4 substrates including atorvastatin and simvastatin; dose adjustment is recommended when lomitapide is used concurrently with these agents. In patients receiving concomitant warfarin, the International Normalized Ratio (INR) should be closely monitored, as lomitapide use may increase INR values. The recommended initial dosage of lomitapide is 5 mg once daily, with subsequent upward dose adjustment at specified intervals according to tolerability. Lomitapide is contraindicated in patients with moderate-to-severe liver disease, patients with sustained abnormal liver function tests, patients taking strong or moderate CYP3A4 inhibitors, and pregnant patients. CONCLUSION: Lomitapide is an oral MTP inhibitor approved for the treatment of HoFH. This agent appears to be a realistic option for patients with HoFH who are unable to attain their LDL-C goal or cannot tolerate statin therapy.

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