Publications by authors named "Nancy L Shapiro"

Background: Infection with viral pneumonia (PNA) is known to offset the coagulation cascade. Recent studies assessing novel SARS-CoV-2 infection observed a high frequency of systemic thrombotic events resulting in ambiguity if severity of infection or specific viral strain drive thrombosis and worsen clinical outcomes. Furthermore, limited data exists addressing SARS-CoV-2 in underrepresented patient populations.

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Background: Assessment for risks associated with acute stable COVID-19 is important to optimize clinical trial enrollment and target patients for scarce therapeutics. To assess whether healthcare system engagement location is an independent predictor of outcomes we performed a secondary analysis of the ACTIV-4B Outpatient Thrombosis Prevention trial.

Methods: A secondary analysis of the ACTIV-4B trial that was conducted at 52 US sites between September 2020 and August 2021.

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Article Synopsis
  • - The study aimed to evaluate whether anticoagulation with apixaban is more effective than a placebo in preventing death and thromboembolic complications for patients discharged after being hospitalized with COVID-19.
  • - Conducted across 127 U.S. hospitals from 2021 to 2022, the trial included adults who were hospitalized for more than 48 hours and had no contraindications to anticoagulation.
  • - Results showed no significant difference in the incidence of the main outcome between the apixaban group (2.13%) and the placebo group (2.31%), indicating that extended thromboprophylaxis post-discharge may not provide additional benefits.
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Outpatient Trials in the Covid-19 Era and BeyondA group of investigators had a meeting at the National Heart, Lung, and Blood Institute in May 2020 to discuss ways to decrease thrombotic complications among symptomatic outpatients with Covid-19. The investigators discuss their approach to three specific challenges: conducting a trial remotely, working through regulatory hurdles, and recruiting a diverse population of participants.

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Chatbots are software applications to simulate a conversation with a person. The effectiveness of chatbots in facilitating the recruitment of study participants in research, specifically among racial and ethnic minorities, is unknown. The objective of this study is to compare a chatbot versus telephone-based recruitment in enrolling research participants from a predominantly minority patient population at an urban institution.

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Importance: Acutely ill inpatients with COVID-19 typically receive antithrombotic therapy, although the risks and benefits of this intervention among outpatients with COVID-19 have not been established.

Objective: To assess whether anticoagulant or antiplatelet therapy can safely reduce major adverse cardiopulmonary outcomes among symptomatic but clinically stable outpatients with COVID-19.

Design, Setting, And Participants: The ACTIV-4B Outpatient Thrombosis Prevention Trial was designed as a minimal-contact, adaptive, randomized, double-blind, placebo-controlled trial to compare anticoagulant and antiplatelet therapy among 7000 symptomatic but clinically stable outpatients with COVID-19.

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Introduction: There is limited efficacy and safety data for direct oral anticoagulants (DOACs) in patients with obesity, and it has been suggested to avoid DOACs in this patient population.

Objective: Describe the prescribing pattern of oral anticoagulants in obese patients in an urban university setting and assess efficacy, safety, and adherence.

Methods: Retrospective, cohort study in patients ≥18 years with a history of VTE and/or atrial fibrillation.

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Purpose: Coronavirus disease 2019 (COVID-19) has been associated with thrombotic complications such as stroke and venous thromboembolism (VTE), and VTE prophylaxis for hospitalized patients with COVID-19 is recommended. However, extended postdischarge VTE prophylaxis and VTE prophylaxis for nonhospitalized patients with COVID-19 are not routinely recommended due to uncertain benefit in these populations.

Summary: Here we report development of a pulmonary embolism (PE) in a young patient without other VTE risk factors who was treated for COVID-19 in an emergency department (ED) and discharged home without VTE prophylaxis, which was consistent with current recommendations.

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Background: How and when to monitor direct oral anticoagulants (DOACs) for safety and efficacy is a question many anticoagulation clinics are trying to answer. A pharmacist-led antithrombosis clinic (ATC) initiated a clinical service to provide oversight for all prescribed DOACs.

Objective: Describe the implementation and outcomes of a DOAC screening service.

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Background: Direct oral anticoagulants (DOACs) are not recommended for venous thromboembolism (VTE) treatment in patients with cancer because their safety and efficacy have not been compared to low molecular weight heparin (LMWH) in large trials. Routine anti-Xa monitoring in cancer patients on LMWH is also not recommended due to limited data correlating anti-Xa levels and outcomes.

Objective: Compare the safety and efficacy of DOACs to LMWH and warfarin and assess the relationship of anti-Xa monitoring and outcomes in patients with cancer taking LMWH in an urban university setting.

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Background: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors alirocumab and evolocumab were approved by the FDA in 2015. In anticipation of provider interest and a potential increase in referrals to the on-site specialty pharmacy, we created a pharmacist-managed consultation service.

Program Description: The development of a clinic-based pharmacist-managed consultation service for the management of the PCSK9 inhibitor agents alirocumab and evolocumab is described.

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Background: Upper-extremity deep-vein thrombosis (UEDVT) causes significant morbidity and mortality and is not well characterized in the existing literature, particularly in underrepresented minorities such as African Americans.

Objective: To describe the characteristics of a cohort of patients with UEDVT seen at an urban academic medical center.

Methods: This was a retrospective cohort study among patients with a confirmed UEDVT at the University of Illinois Hospital and Health Sciences System between 1996 and 2011.

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With the increased focus and anticipated growth in specialty training and certification within the profession of pharmacy, it is important for the profession to step back and evaluate the manner in which its adopted education and certification systems interface. As a result of specialty practice development, significant growth is occurring in both postgraduate year two (PGY2) pharmacy residency programs and individuals seeking certification by the Board of Pharmacy Specialties. As the profession continues to evolve its specialty training and credentialing systems, it is important to consider the inherent relationship between these systems.

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Pulmonary embolism (PE), can be life-threatening without rapid appropriate therapy and often leads to chronic disease and disability. The ambiguity of symptoms makes PE difficult to diagnose, and available imaging strategies have their limitations. Treatment options for acute PE include fibrinolytics, surgical embolectomy, catheter-directed treatment, or vena cava filter placement as well as traditional parenteral anticoagulants, used alone or as a bridge to a vitamin K antagonist (VKA).

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Study Objectives: To characterize the balance of clinical and academic responsibilities of clinical track pharmacy faculty in the United States and evaluate organizational structures that promote satisfactory balance between these responsibilities.

Design: Prospective cross-sectional survey.

Setting: A 22-item online survey was developed and distributed via Qualtrics software.

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Objective: Little is known about genetic contributors to higher than usual warfarin dose requirements, particularly for African Americans. This study tested the hypothesis that the γ-glutamyl carboxylase (GGCX) genotype contributes to warfarin dose requirements greater than 7.5 mg/day in an African American population.

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Study Objective: To test the hypothesis that genotypes for proteins affecting vitamin K availability influence the duration of time required to achieve a stable warfarin dose in African-American patients.

Design: Retrospective cohort study.

Setting: Pharmacist-managed antithrombosis clinic.

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Study Objective: To evaluate dosing requirements and monitoring patterns of low-molecular-weight heparin (LMWH) when used in high-risk pregnancy.

Design: Retrospective, observational, cohort study.

Setting: University-affiliated medical center.

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Introduction: Bleeding is the major complication associated with warfarin therapy. Some antidepressants are also associated with increased bleeding risk. Warfarin and antidepressants are used frequently in combination, but it is unclear whether concomitant use increases the risk of bleeding beyond that with warfarin alone.

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While Hispanics are the largest and most rapidly growing minority population in the United States, they are underrepresented in pharmacogenomic studies with warfarin. We sought to determine the combination of clinical and genetic influences of warfarin dose requirements in Hispanics. In addition, we tested the performance of published warfarin dosing algorithms derived from largely non-Hispanic cohorts in an inner-city U.

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Background: Poor adherence to warfarin therapy is a major contributor to subtherapeutic anticoagulation.

Objective: To determine whether use of a monthly medication organizer, filled at each clinic visit, improves anticoagulation control among warfarin-treated patients.

Methods: Patients who had a history of nonadherence to warfarin and were attending an inner-city anticoagulation clinic were enrolled in this prospective cohort study and provided with a 28-day medication organizer.

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Background: We sought to determine whether cyclooxygenase-1 (PTGS1) genotype is associated with the ability of aspirin to inhibit platelet aggregation in patients at risk for stroke.

Methods: Blood and urine samples were collected from 60 subjects, including 28 African Americans, who were taking aspirin for primary or secondary stroke prevention. Samples were analyzed for the PTGS1 A-707G, PTGS1 P17L, and glycoprotein IIIa (ITGB3)P1(A1/A2) genotypes, ex-vivo platelet aggregation, serum cholesterol, plasma salicylate levels, and urinary 11-dehydrothromboxane B(2) (11-dhTxB(2)) concentrations.

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Objective: We sought to identify contributors to unstable anticoagulation in African Americans.

Patients And Methods: Sixty African Americans on warfarin were enrolled. Cytochrome P450 2C9 and vitamin K epoxide reductase genotypes and vitamin K intake were assessed, and clinical and dietary data during the 12 months prior to enrollment were collected.

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Decades of research have been devoted to developing effective, safe, and convenient anticoagulant agents. In recent years, much emphasis has been placed on the development of direct thrombin inhibitors (DTIs) that offer benefits over agents like heparin and warfarin including the inhibition of both circulating and clot-bound thrombin; a more predictable anticoagulant response, because they do not bind to plasma proteins and are not neutralized by platelet factor 4; lack of required cofactors, such as antithrombin or heparin cofactor II; inhibiting thrombin-induced platelet aggregation; and absence of induction of immune-mediated thrombocytopenia. Various injectable DTIs are currently available and used for many indications.

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Introduction: African-Americans are under-represented in studies assessing contributors to warfarin response. Our primary objective was to determine whether the genes for cytochrome P450 (CYP) 2C9, nicotinamide adenine dinucleotide phosphate, reduced, quinone oxidoreductase (NQO1) and vitamin K epoxide reductase complex subunit 1 (VKORC1) are associated with warfarin dose requirements in African-Americans.

Patients And Methods: The following factors were assessed: demographics; clinical data; the CYP2C9 Arg144Cys (*2), Ile358Leu (*3) and Asp360Glu (*5); NQO1 Pro187Ser (*1/*2); and VKORC1 G6853C genotypes were analyzed in 115 African-Americans on stable warfarin doses.

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