Next generation fatigue crack growth experiments of aerospace materials.

Today's societal challenges require rapid response and smart materials solutions in almost all technical areas. Driven by these needs, data-driven research has emerged as an enabler for faster innovation cycles. In fields such as chemistry, materials science and life sciences, automatic and even autonomous data generation and processing is already accelerating knowledge discovery. In contrast, in experimental mechanics, complex investigations like studying fatigue crack growth in structural materials have traditionally adhered to standardized procedures with limited adoption of the digital transformation. In this work, we present a novel infrastructure for data-centric experimental mechanics in the field of fatigue crack growth. Our methodology incorporates a robust code base that complements a multi-scale digital image correlation and robot-assisted test rig. Using this approach, the information-to-cost ratio of fatigue crack growth experiments in aerospace materials is significantly higher compared to traditional experiments. Thus, serves as a catalyst for discovering new scientific knowledge in the field of structural materials and structures.

Comparative Genitourinary Safety of In-class Sodium-Glucose Cotransporter-2 Inhibitors among Patients with Heart Failure with Preserved Ejection Fraction: A Cohort Study.

PURPOSE: The American Heart Association recommended sodium-glucose cotransporter-2 inhibitors (SGLT2i) for the management of heart failure with preserved ejection fraction (HFpEF). However, little is known about their real-world in-class comparative safety in patients with HFpEF. We aimed to assess the comparative safety of SGLT2i in the risk of urinary tract infection (UTI) or genital infection separately or as a composite outcome among patients with HFpEF. METHODS: This cohort study using MarketScan® Commercial and Medicare supplemental databases (2012-2020) included patients aged ≥ 18 years with a diagnosis of HFpEF who initiated SGLT2i therapy. Three pairwise comparison groups were established: cohort 1, dapagliflozin versus canagliflozin; cohort 2, empagliflozin versus canagliflozin; and cohort 3, dapagliflozin versus empagliflozin. After stabilized inverse probability treatment weighting, Cox proportional hazards regression was used to compare the risk of UTI or genital infection separately or as a composite outcome in each cohort. RESULTS: The risk of the composite outcome did not significantly differ between canagliflozin and dapagliflozin (adjusted hazard ratio [aHR] 0.64; 95% confidence interval [CI] 0.36-1.14) or between empagliflozin and canagliflozin (aHR 1.25; 95% CI 0.77-2.05). Similarly, there was no evidence of difference between dapagliflozin and empagliflozin in this risk (aHR 0.76; 95% CI 0.48-1.21). The results of analyses separately assessing UTI or genital infection were similar. CONCLUSIONS: There was no significant difference in the risk of UTI or genital infection among patients with HFpEF who initiated canagliflozin, dapagliflozin, or empagliflozin.

Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are used for the management of heart failure with preserved ejection fraction (HFpEF). It is important to assess their comparative risk of urinary tract infection (UTI) or genital infection among patients with HFpEF. We compared patients with HFpEF using SGLT2i in three pairwise groups: cohort 1, dapagliflozin versus canagliflozin; cohort 2, empagliflozin versus canagliflozin; and cohort 3, dapagliflozin versus empagliflozin. We found that there was no significant difference in the risk of genitourinary infections including UTI or genital infections among dapagliflozin, empagliflozin, and canagliflozin.

Comparative effectiveness of sacubitril/valsartan versus angiotensin receptor blockers in patients with heart failure with preserved ejection fraction: A real-world study.

PURPOSE: Sacubitril/valsartan (SAC/VAL) or angiotensin receptor blockers (ARBs) are recommended therapy for heart failure with preserved ejection fraction (HFpEF), but little is known about their real-world comparative effectiveness among patients with HFpEF. The objective of this study was to determine the comparative effectiveness of SAC/VAL vs ARBs in preventing HF-related hospitalization or all-cause hospitalization among patients with HFpEF. METHODS: We conducted a cohort study using IBM MarketScan commercial and Medicare supplemental databases to identify patients aged 18 years or older with a diagnosis of HFpEF and initiation of SAC/VAL (2015-2020) or ARB (2009-2014) therapy. The index date was the date of the first SAC/VAL or ARB prescription fill. After propensity score (PS) matching with a ratio of 1 up to 3, Cox proportional hazards regression was used with robust variance estimators to compare the risks of HF-related hospitalization and all-cause hospitalization between the 2 therapies. Several subgroup and sensitivity analyses were conducted to check the robustness of the main analysis. RESULTS: After PS matching, 2,520 patients (846 receiving SAC/VAL and 1,674 receiving an ARB) were included in the final analyses. After controlling for covariates, there was no difference in the risk of HF-related hospitalization between SAC/VAL and ARB recipients (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 0.99-1.77). There was also no difference in the risk of all-cause hospitalization between SAC/VAL and ARB recipients (aHR, 1.06; 95% CI, 0.91-1.24). CONCLUSION: Among individuals with private or Medicare Advantage insurance plans, there was no significant difference in the risk of HF-related hospitalization or all-cause hospitalization between adults with HFpEF who received SAC/VAL and those who received ARB therapy.

Trajectories of adherence to extended treatment with direct oral anticoagulants and risks of recurrent venous thromboembolism and major bleeding.

BACKGROUND: Little is known about medication adherence patterns and their association with effectiveness and safety among patients with venous thromboembolism (VTE) receiving direct oral anticoagulant (DOAC) therapy beyond 3-6 months of initial treatment. OBJECTIVE: To examine the associations between adherence trajectories of extended treatment with DOAC and the risks of recurrent VTE and major bleeding among patients with VTE. METHODS: We conducted a retrospective cohort study of patients with incident VTE who completed 6 months of initial anticoagulant treatment and received either DOAC extended therapy or no extended therapy using MarketScan Commercial and Medicare Supplemental databases (2013-2019). We used group-based trajectory models to identify distinct adherence patterns during extended treatment. Using inverse probability treatment weighted Cox proportional hazards models, we examined the association between the adherence trajectories and the risks of recurrent VTE and major bleeding. RESULTS: Among 10,960 patients with extended treatment with DOACs (rivaroxaban, apixaban, dabigatran, edoxaban) and 5,133 patients with no extended treatment, we identified 4 distinct trajectories (consistently high, gradually declining, rapidly declining, and no extended treatment). Compared with the no extended treatment group, the groups with consistently high adherence (hazard ratio = 0.09, 95% CI = 0.05-0.17) and with gradually declining adherence (0.13, 0.03-0.53) showed decreased recurrent VTE risk without increased major bleeding risk (consistently high adherence 1.19, 0.71-1.99; gradually declining adherence 1.96, 0.81-4.70). There was no difference in the risk of recurrent VTE (0.34, 0.10-1.16) for the group with rapidly declining adherence, but this group was associated with increased major bleeding risk (2.65, 1.01-6.92). CONCLUSIONS: Our findings underscore the clinical importance of continuing and remaining adherent to extended DOAC treatment without increased major bleeding risk for patients with VTE. DISCLOSURES: This research was supported by the BMS/Pfizer Alliance American Thrombosis Investigator Initiated Research Program. The funding source had no role in the design, collection, analysis, or interpretation of the data or the decision to submit the article for publication. Dr Lo-Ciganic reported receiving research funding from Merck Sharp & Dohme Corp. Dr Dietrich reported receiving honorarium for training and education from BMS/Pfizer. Dr DeRemer is a stockholder of Portola Pharmaceuticals and reported receiving personal fees for advisory board meeting from BMS. No other disclosures were reported.

Comparative effectiveness of sodium-glucose cotransporter-2 inhibitors among patients with heart failure with preserved ejection fraction.

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are recommended by the American Heart Association for management of heart failure with preserved ejection fraction (HFpEF), but little is known about their in-class comparative effectiveness in real-world settings. OBJECTIVES: To assess the in-class comparative effectiveness of SGLT2i for preventing HF-related and all-cause hospitalizations among patients with HFpEF. METHODS: Using MarketScan® Commercial and Medicare Supplemental research databases (2012-2020), this cohort study included adults with HFpEF treated with SGLT2i. Stabilized inverse probability treatment weighted Cox proportional hazards regression was used to compare HF-related and all-cause hospitalizations in three pairwise comparisons: dapagliflozin versus canagliflozin, empagliflozin versus canagliflozin, and dapagliflozin versus empagliflozin. Subgroup and sensitivity analyses were conducted to assess robustness of the main analysis. RESULTS: In total, 3629 SGLT2i users (881 dapagliflozin, 1120 canagliflozin, and 1628 empagliflozin) were included. Compared with canagliflozin, dapagliflozin was associated with decreased risk of HF-related hospitalization (adjusted hazard ratio [aHR], 0.75; 95% confidence interval [CI], 0.56-1.01) and all-cause hospitalization (aHR, 0.84; 95% CI 0.73-0.97). Compared with canagliflozin, empagliflozin was associated with 55% decreased risk of HF-related hospitalization (aHR, 0.45; 95% CI 0.34-0.59) and 18% decreased risk of all-cause hospitalization (aHR, 0.82; 95% CI 0.73-0.93). Compared with empagliflozin, dapagliflozin was associated with 50% increased risk of HF-related hospitalization (aHR, 1.50; 95% CI 1.09-2.07) and a statistically nonsignificant increase in the risk of all-cause hospitalization (aHR, 1.05; 95% CI 0.92-1.20). CONCLUSIONS: Compared with canagliflozin or dapagliflozin use, empagliflozin use was associated with decreased risk of HF-related and all-cause hospitalizations. Compared with canagliflozin, dapagliflozin was associated with a reduced risk of HF-related and all-cause hospitalizations.

Trajectories of adherence to extended treatment with warfarin and risks of recurrent venous thromboembolism and major bleeding.

Background: Little is published about warfarin therapy adherence patterns beyond 6 months of initial anticoagulant treatment and their association with effectiveness and safety for patients with venous thromboembolism (VTE). Objectives: To compare the risks of recurrent VTE and major bleeding during extended treatment between adherence patterns using MarketScan Commercial and Medicare Supplemental databases (2013-2019). Methods: In a retrospective cohort study, we included patients with incident VTE who completed an initial 6-month anticoagulant treatment and received either warfarin or no extended therapy. Group-based trajectory models were used to identify distinct extended treatment trajectories. Associations between the trajectories and risk of hospitalization due to recurrent VTE and major bleeding were assessed using inverse probability treatment-weighted Cox proportional hazards models. Results: Compared with no extended treatment, consistently high warfarin adherence was associated with a significantly decreased risk of hospitalization due to recurrent VTE (hazard ratio [HR] = 0.23; 95% CI, 0.12-0.45), but gradually (HR = 0.29; 95CI, 0.08-1.06) or rapidly declining (HR = 0.14; 95% CI, 0.02-1.24) adherence showed no association with the risk of hospitalization due to recurrent VTE. Compared with no extended treatment, warfarin extended therapy was associated with an increased risk of hospitalization due to major bleeding regardless of adherence patterns (consistently high: HR = 2.08; 95% CI, 1.18-3.64, gradually declining: HR = 2.10; 95% CI, 0.74-5.95, and rapidly declining: HR = 9.19; 95% CI, 4.38-19.29). However, compared with rapidly declining adherence, consistently high (HR = 0.23; 95% CI, 0.11-0.47) and gradually declining (HR = 0.23; 95% CI, 0.08-0.64) adherence were associated with decreased risk of hospitalization due to major bleeding. Conclusion: The findings indicated that consistently high adherence to extended warfarin treatment was associated with a decreased risk of hospitalization due to recurrent VTE but an increased risk of hospitalization due to major bleeding compared with no extended treatment.

Trajectories of Oral Anticoagulation Adherence and Associated Clinical Outcomes During Long-Term Anticoagulation Among Medicare Beneficiaries With Venous Thromboembolism.

BACKGROUND: Little is known about anticoagulation medication nonadherence patterns impacting effectiveness and safety outcomes in clinical practice. OBJECTIVE: We identified adherence trajectories of extended therapy with direct-acting oral anticoagulants (DOACs) and warfarin after 6 months initial anticoagulant therapy among Medicare beneficiaries with venous thromboembolism (VTE). We further assessed the associated recurrent VTE and major bleeding risks. METHODS: Using group-based trajectory models, this retrospective cohort study identified distinct beneficiary subgroups with similar adherence patterns of extended-phase anticoagulant treatment (DOACs or warfarin) for patients with VTE who completed 6 months of initial anticoagulant treatment. We examined associations between adherence trajectories and risks of recurrent VTE and major bleeding using inverse probability treatment weighted Cox proportional hazards models. RESULTS: Compared with no extended treatment, consistently high DOAC adherence was associated with decreased recurrent VTE risk (hazard ratio [HR] = 0.33, 95% confidence interval [CI] = 0.21-0.51) without increased major bleeding risk, and consistently high warfarin adherence was associated with decreased recurrent VTE risk (HR = 0.62, 95% CI = 0.40-0.95) and increased major bleeding risk (HR = 1.64, 95% CI = 1.12-2.41). Gradually declining adherence to DOACs (HR = 1.80, 95% CI = 1.07-3.03) or warfarin (HR = 2.34, 95% CI = 1.57-3.47) was associated with increased bleeding risk with no change in recurrent VTE risk. CONCLUSION AND RELEVANCE: This real-world evidence suggests persistently adhering to extended DOAC therapy is associated with lower recurrent VTE risk without increasing major bleeding among Medicare beneficiaries with VTE. Persistently adhering to extended warfarin therapy was associated with lower recurrent VTE risk but higher major bleeding risk.

The Fermi problem: Estimation of potential Billing losses due to Undercoding of Florida Medicare data.

Billing issues are more commonplace than most healthcare professionals, including pharmacists, even realize. Undercoding-or billing outpatient visits for a lower level of service than may be justified-leads to decreased reimbursement, but almost no data captures what is being sacrificed, especially at the state level. Using publicly available data from the National Ambulatory Medical Care Survey and Centers for Medicare and Medicaid Services, we attempt to approximate just how much Medicare reimbursement is lost annually to undercoding in Florida. We also discuss the hidden dangers of undercoding, including how it could hinder the ability of clinical pharmacists to build sustainable clinical services and contribute to the broader healthcare team.

Comparative effectiveness and safety of direct oral anticoagulants versus warfarin among patients with recurrent venous thromboembolism.

The comparative effectiveness and safety of oral anticoagulant therapies to prevent a second recurrent venous thromboembolism (VTE) remains undetermined. We aimed to compare the benefits and harms of direct oral anticoagulant (DOAC) and warfarin therapies in preventing second recurrent VTE and major bleeding events among patients with a recurrent VTE episode following anticoagulation therapy for incident VTE. A retrospective cohort analysis of two large national insurance claims databases was conducted for patients with two episodes of VTE. Cox proportional hazards models were used after inverse probability treatment weighting to compare risks of second recurrent VTE and major bleeding events. Compared with warfarin, DOAC therapy was associated with significantly decreased risk of second recurrent VTE with no significant difference in risk of major bleeding events. Our findings suggest that, compared with warfarin, DOACs may reduce risk of second VTE recurrence among patients who have experienced one recurrence.

Financial reimbursement and productivity metrics for pharmacist-led chronic care management services in rural practice settings.

BACKGROUND: The implementation of chronic care management (CCM) services has often been hindered by issues with reimbursement, raising concerns about sustainability. To date, little if any literature has examined the financial feasibility and sustainability of CCM services in rural practice settings. OBJECTIVE: Assess financial reimbursement and productivity metrics for pharmacist-led CCM services at a rural, medically underserved family medicine clinic. METHODS: This study retrospectively examined data from the clinic's CCM program from October 2020 through May 2021 and included total clinical encounters, minutes of pharmacist time spent on calls, CCM claims, work relative value units (wRVU), financial reimbursement, and overall personnel costs. RESULTS: Over an 8-month period, 46 patients were enrolled in CCM services. Of the 49 CCM calls placed during this time, 31 (63.3%) were billable, though only 20 (64.5% of billable calls) were ultimately reimbursed. Approximately 37% of pharmacist "time-on-task" was not billable. Compared to the $643 required to cover pharmacist time on CCM calls, $822 of reimbursement was collected. This $179 profit, or 27.8% return-on-investment, is similar to results from more urbanized practices. Furthermore, services were "net productive" in wRVU generation, which may appeal to physician stakeholders interested in such targets. CONCLUSIONS: Concerns about profitability and sustainability have prevented more widespread CCM implementation. In the present study, pharmacist-led CCM services achieved a 27.8% return-on-investment. Though rural-based CCM services may never attain significant profit margins, this data suggests they can still be financially self-sustaining and "net productive," all while providing high-quality patient care.

Comparative effectiveness and safety of extended anticoagulant therapy among Medicare beneficiaries with venous thromboembolism.

Guidelines recommend an extended course of anticoagulation therapy for patients who experienced venous thromboembolism (VTE) without transient provocation, however, optimal duration remains uncertain. We assessed effectiveness and safety of extended use of apixaban and warfarin greater than 6 months of initial treatment in patients with VTE. We conducted a retrospective cohort study of Medicare beneficiaries aged greater than or equal to 18 years with deep vein thrombosis or pulmonary embolism. Patients were required to have initiated anticoagulants within 30 days of their first VTE diagnosis, completed 6 months of initial anticoagulant treatment, and received extended phase treatment with apixaban (the apixaban group) or warfarin (the warfarin group) or no extended therapy. Multivariable Cox proportional hazards modeling with inverse probability treatment weighting was used to compare recurrent VTE, mortality, and major bleeding risks among the three groups. Mean extended-treatment duration was up to 10 months and 14 months in apixaban and warfarin groups, respectively. Compared with no extended treatment, apixaban use was associated with decreased risks of recurrent VTE (hazard ratio [HR] = 0.08, [95% confidence interval [CI]: 0.01-0.41]) and mortality (HR = 0.37, [95% CI: 0.27-0.51]) without increased major bleeding risk (HR = 1.29, [95% CI: 0.68-2.45]); warfarin use was associated not with recurrent VTE risk change but with increased major bleeding risk (HR = 2.14, [95% CI: 1.26-3.65]) and decreased mortality risk (HR = 0.39, [95% CI: 0.29-0.51]). Compared with warfarin, apixaban use was associated with decreased recurrent VTE (HR = 0.13, [95% CI: 0.03-0.63]) and major bleeding (HR = 0.56, [95% CI: 0.32-0.98]) risks. Subgroup and sensitivity analyses (e.g., intention-to-treat) findings remained consistent. Compared with warfarin or no extended therapy, extended-apixaban use was associated with reduced risk of recurrent VTE without increased major bleeding risk. Continuing anticoagulant therapy with apixaban greater than 6 months may be effective and safe.

Improvement in Clinical Outcomes and Access to Care With Pharmacist-Led Chronic Care Management Services at a Rural Family Medicine Clinic.

Background: Chronic care management (CCM) can significantly impact the management of chronic diseases in rural patient populations. To date, few practice models have addressed its impact on clinical outcomes and access to care in rural practice settings. Objective: Implement a sustainable pharmacist-led CCM practice model while tracking clinical outcomes and healthcare access at a rural, medically underserved family medicine clinic. Methods: This study retrospectively examined data from the clinic's CCM program from October 2020 through May 2021 and included total clinical encounters at three- and 6-months intervals, as well as changes in clinical outcomes like A1c and systolic blood pressure (SBP) at three- and 6-months intervals. Results: Over an 8-month period, 46 patients were enrolled in pharmacist-led CCM services. Those with a CCM encounter or office visit within 3 months of enrollment showed a mean A1c reduction of 1.07% after 3 months (95% CI -1.70 to -.44, P = .0016), while those with an encounter or office visit within 6 months of enrollment displayed a mean A1c reduction of 1.64% after 6 months (95% CI -2.35 to -.92, P < .001). There was a 73.8% increase in total clinical encounters in the 6 months after CCM enrollment compared to the 6 months preceding it, signifying increased access to care. Conclusion: Patients with CCM encounters or office visits within the first 3-6 months experienced statistically significant reductions in A1c. Moreover, total clinical encounters markedly increased in the 6 months after enrollment, allowing for more frequent engagement between ambulatory pharmacists and traditionally challenging rural patients.

Trends in pharmacotherapy utilization among patients with heart failure with preserved ejection fraction.

Study objective: Half of patients with heart failure have preserved ejection fraction (HFpEF). Over the years, guidelines have recommended or advised against various therapies for HFpEF management. However, there is limited evidence on the trends in utilization of the various medications. The aim of this study was to examine the trends in the use of pharmacotherapies among patients with HFpEF from 2008 through 2020. Design: Retrospective cohort study of patients with HFpEF used MarketScan® Commercial and Medicare Supplemental Databases (2007-2020). Participants: Patients with HFpEF. Outcome measures: Utilization rates for angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), angiotensin receptor-neprilysin inhibitors (ARNIs), aldosterone receptor antagonists (ARAs), diuretics, ß-blockers, calcium channel blockers (CCBs), phosphodiesterase 5 inhibitors (PDE5Is), nitrates, digoxin, and sodium glucose cotransporter-2 inhibitors (SGLT2i) within 90 days of the first HFpEF diagnosis. Results: We identified 156,730 patients with HFpEF (mean [SD] age, 73 [13.4] years; 57 % females). From 2008 to 2020, we found increased utilization rates for ARNIs (0.02 % vs. 0.17 % of all patients, p < 0.01), ARBs (14.3 % vs. 18.6 %, p < 0.01), ARAs (7.0 % vs. 8.4 %, p < 0.01), CCBs (30.6 % vs. 33.4 %, p < 0.01), and SGLT2i (0.001 % vs. 0.021 %, p < 0.01). By contrast, the utilization of ACEIs (30.4 % vs. 20.5 %, p < 0.01), digoxin (9.5 % vs. 2.4 %, p < 0.01), nitrates (10.7 % vs. 4.9 %, p < 0.01), diuretics (54.1 % vs. 50.4 %, p = 0.20), and ß-blockers (52.6 % vs. 51.7 %, p < 0.01) decreased, while utilization rates of PDE5Is remained stable (1.5 % vs. 1.1 %, p = 0.90) . Conclusions: During the 13-year study period, the utilization of ARNIs, ARBs, ARAs, CCBs, and SGLT2i increased while the utilization of digoxin, nitrates, diuretics, and ß-blockers decreased among patients with HFpEF.

Impact of an ambulatory care pharmacist on provider relative value units in a rural clinic.

Introduction: Collaborative team-based care models have been shown to improve the quality of care provided to patients and may increase productivity along with patient access to care. Productivity is often tracked via work relative value units (wRVU). The primary objective of this project was to evaluate how a collaborative practice model affects tracked productivity. Methods: Data regarding wRVU were retrospectively extracted from the electronic medical record from a single center. De-identified data points included total number of patients seen and level of service billed for the visit. Visits were grouped as collaborative (physician-pharmacist) or independent (physician alone). Relative value unit totals were calculated separately for individual physicians and pharmacy visits and also combined for collaborative team wRVU totals. Wilcoxon and descriptive statistics were used for analysis. All statistical analyses were performed using SAS v 9.4 (Cary, NC). Results: A total of 624 patient visits were reviewed. Total number of patients seen by physicians working in collaboration was on average 19.25 per day versus 12.9 per day for those working independently. When evaluating only the average per encounter wRVU for each provider removing collaborative patients, the three providers who worked in the collaborative model averaged 1.45, 1.48, and 1.55 wRVU per patient respectively, compared to those who worked singularly (1.37 and 1.30). This was found to be statistically significant in the unadjusted mixed model (P = 0.0476), but not maintained once adjusted. Conclusion: Physicians working in collaboration with a pharmacist were able to bill at a higher level on average suggesting more productivity.

Effectiveness and Safety of Extended Oral Anticoagulant Therapy in Patients with Venous Thromboembolism: A Retrospective Cohort Study.

Limited real-world evidence exists for effectiveness and safety of extended oral anticoagulation beyond 6 months of initial treatment in prevention of recurrent venous thromboembolism (VTE) and adverse major bleeding events among patients with VTE. Using MarketScan Commercial and Medicare Supplemental databases (2013-2019), we conducted a retrospective cohort study to compare the risk of recurrent VTE and major bleeding events during extended treatment among patients with VTE who completed the 6-month initial treatment and received extended oral anticoagulant treatment with apixaban, warfarin, or no extended treatment. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox proportional hazards modeling with inverse probability treatment weighting. We identified 14,818 patients with extended treatment of apixaban (n = 4,338), warfarin (n = 5,298), or no extended treatment (n = 5,182). Compared with no extended treatment, apixaban use was associated with decreased risk of recurrent VTE (HR: 0.10, 95% CI: 0.04-0.26) without increased risk of major bleeding events (HR: 1.06, 95% CI: 0.52-2.17); warfarin use was associated with decreased risk of recurrent VTE (HR: 0.23, 95% CI: 0.12-0.44) but with increased risk of major bleeding events (HR: 2.64, 95% CI: 1.51-4.59). Compared with warfarin, apixaban use was associated with decreased risk of major bleeding events (HR: 0.42, 95% CI: 0.22-0.80) but no difference in risk of recurrent VTE (HR: 0.46, 95% CI: 0.15-1.36). In a real-world clinical setting, extended anticoagulation with apixaban or warfarin was associated with decreased risk of recurrent VTE compared with no extended treatment, and apixaban had a better safety profile with fewer major bleeding events compared with warfarin among commercially insured patients with VTE.

Comparison of effectiveness and safety for low versus full dose of apixaban during extended phase oral anticoagulation in patients with venous thromboembolism.

BACKGROUND: The optimal dose of apixaban therapy to prevent asecondary venous thromboembolism (VTE) event remains unconfirmed. To investigate the effects of extended phase use of apixaban (2.5 vs. 5 mg twice daily) beyond 6 months of initial treatment on the risk of recurrent VTE and major bleeding events among patients with a history of VTE. METHODS: A retrospective cohort analysis of two large national insurance claims databases was conducted for patients diagnosed with VTE. Cox proportional hazard models after propensity score matching were used to compare the risk of recurrent VTE and major bleeding. RESULTS: There were no detected differences in recurrent VTE or major bleeding events between patients prescribed low versus full dose apixaban. CONCLUSION: This study provides evidence that apixaban 2.5 mg twice daily is an alternative option for extended phase therapy for risk reduction of VTE recurrence compared to apixaban 5 mg twice daily.

Simplifying medical decision-making for clinical pharmacists.

Intense lobbying by the American Medical Association (AMA) and related professional organizations led to significant changes to requirements for documentation of outpatient clinical services. As of 2021, providers are now free to choose between either time or medical decision-making (MDM) when "leveling" such services. Despite this change, many providers and clinical pharmacists may not yet realize its full billing implications. This article discusses why these billing changes occurred, what those changes actually mean in clinical practice, and how the three factors used to determine MDM can be utilized by clinical pharmacists in daily practice. Finally, a brief introduction to other potential billing codes open to pharmacists and discussion of MDM documentation requirements is included.

Cardiovascular and major bleeding outcomes with antiplatelet and direct oral anticoagulants in patients with acute coronary syndrome and atrial fibrillation: A population-based analysis.

BACKGROUND: Direct oral anticoagulants (DOACs) are replacing warfarin for stroke prevention in patients with atrial fibrillation (AF). OBJECTIVE: To assess the effectiveness and safety of concomitant treatment with antiplatelet-DOAC compared to antiplatelet-warfarin in patients with acute coronary syndrome (ACS) and AF. DESIGN: Retrospective propensity score-matched cohort study using United States-based commercial healthcare database from January 2016 to June 2019. PARTICIPANTS: New-users of antiplatelet-DOAC and antiplatelet-warfarin who initiated the combined therapy within 30 days following incident ACS diagnosis. MEASUREMENTS: Primary study outcomes were recurrent cardiovascular diseases (CVD) (ie, a composite of stroke and myocardial infarction) and major bleeding events identified via discharge diagnoses. We controlled for potential confounders via propensity score matching (PSM). We generated marginal hazard ratios (HRs) via Cox proportional hazards regression using a robust variance estimator while adjusting for calendar time. RESULTS: After PSM, a total of 2,472 persons were included (1,236 users of antiplatelet-DOAC and 1,236 users of antiplatelet-warfarin). The use of antiplatelet-DOAC (vs. antiplatelet-warfarin) was associated with a reduced rate of recurrent CVD (adjusted HR 0.72, 95% confidence interval [CI], 0.56-0.92) and major bleeding events (adjusted HR, 0.49, 95% CI 0.33-0.72). LIMITATIONS: Residual confounding. CONCLUSIONS: In real-world data of AF patients with concurrent ACS, the use of antiplatelet-DOAC following ACS diagnosis was associated with a lower rate of recurrent CVD and major bleeding events compared with antiplatelet-warfarin. These findings highlight a potential promising role for DOACs in patients with ACS and AF requiring combined antiplatelet therapy.

Effectiveness of sacubitril/valsartan versus aldosterone antagonists in heart failure with reduced ejection fraction: A retrospective cohort study.

STUDY OBJECTIVE: To assess the effectiveness of sacubitril/valsartan versus angiotensin receptor antagonist therapy for prevention of heart failure (HF)-related hospitalization and all-cause hospitalization in a large cohort of patients with heart failure with reduced ejection fraction (HFrEF). DESIGN: Retrospective cohort study. DATA SOURCE: IBM® MarketScan® research databases (2014-2018). PATIENTS: Patients aged 18 years or older with their first HFrEF hospitalization on or after January 1, 2015, who initiated sacubitril/valsartan or angiotensin receptor antagonist after hospital discharge. INTERVENTION: Sacubitril/Valsartan versus Angiotensin receptor antagonist. MEASUREMENTS AND MAIN RESULTS: The index date was the first sacubitril/valsartan or angiotensin receptor antagonist fill date. After 1 up to 3 propensity score matching, Cox proportional hazards regression was used with robust variance estimators to compare HF-related and all-cause hospitalizations between treatments. Subgroup and sensitivity analyses were conducted to assess the robustness of the main analysis. After propensity score matching, 1,088 sacubitril/valsartan and 2,839 angiotensin receptor antagonist new users were included. The crude incidence of HF-related hospitalization was 13 per 100 person-years for sacubitril/valsartan users and 18 per 100 person-years for angiotensin receptor antagonist users. Compared with angiotensin receptor antagonist use, sacubitril/valsartan use was associated with 27% lower risk of HF-related hospitalization (adjusted hazard ratio, 0.73; 95% confidence interval, 0.58-0.91; p = 0.006) and 31% lower risk of all-cause hospitalization (adjusted hazard ratio, 0.69; 95% confidence interval, 0.61-0.79; p < 0.001). Subgroup analyses revealed no significant heterogeneity, including subpopulations with chronic kidney disease or coronary artery disease. CONCLUSIONS: Compared with angiotensin receptor antagonists, sacubitril/valsartan was associated with lower risk of HF-related and all-cause hospitalizations. Our data suggest that, when added sequentially, sacubitril/valsartan should be the preferred initial agent over angiotensin receptor antagonists.