Zero-Dollar Copayment Impact on Adherence Scores for Centers for Medicare and Medicaid Services Star Ratings Generic Medications.

INTRODUCTION: The Centers for Medicare & Medicaid Services (CMS) Star Ratings system pushes Medicare Advantage health plans to achieve ever greater attainments in key metrics, including adherence to hydroxymethylglutaryl-CoA reductase inhibitor (statins), renin-angiotensin system (RAS) antagonist, and noninsulin antihyperglycemic (DM) medications. The purpose of this observational study was to evaluate the impact of expanding a $0 copayment (copay) benefit from mail order-only to mail order plus retail pharmacies on adherence to statin, RAS, and DM medications. METHODS: Medicare beneficiaries with and without a $0 copay expansion who received ≥ 1 dispensing of a generic, CMS Star Ratings RAS, statin, and/or DM medication during both 2021 and 2022 were included. Outcomes included changes in proportion of days covered (PDC) from 2021 to 2022 and proportions of patients with a PDC ≥ 0.8 in 2022. RESULTS: Overall (N = 65,716), patients had a high ( > 0.930) mean baseline PDC. Patients with $0 copay expansion had a statistically significant greater mean PDC increase for statin (adjusted P = 0.038), reduction for RAS (adjusted P = 0.036), and no difference for DM (adjusted P = 0.696). Patients with a $0 copay expansion had statistically significant higher proportions of beneficiaries with a PDC ≥ 0.8 for statin (adjusted P = 0.003) and RAS (adjusted P = 0.003) but not DM (adjusted P = 0.256). DISCUSSION: An expanded $0 copay was associated with minor increased generic statin medication adherence. CONCLUSION: In populations with a high baseline PDC, expanding a $0 copay benefit on generic statin, RAS, and DM medications to dispensing outside of mail order may only contribute slightly to an increase or sustainment of a health plan's CMS Star Ratings.

Real-World Noninferiority Assessment of Two Filgrastim Biosimilars in Patients Receiving Myelosuppressive Chemotherapy.

PURPOSE: Although multiple filgrastim biosimilars are now available in the United States, no studies comparing clinical outcomes between products have been reported. This analysis evaluated real-world outcomes of filgrastim-aafi and filgrastim-sndz in patients with select solid tumors receiving myelosuppressive chemotherapy to compare the two filgrastim biosimilars. METHODS: This was an observational, noninferiority, cohort study of patients from three integrated health care systems who received myelosuppressive chemotherapy and were prophylactically initiated on filgrastim-sndz between January and November 2021 or filgrastim-aafi between June and November 2022. Patients were followed from filgrastim biosimilar initiation until the start of their next chemotherapy cycle. The primary outcome of severe neutropenia was analyzed using a binary noninferiority test with a 5% upper margin. Secondary outcomes included the incidence of emergency department or hospital encounters due to febrile neutropenia and systemic antibiotic/antifungal medication use. If noninferiority was met, adjusted logistic regression modeling was conducted. RESULTS: A total of 2,730 patients who initiated filgrastim-aafi (n = 880) or filgrastim-sndz (n = 1,850) during the study period were included. The overall mean age was 55 years, 87.4% were female, 42.3% were White, and 76.6% had breast cancer. Severe neutropenia occurred in 1.8% and 1.7% of patients initiated on filgrastim-aafi and filgrastim-sndz, respectively (P < .01 for noninferiority). The adjusted odds ratio for severe neutropenia with filgrastim-aafi compared with filgrastim-sndz was 0.91 (95% CI, 0.49 to 1.68; P = .76). Noninferiority was met for all secondary outcomes (P < .01), and there were no adjusted statistically significant differences between the groups (all P > .05). CONCLUSION: Among patients with select solid tumors receiving myelosuppressive chemotherapy, severe neutropenia outcomes were comparable between filgrastim-aafi and filgrastim-sndz biosimilars. Findings from this study may support utilization of different filgrastim biosimilars in clinical practice.

Prior authorization for diabetes medications: Clinical outcomes and health disparities.

BACKGROUND: Prior authorization (PA) is a utilization management strategy used by health plans to ensure affordable, cost-effective care; however, PA may lead to therapy delay/abandonment and exacerbate health disparities. The purpose of this observational study was to assess the clinical outcomes and any health disparities associated with PA for diabetes mellitus (DM) medications. MATERIALS AND METHODS: This was a cohort study of US adult patients from health plans with integrated and non-integrated system providers who were prescribed a DM medication that required a PA. Patients were categorized into three groups: received the requested DM medication (PA Med) or a new, alternative DM medication (DM Med), or did not receive the requested or new DM medication (No Med). The primary outcome was change in hemoglobin A1c (HbA1c). Adjusted and unadjusted analyses were performed. Patient characteristics associated with the No Med group were identified, also, with multivariable logistic regression modeling. RESULTS: 6305 patients were included: 2434, 1323, and 2548 in the PA Med, DM Med, and No Med groups, respectively. Patients in the PA Med (-0.9 %) and DM Med (-1.0 %) groups had statistically significantly greater reductions in HbA1c compared to the No Med group (-0.4 %) in both unadjusted and adjusted analyses (all p < 0.05). Patients who were Hispanic/Latino, had a non-integrated system prescriber, and had a higher burden of chronic disease were statistically significantly associated with the No Med group. CONCLUSIONS: Receiving a new DM medication following PA was associated with better clinical outcomes but health disparities were present in the PA process.

Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer.

BACKGROUND: Bevacizumab-awwb was the first biosimilar approved for cancer treatment in the USA. Limited information is available on the real-world comparative safety and effectiveness of bevacizumab biosimilars, especially for indications granted approval through extrapolation. OBJECTIVE: To evaluate the real-world outcomes of patients with metastatic colorectal cancer (mCRC) initiated on bevacizumab-awwb versus bevacizumab reference product. PATIENTS AND METHODS: This was an observational, longitudinal cohort study of US adult patients with mCRC from four integrated care delivery systems who were newly initiated on bevacizumab-awwb between 1 July 2019 and 30 March 2020 or bevacizumab reference product between 1 July 2015 and 30 June 2018. Patients were followed until 1 year after treatment initiation, end of plan membership, or death, whichever occurred first. The primary outcome of overall survival (OS) was analyzed using a binary non-inferiority test with lower margin of 10% and adjusted Cox proportional hazards regression analysis to assess all-cause mortality if non-inferiority was met. Secondary outcomes included counts of doses received, treatment duration, all-cause hospitalizations, and incidence of serious adverse events. RESULTS: A total of 1445 patients initiated on either bevacizumab-awwb (n = 239) or bevacizumab reference product (n = 1206) were included in the analysis. The mean overall age was 60 ± 13 years, 46% of patients were female, and 51% were white. The OS rate was 72.8% and 73.1% for patients receiving bevacizumab-awwb and bevacizumab reference product, respectively (p < 0.01 for non-inferiority). The adjusted hazard ratio for mortality was 1.01 (0.77-1.33, p = 0.93). There were no statistically significant differences in secondary outcomes between the study groups. CONCLUSIONS: These findings suggest that bevacizumab-awwb is as effective and safe as bevacizumab reference product for the real-world treatment of mCRC.

Transthyretin Amyloid Cardiomyopathy Risk Evaluation in a Cohort of Patients With Heart Failure.

Introduction Transthyretin amyloid cardiomyopathy (ATTR-CM) is a progressive, infiltrative form of heart failure (HF). Nevertheless, ATTR-CM is a largely underrecognized and misdiagnosed condition. This study's objective was to develop an efficient model to assess the chance of ATTR-CM in patients with HF. Methods This was an observational study of patients with HF who had a confirmed diagnosis of ATTR-CM and those with HF but without known ATTR-CM between January 1, 2019, and July 1, 2021. Patient characteristics were extracted from administrative and claims electronic databases and compared between the groups. A propensity score for having ATTR-CM was modeled. Samples of 50 control patients with the highest and lowest propensity scores were adjudicated to assess whether further workup to evaluate for ATTR-CM was warranted for each patient. The sensitivity and specificity of the model were calculated. Results Thirty-one patients with confirmed ATTR-CM and 7620 patients without known ATTR-CM were included in the study. Patients with ATTR-CM were more likely to be Black and to have atrial flutter/fibrillation, cardiomegaly, HF with preserved ejection fraction, pericardial effusion, carpal tunnel syndrome, joint disorders, and lumbar spinal stenosis and to use a diuretic (all p < 0.05). A propensity model with 16 inputs was developed (c-statistic = 0.875). The model's sensitivity and specificity were 71.9% and 95.2%, respectively. Conclusion The propensity model developed in this study provided an efficient means for identifying patients with HF who are more likely to have ATTR-CM and may warrant further workup.

Real-World Outcomes of Proprotein Convertase Subtilisin Kexin-9 Inhibitor Use.

ABSTRACT: Although the proprotein convertase subtilisin kexin-9 inhibitors (PCSK9i) were shown to significantly lower low-density lipoprotein and reduce atherosclerotic cardiovascular disease events in clinical trials, there is a dearth of use data on these agents in real-world settings. This study compares PCSK9i use in a population of real-world patients with atherosclerotic cardiovascular disease or familial hypercholesterolemia. This was a matched cohort study of adult patients who were dispensed a PCSK9i along with adult patients who did not receive a PCSK9i. PCSK9i patients were matched on a propensity to have received a PCSK9i score up to 1:10 to non-PCSK9i patients. The primary outcomes were changes in cholesterol levels. Secondary outcomes included a composite outcome of all-cause mortality, major cardiovascular events, and ischemic strokes along with health care utilization during follow-up. Adjusted conditional, multivariate Cox proportional hazards, and negative binomial modeling were performed. Ninety-one PCSK9i patients were matched to 840 non-PCSK9i patients. Seventy-one percent of PCSK9i patients either discontinued or switched PCSK9i therapy. PCSK9i patients had greater median reductions in low-density lipoprotein (-73.0 mg/dL vs. -30.0 mg/dL) and total (-77.0 vs. -31.0) cholesterol (both P < 0.001). No adjusted between-group differences in the composite outcome or individual components of the composite outcome were identified (all P > 0.05). PCSK9i patients had a lower rate of medical office visits during follow-up (adjusted incidence rate ratio = 0.61, P = 0.019). These findings support the effectiveness of PCSK9i therapy in real-world settings but suggest that use may be limited by PCSK9i adverse reactions and patient cost barriers.

Effectiveness and safety of direct oral anticoagulants in patients with venous thromboembolism and creatinine clearance < 30 mL/min.

The few studies that compared direct oral anticoagulants (DOAC) vs. warfarin in the setting of advanced renal insufficiency have focused on patients with atrial fibrillation. The purpose of this observational, matched, cohort study of patients was to assess the effectiveness and safety of DOAC vs. warfarin for the treatment of venous thromboembolism (VTE) among patients with a creatinine clearance (CrCl) < 30 mL/min. This observational, cohort study included patients with VTE and CrCl < 30 mL/min who were newly initiated on a DOAC or warfarin between January 1, 2016 and December 31, 2020. DOAC patients were matched up to 1:2 to warfarin patients. Primary outcome was a composite of recurrent VTE, clinically-relevant bleeding, ischemic stroke, and all-cause mortality. Adjusted conditional, multivariate Cox proportional hazards modeling was used to assess outcomes. 626 DOAC patients were matched to 1071 warfarin patients. DOAC patients had a higher mean age, higher mean baseline CrCl, and were less likely to have been receiving dialysis. There was no statistically significant difference in the composite outcome between groups (adjusted hazard ratio [aHR] 1.13, 95% confidence interval [CI] 0.87-1.47) or in the individual components of the composite (all HR 95% CI crossed 1.00). Identification of statistically non-significant rates of bleeding and thromboembolic outcomes suggest that the use of DOAC or warfarin is reasonable in patients with VTE and CrCl < 30 mL/min.

Clinical Factors Associated With Nonadherence to Chronic Medications in People With Cognitive Impairment.

Objective To study assessed adherence to 11 chronic medications and one medication class with high medical necessity in people with cognitive impairment (CIM) and identified clinical characteristics associated with nonadherence. Design This was a retrospective cohort study. 180-day adherence was calculated as the percent of days covered (PDC). Multi-variable logistic regression modeling was used to identify clinical factors associated with a PDC less than 80% (ie, nonadherence) to one or more studied chronic medication(s). Setting Primary care in an integrated health care delivery system. Patients People with CIM 65 years of age or older who were dispensed five or more chronic medications in one month between March 1, 2019, and October 31, 2019. Results Overall, the 1,109 patients included were older (mean age = 79.8 years of age), female (54.1%), White (78.6%), had a high burden of chronic disease, and 396 (35.7%) were nonadherent to one or more study medication(s). Two medications (tiotropium and venlafaxine) and one medication class (direct oral anticoagulants) had a mean PDC less than 80%. Alzheimer's disease and related dementias (ADRD), chronic pain, chronic obstructive pulmonary disease (COPD), male, nonwhite race, and one or more mental health visits were associated independently with nonadherence. Conclusions Chronic pain, COPD, ADRD, male sex, nonwhite race, and mental health care use were associated with nonadherence. These findings can help guide clinicians as they navigate medication therapy in people with CIM.

Impact of Palliative Care Clinical Pharmacists in an Inpatient Care Setting on Total Health Care Expenditures.

Background: Inpatient palliative care clinical pharmacy specialists (IPCPS) on multidisciplinary palliative care (PC) teams have expanding roles in the treatment of pain, nausea, and other symptoms for patients with serious illnesses. Objectives: The aim of this study was to assess the clinical and financial outcomes associated with an IPCPS on an inpatient PC team. Setting and Design: This was a retrospective cohort study conducted in Colorado. Adult patients with an inpatient stay and a PC consult between October 1, 2016 and February 28, 2019 were included. Patients were assigned to the observation group if they received PC from a clinical pharmacist and control group if they received usual PC. The primary outcome was the 180-day change in daily total cost-of-care expenditures. Secondary outcomes included length of index hospitalization and 180-day change in daily morphine milligram equivalents (MME), health care utilization, and opioid adverse effects (AE). Results: A total of 1543 patients were included with 228 and 1315 in the IPCPS and usual care groups, respectively. After adjustment, the IPCPS group had a greater median decrease in daily expenditures (-$22 vs. $6, p = 0.003), higher median increase in daily MME (16.5 vs. 9.7 mg, p = 0.007), and fewer patients with a subsequent hospitalization (34.2% vs. 39.2%, p = 0.010) or urgent care visit (10.5% vs. 14.6%, p = 0.024) but longer mean index hospitalization (9.3 vs. 7.7 days, p = 0.003) and no differences in AE during follow-up (all p > 0.05). Conclusion: IPCPS participation on the PC team can be a component of health care cost reduction while contributing to patient-centered quality care.

Clinical outcomes of dabigatran use in patients with non-valvular atrial fibrillation and weight >120 kg.

BACKGROUND: Patients with obesity were underrepresented in studies evaluating the safety and effectiveness of direct oral anticoagulants (DOAC) in patients with non-valvular atrial fibrillation (NVAF). This study compared clinical outcomes in patients with NVAF and weighing >120 kg and ≤120 kg who were receiving dabigatran. MATERIALS AND METHODS: This retrospective, matched, longitudinal cohort study included patients from three integrated healthcare delivery systems. Patients ≥18 years of age with NVAF were included if between September 1, 2016 and June 30, 2019 they received dabigatran. Patients >120 kg and ≤120 kg were matched up to 1:6 on age, sex, and CHA2DS2-VASc score. Data were extracted from administrative databases. The primary outcome was a composite of ischemic stroke, clinically-relevant bleeding, systemic embolism, and all-cause mortality. Multivariable regression analyses were performed. RESULTS: 777 and 3522 patients >120 kg and ≤120 kg, respectively, were matched. The >120 kg group tended to be younger with a higher burden of chronic disease. There was no difference between groups in the composite outcome (adjusted hazard ratio [AHR] 1.10, 95% confidence interval 0.89-1.37) or individual components of the composite. A subanalysis of clinically-relevant bleeding identified that patients >120 kg were at a greater risk of gastrointestinal bleeding (AHR 1.44, 95% CI 1.01-2.05). CONCLUSIONS: In patients with NVAF and >120 kg, dabigatran use was associated with a small increased risk of gastrointestinal bleeding but no differences in stroke, mortality or clinically-relevant bleeding. These findings suggest that dabigatran use is reasonable in patients with NVAF and weight >120 kg.

Retrospective assessment of antimicrobial stewardship initiative in outpatient use of ertapenem for uncomplicated extended spectrum beta lactamase Enterobacteriaceae urinary tract infections.

BACKGROUND: Urinary tract infections (UTI) are often over-diagnosed and over-treated, which can induce and select for resistant pathogens. After observing wide-spread outpatient use of ertapenem, a broad-spectrum antibiotic, a structured antimicrobial stewardship initiative (ASI) to improve appropriate antimicrobial prescribing was undertaken. ASI objectives were to achieve a goal of reducing ertapenem utilization for extended spectrum beta lactamase Enterobacteriaceae (ESBL-EB) UTI by 10% and evaluate the clinical outcomes associated with the ASI. METHODS: A pre-to-post cohort study was conducted at a single-center integrated healthcare system between November 1, 2014 and February 26, 2017. An intensive, 90-day, pharmacist-driven, structured ASI was implemented between November 1, 2015 and January 29, 2016. Female patients aged ≥18 years who were treated for an uncomplicated, ESBL-EB urinary tract infection (UTI) were included. Primary outcome was clinical resolution defined as cure, persistence, relapse and recurrence. Secondary outcome measured was monthly ertapenem use expressed as number of days of therapy (DOT)/1000 adjusted patient days (APD). Segmented regression analysis for interrupted time series was performed to estimate ASI intervention effect. RESULTS: A total of 184 patients were included in the study. Ertapenem utilization decreased from 0.0145 DOT/1000 APD in Nov. 2014 to 0.0078 DOT/1000 APD Feb. 2017(p < 0.01). The mean ertapenem DOT declined 19% overall from the pre vs. post intervention periods (32 vs 26, p < 0.01). Frequency of recurrent UTIs between treatments did not significantly differ and no adverse effects were reported in patients treated with aminoglycosides. CONCLUSIONS: A structured ASI for uncomplicated ESBL-EB UTI was associated with a clinically meaningful decrease in ertapenem utilization and once-daily, 5-day aminoglycoside treatment was well-tolerated.

Aligning care with the personal values of patients with complex care needs.

OBJECTIVE: To identify opportunities to align care with the personal values of patients from three distinct groups with complex medical, behavioral, and social needs. DATA SOURCES/STUDY SETTING: Between June and August 2019, we conducted semi-structured interviews with individuals with complex care needs in two integrated health care delivery systems. STUDY DESIGN: Qualitative study using semi-structured interviews. DATA COLLECTION METHODS: We interviewed three groups of patients at Kaiser Permanente Washington and Kaiser Permanente Colorado representing three distinct profiles of complex care needs: Group A ("obesity, opioid prescription, and low-resourced neighborhood"), Group B ("older, high medical morbidity, emergency department, and hospital use"), and Group C ("older, mental and physical health concerns, and low-resourced neighborhood"). These profiles were identified based on prior work and prioritized by internal primary care stakeholders. Interview transcripts were analyzed using thematic analysis. PRINCIPAL FINDINGS: Twenty-four patients participated; eight from each complex needs profile. Mean age across groups was 71 (range 48-86) years. We identified five themes common across the three groups that captured patients' views regarding values-aligned care. These themes focused on the importance of care teams exploring and acknowledging a patient's values, providing access to nonphysician providers who have different perspectives on care delivery, offering values-aligned mental health care, ensuring connection to community-based resources that support values and address needs, and providing care that supports the patient plus their family and caregivers. CONCLUSIONS: Our results suggest several opportunities to improve how care is delivered to patients with different complex medical, behavioral, and social needs. Future research is needed to better understand how to incorporate these opportunities into health care.

Clinical Effectiveness of an Outpatient Multidisciplinary Chronic Pain Management Telementoring Service.

OBJECTIVE: The objective of this study was to assess the effectiveness of a Pain E-Consult Program (PEP), a multidisciplinary telementoring service based on the Extension for Community Healthcare Outcomes (ECHO) model to reduce opioid use in the outpatient setting. MATERIALS AND METHODS: This was a retrospective matched cohort study conducted in an integrated health care delivery system. Adult patients without cancer and with a 90-day morphine milligram equivalent (MME) ≥30 mg/d between April 1, 2016, and June 30, 2017, were included. Patients whose primary care clinician received the PEP (observation) were compared with usual care (control) patients. Observation patients were matched up to 1:5 to control patients. Outcomes included change in MME and initiation of nonopioid alternative medications. Multivariable regression analyses were performed. RESULTS: A total of 665 patients were matched: 125 and 540 in the observation and control groups, respectively. Patients were primarily female, white, and Medicare beneficiaries. The observation group had a statistically significantly greater decrease in median MME/day during the 6-month (-7.4 vs. 1.5 mg, P=0.002) and 12-month (-15.1 vs. -2.8 mg, P<0.001) follow-up and rates of ≥20% decrease (6 mo: 41.6% vs. 24.6%, P=0.003; 12 mo: 48.0% vs. 32.6%, P=0.017). There were no differences in the rates of initiation of nonopioid alternative medications. CONCLUSIONS: A PEP was associated with greater reductions in MME/day compared with usual care despite similar rates of nonopioid alternative medication initiation. A prospective randomized study of this program should be undertaken to confirm these findings.

Factors associated with A1C reduction with GLP-1 agonist or SGLT-2 inhibitor use.

BACKGROUND: While use of glucagon-like peptide-1 (GLP-1) agonists and sodium-glucose cotransporter-2 (SGLT-2) inhibitors reduces the risk of atherosclerotic cardiovascular disease outcomes and lowers glycosylated haemoglobin (A1C), evidence on patient characteristics associated with clinically relevant A1C reduction is lacking. OBJECTIVE: The objective of this retrospective cohort study was to identify patient characteristics associated with A1C reduction with initial GLP-1 or SGLT-2 use. METHODS: Patients with type 2 diabetes and a baseline A1C ≥7% who were dispensed a GLP-1 or SGLT-2 between 01/01/10 and 12/31/17 were included. Patients were categorized as having a ≥1% or <1% A1C reduction during the 90-365 days after GLP-1/SGLT-2 initiation. Patient characteristics were collected during the 180 days prior to initiation. Multivariable logistic and linear regression modelling was performed to identify characteristics associated with a ≥1% A1C reduction and absolute change in A1C, respectively. RESULTS: Five hundred and seventy-two patients were included with 261 (46%) and 311 (54%) having and not having an ≥1% A1C reduction. Patients were primarily middle-aged, female, white, non-Hispanic and had a high burden of chronic disease. Characteristics associated with a ≥1% A1C reduction included: GLP-1/SGLT-2 persistence, congestive heart failure comorbidity, phentermine dispensing, care management team (CMT) enrollee and higher baseline A1C. Characteristics associated with absolute A1C reduction included: age, baseline A1C, CMT enrollee, GLP-1/SGLT-2 persistence and a phentermine dispensing. CONCLUSIONS: The results of this study provide practitioners with guidance on the patients who are most likely to have a clinically relevant A1C reduction with GLP-1 or SGLT-2 use.

Retrospective Cohort Study Comparing Infliximab-dyyb and Infliximab in Biologic-Naive Patients With Inflammatory Bowel Disease in the United States.

Background: Real-world assessments of biosimilars are needed to understand their effectiveness and safety in practice settings that may differ from those seen in clinical trials or healthcare systems in different countries. To assess the effectiveness and safety of a biosimilar (infliximab-dyyb) and its reference product (infliximab) in patients with inflammatory bowel disease (IBD) in the United States. Methods: We conducted a retrospective cohort study of biologic-naive patients with IBD who started treatment with infliximab-dyyb or infliximab. The study included 3206 patients identified through electronic health records in a US integrated healthcare delivery system. The effectiveness outcome was a composite of IBD-related surgery, IBD-related emergency room visit, and IBD-related hospitalization within 12 months of initiation. Safety outcomes included incidence of any or serious infection, cancer, acute liver dysfunction, and tuberculosis. We used a non-inferiority test with an upper-limit margin of 10% to analyze effectiveness. Doubly robust methods incorporating Cox proportional hazard regression with standardized inverse probability of treatment weighting were used to analyze both effectiveness and safety outcomes. Results: The composite effectiveness outcome occurred in 107 of 870 patients (12.3%) in the infliximab-dyyb and 379 of 2336 patients (16.2%) in the infliximab groups. Infliximab-dyyb was non-inferior (P < .01) and was not different (hazard ratio [HR] 0.81; confidence interval [CI] 0.65-1.01; P = .06) to infliximab. Safety outcomes were not different between infliximab-dyyb and infliximab for any infections (HR 1.01; CI 0.86-1.17; P = .95), serious infections (HR 0.83; CI 0.54-1.26; P = .38), cancers (HR 0.83; CI 0.44-1.54; P = .55), and tuberculosis (HR 0.59; CI 0.10-3.55; P = .57). Conclusions: Initiation of infliximab-dyyb was non-inferior to infliximab among biologic-naive patients with IBD in an US integrated healthcare delivery system.

Patterns of Care and Treatment Outcomes for Outpatient Daptomycin-Containing Regimens in Osteomyelitis.

BACKGROUND: Use of daptomycin at doses ≥ 6 mg/kg for treatment of osteomyelitis is increasing in clinical practice; unfortunately, limited data are available to guide optimal dosing and duration. The objective of this study was to assess daptomycin dosing and duration regimens for osteomyelitis treatment. METHODS: This was a retrospective, multi-site, cohort study conducted in an integrated healthcare delivery system. Nonpregnant patients ≥ 18 years of age with osteomyelitis diagnosed between November 1, 2003 and June 30, 2011, ≥ 2 weeks outpatient daptomycin therapy, and ≥ 1 month of follow-up were included. Daptomycin doses < 6 mg/kg and ≥ 6 mg/kg at durations of < 6 weeks and ≥ 6 weeks were examined with univariate and multivariate analyses to assess treatment success and all-cause mortality. RESULTS: A total of 247 patients were included, with 39 (15.8%), 37 (15.0%), 107 (43.3%), and 64 (25.9%) receiving < 6 mg/kg and ≥ 6 weeks, < 6 mg/kg and < 6 weeks, ≥ 6 mg/kg and ≥ 6 weeks, and ≥ 6 mg/kg and < 6 weeks of daptomycin therapy, respectively. Patients had a mean age of 58 years and had received prior vancomycin therapy (65.6%). Patients receiving < 6 weeks of therapy were less likely to experience treatment success compared with ≥ 6 weeks (41.5% vs 25.3%, adjusted odds ratio = 0.55; 95% confidence interval = 0.31-0.98) independent of duration. There were no differences across groups in mortality after adjustment. CONCLUSION: In a diverse clinical population, daptomycin for treatment of osteomyelitis of 6 weeks or longer duration was associated with success independent of dose. This finding supports longer treatment with daptomycin as a first-line agent in antimicrobial stewardship initiatives.

Twice-daily versus once-daily lisinopril and losartan for hypertension: Real-world effectiveness and safety.

BACKGROUND: Lisinopril and losartan manufacturer labels recommend twice-daily dosing (BID) if once-daily (QDay) is insufficient to lower blood pressure (BP). METHODS AND RESULTS: Retrospective cohort study of patients taking QDay lisinopril and losartan who experienced a dose-doubling (index date). A text-processing tool categorized BID and QDay groups at the index date based on administration instructions. We excluded: pregnant/hospice, regimens other than BID/QDay, and without BP measurements -6 months/+12 months of the index date. The most proximal BP measurements -6 months and +2 weeks to 12 months of the index date were used to evaluate BP differences. Propensity scores were generated, and differences in BP and adverse events (angioedema, acute kidney injury, hyperkalemia) between BID/QDay groups were analyzed within dosing cohorts using inverse propensity of treatment-weighted regression models. Of 11,210 and 6,051 patients who met all criteria for lisinopril and losartan, 784 (7.0%) and 453 (7.5%) were taking BID, respectively. BID patients were older and had higher comorbidity and medication burdens. There were no differences in systolic/diastolic BP between BID and QDay, with absolute differences in mean systolic BP ranging from -1.8 to 0.7 mmHg and diastolic BP ranging from -1.1 to 0.1 mmHg (all 95% confidence intervals [CI] cross 0). Lisinopril 10mg BID was associated with an increased odds of angioedema compared to lisinopril 20mg QDay (odds ratio 2.27, 95%CI 1.13-4.58). CONCLUSIONS: Adjusted models do not support improved effectiveness or safety of BID lisinopril and losartan.

Temporal trends in first-line outpatient anticoagulation treatment for cancer-associated venous thromboembolism.

BACKGROUND: First-line treatment and secondary prevention of venous thromboembolism (VTE) in patients with cancer consisted, historically, of unfractionated heparin or low-molecular weight heparin (LMWH). With recent clinical trials of direct oral anticoagulants (DOAC) showing similar efficacy as LMWH, little is known about anticoagulant prescribing patterns in patients with cancer and a VTE. This study characterized the temporal trends in first-line outpatient anticoagulation therapy for cancer-associated VTE. MATERIALS AND METHODS: This retrospective cohort study of patients who were hospitalized for a cancer-associated venous thromboembolism (VTE) between 01/01/2000 and 10/31/2017 identified patients from the cancer registries at two regions of an integrated healthcare delivery system. The primary outcome was the trend in age- and sex-adjusted rates of first-line anticoagulant therapy during the 30 days post-hospital discharge. Therapies were categorized as 1) injectable LMWH monotherapy, 2) warfarin ± injectable, 3) injectable fondaparinux monotherapy, or 4) DOAC ± injectable. RESULTS: Overall, 9816 patients were included with a mean age of 66 ± 13 years and 54% were female. From 2000 to 2003, warfarin ± injectable was used in ≈90% of cases. After 2003, there was a steady decline in warfarin use (25% in 2017) corresponding with increased LMWH use: 11% in 2003 to 55% in 2017. The DOAC ± injectable use has rapidly increased from <1% in 2014 to 20% in 2017. CONCLUSIONS: From 2000 to 2017, first-line anticoagulant therapy for cancer-associated VTE has experienced a substantial increase in LMWH and DOAC use with a resultant decline in warfarin use.