Comparison of real-world clinical and economic outcomes in patients receiving oral anticoagulants: A retrospective claims analysis.

BACKGROUND: Direct oral anticoagulants (DOACs) have become widely used for the prevention of stroke in nonvalvular atrial fibrillation (AF) and for the treatment of venous thromboembolism (VTE). Warfarin, the standard of care prior to DOACs, requires monitoring and dose adjustment to ensure patients remain appropriately anticoagulated. DOACs do not require monitoring but are significantly more expensive. We sought to examine real-world effectiveness and costs of DOACs and warfarin in patients with AF and VTE. OBJECTIVE: To examine clinical and economic outcomes. The clinical objectives were to determine the bleeding and thrombotic event rates associated with DOACs vs warfarin. The economic objectives were to determine the cost associated with these events, as well as the all-cause medical and pharmacy costs associated with DOACs vs warfarin. METHODS: This analysis was an observational, propensity-matched comparison of retrospective medical and pharmacy claims data for members enrolled in an integrated health plan between October 1, 2015, and September 30, 2020. Members who were older than 18 years of age with at least 1 30-day supply of warfarin or a DOAC filled within 30 days of a new diagnosis of VTE or nonvalvular AF were eligible for the analysis. Cox hazard ratios were used to compare differences in clinical outcomes, where paired t-tests were used to evaluate economic outcomes. RESULTS: After matching, there were 893 patients in each group. Among matched members, warfarin was associated with increased risk of nonmajor bleeds relative to apixaban (hazard ratio [HR] = 1.526; P = 0.0048) and increased risk of pulmonary embolism relative to both DOACs (apixaban: HR = 1.941 [P = 0.0328]; rivaroxaban: HR = 1.833 [P = 0.0489]). No statistically significant difference was observed in hospitalizations or in length of stay between warfarin and either DOAC. The difference-in-difference (DID) in total costs of care per member per month for apixaban and rivaroxaban relative to warfarin were $801.64 (P = 0.0178) and $534.23 (P = 0.0998) more, respectively. DID in VTE-related cost for apixaban was $177.09 less, relative to warfarin (P = 0.0098). DID in all-cause pharmacy costs for apixaban and rivaroxaban relative to warfarin were $342.47 (P < 0.0001) and $386.42 (P < 0.001) more, respectively. CONCLUSIONS: Warfarin use was associated with a significant decrease in total cost of care despite a significant increase in VTE-related costs vs apixaban. Warfarin was also associated with a significant increase in other nonmajor bleeds relative to apixaban, as well as a significant increase in pulmonary embolism relative to both DOACs. Warfarin was associated with a significant reduction in all-cause pharmacy cost compared with either DOAC. DISCLOSURES: The authors of this study have nothing to disclose.

Factors associated with ciprofloxacin-resistant Escherichia coli urinary tract infections in discharged ED patients.

BACKGROUND: We sought to identify factors associated with Escherichia coli resistance to ciprofloxacin among discharged emergency department (ED) patient visits treated for a urinary tract infection (UTI). We hypothesized that specific historical factors available upon ED presentation would be associated with increased odds of ciprofloxacin resistance in this population. METHODS: We conducted a retrospective, observational cohort study of consecutive discharged adult ED patient visits with a primary diagnosis of UTI caused by E coli to a single center from 2011 to 2014. Two investigators separately abstracted to a preconstructed data collection form the following independent variables on each included visit: patient age, sex, residence, active immunosuppressive condition or medication, chronic indwelling Foley catheter, hospitalization or antibiotic use within 90 days prior to presentation, and history of recurrent UTIs. We used multivariable logistic regression after taking into account colinearity to identify those independent variables associated with increased odds of ciprofloxacin resistance and report descriptive characteristics of the study cohort, odds ratios (ORs) with 95% confidence interval (CI) and model strength. RESULTS: Age at least 65 years (OR, 3.15; 95% CI, 1.44-6.87; P=.004), recurrent UTI (OR, 6.23; 95% CI, 2.38-16.30; P<.001), and recent hospitalization (OR, 3.99; 95% CI, 1.56-10.23; P=.004) were significantly associated with ciprofloxacin-resistant E coli UTIs in relevant visits. CONCLUSION: In this single-center study, age at least 65 years, recurrent UTI, and recent hospitalization were most clearly associated with increased odds of ciprofloxacin-resistant UTIs in discharged adult ED patient visits. If validated, these factors should suggest that alternative antimicrobial agents should be considered in the treatment of this condition among discharged adult ED patients.

High frequency of nonadherence to Clostridium difficile treatment guidelines.

OBJECTIVES: The 2010 Infectious Diseases Society of America/Society for Healthcare Epidemiology of America treatment guidelines for Clostridium difficile infections (CDI) recommend oral metronidazole for mild-to-moderate disease and oral vancomycin for severe disease. Given that disease severity is easily determined by the peripheral white blood cell count and serum creatinine level, a computerized decision support (CDS) pathway to guide treatment is inherently appealing. Because providers often override or ignore the computer-based alerts, the proposed CDS pathway should be justified before implementation. METHODS: We undertook this study to ascertain the frequency of nonadherence to CDI guidelines. Between October 1, 2007 and September 30, 2008, a total of 229 cases were screened and 78 cases were included in the study, which took place at a 661-bed acute tertiary care teaching hospital. RESULTS: During the year-long study of CDI cases at our tertiary care hospital, 61.5% (48/78) of the patients received an antibiotic regimen that was not recommended by the 2010 guidelines. Among the 35 patients with mild-to-moderate CDI, 85.7% (30/35) received the recommended treatment of oral metronidazole monotherapy; in contrast, among the 43 patients with severe disease, none (0/43) received the recommended treatment of oral vancomycin monotherapy (P < 0.01). Moreover, 17.9% (14/78) of patients received concurrent oral metronidazole and vancomycin, a regimen that is not recommended anywhere in the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines and which may be associated with a poor outcome. Patients who received combination oral metronidazole and vancomycin were not more likely to have comorbidities or severe CDI compared with those who received a single antibiotic agent. CONCLUSIONS: As a result of this study, we plan to educate our providers on the treatment of CDI through a CDS pathway in an effort to increase guideline adherence, decrease inappropriate antibiotic use, and potentially improve patient outcomes.

Pharmacist addition to the post-ED visit review of discharge antimicrobial regimens.

OBJECTIVE: Our objective was to evaluate whether pharmacist addition to the postvisit review of discharged adult emergency department (ED) visits' prescriptions/cultures would reduce the prevalence of revised antimicrobial regimen inappropriateness. METHODS: We conducted a retrospective observational study of discharged adult ED visits to a single center with positive cultures requiring antimicrobial regimen revision (May 1 to October 31, 2012, nurse process; February 1 to July 31, 2013, nurse/pharmacist process). Investigators abstracted cohorts' medical records for demographic, ED diagnosis, original/revised antibiotic regimen, culture result, medical history, medications, and patient instruction data and determined whether the revised regimen was inappropriate based on Infectious Diseases Society of America/Centers for Disease Control and Prevention and clinical guidelines. We used the large sample z-test to compare the prevalence of revised antimicrobial regimen inappropriateness between the 2 cohorts. RESULTS: In the prepharmacist cohort, there were 411 positive ED discharge cultures. Seventy-three (17.8%; 95% confidence interval [CI], 14.1%-21.5%) required antimicrobial regimen revision; 34 of these met 1 or more level of inappropriateness (46.6%; 95% CI, 35.1%-58.0%). In the postpharmacist cohort, there were 459 positive ED discharge cultures. Seventy-five (16.3%; 95% CI, 13.0%-19.7%) required revision; 11 of these met 1 or more level of inappropriateness (14.7%; 95% CI, 6.7%-22.7%; z = 4.2; P < .0001 for comparison). CONCLUSION: In this single-center study, pharmacist addition to the postvisit review of discharged adult ED patients' prescriptions/cultures reduced the prevalence of revised antimicrobial regimen inappropriateness.