Hospitalization for Myocardial Infarction with Ticagrelor or Clopidogrel in Patients with Acute Coronary Syndrome: An On-Treatment Comparative Effectiveness Analysis.

INTRODUCTION: Prescribing patterns and suboptimal adherence present methodological challenges for real-world head-to-head comparisons of ticagrelor and clopidogrel in intent-to-treat studies. The aim of this study was to compare ticagrelor and clopidogrel in an on-treatment population. METHODS: This retrospective cohort study used the Optum™ Clinformatics™ database to identify patients with acute coronary syndrome (ACS) discharged on ticagrelor or clopidogrel between January 1, 2012 and September 30, 2019. The primary end point was hospitalization for myocardial infarction (MI); the secondary end point was hospitalization for major bleeding. The ticagrelor and clopidogrel cohorts were balanced by propensity score matching (PSM) 1:3 for demographic and clinical characteristics. Outcomes were ascertained from day 31 until day 365 or end of follow-up. RESULTS: Of 339,387 patients with ACS, 14,110 ticagrelor- and 57,482 clopidogrel-treated patients met the study criteria. After PSM, 13,373 ticagrelor- and 29,656 clopidogrel-treated patients provided 4945 and 13,895 patient-years of data, respectively, for the primary end point. Hospitalization for MI was significantly lower in the ticagrelor compared to the clopidogrel cohort (2.22 vs. 3.52 per 100 patient-years; 36.8% relative risk reduction [RRR]; P < 0.0001). Hospitalization for major bleeding was similar in the ticagrelor and clopidogrel cohorts (2.04 vs. 2.06 per 100 patient-years; 1.1% RRR, P = 0.9214). CONCLUSIONS: In this real-world on-treatment analysis, hospitalization for MI was significantly lower with ticagrelor compared to clopidogrel, with similar rates of hospitalization for major bleeding. Study findings underscore the importance of being on the appropriate guideline-recommended therapy and support the use of ticagrelor over clopidogrel.

Clinical Outcomes and Healthcare Resource Utilization in a Real-World Population Reflecting the DAPA-CKD Trial Participants.

INTRODUCTION: The DAPA-CKD trial assessed dapagliflozin in patients with chronic kidney disease (CKD) with or without type 2 diabetes (T2D). To aid interpretation of results, renal and cardiovascular outcomes plus healthcare resource utilization (HCRU) and costs were assessed in a real-world population similar to that of DAPA-CKD. METHODS: Henry Ford Health System (2006-2016) data were used to identify patients with CKD stages 2-4 [estimated glomerular filtration rate (eGFR) 25-75 ml/min/1.73 m2 at index and urine albumin-to-creatinine ratio (UACR) 0-5000 mg/g; n = 22,251]. Included patients had confirmatory eGFR ≥ 90 days post-index and no kidney transplant or progression to end-stage kidney disease during 12 months pre-index. The final population (n = 6557) was stratified by UACR (0-29, 30-199 and 200-5000 mg/g; the last comprising the DAPA-CKD-like cohort). Patients were followed for 5 years post-index. RESULTS: Adverse clinical outcomes incidence increased with UACR and was highest for the DAPA-CKD-like cohort (UACR 200-5000 mg/g) versus lower UACR categories (0-29 mg/g and 30-199 mg/g): renal composite outcome (progression to CKD stage 5, dialysis, transplant, ≥ 50% sustained eGFR decline): 26.0% versus 2.2% and 5.8%; heart failure (HF): 36.1% versus 13.9% and 24.6%; myocardial infarction: 11.3% versus 4.7% and 7.4%; stroke: 8.9% versus 4.0% and 5.7%; and mortality: 18.5% versus 6.0% and 11.7%, respectively. Within the DAPA-CKD-like cohort, patients with versus without T2D or HF had a higher frequency of adverse outcomes. The DAPA-CKD-like cohort also had significantly higher annualized per-patient healthcare costs ($39,222/year versus $19,547/year), hospital admission rate (0.55/year versus 0.20/year) and outpatient specialist visit rate (7.55/year versus 6.74/year) versus the lowest UACR category. CONCLUSION: The significant adverse renal and cardiovascular outcomes observed, particularly in the DAPA-CKD-like cohort, represent a substantial burden resulting in increased mortality, HCRU and costs, demonstrating the need for additional treatment options.

Treatment patterns, clinical outcomes, health resource utilization, and cost in patients with BRCA-mutated metastatic breast cancer treated in community oncology settings.

PURPOSE: This retrospective study of community oncology patients with breast cancer gene (BRCA)-mutated metastatic breast cancer (MBC) examined treatment outcomes and health resource utilization (HRU) and costs for a sample of patients with human epidermal growth factor receptor 2 (HER2)-negative disease who were either hormone receptor positive (HR+) or triple negative breast cancer (TNBC). METHODS: Evidence from the Vector Oncology Data Warehouse, a repository of electronic medical records/billing data and provider notes, was analyzed. Treatment outcomes were progression-free survival (PFS) and overall survival (OS) from start of first-line therapy in the metastatic setting. HRU and cost measures were collected from the time of MBC diagnosis to end of the record. HRU included hospitalizations, emergency room visits, infused/parenteral supportive care drugs, and outpatient visits. Costs were computed both as total and monthly costs. RESULTS: 57 HR+ and 57 TNBC patients (2013-2015) met inclusion criteria. Eight TNBC patients did not get treatment. HR+ patients had median first line PFS of 12.1 months and TNBC patients had 6.1 months. HR+ patients had median OS from start of first line of 38.4 months, and TNBC patients had 23.4 months. Rate of use of infused/parenteral supportive care drugs was 25.5% overall and 36.7% among TNBC patients with 15.8% among HR+ patients. CONCLUSION: There is an unmet need in BRCA-mutated patients with MBC, including those with HR+ and TNBC disease. The unmet need among TNBC patients was most evident in that 12% were not treated and TNBC patients appeared to have poor treatment outcomes. MICRO ABSTRACT: Reviewed medical records for outcomes, resource utilization, and costs in 114 community patients with BRCA mutated metastatic breast cancer. 57 hormone positive (HP); 57 triple negative (TN). RESULTS: median PFS: 12.1 months HP; 6.1 TN. HP OS was 38.4; TN 23.4. Rate of infused supportive care drugs: 25.5% HP; 36.7% TN. Patients with TN disease need better therapeutic options.

Effectiveness of informational decision aids and a live donor financial assistance program on pursuit of live kidney transplants in African American hemodialysis patients.

BACKGROUND: African Americans have persistently poor access to living donor kidney transplants (LDKT). We conducted a small randomized trial to provide preliminary evidence of the effect of informational decision support and donor financial assistance interventions on African American hemodialysis patients' pursuit of LDKT. METHODS: Study participants were randomly assigned to receive (1) Usual Care; (2) the Providing Resources to Enhance African American Patients' Readiness to Make Decisions about Kidney Disease (PREPARED); or (3) PREPARED plus a living kidney donor financial assistance program. Our primary outcome was patients' actions to pursue LDKT (discussions with family, friends, or doctor; initiation or completion of the recipient LDKT medical evaluation; or identification of a donor). We also measured participants' attitudes, concerns, and perceptions of interventions' usefulness. RESULTS: Of 329 screened, 92 patients were eligible and randomized to Usual Care (n = 31), PREPARED (n = 30), or PREPARED plus financial assistance (n = 31). Most participants reported interventions helped their decision making about renal replacement treatments (62%). However there were no statistically significant improvements in LDKT actions among groups over 6 months. Further, no participants utilized the living donor financial assistance benefit. CONCLUSIONS: Findings suggest these interventions may need to be paired with personal support or navigation services to overcome key communication, logistical, and financial barriers to LDKT. TRIAL REGISTRATION: ClinicalTrials.gov [ NCT01439516 ] [August 31, 2011].

Comparing Healthcare Utilization and Costs Among Medicaid-Insured Patients with Chronic Noncancer Pain with and without Opioid-Induced Constipation: A Retrospective Analysis.

BACKGROUND: Constipation is a common adverse effect of opioid use and has been associated with increased healthcare utilization and costs among patients receiving opioids for pain management. OBJECTIVE: To compare the healthcare utilization and costs of Medicaid patients with chronic noncancer pain with and without constipation who were receiving opioids. METHODS: This retrospective, claims-based study was conducted using data from the Truven Health MarketScan Medicaid Multi-State database. Patients with no evidence of cancer who initiated opioid therapy between January 1, 2009, and June 30, 2013, were eligible for the study. Patients had to have continuous enrollment in the database in the 6 months before and 12 months after opioid initiation, with no evidence of substance abuse or functional or inflammatory bowel disease. Medical and pharmacy claims during the 12 months after opioid initiation were evaluated for a diagnosis of constipation or for prescription or over-the-counter medications indicative of constipation. All-cause healthcare utilization and costs were measured over the same period and were compared between propensity score-matched cohorts of patients with evidence of constipation and patients without constipation. RESULTS: Of the 25,744 patients meeting the study inclusion criteria, 2716 (10.5%) had evidence of constipation. After 1:1 propensity score matching, the 2 cohorts had similar demographic and clinical characteristics (ie, mean age, 47 years; 26%-27% male). During the 12-month follow-up period, healthcare utilization was more frequent among patients with constipation, including inpatient admissions and emergency department visits, than in the matched patients without constipation. The total all-cause mean healthcare costs were substantially higher among the patients with constipation ($28,234; 95% confidence interval [CI], $24,307-$32,160) than in the patients without constipation ($13,709; 95% CI, $12,618-$14,801), with a median cost difference of $4166 per patient (P <.001). CONCLUSION: Among Medicaid enrollees who receive opioids for chronic noncancer pain, constipation is associated with increased all-cause healthcare utilization and costs.