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BACKGROUND: The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved empagliflozin for reducing cardiovascular mortality and heart failure (HF) hospitalization in patients with both HF with reduced ejection fraction (HFrEF) and HF with preserved ejection fraction (HFpEF). However, limited data are available on the generalizability of empagliflozin to clinical practice. Therefore, we evaluated real-world eligibility and potential cost-effectiveness based on a nationwide prospective HF registry. METHODS: A total of 3,108 HFrEF and 2,070 HFpEF patients from the Korean Acute Heart Failure (KorAHF) registry were analyzed. Eligibility was estimated by inclusion and exclusion criteria of EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced) and EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved) trials and by FDA & EMA label criteria. The cost-utility analysis was done using a Markov model to project the lifetime medical cost and quality-adjusted life year (QALY). RESULTS: Among the KorAHF patients, 91.4% met FDA & EMA label criteria, while 44.7% met the clinical trial criteria. The incremental cost-effectiveness ratio of empagliflozin was calculated at US$6,764 per QALY in the overall population, which is far below a threshold of US$18,182 per QALY. The cost-effectiveness benefit was more evident in patients with HFrEF (US$5,012 per QALY) than HFpEF (US$8,971 per QALY). CONCLUSION: There is a large discrepancy in real-world eligibility for empagliflozin between FDA & EMA labels and clinical trial criteria. Empagliflozin is cost-effective in HF patients regardless of ejection fraction in South Korea health care setting. The efficacy and safety of empagliflozin in real-world HF patients should be further investigated for a broader range of clinical applications. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01389843.

Purpose: Drug shortages directly affect the final stage in the pharmaceutical supply chain, prescription fulfillment in community pharmacies (CPs). This study investigated the current state of drug shortages, their resolution, and influencing factors within CPs. Methods: A cross-sectional online survey was conducted among pharmacists working at pharmacies in Seoul between 7 and 31 October 2022. The survey gathered data on pharmacies and pharmacists' characteristics, drug distribution, information, communication, and administrative practices. Logistic regression was used to identify the factors influencing these rates. Regression results are presented as odds ratios (OR) and 95% confidence intervals (CIs). Results: Of the 1200 pharmacists approached, 713 participated, yielding a response rate of 59.4%. After excluding incomplete responses, data from 671 respondents were analyzed. Pharmacies with higher prescription drug sales demonstrated a lower OR for drug shortages (OR=0.66, 95% CI=0.60– 0.72) compared to those with lower sales volumes. Resolution rates were significantly higher when pharmacies were located near clinics (OR=3.30, 95% CI=2.3– 4.74) and general hospitals (OR=3.45, 95% CI=2.35– 5.07) compared to those without nearby medical facilities. Additionally, good communication with prescribers increased the resolution rates (OR=1.46, 95% CI=1.26– 1.69). Conclusion: This study examines the influence of pharmacy purchasing power on drug shortages, identifying proximity to healthcare facilities and communication with prescribers as factors affecting the resolution rates. These findings provide valuable insights for pharmacists, policymakers, and future researchers to optimize drug supply chain management and mitigate shortages in community settings. [ABSTRACT FROM AUTHOR]

What is known and objective: Metastatic renal cell carcinoma (mRCC) is the most common type of kidney cancers. Disease‐specific survival for mRCC has been significantly improved with the introduction of new targeted agents since 2005. However, there is a lack of head‐to‐head clinical trials comparing the efficacy between therapies. This study compared indirectly progression‐free survival (PFS) and overall survival (OS) among first‐line and second‐line therapies in patients with mRCC using network meta‐analysis (NMA). Methods: The PubMed, MEDLINE, Cochrane Library and Web of Science were searched to identify phase II or phase III randomized controlled trials (RCTs) of targeted and biological therapies in patients with mRCC published between January 2000 and June 2020. The Bayesian fixed‐effect NMA was performed to evaluate relative PFS and OS of first‐line and second‐line therapies of axitinib, bevacizumab, cabozantinib, everolimus, lenvatinib, nivolumab, ipilimumab, pazopanib, sorafenib, sunitinib, temsirolimus, tivozanib, avelumab and pembrolizumab, which were approved by the Food and Drug Administration or European Medicines Agency. End points were compared using hazard ratio (HR) and 95% credible interval (CrI). The surface under the cumulative ranking curve (SUCRA) was estimated to assess the probability of being the best treatment. Results and discussion: A total of 26 RCTs (first line: 19, second line: 9) with 13 893 patients were included in the NMA. For the first‐line therapy, cabozantinib was associated with the highest improved PFS (HR = 0.26, 95% CrI = 0.14‐0.44) followed by avelumab + axitinib and pembrolizumab + axitinib (HR = 0.27, SUCRA = 90%). Pembrolizumab + axitinib had a high likelihood of being the preferred treatment when using OS as the outcome measure (HR = 0.41, 95% CrI = 0.16‐0.85). Avelumab + axitinib had the lowest HR compared with placebo + interferon on discontinuations due to AE (HR = 1.04, 95% CrI = 0.54‐1.86). For second‐line therapy, cabozantinib was identified as the most effective treatment option when assessing PFS (HR = 0.17, 95% CrI = 0.12‐0.24). Axitinib had the lowest HR of OS and discontinuation due to AE (HR = 0.54, 95% CrI = 0.40‐0.71; HR = 0.98, 95% CrI = 0.42‐1.97, respectively). Pazopanib was the second choice in terms of OS (HR = 0.56, 95% CrI = 0.28‐1.00; SUCRA = 76%) compared with placebo. What is new and conclusion: With respect to PFS and OS improvement, cabozantinib, avelumab + axitinib and pembrolizumab + axitinib are likely to be the preferred options for the first‐line therapy and cabozantinib and axitinib for the second‐line therapy in the management of mRCC. Regarding safety, avelumab + axitinib and temsirolimus were considered preferred treatment options in first‐line and second‐line therapies. More future research is needed to establish subgroup analyses, allowing evaluation of the impact of some of the differences in patient characteristics, including treatment effect modifiers. [ABSTRACT FROM AUTHOR]

Objectives: Hospital utilization and costs of female breast cancer have been well documented. However, evidence focusing on male breast cancer is scarce, despite the different clinical characteristics between female and male breast cancer. We aim to estimate hospital length of stay (LOS) and costs associated with male breast cancer in the United States., Study Design: Retrospective observational study., Methods: We analyzed the 2012-2016 Health Care Utilization Project National Inpatient Sample of 416 hospitalization events of male patients with breast cancer. Patients who had breast cancer diagnoses were selected based on the primary International Classification of Disease, Ninth Revision or Tenth Revision, Clinical Modification codes. A negative binomial regression and a generalized linear model with a gamma distribution and log-link function were conducted to estimate the LOS and hospital costs after controlling for sociodemographics, clinical characteristics (eg, metastatic status, Elixhauser Comorbidity Index [ECI] score), and hospital characteristics., Results: On average, male patients with breast cancer stayed for 2.42 days and expensed $9059 per hospital visit. Patients with metastatic status had longer LOS (5.39 vs 3.24 days; P = .005) and higher hospital costs ($11,185 vs $8547; P = .03) than those without. Patients with an ECI score of 3 or more showed longer LOS (4.05 vs 2.68 days; P = .003) and higher hospital costs ($10,043 vs $7022; P < .001) than those with an ECI score of 0., Conclusions: LOS and hospital costs for male patients with breast cancer were associated with metastatic status and comorbidities. This information can be used to assess the health care resources needed to treat male breast cancer.

Objectives: The purpose of this study was to compare the discontinuation rates of tofacitinib and biologics (tumour necrosis factor inhibitors (TNFi), abatacept, rituximab, and tocilizumab) in rheumatoid arthritis (RA) patients considering inadequate responses (IRs) to previous treatment(s)., Methods: Randomised controlled trials of tofacitinib and biologics - reporting at least one total discontinuation, discontinuation due to lack of efficacy (LOE), and discontinuation due to adverse events (AEs) - were identified through systematic review. The analyses were conducted for patients with IRs to conventional synthetic disease-modifying anti-rheumatic drugs (cDMARDs) and for patients with biologics-IR, separately. Bayesian network meta-analysis was used to estimate rate ratio (RR) of a biologic relative to tofacitinib with 95% credible interval (CrI), and probability of RR being <1 (P[RR<1])., Results: The analyses of 34 studies showed no significant differences in discontinuation rates between tofacitinib and biologics in the cDMARDs-IR group. In the biologics-IR group, however, TNFi (RR 0.17, 95% CrI 0.01-3.61, P[RR<1] 92.0%) and rituximab (RR 0.20, 95% CrI 0.01-2.91, P[RR<1] 92.3%) showed significantly lower total discontinuation rates than tofacitinib did. Despite the difference, discontinuation cases owing to LOE and AEs revealed that tofacitinib was comparable to the biologics., Conclusions: The comparability of discontinuation rate between tofacitinib and biologics was different based on previous treatments and discontinuation reasons: LOE, AEs, and total (due to other reasons). Therefore, those factors need to be considered to decide the optimal treatment strategy.