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Background/aimsThe objective of this study was to examine health care costs and utilization and the risks of dialysis or mortality among diabetic predialysis chronic kidney disease (CKD) patients with and without secondary hyperparathyroidism (SHPT).MethodsThis retrospective, matched cohort study examined insurance claims from 703 adult diabetic predialysis CKD patients with and without SHPT during a 72-month follow-up period. Annualized estimates of health care service utilization, costs and disease progression to dialysis or death following index CKD diagnosis were compared.ResultsPreindex (baseline) characteristics were similar between the cohorts. Postindex numbers of prescription utilization, outpatient service utilization and hospitalizations were all higher (p < 0.0001) in diabetic CKD patients with SHPT compared to those without SPHT in both unadjusted and adjusted analyses even after multivariate adjustment for known confounders. The rate of progression to dialysis or death was higher for diabetic CKD patients with SHPT compared to those without SPHT. Those with SHPT were at higher risk of requiring dialysis treatment [hazard ratio (HR) = 6.7; 95% confidence interval (CI) = 4.3-10.6] and death (HR = 2.3; 95% CI = 1.1-4.9) compared to those without SHPT.ConclusionIn diabetic predialysis CKD patients, the presence of SHPT is associated with significantly greater health care resource utilization and costs, and a faster rate of disease progression.

Background and objectivesSecondary hyperparathyroidism (SHPT) can lead to significant morbidity, mortality, and additional healthcare resource utilization in chronic kidney disease (CKD) stage 5. The objective of this study was to examine healthcare costs and utilization, and the risks of dialysis or mortality, among pre-dialysis CKD patients with and without SHPT.Research design and methodsThis retrospective cohort study examined insurance claims from 66 644 adult, pre-dialysis, CKD patients with and without SHPT during a 72-month period. Annualized estimates of healthcare costs and utilization, and disease progression to dialysis or death following index CKD diagnosis were compared.ResultsPost-index annualized costs and inpatient healthcare resource utilization was higher in those with SHPT in both unadjusted and adjusted (controlling for gender, age, plan type, payer type, geographic region, physician specialty, pre-index co-morbidities, and pre-index total healthcare costs), and unmatched and matched analyses. Kaplan-Meier analysis demonstrated that the rate of progression to dialysis or death was higher for CKD with SHPT compared to CKD without SHPT, and Cox proportional hazard models suggested that CKD patients with SHPT were more than four to five times as likely to initiate dialysis or die as compared to CKD without SHPT.ConclusionSHPT in pre-dialysis CKD patients is associated with significantly greater healthcare costs, inpatient hospitalizations, and a faster rate of disease progression compared to pre-dialysis CKD without SHPT. Since observational studies are designed to demonstrate associations rather than causality, further investigation is required to confirm these findings.

Purpose: To describe medication adherence and persistence of HIV PrEP overall and compare between sex and age groups of commercially insured individuals in the United States. Methods: We conducted a national retrospective cohort study of the Merative MarketScan Claims Database from 2011 to 2019 to describe adherence and persistence of PrEP overall and compared between sex and age groups. High adherence was defined as ≥80% of proportion of days covered and persistence was measured in days from initiation to the first day of a 60‐day treatment gap. Results: A total of 29 689 new PrEP users identified. Overall adherence was high (81.9%; 95% confidence interval [CI]: 81.5%–82.3%). Females were more adherent than males (adjusted odds ratio [aOR] 1.87; 95% CI: 1.50–2.34), while those ≥45‐years were less adherent than individuals <45‐years (aOR 0.87: 95% CI: 0.81–0.93). More than half of individuals discontinued therapy within the first year (median 238.0 days; interquartile range 99.0–507.0 days). Females were less persistent than males (hazard ratio [HR] 1.49; 95% CI: 1.34–1.65), and people ≥45‐years old were more persistent (i.e., lower risk of discontinuation) than those <45‐years (HR 0.43; 95% CI: 0.33–0.55). Conclusions: These findings show adherence to daily PrEP is high among commercially insured individuals but the majority still discontinue in the first year. Future research should investigate what factors influence PrEP discontinuation among this population and ways to reduce barriers to therapy maintenance to ensure the population‐level benefits of PrEP treatment. [ABSTRACT FROM AUTHOR]

A study was conducted to evaluate the structure, operations, and preliminary findings from the Research on Adverse Drug events And Reports (RADAR) project and related dissemination efforts by pharmaceutical suppliers and the US Food and Drug Administration. The result showed that a new, clinically based, hypothesis-driven approach to postmarketing surveillance may supplement existing regulatory surveillance and improve patients safety.

Reports of epoetin-associated pure red-cell aplasia from the Food and Drug Administration (FDA) and from the manufacturers of Eprex, Epogen and Neorecormon were obtained and analyzed. The results indicate a reduction of more than 80 percent in the incidence of pure red-cell aplasia due to Eprex.