Original Research
Tuesday, November 14, 2023
08:30 AM–10:00 AM
Abstract
Introduction: Erythropoiesis-stimulating agents (ESAs) targeting hemoglobin levels >11 g/dL increase mortality and serious adverse events without clinical benefit. Thus, the FDA changed hemoglobin targets for ESAs from "10-12" to "10-11". To maintain hemoglobin levels, a pharmacist-monitored ESA prescribing and monitoring protocol was created.
Research Question or Hypothesis: Will the ESA protocol reduce venous thromboembolism (VTE), maintain hemoglobin levels, and lower ESA costs in adults with chronic kidney disease (CKD)?
Study Design: A single-center case-crossover study
Methods: The study included adults with CKD who received epoetin for at least six months and had their orders renewed after the protocol was implemented. Cancer patients were excluded because their hemoglobin target was lower. The study compared patient outcomes six months before and after the protocol. The development of VTE during the study period was the primary endpoint. Secondary outcomes included VTE-related mortality, any hemoglobin concentration >11.3 or <9, and the mean epoetin cost per patient. The McNemar's test was used to compare the rate of VTE, mortality, and hemoglobin levels outside targets, while the paired t-test was used to compare costs. For statistical test comparisons, a two-sided p value of 0.05 was used to define statistical significance, and IBM SPSS Statistics software version 26 was used.
Results: The inclusion criteria were met by 61 patients. Fifteen (25%) VTE occurred before and one (1.6%) after the protocol was initiated [p<0.001], one VTE-related death occurred before and none after, and 62% of patients had hemoglobin >11.3 before and 30% after [p<0.001], 36% had hemoglobin <9 before and 45% after [p=0.319]. The mean±SD hemoglobin pre-protocol was 10.27±1.57 and 10.02±1.44 after [p=0.181]. The six-month cost of epoetin per patient was US $526 before and $503 after [p=0.842].
Conclusion: In this study, the ESA protocol reduced VTE and helped maintain hemoglobin levels within the target range in CKD adult patients, but it did not lower the epoetin cost.
Presenting Author
Sulaiman A Al-Zubairy PharmD, MBA, BCPS, BCOP, SIDP, LSSGBJohns Hopkins Aramco Healthcare
Authors
Maha Islami PharmD
King Abdulaziz University