MedicalResearch.com Interview with:
Dennis J. Cotter
Medical Technology and Practice Patterns Institute, Inc.
Bethesda, MD 20816
Medical Research: What are the main findings of the study?
Answer: This is the first study to document anemia management practice patterns among predialysis CKD patients before and after publication of TREAT. Using a retrospective observational design based on a large US health plan database with over 1.2 million claims for predialysis CKD stage 3 and 4 patients, we report 4 main study findings.
1) For CKD stage 3 patients, the proportion prescribed ESA therapy declined from 17% pre-TREAT to 11% post-TREAT (a 38% decline) and for CKD stage 4 patients, from 34% to 27% (a 22% decline).
2) Prescribing of ESA therapy was declining even before TREAT, but the decline accelerated in the post-TREAT period.
3) ESA prescribing declined after TREAT regardless of anemia status; among patients with hemoglobin <10 g/dL, only 25% of stage 3 and 33% of stage 4 CKD were prescribed ESAs two years after TREAT, a notable 50% decline.
4) After adjusting for all covariates, the probability of prescribing ESAs was 35% less during a two year period after vs. before TREAT publication.
Medical Research: Were any of the findings unexpected?
Answer: Our finding that cancer patients were 42% more likely to receive ESA therapy compared to noncancer patients both before and after TREAT was unanticipated given the stringent restrictions on ESA use among cancer patients.
We speculate that:
1) Cancer CKD patients have more severe anemia compared to their noncancer counterparts; and
2) Use of CKD diagnoses by oncologists were perhaps used to justify ESA therapy given that CMS restricted ESA reimbursement for cancer patients in 2007. After this time oncologists had a marked increase in prescribing ESA using the CKD diagnoses, and marked decrease in using their previously acceptable cancer diagnoses.
Medical Research What should clinicians and patients take away from your report?
Answer: We conclude by saying, “Several clinical trials have raised important safety concerns regarding ESA therapy among the CKD population. The most recent trial – the TREAT study – appears to have accelerated the previous decline in physician prescribing of ESAs among stage 3 and 4 CKD patients.” In other words, the physicians observed in our study appeared to be influenced by the TREAT authors who concluded that the risk of using ESA in CKD patients with moderate anemia who were not undergoing dialysis “will outweigh the potential benefits.”
Medical Research What recommendations do you have for future research as a result of this study?
Answer: Previous publications have indicated limited change in physician practice following the publication of clinical trial findings, yet we found that TREAT resulted in significant declines in ESA dosing. Perhaps future research could determine why trials like TREAT vs. other clinical findings make a difference in clinical practice. For example, an FDA meeting highlighting TREAT results after publication may have contributed to the dissemination and implementation of TREAT recommendations.
Erythropoiesis-Stimulating Agent Use Among Non–Dialysis-Dependent CKD Patients Before and After the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT) Using a Large US Health Plan Database