What’s New in the Patient Safety World

May 2009 Erythropoiesis-Stimulating Agents and Mortality

Sometimes certain practices get incorporated into clinical practice without a solid evidence base. Only years later do we recognize that such practices may actually be harming patients. Erythropoiesis-stimulating agents are a prime example. The evidence base for using these agents in some conditions has been surprisingly weak. Yet they have become a mainstay in treatment of chronic kidney disease and chemotherapy-associated anemia. In the previous section we noted how some conflicts of interest may lead to excessive or unnecessary use of certain products. Well, economic incentives to providers have played a huge role in not only using erythropoiesis-stimulating agents in many conditions but also in using them in higher and higher doses. Direct-to-consumer advertising undoubtedly has also played a role in promoting their use.

Only in the last couple years did the possibility of an adverse effect of these agents on mortality become apparent. The practice of aiming for higher target hemoglobin levels came under fire when it was demonstrated that mortality was higher in groups randomized to higher hemoglobin targets (Phrommintikul et al 2007). Now a new meta-analysis of randomized controlled trials of erythropoiesis-stimulating agents in cancer patients (Bohlius et al 2009) has demonstrated higher mortality in those treated with erythropoiesis-stimulating agents and transfusions compared to those treated with transfusions alone. The higher mortality rates were seen in cancer patients whether or not they were being treated with chemotherapy and was seen across a variety of cancers and cancer treatments. The mortality rates were higher during the active treatment period and overall survival was also affected.

Admittedly, there may be benefits of such agents on quality of life. But we need to make sure we appropriately weigh those potential benefits against the risks.

And, again, the lesson here is that continued surveillance is needed long after initial FDA approval of drugs and devices. The failure of our system to effectively carry out that surveillance has often led to adverse outcomes for our patients and contributed to the rapidly rising costs of healthcare in our current system.

References:

Phrommintikul A, SJ, M, Krum H. Mortality and target haemoglobin concentrations in anaemic patients with chronic kidney disease treated with erythropoietin: a meta-analysis. The Lancet 2007; 369: 381 - 388

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)60194-9/abstract

Bohlius J, Schmidlin K, Brillant C, et al. Recombinant human erythropoiesis-stimulating agents and mortality in patients with cancer: a meta-analysis of randomised trials. The Lancet 2009; 373: 1532 - 1542

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(09)60502-X/abstract

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