VIDEO: Treatment approaches for high risk patients with anemia, CKD

Editor’s note: This is a previously posted video, and the below is an automatically generated transcript to be used for informational purposes. Please notify editor@healio.com if there are concerns regarding accuracy of the transcription.

The major risk for patients with chronic kidney disease both before they're on dialysis and once they're on dialysis is cardiovascular disease. A patient with stage three chronic kidney disease is 10 times more likely to die of a cardiovascular complication than they are to survive to needing dialysis. Patient with stage four CKD has a 50-50 chance of dying of a cardiovascular complication prior to requiring dialysis. And of course, among dialysis patients, cardiovascular disease, meaning myocardial infarction, heart failure and stroke are overwhelmingly the leading cause of morbidity and mortality. So when we're talking about high risk, primarily we're talking about high risk for cardiovascular disease. So our approach to these patients really should be cardiovascular risk reduction, just like we do for patients without chronic kidney disease. So it means watching their diet, keeping their weight under control, regular exercise.

For non-dialysis patients, reduction in cholesterol also is beneficial though it may be not so much in dialysis patients, smoking cessation. All those things that we would do in a non-CKD population are clearly a benefit in terms of reducing the risk among patients on dialysis. Now, the role of anemia there is somewhat controversial, because the large randomized controlled trials were actually designed in an attempt to demonstrate a decrease in cardiovascular risk of morbidity and mortality, what we call MACE outcomes, major adverse cardiovascular events. When patients were treated to a higher close to normal hemoglobin level of 13 or so, versus the conventional target for CKD patients, which is somewhere in the 10 1/2 to 11 range, none of the studies demonstrated a cardiovascular risk reduction in treating patients to higher hemoglobin levels. In fact, three of the four studies actually demonstrated a increase in risk of cardiovascular events when patients were treated to higher target hemoglobin levels. The CHOIR study in 2006 showed an increase in composite cardiovascular outcomes of almost 40%, and the TREAT study in 2009, which was done in type two diabetic patients, showed almost a twofold increase in stroke among patients treated to higher hemoglobin levels. So treating to higher hemoglobin levels does not seem to lead to cardiovascular risk reduction, at least with our current treatment, which includes ESAs and iron.

Now, the question is, will a new agent decrease that risk? Will new agents show that higher hemoglobin levels lead to improved cardiovascular outcomes versus the conventional hemoglobin levels? And the answer is we don't know yet, because all of the Phase 3 studies that have been done with these newer agents have been done to the conventional target hemoglobin levels between 10 and 12. So the question is if eventually these drugs are approved and patients do not demonstrate cardiovascular risk reduction with these agents at those levels of hemoglobin, would we have a new round of higher hemoglobin target studies to see if that's effective? I'm skeptical that that will ever happen. So I think for the time being, we need to be satisfied that treating patients with anemia to the 10 to 11 range is probably beneficial. We don't know for sure, because there really aren't any placebo-controlled trials that fail to treat patients to those levels and compare their cardiovascular risk. And we don't really know with regards to the newer agents because they really haven't been tested in large populations. Now, the other question is quality of life. How does treatment of anemia patients with chronic kidney disease affect quality of life, and are the patients at high risk because of poor quality of life? They can't exercise, they can't engage in the kinds of cardiovascular risk reduction activities that we like to recommend. And the answer is again, there's very little data showing that quality of life is improved sufficiently with the ESAs treating patients to conventional hemoglobin targets that improves quality of life sufficiently to decrease cardiovascular risk.