Was Amgen's New Anemia Study a Trick or TREAT?

It may be a little early to start thinking about Halloween. But Labor Day, the unofficial end of summer is upon us and Amgen's recently reported study has gotten me in the mood.

So, was Amgen's latest study a trick or a TREAT (Trial to Reduce cardiovascular Endpoints with Aranesp Therapy)?

Apparently the answer is neither. Aranesp did not benefit, nor did it hurt the cardiovascular health of CKD patients with anemia and type 2 diabetes.

This was a well designed randomized double-blind placebo based study of more than 4000 CKD patients making it the largest ESA-CKD study to date.

The study had 2 endpoints:

1) Deaths from any cause or cardiovascular morbidity (CHF, Acute MI, Stroke, hospitalization for myocardial ischemia)

2) Time until death or renal replacement therapy

Patients in the study received Aranesp to a goal hemoglobin of 13 g/dL or placebo. If the Hb dipped below 9 mg/dL patients received Aranesp to keep from not falling too far.

The conclusion: no statistically significant effect on either of two primary endpoints compared with placebo treatment. There was a however, an increase in strokes within the Aranesp group.

Amgen spoke of the trial in a press release with more details to follow. I would like to see the rest of the data and would like to know if there was a quality of life (QoL) assessment analysis. For now it seems the recommendation of keeping the target between 10-12 g/dL is prudent. There was a higher incidence of stroke and no benefit mentioned reaching for a goal hemoglobin of 13 g/dL (?QoL).