A nicely balanced and well written editorial by Drs. Tayek and Kalantar-Zadeh in the American Journal of Nephrology [available full text] provides a closure to the Bardoxolone study. Here is a quote from the paper:"The valuable lesson is that the enthusiasm and hope for ultimate cure of diabetic nephropathy should not cloud our judgment when designing and conducting future trials, or similar negative outcomes can be observed with any trial where the investigator chose to ignore the prior signs and loud warnings [20]."
The two points that they make are that the rise in GFR observed in the BEAM study could have been because of erroneous calculation of GFR (fall in creatinine because of weight loss) and the vasodilatory prostaglandin-like effects of bardoxolone, which structurally resembles the renal vasodilatory cyclopentenone prostaglandins.
The two points that they make are that the rise in GFR observed in the BEAM study could have been because of erroneous calculation of GFR (fall in creatinine because of weight loss) and the vasodilatory prostaglandin-like effects of bardoxolone, which structurally resembles the renal vasodilatory cyclopentenone prostaglandins.
Is it known why NEJM published Phase II in the first place?
ReplyDeleteClosure from an editorial? Really?
ReplyDeletein Table 1 they state that the weight loss may lead to a drop in the creatinine leading to erroneously estimated LOW eGFR. They get it right in the text though
ReplyDeleteThis article was written by a real thinking writer. I agree many of the with the solid points made by the writer. I’ll be back.
ReplyDelete