UPDATE:
On April 6, 2021 Fibrogen announced that the analysis of the cardiovascular outcomes was adjusted after the data was unblinded. When the data was reanalyzed without this adjustment roxadustat is less impactful. Importantly for this NephJC discussion, the previously impressive MACE and MACE+ advantage for incident dialysis is no longer found. Roxadustat remains non-inferior in all outcomes, though the confidence intervals have widened.
Episode 033: Swap and Joel discuss the statistical shenanigans with Dr. Daniel Coyne
The Filtrate:
Joel Topf
Swapnil Hiremath
And a special guest:
Daniel Coyne Lead author of the ANDES Trial and anemia rock star.
Show Notes:
NephJC coverage of these two roxadustat trials.
The Fibrogen press release: http://www.globenewswire.com/en/news-release/2021/04/06/2205376/33525/en/FibroGen-Provides-Additional-Information-on-Roxadustat.html
Best coverage of the Fibrogen bombshell: https://www.fiercepharma.com/pharma/fibrogen-admits-to-messing-safety-data-for-anemia-drug-roxadustat-as-analysts-dramatically
Lessons learned from the EVOLVE Trial: https://cjasn.asnjournals.org/content/11/3/539
The PIVOTAL Trial (NephJC coverage): http://www.nephjc.com/news/pivotal