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A Second Opinion: Untangling and Understanding the Implications of Roxadustat's MACE Results from 5/9/19Ticker(s): FGEN, AZN, AKBA
Name: Dr Richard Hellman - MD
Institution: Indiana University
- Emeritus Associate Professor of Clinical Medicine, Division of Nephrology at Indiana University.
- Attends on Renal Services 12-18 weeks per year.
- Investigator in multiple CKD clinical trials including epoetin alfa and darbepoetin alfa.
What is your initial reaction to the MACE Analysis release on 5/9/19?Added By: joe_mccann
Is the annual
reduction in eGFR decline versus placebo in NDD (1.62 mL/min/1.73m2 reduction, or 38% reduction vs placebo) clinically meaningful? How does this
factor into your risk/benefit analysis for NDD patients?
How does the MACE/MACE+
hazard ratio (HR) point estimate versus upper bound of the 95% CI factor into
your risk/benefit analysis? For example, do you think roxa will get wide use in
NDD if the HR is between 1.0-1.1 but the upper bound of the 95% CI is less than
1.3 (assuming no black box for CV events)?
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