Individual patient risk assessment and cost–benefit analysis of patiromer in AMBER – Authors' reply

[...]we do not believe that O'Sullivan and MacIntyre's description of the left side of the U-shaped curve is relevant to the findings of our study. The change in systolic blood pressure from baseline to 12 weeks was a secondary endpoint in AMBER.1 We have proposed that our finding of unant...

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Veröffentlicht in:The Lancet (British edition) 2020-08, Vol.396 (10247), p.311-312
Hauptverfasser: Agarwal, Rajiv, Rossignol, Patrick, White, William B, Williams, Bryan
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container_title The Lancet (British edition)
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creator Agarwal, Rajiv
Rossignol, Patrick
White, William B
Williams, Bryan
description [...]we do not believe that O'Sullivan and MacIntyre's description of the left side of the U-shaped curve is relevant to the findings of our study. The change in systolic blood pressure from baseline to 12 weeks was a secondary endpoint in AMBER.1 We have proposed that our finding of unanticipatedly long half-lives of biologically active spironolactone metabolites in patients with chronic kidney disease explains why blood pressure remained lower in the placebo group for several weeks after discontinuation of spironolactone.2 But we do agree with O'Sullivan and MacIntyre that systolic blood pressure is a clinically relevant endpoint, and a longer study would have been more desirable to show differences in blood pressure; however, enabling the safer use of spironolactone was the necessary first step towards designing an outcomes trial. RA reports personal fees from AbbVie, Akebia, Amgen, AstraZeneca, Bayer, Birdrock Bio, Boehringer Ingelheim, Celgene, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Ironwood Pharmaceuticals, Johnson & Johnson, Merck, Novartis, Opko, Otsuka, Reata, Relypsa, Sandoz, Sanofi, Takeda, and ZS Pharma, unrelated to this Correspondence; has served as associate editor of the American Journal of Nephrology, Nephrology Dialysis and Transplantation, is an author of UpToDate; and has received research grants from the US Veterans Administration and the National Institutes of Health.
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subjects Biological activity
Blood pressure
Correspondence
Cost benefit analysis
Dialysis
Kidney diseases
Metabolites
Nephrology
Patients
Pharmaceuticals
Potassium
Risk assessment
Transplantation
title Individual patient risk assessment and cost–benefit analysis of patiromer in AMBER – Authors' reply
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