key: cord-0048283-w6rnq1lm
authors: nan
title: Department of Error
date: 2020-07-30
journal: Lancet
DOI: 10.1016/s0140-6736(20)31646-9
sha: 7318f998b3b251d5cc26734014e15e104d0d0fdc
doc_id: 48283
cord_uid: w6rnq1lm

nan

www.thelancet.com Vol 396 August 1, 2020 in blood pressure; however, enabling the safer use of spironolactone was the necessary first step towards designing an outcomes trial. The ongoing DIAMOND (NCT03888066) randomised trial builds on our findings. The trial of nearly 2400 study participants will examine the safety and efficacy of patiromer enablement of spironolactone for cardiovascular death or hospitalisation. DIAMOND will definitively answer the important question regarding costs and benefits of patiromer therapy to enable spiro nolactone use in patients at a high risk of cardiovascular events. with a declared adverse event of hyperkalaemia or increased blood potassium.

The number needed to treat for patiromer to enable one patient remaining on spironolactone for 12 weeks was 5 (95% CI 3-10). 1 The small number needed to treat supports the use of patiromer to maintain spironolactone use because without patiromer, the risk of stopping spironolactone in this group at high risk of hyperkalaemia with advanced chronic kidney disease was one in three over 12 weeks. 1 Four (3%) of 148 patients in the placebo group and six (4%) of 147 patients in the patiromer group had a serum potassium concentra tion lower than 3·8 mmol/L (in one patient in the patiromer group, the serum potassium concentration was less than 3·5 mmol/L but at least ≥3·0 mmol/L). One patient in the patiromer group and one patient in the placebo group had to discon tinue the treatment early becaues of low serum potassium concentration, as detailed in the supplementary information. 1 Thus, the overwhelming evidence shows that patiromer substantially reduces the occurrence of hyper kalaemia in these patients and does not provoke hypokalaemia. Hence, we do not believe that O'Sullivan and MacIntyre's description of the left side of the Ushaped 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 halflives 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 figure 5 were incorrectly labelled. These corrections have made to the online version as of July 30, 2020, and the printed version is correct.

Variations between women and men in risk factors, treatments, cardiovascular disease incidence, and death in 27 high-income, middleincome, and low-income countries (PURE): a prospective cohort study. Lancet 2020; 396: 97-109-In this Article the

Patiromer versus placebo to enable spironolactone use in patients with resistant hypertension and chronic kidney disease (AMBER): a phase 2, randomised, double blind, placebocontrolled trial

Patiromer to enable spironolactone use in the treatment of patients with resistant hypertension and chronic kidney disease: rationale and design of the AMBER Study

Acknowledgments section has been added. This correction has been made to the online version as of July 30, 2020.