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• W4366692783 abstract "We thank Donald E Kohan and Hiddo J L Heerspink for their interest in the PRECISION study and their comments regarding the potential for fluid retention and heart failure associated with endothelin receptor antagonists. Indeed, as described in publications from the past few years,1Schlaich MP Bellet M Weber MA et al.Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial.Lancet. 2022; 400: 1927-1937Summary Full Text Full Text PDF PubMed Scopus (23) Google Scholar, 2Verweij P Danaietash P Flamion B Menard J Bellet M Randomized dose-response study of the new dual endothelin receptor antagonist aprocitentan in hypertension.Hypertension. 2020; 75: 956-965Crossref PubMed Scopus (39) Google Scholar there was a dose-dependent effect of aprocitentan on oedema and fluid retention occurring in 9·1% and 18·4% of patients treated with 12·5 mg or 25 mg of aprocitentan per day, respectively (2·1% on placebo). As expected, this was accompanied by reduced haemoglobin concentration and increased plasma volume.1Schlaich MP Bellet M Weber MA et al.Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial.Lancet. 2022; 400: 1927-1937Summary Full Text Full Text PDF PubMed Scopus (23) Google Scholar, 2Verweij P Danaietash P Flamion B Menard J Bellet M Randomized dose-response study of the new dual endothelin receptor antagonist aprocitentan in hypertension.Hypertension. 2020; 75: 956-965Crossref PubMed Scopus (39) Google Scholar However, discontinuation of therapy due to oedema or fluid retention was rare and reported in seven patients on 25 mg of aprocitentan across the entire study period of 48 weeks, even though all 704 patients were on 25 mg of aprocitentan for 32 weeks during the single-blind part 2 of the trial.1Schlaich MP Bellet M Weber MA et al.Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial.Lancet. 2022; 400: 1927-1937Summary Full Text Full Text PDF PubMed Scopus (23) Google Scholar Hospitalisation for heart failure is one possible consequence of fluid retention and occurred in 11 patients during the trial, ten of whom were on aprocitentan 25 mg and one of whom was on placebo for a respective exposure of 550·8 and 85·5 subject-years, per study design. In this context it is noteworthy that all these 11 patients had clinical features associated with a higher likelihood for adverse events: all 11 had diabetes, six had chronic kidney disease stage 3–4, and five had pre-existing heart failure. Two of these 11 patients had to be discontinued, ten of 11 were on 10 mg of amlodipine as part of the background single pill therapy, and, importantly, six of 11 were on higher doses or additional diuretics (loop diuretics or spironolactone, or both) before being switched to the protocol mandated single pill background medication consisting of valsartan, amlodipine, and hydrochlorothiazide, the latter at a maximum dose of 25 mg per day. In a clinical (non-trial) scenario, additional diuretic therapy would usually not have been discontinued before adding another medication. Although we believe that our conclusion that aprocitentan is well tolerated is justified, we agree that clinical judgement and assessment for the potential for adverse consequences of fluid retention (particularly in patients who are highly susceptible to fluid retention, including people with diabetes, chronic kidney disease, and pre-existing heart failure) is important. Using adequate, effective diuretic therapy with agents such as indapamide or chlortalidone when prescribing aprocitentan should be considered. Initiating therapy with the lower dose of 12·5 mg aprocitentan and monitoring fluid retention, which usually occurs in the first 4 weeks of treatment, particularly in clinically vulnerable cohorts, also seems a very reasonable clinical approach when considering aprocitentan. MPS has received institutional grants or contracts and personal consulting fees from Medtronic, Abbott Laboratories, and ReCor Medical; personal payment or honoraria from Medtronic, Abbott Laboratories, Merck, and Servier Laboratories; and personal support for attending meetings, travel, or both from Medtronic and Abbott Laboratories. MPS serves as the President of Hypertension Australia. MB is an employee of Idorsia Pharmaceuticals. MAW has received consulting fees or performed research services for Janssen, Bristol Myers Squibb, CinCor, Medtronic, ReCor, and Ablative Solutions. GLB has received consulting fees from Bayer, KBP BioSciences, Ionis Pharmaceuticals, Alnylam Pharmaceuticals, AstraZeneca, Quantum Genomics, Novo Nordisk, Janssen, Dia Medica Therapeutics, and InREGEN. J-GW declares no competing interests. Fluid retention and heart failure in the PRECISION trialWe congratulate Markus P Schlaich and colleagues on the PRECISION trial showing that aprocitentan, an endothelin receptor antagonist, lowered blood pressure more than placebo in patients with resistant hypertension.1 However, we urge caution in accepting the authors’ conclusion that aprocitentan was well tolerated. Full-Text PDF Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trialIn patients with resistant hypertension, aprocitentan was well tolerated and superior to placebo in lowering blood pressure at week 4 with a sustained effect at week 40. Full-Text PDF" @default.
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• W4366692783 date "2023-04-01" @default.
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• W4366692783 title "Fluid retention and heart failure in the PRECISION trial – Authors' reply" @default.
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