{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T16:04:23Z","timestamp":1791475463637,"version":"4.3.4"},"reference-count":67,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2023,6,23]],"date-time":"2023-06-23T00:00:00Z","timestamp":1687478400000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,1,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are new therapeutic agents for anaemia in chronic kidney disease (CKD). We evaluated by meta-analysis and meta-regression the efficacy and safety of HIF-PHIs in patients with CKD-related anaemia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We selected phase 3 randomized clinical trials (RCTs) comparing HIF-PHIs and erythropoiesis-stimulating agents (ESAs) in dialysis and non-dialysis patients. Efficacy outcomes were the changes from baseline of haemoglobin, iron parameters (hepcidin, serum iron, TIBC, TSAT, ferritin) and intravenous iron dose; as safety outcomes we considered cancer, adjudicated major adverse cardiovascular events (MACE), MACE+ (MACE plus hospitalization for hearth failure or unstable angina or thromboembolic event), thrombotic events (deep vein thrombosis, pulmonary embolism), arterovenous fistula (AVF) thrombosis and death.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We included 26 RCTs with 24\u00a0387 patients. Random effect meta-analysis of the unstandardized mean difference between HIF-PHIs and ESAs showed a significant change in haemoglobin levels from baseline of 0.10\u00a0g\/dL (95% CI 0.02 to 0.17). Meta-regression analysis showed a significantly higher haemoglobin change for HIF-PHIs in younger patients and versus short-acting ESA (0.21\u00a0g\/dL, 95% CI 0.12 to 0.29 versus \u20130.01, 95% CI \u20130.09 to 0.07 in studies using long-acting ESA, P\u00a0&amp;lt;\u00a0.001). No significant effect on heterogeneity was found for type of HIF-PHIs. In comparison with ESAs, HIF-PHIs induced a significant decline in hepcidin and ferritin and a significant increase in serum iron and TIBC, while TSAT did not change; intravenous iron dose was lower with HIF-PHI (\u20133.1\u00a0mg\/week, 95% CI \u20135.6 to \u20130.6, P\u00a0=\u00a0.020). Rate ratio of cancer (0.93, 95% CI 0.76 to 1.13), MACE (1.00, 95% CI 0.94 to 1.07), MACE+ (1.01, 95% CI 0.95 to 1.06), thrombotic events (1.08, 95% CI 0.84 to 1.38), AVF thrombosis (1.02, 95% CI 0.93 to 1.13) and death (1.02, 95% CI 0.95 to 1.13) did not differ between HIF-PHIs and ESAs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>HIF-PHIs at the doses selected for the comparisons are effective in correcting anaemia in comparison with ESA therapy with a significant impact on iron metabolism without notable difference among various agents. No safety signals emerge with use of HIF-PHIs.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ckj\/sfad143","type":"journal-article","created":{"date-parts":[[2023,6,23]],"date-time":"2023-06-23T01:09:16Z","timestamp":1687482556000},"source":"Crossref","is-referenced-by-count":42,"title":["Efficacy and safety of hypoxia-inducible factor prolyl hydroxylase inhibitors in patients with chronic kidney disease: meta-analysis of phase 3 randomized controlled trials"],"prefix":"10.1093","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5686-2089","authenticated-orcid":false,"given":"Roberto","family":"Minutolo","sequence":"first","affiliation":[{"name":"Nephrology Unit, University of Campania \u201cLuigi Vanvitelli\u201d , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Elena","family":"Liberti","sequence":"additional","affiliation":[{"name":"Nephrology Unit, University of Campania \u201cLuigi Vanvitelli\u201d , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vittorio","family":"Simeon","sequence":"additional","affiliation":[{"name":"Medical Statistic Unit , , Naples , Italy"},{"name":"University of Campania \u201cLuigi Vanvitelli\u201d , , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ferdinando C","family":"Sasso","sequence":"additional","affiliation":[{"name":"Department of Advanced Medical and Surgical Sciences, University of Campania \u201cLuigi Vanvitelli\u201d , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio","family":"Borrelli","sequence":"additional","affiliation":[{"name":"Nephrology Unit, University of Campania \u201cLuigi Vanvitelli\u201d , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8532-0182","authenticated-orcid":false,"given":"Luca","family":"De Nicola","sequence":"additional","affiliation":[{"name":"Nephrology Unit, University of Campania \u201cLuigi Vanvitelli\u201d , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Garofalo","sequence":"additional","affiliation":[{"name":"Nephrology Unit, University of Campania \u201cLuigi Vanvitelli\u201d , Naples , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,6,22]]},"reference":[{"key":"2024020711402100200_bib1","doi-asserted-by":"crossref","first-page":"1501","DOI":"10.1185\/030079904X2763","article-title":"The prevalence of anemia in patients with chronic kidney disease","volume":"20","author":"McClellan","year":"2004","journal-title":"Curr Med Res Opin"},{"key":"2024020711402100200_bib2","doi-asserted-by":"crossref","first-page":"613","DOI":"10.1093\/ckj\/sfz091","article-title":"Anemia and iron deficiency among chronic kidney disease Stages 3-5ND patients in the Chronic Kidney Disease Outcomes and Practice Patterns Study: often unmeasured, variably treated","volume":"13","author":"Wong","year":"2020","journal-title":"Clin Kidney J"},{"key":"2024020711402100200_bib3","doi-asserted-by":"crossref","first-page":"3035","DOI":"10.1093\/ndt\/gft338","article-title":"Anaemia management in non-dialysis chronic kidney disease (CKD) patients: a multicenter prospective study in renal clinics","volume":"28","author":"Minutolo","year":"2013","journal-title":"Nephrol Dial Transplant"},{"key":"2024020711402100200_bib4","doi-asserted-by":"crossref","first-page":"1120","DOI":"10.1093\/ckj\/sfac004","article-title":"New-onset anemia and associated risk of ESKD and death in non-dialysis CKD patients: a multicohort observational study","volume":"15","author":"Minutolo","year":"2022","journal-title":"Clin Kidney J"},{"key":"2024020711402100200_bib5","first-page":"A8","article-title":"US renal data system 2021 annual data report: epidemiology of kidney disease in the United States","volume-title":"Am J Kidney Dis","author":"Johansen","year":"2022"},{"key":"2024020711402100200_bib6","doi-asserted-by":"crossref","first-page":"1631","DOI":"10.1681\/ASN.2011111078","article-title":"Mechanisms of anemia in CKD","volume":"23","author":"Babitt","year":"2012","journal-title":"J Am Soc Nephrol"},{"key":"2024020711402100200_bib7","first-page":"279","article-title":"Kidney Disease: Improving Global Outcomes Anemia Work Group. 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