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Individualized anemia management enhanced by ferric pyrophosphate citrate protocol
The optimal use of erythropoiesis-stimulating agents (ESAs) and parenteral iron in managing anemia in end-stage renal disease (ESRD) remains controversial. One-size-fits-all rule-based algorithms dominate dosing protocols for ESA and parenteral iron. However, the Food & Drug Administration (FDA)...
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Published in: | Scientific reports 2022-11, Vol.12 (1), p.20122-20122, Article 20122 |
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description | The optimal use of erythropoiesis-stimulating agents (ESAs) and parenteral iron in managing anemia in end-stage renal disease (ESRD) remains controversial. One-size-fits-all rule-based algorithms dominate dosing protocols for ESA and parenteral iron. However, the Food & Drug Administration (FDA) guidelines for using ESAs in chronic kidney disease recommend individualized therapy for the patient. This prospective quality assurance project was at a single hemodialysis (HD) center comprising three 6-month phases (A, B, C) separated by 3-month washout periods. Standard bi-weekly ESA dose titration and intravenous (IV) iron sucrose protocols were used in baseline Phase A, and ferric pyrophosphate citrate (FPC) augmented iron in Phase B. In Phase C, an FPC protocol and weekly, individualized ESA management were used. We examined clinic-level mean differences in hemoglobin (Hb) and ESRD-related outcomes by phase with repeated ANOVA. To examine the Hb at the patient level, we used multi-level mixed-effect regression adjusting for phase, month, and other relevant confounders at each month over time to derive the mean marginal effects of phase. There were 54, 78, and 66 patients in phases A, B, and C, respectively, with raw mean Hb values of 9.9, 10.2, and 10.3 g/dL. The percentage of Hb values |
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One-size-fits-all rule-based algorithms dominate dosing protocols for ESA and parenteral iron. However, the Food & Drug Administration (FDA) guidelines for using ESAs in chronic kidney disease recommend individualized therapy for the patient. This prospective quality assurance project was at a single hemodialysis (HD) center comprising three 6-month phases (A, B, C) separated by 3-month washout periods. Standard bi-weekly ESA dose titration and intravenous (IV) iron sucrose protocols were used in baseline Phase A, and ferric pyrophosphate citrate (FPC) augmented iron in Phase B. In Phase C, an FPC protocol and weekly, individualized ESA management were used. We examined clinic-level mean differences in hemoglobin (Hb) and ESRD-related outcomes by phase with repeated ANOVA. To examine the Hb at the patient level, we used multi-level mixed-effect regression adjusting for phase, month, and other relevant confounders at each month over time to derive the mean marginal effects of phase. There were 54, 78, and 66 patients in phases A, B, and C, respectively, with raw mean Hb values of 9.9, 10.2, and 10.3 g/dL. The percentage of Hb values < 9 g/dL declined from 14.3% in Phase A to 7.6% in Phase C (p = 0.007). The multivariable mixed-effect regression results showed mean marginal Hb was higher by 0.3 mg/dL and 0.4 mg/dL in Phases B and C, respectively, compared to Phase A. We also observed reduced ferritin (p = 0.003) and transferrin saturation (TSAT) (p = 0.008) levels from Phase A to Phase C with the repeated ANOVA analysis. Ferric pyrophosphate citrate (FPC) appears to support more efficient ESA-stimulated erythropoiesis. Moreover, individualized ESA management combined with FPC (Phase C) was associated with further improvement in efficiency as we observed the fewest patients with Hb values < 9 g/dL concurrent with greater decreases in ferritin levels and reduced ESA doses. However, future prospective studies to confirm these findings on a larger, more diverse cohort of ESRD patients are warranted.</description><identifier>ISSN: 2045-2322</identifier><identifier>EISSN: 2045-2322</identifier><identifier>DOI: 10.1038/s41598-022-23262-1</identifier><identifier>PMID: 36418453</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>692/308 ; 692/4022 ; Anemia - complications ; Anemia - etiology ; Citrates - therapeutic use ; Ferritins ; Hematinics - therapeutic use ; Hemoglobins - metabolism ; Humanities and Social Sciences ; Humans ; Iron - metabolism ; Kidney Failure, Chronic - drug therapy ; Kidney Failure, Chronic - therapy ; multidisciplinary ; Prospective Studies ; Science ; Science (multidisciplinary)</subject><ispartof>Scientific reports, 2022-11, Vol.12 (1), p.20122-20122, Article 20122</ispartof><rights>The Author(s) 2022</rights><rights>2022. The Author(s).</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c512t-32285072815b3c9d73676f9b7e646e767d19c4d1a3954bee082fd1c43c730183</citedby><cites>FETCH-LOGICAL-c512t-32285072815b3c9d73676f9b7e646e767d19c4d1a3954bee082fd1c43c730183</cites><orcidid>0000-0002-6581-8124</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9684411/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9684411/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,36990,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36418453$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chait, Yossi</creatorcontrib><creatorcontrib>Nathanson, Brian H.</creatorcontrib><creatorcontrib>Germain, Michael J.</creatorcontrib><title>Individualized anemia management enhanced by ferric pyrophosphate citrate protocol</title><title>Scientific reports</title><addtitle>Sci Rep</addtitle><addtitle>Sci Rep</addtitle><description>The optimal use of erythropoiesis-stimulating agents (ESAs) and parenteral iron in managing anemia in end-stage renal disease (ESRD) remains controversial. One-size-fits-all rule-based algorithms dominate dosing protocols for ESA and parenteral iron. However, the Food & Drug Administration (FDA) guidelines for using ESAs in chronic kidney disease recommend individualized therapy for the patient. This prospective quality assurance project was at a single hemodialysis (HD) center comprising three 6-month phases (A, B, C) separated by 3-month washout periods. Standard bi-weekly ESA dose titration and intravenous (IV) iron sucrose protocols were used in baseline Phase A, and ferric pyrophosphate citrate (FPC) augmented iron in Phase B. In Phase C, an FPC protocol and weekly, individualized ESA management were used. We examined clinic-level mean differences in hemoglobin (Hb) and ESRD-related outcomes by phase with repeated ANOVA. To examine the Hb at the patient level, we used multi-level mixed-effect regression adjusting for phase, month, and other relevant confounders at each month over time to derive the mean marginal effects of phase. There were 54, 78, and 66 patients in phases A, B, and C, respectively, with raw mean Hb values of 9.9, 10.2, and 10.3 g/dL. The percentage of Hb values < 9 g/dL declined from 14.3% in Phase A to 7.6% in Phase C (p = 0.007). The multivariable mixed-effect regression results showed mean marginal Hb was higher by 0.3 mg/dL and 0.4 mg/dL in Phases B and C, respectively, compared to Phase A. We also observed reduced ferritin (p = 0.003) and transferrin saturation (TSAT) (p = 0.008) levels from Phase A to Phase C with the repeated ANOVA analysis. Ferric pyrophosphate citrate (FPC) appears to support more efficient ESA-stimulated erythropoiesis. Moreover, individualized ESA management combined with FPC (Phase C) was associated with further improvement in efficiency as we observed the fewest patients with Hb values < 9 g/dL concurrent with greater decreases in ferritin levels and reduced ESA doses. However, future prospective studies to confirm these findings on a larger, more diverse cohort of ESRD patients are warranted.</description><subject>692/308</subject><subject>692/4022</subject><subject>Anemia - complications</subject><subject>Anemia - etiology</subject><subject>Citrates - therapeutic use</subject><subject>Ferritins</subject><subject>Hematinics - therapeutic use</subject><subject>Hemoglobins - metabolism</subject><subject>Humanities and Social Sciences</subject><subject>Humans</subject><subject>Iron - metabolism</subject><subject>Kidney Failure, Chronic - drug therapy</subject><subject>Kidney Failure, Chronic - therapy</subject><subject>multidisciplinary</subject><subject>Prospective Studies</subject><subject>Science</subject><subject>Science (multidisciplinary)</subject><issn>2045-2322</issn><issn>2045-2322</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>DOA</sourceid><recordid>eNp9kU1r3DAQhk1oSUKaP9BD8LEXN_qyPi6FEvqxECiU3IUsjXa12JYj2YHtr482TkJyqS4jad55NJq3qj5j9BUjKq8zw62SDSKkIZRw0uCT6pwg1h6P5MOb_Vl1mfMeldUSxbA6rc4oZ1iylp5XfzejCw_BLaYP_8DVZoQhmHowo9nCAONcw7gzoy2p7lB7SCnYejqkOO1innZmhtqGOR3jlOIcbew_VR-96TNcPseL6u7nj7ub383tn1-bm--3jW0xmZvSmWyRIBK3HbXKCcoF96oTwBkHwYXDyjKHDVUt6wCQJN5hy6gVFGFJL6rNinXR7PWUwmDSQUcT9NNFTFtt0hxsD5p2HhAQz5X0TPjWYMI7I53xkuCOQmF9W1nT0g3gbPl3Mv076PvMGHZ6Gx-04pIxjAvgyzMgxfsF8qyHkC30fZlnXLImgirBGCW0SMkqtSnmnMC_PoORPlqrV2t1sVY_WauP_Ku3Db6WvBhZBHQV5JIat5D0Pi5pLPP_H_YROhWwNg</recordid><startdate>20221122</startdate><enddate>20221122</enddate><creator>Chait, Yossi</creator><creator>Nathanson, Brian H.</creator><creator>Germain, Michael J.</creator><general>Nature Publishing Group UK</general><general>Nature Portfolio</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-6581-8124</orcidid></search><sort><creationdate>20221122</creationdate><title>Individualized anemia management enhanced by ferric pyrophosphate citrate protocol</title><author>Chait, Yossi ; Nathanson, Brian H. ; Germain, Michael J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c512t-32285072815b3c9d73676f9b7e646e767d19c4d1a3954bee082fd1c43c730183</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>692/308</topic><topic>692/4022</topic><topic>Anemia - complications</topic><topic>Anemia - etiology</topic><topic>Citrates - therapeutic use</topic><topic>Ferritins</topic><topic>Hematinics - therapeutic use</topic><topic>Hemoglobins - metabolism</topic><topic>Humanities and Social Sciences</topic><topic>Humans</topic><topic>Iron - metabolism</topic><topic>Kidney Failure, Chronic - drug therapy</topic><topic>Kidney Failure, Chronic - therapy</topic><topic>multidisciplinary</topic><topic>Prospective Studies</topic><topic>Science</topic><topic>Science (multidisciplinary)</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Chait, Yossi</creatorcontrib><creatorcontrib>Nathanson, Brian H.</creatorcontrib><creatorcontrib>Germain, Michael J.</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Scientific reports</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Chait, Yossi</au><au>Nathanson, Brian H.</au><au>Germain, Michael J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Individualized anemia management enhanced by ferric pyrophosphate citrate protocol</atitle><jtitle>Scientific reports</jtitle><stitle>Sci Rep</stitle><addtitle>Sci Rep</addtitle><date>2022-11-22</date><risdate>2022</risdate><volume>12</volume><issue>1</issue><spage>20122</spage><epage>20122</epage><pages>20122-20122</pages><artnum>20122</artnum><issn>2045-2322</issn><eissn>2045-2322</eissn><abstract>The optimal use of erythropoiesis-stimulating agents (ESAs) and parenteral iron in managing anemia in end-stage renal disease (ESRD) remains controversial. One-size-fits-all rule-based algorithms dominate dosing protocols for ESA and parenteral iron. However, the Food & Drug Administration (FDA) guidelines for using ESAs in chronic kidney disease recommend individualized therapy for the patient. This prospective quality assurance project was at a single hemodialysis (HD) center comprising three 6-month phases (A, B, C) separated by 3-month washout periods. Standard bi-weekly ESA dose titration and intravenous (IV) iron sucrose protocols were used in baseline Phase A, and ferric pyrophosphate citrate (FPC) augmented iron in Phase B. In Phase C, an FPC protocol and weekly, individualized ESA management were used. We examined clinic-level mean differences in hemoglobin (Hb) and ESRD-related outcomes by phase with repeated ANOVA. To examine the Hb at the patient level, we used multi-level mixed-effect regression adjusting for phase, month, and other relevant confounders at each month over time to derive the mean marginal effects of phase. There were 54, 78, and 66 patients in phases A, B, and C, respectively, with raw mean Hb values of 9.9, 10.2, and 10.3 g/dL. The percentage of Hb values < 9 g/dL declined from 14.3% in Phase A to 7.6% in Phase C (p = 0.007). The multivariable mixed-effect regression results showed mean marginal Hb was higher by 0.3 mg/dL and 0.4 mg/dL in Phases B and C, respectively, compared to Phase A. We also observed reduced ferritin (p = 0.003) and transferrin saturation (TSAT) (p = 0.008) levels from Phase A to Phase C with the repeated ANOVA analysis. Ferric pyrophosphate citrate (FPC) appears to support more efficient ESA-stimulated erythropoiesis. Moreover, individualized ESA management combined with FPC (Phase C) was associated with further improvement in efficiency as we observed the fewest patients with Hb values < 9 g/dL concurrent with greater decreases in ferritin levels and reduced ESA doses. However, future prospective studies to confirm these findings on a larger, more diverse cohort of ESRD patients are warranted.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>36418453</pmid><doi>10.1038/s41598-022-23262-1</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0002-6581-8124</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | 692/308 692/4022 Anemia - complications Anemia - etiology Citrates - therapeutic use Ferritins Hematinics - therapeutic use Hemoglobins - metabolism Humanities and Social Sciences Humans Iron - metabolism Kidney Failure, Chronic - drug therapy Kidney Failure, Chronic - therapy multidisciplinary Prospective Studies Science Science (multidisciplinary) |
title | Individualized anemia management enhanced by ferric pyrophosphate citrate protocol |
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