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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">We are grateful for the interest shown by Dr Lorente in the consensus document on the management of hyperkalaemia&#44; which was open for public comment between December 2022 and January 2023&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Dr Lorente made a number of comments&#44; which we have summarised and responded to below&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Boxes 1 and 2 refer to the acute treatment of severe hyperkalaemia&#44; not to the mechanism of action of the interventions&#46; In a section on the acute treatment of severe hyperkalaemia&#44; it should be noted that the first measures are still&#58; &#40;1&#41; Antagonise the effects of potassium on the cell membrane&#58; calcium gluconate or calcium chloride&#59; and &#40;2&#41; Introduce potassium into the cells&#44; as shown in Box 1&#46; Avoid giving the impression that the only measure to be applied is to increase digestive elimination&#46; In this regard&#44; ENERGIZE &#40;NCT03337477&#41; was a multicentre&#44; double-blind&#44; placebo-controlled&#44; Phase 2 clinical trial evaluating the efficacy of sodium zirconium cyclosilicate &#40;SZC&#41; in the emergency treatment of hyperkalaemia&#44; added to glucose and insulin&#44; with the primary endpoint being the change in serum potassium&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> We have not found a similar clinical trial for patiromer &#40;standard measures plus patiromer compared to standard measures plus placebo&#41; with published results&#44;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> so it was not possible to include patiromer in Boxes 1 and 2&#46; However&#44; the document notes that the PLATINUM study &#40;NCT04443608&#41;&#44; a multicentre&#44; randomised&#44; placebo-controlled clinical trial evaluating aspects relating to the use of patiromer in the context of hyperkalaemia in the emergency department&#44; is currently underway&#46; Although we agree with Dr Lorente that it seems reasonable to start chronic treatment as early as possible&#44; Boxes 1 and 2 refer to a specific situation&#44; which is the acute treatment of severe hyperkalaemia&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">We also agree with Dr Lorente that the 2022 consensus document&#44; &#34;Recommendations for the management of hyperkalaemia in the emergency department&#34;&#44; of the Spanisch Society of Emergency Medicine and Emergencies &#40;SEMES&#41; &#91;Sociedad Espa&#241;ola de Medicina de Urgencias y Emergencias&#93;&#44; the Spanish Society of Cardiology &#40;SEC&#41; &#91;Sociedad Espa&#241;ola de Cardiolog&#237;a&#93; and the Spanish Society of Nephrology &#40;S&#46;E&#46;N&#41; &#91;Sociedad Espa&#241;ola de Nefrolog&#237;a&#93; mentions gastrointestinal cation exchangers in the algorithm for the treatment of hyperkalaemic emergency&#44; without naming any one in particular&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> Moreover&#44; we also agree that patiromer&#44; SZC and ion exchange resins such as sodium or calcium polystyrene sulfonate are mentioned in the text&#46; However&#44; the text does not present evidence on the use of patiromer or ion exchange resins in this area&#46; The only clinical trial cited in the setting of emergency hyperkalaemia is ENERGIZE&#44;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> whose authors conclude that SZC with insulin and glucose may provide incremental benefit in the emergency treatment of hyperkalaemia over insulin and glucose alone&#46; Therefore&#44; our interpretation is that although the SEMES-SEC-S&#46;E&#46;N document does not mention any specific gastrointestinal cation exchanger in the algorithm for the treatment of hyperkalaemic emergency&#44; the fact that it only presents evidence for one of them would clarify its position&#46; We would have liked to be able to include patiromer in this area to avoid controversy&#44; but we cannot do this arbitrarily&#44; and we must to base the decision on the available evidence&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">We agree with Dr Lorente that the &#34;European Resuscitation Council Guidelines 2021&#58; Cardiac arrest in special circumstances&#34; include patiromer&#44; SZC and calcium polystyrene sulfonate among the measures to remove potassium from the body in the emergency treatment of hyperkalaemia&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> The text explains that SZC takes effect within the first hour and lowers blood potassium by 1&#46;1 mmol&#47;l in the first 48 h&#44; while the onset of patiromer action is slower&#44; being evident at 4&#8722;7 h and lowering blood potassium by 0&#46;36 mmol&#47;l in 72 h&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> They consider the above-mentioned studies to be inconclusive&#46;<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#44;4</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Dr Lorente points out that Box 3 gives a broad description of SZC&#44; but not of patiromer&#46; The extra information is that SZC contributes to the correction of metabolic acidosis&#46; This statement is based on an exploratory analysis of three clinical trials&#44; as reported in the text&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;7</span></a> Dr Lorente points out that patiromer also provides pleiotropic effects&#44; such as lowering phosphorus levels&#46; We agree with Dr Lorente that this may be an advantage for patients with chronic kidney disease &#40;CKD&#41; and hyperphosphataemia&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Unfortunately&#44; the reference he provides is from July 2023&#44;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> so it is outside the evidence review period&#46; This information will be taken into account in subsequent updates of the document&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Dr Lorente asks on what studies we based the suggestion in the algorithm that SZC should be considered particularly in patients with CKD or metabolic acidosis&#46; The rationale for considering SZC in patients with metabolic acidosis&#44; a common and often undiagnosed condition in CKD patients&#44; is that SZC can correct it&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Given the high prevalence of undiagnosed metabolic acidosis in CKD&#44; this was expressed as &#8220;CKD or metabolic acidosis&#8221;&#46; However&#44; in an ideal world where the acid-base status of CKD patients is regularly assessed&#44; the term &#8220;CKD with metabolic acidosis&#8221; could preferably be used in addition to isolated metabolic acidosis&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Dr Lorente points out that in the meta-analysis cited above&#44; there is a higher prevalence of CKD and other comorbidities expressed as a percentage among the 654 participants in the trials testing patiromer than among the 1102 participants in the trials testing SZC&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Although this is a minor point&#44; it is worth noting that the total number of patients with CKD and other comorbidities was higher in the trials testing CSZ than in those testing patiromer&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Dr Lorente points out that there is no mention in the consensus document that SZC has a European Medicines Agency &#40;EMA&#41; alert for intestinal perforations&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Indeed&#44; the EMA states that&#44; <span class="elsevierStyleItalic">&#34;The risk for intestinal perforation with the use of Lokelma is currently unknown&#46; Since intestinal perforation has been reported with potassium binders including Lokelma&#44; specific attention should be paid to signs and symptoms related to intestinal perforation&#34;</span>&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> For patiromer&#44; <span class="elsevierStyleItalic">&#34;Patients with a history of bowel obstruction or major gastrointestinal surgery&#44; severe gastrointestinal disorders&#44; or swallowing disorders were not included in the clinical studies&#46; Gastrointestinal ischaemia&#44; necrosis and&#47;or intestinal perforation have been reported with other potassium binders&#46; The benefits and risks of administering patiromer should be carefully evaluated in patients with current or history of severe gastrointestinal disorders&#44; before and during treatment&#34;</span>&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Dr Lorente cites the EMA as stating that SZC should be separated by 2 h from tacrolimus administration because of a possible interaction with tacrolimus&#59; this decision is dated 10 January 2023 and was therefore issued after the evidence review period&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> In any case&#44; it is correct that the consensus document does not detail the drug-drug interactions of the drugs discussed&#46; It is obvious that every prescribing physician should periodically review the conditions of use of the medicines he or she prescribes&#46; In this regard&#44; the EMA&#39;s &#8220;summary of product characteristics&#8221; for patiromer explains in the &#8220;Posology&#8221; section that &#8220;Administration of Veltassa should be separated by 3 <span class="elsevierStyleItalic">hours from other oral medicinal products</span> &#40;see section 4&#46;5&#44; shown in the annex&#41;&#8221;&#46; Notably&#44; it does not make an exception for tacrolimus&#44; and the EMA does not include <span class="elsevierStyleItalic">in vivo</span> studies on patiromer and tacrolimus where the area under the tacrolimus curve is determined&#44; such as the study that motivated the EMA recommendation for SZC&#44; which analysed a dose of SZC &#40;15 g&#41; which is not among the presentations available in Europe &#40;5 and 10 g&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> The &#34;Posology&#34; section of the EMA&#39;s &#34;summary of product characteristics&#34; for SZC has no limitations with respect to other drugs&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> However&#44; in section 4&#46;5&#44; shown in the Annex&#44; it states&#44; &#8220;However&#44; sodium zirconium cyclosilicate should be administered at least <span class="elsevierStyleItalic">2 hours before or 2 hours after oral medicinal products with clinically meaningful gastric pH dependent bioavailability</span>&#8221;&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Finally&#44; Dr Lorente suggests that the use of patiromer could be associated with a lower risk of heart failure hospitalisations compared to SZC in real clinical practice&#46; However&#44; the article he cites found no statistically significant differences in heart failure hospitalisations between SZC and patiromer&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a></p></span>"
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Letter to the Editor
Reply to "Letter to the Editor — Consensus document on the management of hyperkalaemia"
Respuesta a «Carta al Director - Documento de consenso sobre el abordaje de la hiperpotasemia»
Alberto Ortiza,
Corresponding author
aortiz@fjd.es

Corresponding author.
, Carmen del Arco Galánb, José Carlos Fernández-Garcíac, Jorge Gómez Cerezod, Rosa Ibán Ochoab, Julio Núñeze, Francisco Pita Gutiérrezc, Juan F. Navarro-Gonzáleza,
Corresponding author
jnavgon@gobiernodecanarias.org

Corresponding author.
a Sociedad Española de Nefrología (S.E.N.), Spain
b Sociedad Española de Medicina de Urgencias y Emergencias (SEMES), Spain
c Sociedad Española de Endocrinología y Nutrición (SEEN), Spain
d Sociedad Española de Medicina Interna (SEMI), Spain
e Sociedad Española de Cardiología (SEC), Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">We are grateful for the interest shown by Dr Lorente in the consensus document on the management of hyperkalaemia&#44; which was open for public comment between December 2022 and January 2023&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Dr Lorente made a number of comments&#44; which we have summarised and responded to below&#46;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Boxes 1 and 2 refer to the acute treatment of severe hyperkalaemia&#44; not to the mechanism of action of the interventions&#46; In a section on the acute treatment of severe hyperkalaemia&#44; it should be noted that the first measures are still&#58; &#40;1&#41; Antagonise the effects of potassium on the cell membrane&#58; calcium gluconate or calcium chloride&#59; and &#40;2&#41; Introduce potassium into the cells&#44; as shown in Box 1&#46; Avoid giving the impression that the only measure to be applied is to increase digestive elimination&#46; In this regard&#44; ENERGIZE &#40;NCT03337477&#41; was a multicentre&#44; double-blind&#44; placebo-controlled&#44; Phase 2 clinical trial evaluating the efficacy of sodium zirconium cyclosilicate &#40;SZC&#41; in the emergency treatment of hyperkalaemia&#44; added to glucose and insulin&#44; with the primary endpoint being the change in serum potassium&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> We have not found a similar clinical trial for patiromer &#40;standard measures plus patiromer compared to standard measures plus placebo&#41; with published results&#44;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> so it was not possible to include patiromer in Boxes 1 and 2&#46; However&#44; the document notes that the PLATINUM study &#40;NCT04443608&#41;&#44; a multicentre&#44; randomised&#44; placebo-controlled clinical trial evaluating aspects relating to the use of patiromer in the context of hyperkalaemia in the emergency department&#44; is currently underway&#46; Although we agree with Dr Lorente that it seems reasonable to start chronic treatment as early as possible&#44; Boxes 1 and 2 refer to a specific situation&#44; which is the acute treatment of severe hyperkalaemia&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">We also agree with Dr Lorente that the 2022 consensus document&#44; &#34;Recommendations for the management of hyperkalaemia in the emergency department&#34;&#44; of the Spanisch Society of Emergency Medicine and Emergencies &#40;SEMES&#41; &#91;Sociedad Espa&#241;ola de Medicina de Urgencias y Emergencias&#93;&#44; the Spanish Society of Cardiology &#40;SEC&#41; &#91;Sociedad Espa&#241;ola de Cardiolog&#237;a&#93; and the Spanish Society of Nephrology &#40;S&#46;E&#46;N&#41; &#91;Sociedad Espa&#241;ola de Nefrolog&#237;a&#93; mentions gastrointestinal cation exchangers in the algorithm for the treatment of hyperkalaemic emergency&#44; without naming any one in particular&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> Moreover&#44; we also agree that patiromer&#44; SZC and ion exchange resins such as sodium or calcium polystyrene sulfonate are mentioned in the text&#46; However&#44; the text does not present evidence on the use of patiromer or ion exchange resins in this area&#46; The only clinical trial cited in the setting of emergency hyperkalaemia is ENERGIZE&#44;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> whose authors conclude that SZC with insulin and glucose may provide incremental benefit in the emergency treatment of hyperkalaemia over insulin and glucose alone&#46; Therefore&#44; our interpretation is that although the SEMES-SEC-S&#46;E&#46;N document does not mention any specific gastrointestinal cation exchanger in the algorithm for the treatment of hyperkalaemic emergency&#44; the fact that it only presents evidence for one of them would clarify its position&#46; We would have liked to be able to include patiromer in this area to avoid controversy&#44; but we cannot do this arbitrarily&#44; and we must to base the decision on the available evidence&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">We agree with Dr Lorente that the &#34;European Resuscitation Council Guidelines 2021&#58; Cardiac arrest in special circumstances&#34; include patiromer&#44; SZC and calcium polystyrene sulfonate among the measures to remove potassium from the body in the emergency treatment of hyperkalaemia&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> The text explains that SZC takes effect within the first hour and lowers blood potassium by 1&#46;1 mmol&#47;l in the first 48 h&#44; while the onset of patiromer action is slower&#44; being evident at 4&#8722;7 h and lowering blood potassium by 0&#46;36 mmol&#47;l in 72 h&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> They consider the above-mentioned studies to be inconclusive&#46;<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3&#44;4</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Dr Lorente points out that Box 3 gives a broad description of SZC&#44; but not of patiromer&#46; The extra information is that SZC contributes to the correction of metabolic acidosis&#46; This statement is based on an exploratory analysis of three clinical trials&#44; as reported in the text&#46;<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1&#44;7</span></a> Dr Lorente points out that patiromer also provides pleiotropic effects&#44; such as lowering phosphorus levels&#46; We agree with Dr Lorente that this may be an advantage for patients with chronic kidney disease &#40;CKD&#41; and hyperphosphataemia&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Unfortunately&#44; the reference he provides is from July 2023&#44;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> so it is outside the evidence review period&#46; This information will be taken into account in subsequent updates of the document&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Dr Lorente asks on what studies we based the suggestion in the algorithm that SZC should be considered particularly in patients with CKD or metabolic acidosis&#46; The rationale for considering SZC in patients with metabolic acidosis&#44; a common and often undiagnosed condition in CKD patients&#44; is that SZC can correct it&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> Given the high prevalence of undiagnosed metabolic acidosis in CKD&#44; this was expressed as &#8220;CKD or metabolic acidosis&#8221;&#46; However&#44; in an ideal world where the acid-base status of CKD patients is regularly assessed&#44; the term &#8220;CKD with metabolic acidosis&#8221; could preferably be used in addition to isolated metabolic acidosis&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">Dr Lorente points out that in the meta-analysis cited above&#44; there is a higher prevalence of CKD and other comorbidities expressed as a percentage among the 654 participants in the trials testing patiromer than among the 1102 participants in the trials testing SZC&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> Although this is a minor point&#44; it is worth noting that the total number of patients with CKD and other comorbidities was higher in the trials testing CSZ than in those testing patiromer&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">Dr Lorente points out that there is no mention in the consensus document that SZC has a European Medicines Agency &#40;EMA&#41; alert for intestinal perforations&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Indeed&#44; the EMA states that&#44; <span class="elsevierStyleItalic">&#34;The risk for intestinal perforation with the use of Lokelma is currently unknown&#46; Since intestinal perforation has been reported with potassium binders including Lokelma&#44; specific attention should be paid to signs and symptoms related to intestinal perforation&#34;</span>&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> For patiromer&#44; <span class="elsevierStyleItalic">&#34;Patients with a history of bowel obstruction or major gastrointestinal surgery&#44; severe gastrointestinal disorders&#44; or swallowing disorders were not included in the clinical studies&#46; Gastrointestinal ischaemia&#44; necrosis and&#47;or intestinal perforation have been reported with other potassium binders&#46; The benefits and risks of administering patiromer should be carefully evaluated in patients with current or history of severe gastrointestinal disorders&#44; before and during treatment&#34;</span>&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">Dr Lorente cites the EMA as stating that SZC should be separated by 2 h from tacrolimus administration because of a possible interaction with tacrolimus&#59; this decision is dated 10 January 2023 and was therefore issued after the evidence review period&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> In any case&#44; it is correct that the consensus document does not detail the drug-drug interactions of the drugs discussed&#46; It is obvious that every prescribing physician should periodically review the conditions of use of the medicines he or she prescribes&#46; In this regard&#44; the EMA&#39;s &#8220;summary of product characteristics&#8221; for patiromer explains in the &#8220;Posology&#8221; section that &#8220;Administration of Veltassa should be separated by 3 <span class="elsevierStyleItalic">hours from other oral medicinal products</span> &#40;see section 4&#46;5&#44; shown in the annex&#41;&#8221;&#46; Notably&#44; it does not make an exception for tacrolimus&#44; and the EMA does not include <span class="elsevierStyleItalic">in vivo</span> studies on patiromer and tacrolimus where the area under the tacrolimus curve is determined&#44; such as the study that motivated the EMA recommendation for SZC&#44; which analysed a dose of SZC &#40;15 g&#41; which is not among the presentations available in Europe &#40;5 and 10 g&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> The &#34;Posology&#34; section of the EMA&#39;s &#34;summary of product characteristics&#34; for SZC has no limitations with respect to other drugs&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> However&#44; in section 4&#46;5&#44; shown in the Annex&#44; it states&#44; &#8220;However&#44; sodium zirconium cyclosilicate should be administered at least <span class="elsevierStyleItalic">2 hours before or 2 hours after oral medicinal products with clinically meaningful gastric pH dependent bioavailability</span>&#8221;&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Finally&#44; Dr Lorente suggests that the use of patiromer could be associated with a lower risk of heart failure hospitalisations compared to SZC in real clinical practice&#46; However&#44; the article he cites found no statistically significant differences in heart failure hospitalisations between SZC and patiromer&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a></p></span>"
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ISSN: 20132514
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