New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval.
Identifieur interne : 000011 ( PubMed/Checkpoint ); précédent : 000010; suivant : 000012New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval.
Auteurs : Faiez Zannad [France] ; Patrick Rossignol [France] ; Wendy Gattis Stough [États-Unis] ; Murray Epstein [États-Unis] ; Maria De Los Angeles Alonso Garcia [Royaume-Uni] ; George L. Bakris [États-Unis] ; Javed Butler [États-Unis] ; Mikhail Kosiborod [États-Unis] ; Lance Berman [États-Unis] ; Alexandre Mebazaa [France] ; Henrik S. Rasmussen [États-Unis] ; Luis M. Ruilope [Espagne] ; Norman Stockbridge [États-Unis] ; Aliza Thompson [États-Unis] ; Janet Wittes [États-Unis] ; Bertram Pitt [États-Unis]Source :
- International journal of cardiology [ 1874-1754 ] ; 2016.
Abstract
Hyperkalemia is a common clinical problem, especially in patients with chronic kidney disease, diabetes mellitus, or heart failure. Treatment with renin angiotensin aldosterone system inhibitors exacerbates the risk of hyperkalemia in these patients. Concern about hyperkalemia can result in the failure to initiate, suboptimal dosing, or discontinuation of renin angiotensin aldosterone system inhibitor therapy in patients; effective treatments for hyperkalemia might mitigate such undertreatment. New treatments for hyperkalemia in development may offer better efficacy, tolerability and safety profiles than do existing approved treatments. These compounds might enable more eligible patients to receive renin angiotensin aldosterone system inhibitor therapy or to receive renin angiotensin aldosterone system inhibitors at target doses. The evidence needed to support a treatment claim (reduction in serum potassium) differs from that needed to support a prevention claim (preventing hyperkalemia to allow renin angiotensin aldosterone system inhibitor treatment). Thus, several issues related to clinical trial design and drug development need to be considered. This paper summarizes and expands upon a discussion at the Global Cardiovascular Clinical Trialists 2014 Forum and examines methodologic considerations for trials of new potassium binders for the prevention and management of hyperkalemia in patients with renin angiotensin aldosterone system inhibitor indications.
DOI: 10.1016/j.ijcard.2016.04.127
PubMed: 27140336
Affiliations:
- Espagne, France, Royaume-Uni, États-Unis
- Angleterre, Communauté de Madrid, Grand Est, Grand Londres, Lorraine (région), Île-de-France
- Londres, Madrid, Nancy, Paris
- Université de Lorraine
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:27140336Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval.</title><author><name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name><affiliation wicri:level="4"><nlm:affiliation>INSERM, Centre d'Investigation Clinique - 1433 and Unité 1116, CHU Nancy, Université de Lorraine, and F-CRIN INI-CRCT, Nancy, France. Electronic address: f.zannad@chu-nancy.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>INSERM, Centre d'Investigation Clinique - 1433 and Unité 1116, CHU Nancy, Université de Lorraine, and F-CRIN INI-CRCT, Nancy</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName><orgName type="university">Université de Lorraine</orgName></affiliation></author><author><name sortKey="Rossignol, Patrick" sort="Rossignol, Patrick" uniqKey="Rossignol P" first="Patrick" last="Rossignol">Patrick Rossignol</name><affiliation wicri:level="4"><nlm:affiliation>INSERM, Centre d'Investigations Cliniques- 1433, and Inserm U1116, CHU Nancy, Université de Lorraine, Association Lorraine pour le Traitement de l'Insuffisance Rénale, and F-CRIN INI-CRCT, Nancy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>INSERM, Centre d'Investigations Cliniques- 1433, and Inserm U1116, CHU Nancy, Université de Lorraine, Association Lorraine pour le Traitement de l'Insuffisance Rénale, and F-CRIN INI-CRCT, Nancy</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName><orgName type="university">Université de Lorraine</orgName></affiliation></author><author><name sortKey="Stough, Wendy Gattis" sort="Stough, Wendy Gattis" uniqKey="Stough W" first="Wendy Gattis" last="Stough">Wendy Gattis Stough</name><affiliation wicri:level="1"><nlm:affiliation>Campbell University College of Pharmacy and Health Sciences, NC, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Campbell University College of Pharmacy and Health Sciences, NC</wicri:regionArea><wicri:noRegion>NC</wicri:noRegion></affiliation></author><author><name sortKey="Epstein, Murray" sort="Epstein, Murray" uniqKey="Epstein M" first="Murray" last="Epstein">Murray Epstein</name><affiliation wicri:level="1"><nlm:affiliation>Division of Nephrology and Hypertension, University of Miami, Miller School of Medicine, Miami, FL, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Nephrology and Hypertension, University of Miami, Miller School of Medicine, Miami, FL</wicri:regionArea><wicri:noRegion>FL</wicri:noRegion></affiliation></author><author><name sortKey="Alonso Garcia, Maria De Los Angeles" sort="Alonso Garcia, Maria De Los Angeles" uniqKey="Alonso Garcia M" first="Maria De Los Angeles" last="Alonso Garcia">Maria De Los Angeles Alonso Garcia</name><affiliation wicri:level="3"><nlm:affiliation>Scientific Advice Working Party European Medicines Agency, Medicines and Healthcare Products Regulatory Agency (MHRA), Cardiology, Imperial College Healthcare, NHS Trust, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Scientific Advice Working Party European Medicines Agency, Medicines and Healthcare Products Regulatory Agency (MHRA), Cardiology, Imperial College Healthcare, NHS Trust, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Bakris, George L" sort="Bakris, George L" uniqKey="Bakris G" first="George L" last="Bakris">George L. Bakris</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, University of Chicago Medicine, Chicago, IL, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, University of Chicago Medicine, Chicago, IL</wicri:regionArea><wicri:noRegion>IL</wicri:noRegion></affiliation></author><author><name sortKey="Butler, Javed" sort="Butler, Javed" uniqKey="Butler J" first="Javed" last="Butler">Javed Butler</name><affiliation wicri:level="1"><nlm:affiliation>Stony Brook Heart Institute, Stony Brook University School of Medicine, Stony Brook, NY, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Stony Brook Heart Institute, Stony Brook University School of Medicine, Stony Brook, NY</wicri:regionArea><wicri:noRegion>NY</wicri:noRegion></affiliation></author><author><name sortKey="Kosiborod, Mikhail" sort="Kosiborod, Mikhail" uniqKey="Kosiborod M" first="Mikhail" last="Kosiborod">Mikhail Kosiborod</name><affiliation wicri:level="1"><nlm:affiliation>Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO</wicri:regionArea><wicri:noRegion>MO</wicri:noRegion></affiliation></author><author><name sortKey="Berman, Lance" sort="Berman, Lance" uniqKey="Berman L" first="Lance" last="Berman">Lance Berman</name><affiliation wicri:level="1"><nlm:affiliation>Relypsa, Redwood City, CA, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Relypsa, Redwood City, CA</wicri:regionArea><wicri:noRegion>CA</wicri:noRegion></affiliation></author><author><name sortKey="Mebazaa, Alexandre" sort="Mebazaa, Alexandre" uniqKey="Mebazaa A" first="Alexandre" last="Mebazaa">Alexandre Mebazaa</name><affiliation wicri:level="3"><nlm:affiliation>University Paris Diderot, Sorbonne Paris Cité, U942 Inserm, Paris, AP-HP, Department of Anesthesia and Critical Care, Hôpitaux Universitaires Saint Louis-Lariboisière, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>University Paris Diderot, Sorbonne Paris Cité, U942 Inserm, Paris, AP-HP, Department of Anesthesia and Critical Care, Hôpitaux Universitaires Saint Louis-Lariboisière, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Rasmussen, Henrik S" sort="Rasmussen, Henrik S" uniqKey="Rasmussen H" first="Henrik S" last="Rasmussen">Henrik S. Rasmussen</name><affiliation wicri:level="1"><nlm:affiliation>ZS Pharma, Coppell, TX, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>ZS Pharma, Coppell, TX</wicri:regionArea><wicri:noRegion>TX</wicri:noRegion></affiliation></author><author><name sortKey="Ruilope, Luis M" sort="Ruilope, Luis M" uniqKey="Ruilope L" first="Luis M" last="Ruilope">Luis M. Ruilope</name><affiliation wicri:level="3"><nlm:affiliation>Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Stockbridge, Norman" sort="Stockbridge, Norman" uniqKey="Stockbridge N" first="Norman" last="Stockbridge">Norman Stockbridge</name><affiliation wicri:level="1"><nlm:affiliation>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD</wicri:regionArea><wicri:noRegion>MD</wicri:noRegion></affiliation></author><author><name sortKey="Thompson, Aliza" sort="Thompson, Aliza" uniqKey="Thompson A" first="Aliza" last="Thompson">Aliza Thompson</name><affiliation wicri:level="1"><nlm:affiliation>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD</wicri:regionArea><wicri:noRegion>MD</wicri:noRegion></affiliation></author><author><name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name><affiliation wicri:level="1"><nlm:affiliation>Statistics Collaborative, Inc., Washington, D.C., United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Statistics Collaborative, Inc., Washington, D.C.</wicri:regionArea><wicri:noRegion>D.C.</wicri:noRegion></affiliation></author><author><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name><affiliation wicri:level="1"><nlm:affiliation>University of Michigan School of Medicine, Ann Arbor, MI, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Michigan School of Medicine, Ann Arbor, MI</wicri:regionArea><wicri:noRegion>MI</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="doi">10.1016/j.ijcard.2016.04.127</idno><idno type="RBID">pubmed:27140336</idno><idno type="pmid">27140336</idno><idno type="wicri:Area/PubMed/Corpus">000001</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000001</idno><idno type="wicri:Area/PubMed/Curation">000001</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000001</idno><idno type="wicri:Area/PubMed/Checkpoint">000011</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000011</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval.</title><author><name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name><affiliation wicri:level="4"><nlm:affiliation>INSERM, Centre d'Investigation Clinique - 1433 and Unité 1116, CHU Nancy, Université de Lorraine, and F-CRIN INI-CRCT, Nancy, France. Electronic address: f.zannad@chu-nancy.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>INSERM, Centre d'Investigation Clinique - 1433 and Unité 1116, CHU Nancy, Université de Lorraine, and F-CRIN INI-CRCT, Nancy</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName><orgName type="university">Université de Lorraine</orgName></affiliation></author><author><name sortKey="Rossignol, Patrick" sort="Rossignol, Patrick" uniqKey="Rossignol P" first="Patrick" last="Rossignol">Patrick Rossignol</name><affiliation wicri:level="4"><nlm:affiliation>INSERM, Centre d'Investigations Cliniques- 1433, and Inserm U1116, CHU Nancy, Université de Lorraine, Association Lorraine pour le Traitement de l'Insuffisance Rénale, and F-CRIN INI-CRCT, Nancy, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>INSERM, Centre d'Investigations Cliniques- 1433, and Inserm U1116, CHU Nancy, Université de Lorraine, Association Lorraine pour le Traitement de l'Insuffisance Rénale, and F-CRIN INI-CRCT, Nancy</wicri:regionArea><placeName><region type="region">Grand Est</region><region type="old region">Lorraine (région)</region><settlement type="city">Nancy</settlement></placeName><orgName type="university">Université de Lorraine</orgName></affiliation></author><author><name sortKey="Stough, Wendy Gattis" sort="Stough, Wendy Gattis" uniqKey="Stough W" first="Wendy Gattis" last="Stough">Wendy Gattis Stough</name><affiliation wicri:level="1"><nlm:affiliation>Campbell University College of Pharmacy and Health Sciences, NC, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Campbell University College of Pharmacy and Health Sciences, NC</wicri:regionArea><wicri:noRegion>NC</wicri:noRegion></affiliation></author><author><name sortKey="Epstein, Murray" sort="Epstein, Murray" uniqKey="Epstein M" first="Murray" last="Epstein">Murray Epstein</name><affiliation wicri:level="1"><nlm:affiliation>Division of Nephrology and Hypertension, University of Miami, Miller School of Medicine, Miami, FL, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Nephrology and Hypertension, University of Miami, Miller School of Medicine, Miami, FL</wicri:regionArea><wicri:noRegion>FL</wicri:noRegion></affiliation></author><author><name sortKey="Alonso Garcia, Maria De Los Angeles" sort="Alonso Garcia, Maria De Los Angeles" uniqKey="Alonso Garcia M" first="Maria De Los Angeles" last="Alonso Garcia">Maria De Los Angeles Alonso Garcia</name><affiliation wicri:level="3"><nlm:affiliation>Scientific Advice Working Party European Medicines Agency, Medicines and Healthcare Products Regulatory Agency (MHRA), Cardiology, Imperial College Healthcare, NHS Trust, London, United Kingdom.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Scientific Advice Working Party European Medicines Agency, Medicines and Healthcare Products Regulatory Agency (MHRA), Cardiology, Imperial College Healthcare, NHS Trust, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Bakris, George L" sort="Bakris, George L" uniqKey="Bakris G" first="George L" last="Bakris">George L. Bakris</name><affiliation wicri:level="1"><nlm:affiliation>Department of Medicine, University of Chicago Medicine, Chicago, IL, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Medicine, University of Chicago Medicine, Chicago, IL</wicri:regionArea><wicri:noRegion>IL</wicri:noRegion></affiliation></author><author><name sortKey="Butler, Javed" sort="Butler, Javed" uniqKey="Butler J" first="Javed" last="Butler">Javed Butler</name><affiliation wicri:level="1"><nlm:affiliation>Stony Brook Heart Institute, Stony Brook University School of Medicine, Stony Brook, NY, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Stony Brook Heart Institute, Stony Brook University School of Medicine, Stony Brook, NY</wicri:regionArea><wicri:noRegion>NY</wicri:noRegion></affiliation></author><author><name sortKey="Kosiborod, Mikhail" sort="Kosiborod, Mikhail" uniqKey="Kosiborod M" first="Mikhail" last="Kosiborod">Mikhail Kosiborod</name><affiliation wicri:level="1"><nlm:affiliation>Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO</wicri:regionArea><wicri:noRegion>MO</wicri:noRegion></affiliation></author><author><name sortKey="Berman, Lance" sort="Berman, Lance" uniqKey="Berman L" first="Lance" last="Berman">Lance Berman</name><affiliation wicri:level="1"><nlm:affiliation>Relypsa, Redwood City, CA, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Relypsa, Redwood City, CA</wicri:regionArea><wicri:noRegion>CA</wicri:noRegion></affiliation></author><author><name sortKey="Mebazaa, Alexandre" sort="Mebazaa, Alexandre" uniqKey="Mebazaa A" first="Alexandre" last="Mebazaa">Alexandre Mebazaa</name><affiliation wicri:level="3"><nlm:affiliation>University Paris Diderot, Sorbonne Paris Cité, U942 Inserm, Paris, AP-HP, Department of Anesthesia and Critical Care, Hôpitaux Universitaires Saint Louis-Lariboisière, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>University Paris Diderot, Sorbonne Paris Cité, U942 Inserm, Paris, AP-HP, Department of Anesthesia and Critical Care, Hôpitaux Universitaires Saint Louis-Lariboisière, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Rasmussen, Henrik S" sort="Rasmussen, Henrik S" uniqKey="Rasmussen H" first="Henrik S" last="Rasmussen">Henrik S. Rasmussen</name><affiliation wicri:level="1"><nlm:affiliation>ZS Pharma, Coppell, TX, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>ZS Pharma, Coppell, TX</wicri:regionArea><wicri:noRegion>TX</wicri:noRegion></affiliation></author><author><name sortKey="Ruilope, Luis M" sort="Ruilope, Luis M" uniqKey="Ruilope L" first="Luis M" last="Ruilope">Luis M. Ruilope</name><affiliation wicri:level="3"><nlm:affiliation>Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Madrid, Spain.</nlm:affiliation><country xml:lang="fr">Espagne</country><wicri:regionArea>Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Madrid</wicri:regionArea><placeName><settlement type="city">Madrid</settlement><region nuts="2" type="region">Communauté de Madrid</region></placeName></affiliation></author><author><name sortKey="Stockbridge, Norman" sort="Stockbridge, Norman" uniqKey="Stockbridge N" first="Norman" last="Stockbridge">Norman Stockbridge</name><affiliation wicri:level="1"><nlm:affiliation>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD</wicri:regionArea><wicri:noRegion>MD</wicri:noRegion></affiliation></author><author><name sortKey="Thompson, Aliza" sort="Thompson, Aliza" uniqKey="Thompson A" first="Aliza" last="Thompson">Aliza Thompson</name><affiliation wicri:level="1"><nlm:affiliation>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD</wicri:regionArea><wicri:noRegion>MD</wicri:noRegion></affiliation></author><author><name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name><affiliation wicri:level="1"><nlm:affiliation>Statistics Collaborative, Inc., Washington, D.C., United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Statistics Collaborative, Inc., Washington, D.C.</wicri:regionArea><wicri:noRegion>D.C.</wicri:noRegion></affiliation></author><author><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name><affiliation wicri:level="1"><nlm:affiliation>University of Michigan School of Medicine, Ann Arbor, MI, United States.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Michigan School of Medicine, Ann Arbor, MI</wicri:regionArea><wicri:noRegion>MI</wicri:noRegion></affiliation></author></analytic><series><title level="j">International journal of cardiology</title><idno type="eISSN">1874-1754</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Hyperkalemia is a common clinical problem, especially in patients with chronic kidney disease, diabetes mellitus, or heart failure. Treatment with renin angiotensin aldosterone system inhibitors exacerbates the risk of hyperkalemia in these patients. Concern about hyperkalemia can result in the failure to initiate, suboptimal dosing, or discontinuation of renin angiotensin aldosterone system inhibitor therapy in patients; effective treatments for hyperkalemia might mitigate such undertreatment. New treatments for hyperkalemia in development may offer better efficacy, tolerability and safety profiles than do existing approved treatments. These compounds might enable more eligible patients to receive renin angiotensin aldosterone system inhibitor therapy or to receive renin angiotensin aldosterone system inhibitors at target doses. The evidence needed to support a treatment claim (reduction in serum potassium) differs from that needed to support a prevention claim (preventing hyperkalemia to allow renin angiotensin aldosterone system inhibitor treatment). Thus, several issues related to clinical trial design and drug development need to be considered. This paper summarizes and expands upon a discussion at the Global Cardiovascular Clinical Trialists 2014 Forum and examines methodologic considerations for trials of new potassium binders for the prevention and management of hyperkalemia in patients with renin angiotensin aldosterone system inhibitor indications.</div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">27140336</PMID><DateCreated><Year>2016</Year><Month>5</Month><Day>3</Day></DateCreated><DateRevised><Year>2016</Year><Month>5</Month><Day>4</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1874-1754</ISSN><JournalIssue CitedMedium="Internet"><Volume>216</Volume><PubDate><Year>2016</Year><Month>Apr</Month><Day>19</Day></PubDate></JournalIssue><Title>International journal of cardiology</Title><ISOAbbreviation>Int. J. Cardiol.</ISOAbbreviation></Journal><ArticleTitle>New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval.</ArticleTitle><Pagination><MedlinePgn>46-51</MedlinePgn></Pagination><ELocationID EIdType="pii">S0167-5273(16)30827-0</ELocationID><ELocationID EIdType="doi">10.1016/j.ijcard.2016.04.127</ELocationID><Abstract><AbstractText NlmCategory="UNASSIGNED">Hyperkalemia is a common clinical problem, especially in patients with chronic kidney disease, diabetes mellitus, or heart failure. Treatment with renin angiotensin aldosterone system inhibitors exacerbates the risk of hyperkalemia in these patients. Concern about hyperkalemia can result in the failure to initiate, suboptimal dosing, or discontinuation of renin angiotensin aldosterone system inhibitor therapy in patients; effective treatments for hyperkalemia might mitigate such undertreatment. New treatments for hyperkalemia in development may offer better efficacy, tolerability and safety profiles than do existing approved treatments. These compounds might enable more eligible patients to receive renin angiotensin aldosterone system inhibitor therapy or to receive renin angiotensin aldosterone system inhibitors at target doses. The evidence needed to support a treatment claim (reduction in serum potassium) differs from that needed to support a prevention claim (preventing hyperkalemia to allow renin angiotensin aldosterone system inhibitor treatment). Thus, several issues related to clinical trial design and drug development need to be considered. This paper summarizes and expands upon a discussion at the Global Cardiovascular Clinical Trialists 2014 Forum and examines methodologic considerations for trials of new potassium binders for the prevention and management of hyperkalemia in patients with renin angiotensin aldosterone system inhibitor indications.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList><Author><LastName>Zannad</LastName><ForeName>Faiez</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>INSERM, Centre d'Investigation Clinique - 1433 and Unité 1116, CHU Nancy, Université de Lorraine, and F-CRIN INI-CRCT, Nancy, France. Electronic address: f.zannad@chu-nancy.fr.</Affiliation></AffiliationInfo></Author><Author><LastName>Rossignol</LastName><ForeName>Patrick</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>INSERM, Centre d'Investigations Cliniques- 1433, and Inserm U1116, CHU Nancy, Université de Lorraine, Association Lorraine pour le Traitement de l'Insuffisance Rénale, and F-CRIN INI-CRCT, Nancy, France.</Affiliation></AffiliationInfo></Author><Author><LastName>Stough</LastName><ForeName>Wendy Gattis</ForeName><Initials>WG</Initials><AffiliationInfo><Affiliation>Campbell University College of Pharmacy and Health Sciences, NC, United States.</Affiliation></AffiliationInfo></Author><Author><LastName>Epstein</LastName><ForeName>Murray</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Division of Nephrology and Hypertension, University of Miami, Miller School of Medicine, Miami, FL, United States.</Affiliation></AffiliationInfo></Author><Author><LastName>Alonso Garcia</LastName><ForeName>Maria de Los Angeles</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>Scientific Advice Working Party European Medicines Agency, Medicines and Healthcare Products Regulatory Agency (MHRA), Cardiology, Imperial College Healthcare, NHS Trust, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author><LastName>Bakris</LastName><ForeName>George L</ForeName><Initials>GL</Initials><AffiliationInfo><Affiliation>Department of Medicine, University of Chicago Medicine, Chicago, IL, United States.</Affiliation></AffiliationInfo></Author><Author><LastName>Butler</LastName><ForeName>Javed</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Stony Brook Heart Institute, Stony Brook University School of Medicine, Stony Brook, NY, United States.</Affiliation></AffiliationInfo></Author><Author><LastName>Kosiborod</LastName><ForeName>Mikhail</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, United States.</Affiliation></AffiliationInfo></Author><Author><LastName>Berman</LastName><ForeName>Lance</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Relypsa, Redwood City, CA, United States.</Affiliation></AffiliationInfo></Author><Author><LastName>Mebazaa</LastName><ForeName>Alexandre</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>University Paris Diderot, Sorbonne Paris Cité, U942 Inserm, Paris, AP-HP, Department of Anesthesia and Critical Care, Hôpitaux Universitaires Saint Louis-Lariboisière, Paris, France.</Affiliation></AffiliationInfo></Author><Author><LastName>Rasmussen</LastName><ForeName>Henrik S</ForeName><Initials>HS</Initials><AffiliationInfo><Affiliation>ZS Pharma, Coppell, TX, United States.</Affiliation></AffiliationInfo></Author><Author><LastName>Ruilope</LastName><ForeName>Luis M</ForeName><Initials>LM</Initials><AffiliationInfo><Affiliation>Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author><LastName>Stockbridge</LastName><ForeName>Norman</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.</Affiliation></AffiliationInfo></Author><Author><LastName>Thompson</LastName><ForeName>Aliza</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, United States.</Affiliation></AffiliationInfo></Author><Author><LastName>Wittes</LastName><ForeName>Janet</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Statistics Collaborative, Inc., Washington, D.C., United States.</Affiliation></AffiliationInfo></Author><Author><LastName>Pitt</LastName><ForeName>Bertram</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>University of Michigan School of Medicine, Ann Arbor, MI, United States.</Affiliation></AffiliationInfo></Author></AuthorList><Language>ENG</Language><PublicationTypeList><PublicationType UI="">REVIEW</PublicationType><PublicationType UI="">JOURNAL ARTICLE</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2016</Year><Month>4</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><MedlineTA>Int J Cardiol</MedlineTA><NlmUniqueID>8200291</NlmUniqueID><ISSNLinking>0167-5273</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Chronic</Keyword><Keyword MajorTopicYN="N">Clinical trials as topic</Keyword><Keyword MajorTopicYN="N">Heart failure</Keyword><Keyword MajorTopicYN="N">Hyperkalemia</Keyword><Keyword MajorTopicYN="N">Polymers</Keyword><Keyword MajorTopicYN="N">Renal insufficiency</Keyword><Keyword MajorTopicYN="N">Renin–angiotensin system</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>4</Month><Day>12</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>4</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>5</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>5</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>5</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pii">S0167-5273(16)30827-0</ArticleId><ArticleId IdType="doi">10.1016/j.ijcard.2016.04.127</ArticleId><ArticleId IdType="pubmed">27140336</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Espagne</li><li>France</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Communauté de Madrid</li><li>Grand Est</li><li>Grand Londres</li><li>Lorraine (région)</li><li>Île-de-France</li></region><settlement><li>Londres</li><li>Madrid</li><li>Nancy</li><li>Paris</li></settlement><orgName><li>Université de Lorraine</li></orgName></list><tree><country name="France"><region name="Grand Est"><name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name></region><name sortKey="Mebazaa, Alexandre" sort="Mebazaa, Alexandre" uniqKey="Mebazaa A" first="Alexandre" last="Mebazaa">Alexandre Mebazaa</name><name sortKey="Rossignol, Patrick" sort="Rossignol, Patrick" uniqKey="Rossignol P" first="Patrick" last="Rossignol">Patrick Rossignol</name></country><country name="États-Unis"><noRegion><name sortKey="Stough, Wendy Gattis" sort="Stough, Wendy Gattis" uniqKey="Stough W" first="Wendy Gattis" last="Stough">Wendy Gattis Stough</name></noRegion><name sortKey="Bakris, George L" sort="Bakris, George L" uniqKey="Bakris G" first="George L" last="Bakris">George L. Bakris</name><name sortKey="Berman, Lance" sort="Berman, Lance" uniqKey="Berman L" first="Lance" last="Berman">Lance Berman</name><name sortKey="Butler, Javed" sort="Butler, Javed" uniqKey="Butler J" first="Javed" last="Butler">Javed Butler</name><name sortKey="Epstein, Murray" sort="Epstein, Murray" uniqKey="Epstein M" first="Murray" last="Epstein">Murray Epstein</name><name sortKey="Kosiborod, Mikhail" sort="Kosiborod, Mikhail" uniqKey="Kosiborod M" first="Mikhail" last="Kosiborod">Mikhail Kosiborod</name><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name><name sortKey="Rasmussen, Henrik S" sort="Rasmussen, Henrik S" uniqKey="Rasmussen H" first="Henrik S" last="Rasmussen">Henrik S. Rasmussen</name><name sortKey="Stockbridge, Norman" sort="Stockbridge, Norman" uniqKey="Stockbridge N" first="Norman" last="Stockbridge">Norman Stockbridge</name><name sortKey="Thompson, Aliza" sort="Thompson, Aliza" uniqKey="Thompson A" first="Aliza" last="Thompson">Aliza Thompson</name><name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Alonso Garcia, Maria De Los Angeles" sort="Alonso Garcia, Maria De Los Angeles" uniqKey="Alonso Garcia M" first="Maria De Los Angeles" last="Alonso Garcia">Maria De Los Angeles Alonso Garcia</name></region></country><country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Ruilope, Luis M" sort="Ruilope, Luis M" uniqKey="Ruilope L" first="Luis M" last="Ruilope">Luis M. Ruilope</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Lorraine/explor/InforLorV4/Data/PubMed/Checkpoint
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000011 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/PubMed/Checkpoint/biblio.hfd -nk 000011 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Lorraine
|area= InforLorV4
|flux= PubMed
|étape= Checkpoint
|type= RBID
|clé= pubmed:27140336
|texte= New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/PubMed/Checkpoint/RBID.i -Sk "pubmed:27140336" \
| HfdSelect -Kh $EXPLOR_AREA/Data/PubMed/Checkpoint/biblio.hfd \
| NlmPubMed2Wicri -a InforLorV4
| This area was generated with Dilib version V0.6.33. |  |