New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval.
Identifieur interne : 000001 ( PubMed/Corpus ); précédent : 000000; suivant : 000002New approaches to hyperkalemia in patients with indications for renin angiotensin aldosterone inhibitors: Considerations for trial design and regulatory approval.
Auteurs : Faiez Zannad ; Patrick Rossignol ; Wendy Gattis Stough ; Murray Epstein ; Maria De Los Angeles Alonso Garcia ; George L. Bakris ; Javed Butler ; Mikhail Kosiborod ; Lance Berman ; Alexandre Mebazaa ; Henrik S. Rasmussen ; Luis M. Ruilope ; Norman Stockbridge ; Aliza Thompson ; Janet Wittes ; Bertram PittSource :
- 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
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Electronic address: f.zannad@chu-nancy.fr.</nlm:affiliation></affiliation></author><author><name sortKey="Rossignol, Patrick" sort="Rossignol, Patrick" uniqKey="Rossignol P" first="Patrick" last="Rossignol">Patrick Rossignol</name><affiliation><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></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><nlm:affiliation>Campbell University College of Pharmacy and Health Sciences, NC, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Epstein, Murray" sort="Epstein, Murray" uniqKey="Epstein M" first="Murray" last="Epstein">Murray Epstein</name><affiliation><nlm:affiliation>Division of Nephrology and Hypertension, University of Miami, Miller School of Medicine, Miami, FL, United States.</nlm:affiliation></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><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></affiliation></author><author><name sortKey="Bakris, George L" sort="Bakris, George L" uniqKey="Bakris G" first="George L" last="Bakris">George L. 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Electronic address: f.zannad@chu-nancy.fr.</nlm:affiliation></affiliation></author><author><name sortKey="Rossignol, Patrick" sort="Rossignol, Patrick" uniqKey="Rossignol P" first="Patrick" last="Rossignol">Patrick Rossignol</name><affiliation><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></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><nlm:affiliation>Campbell University College of Pharmacy and Health Sciences, NC, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Epstein, Murray" sort="Epstein, Murray" uniqKey="Epstein M" first="Murray" last="Epstein">Murray Epstein</name><affiliation><nlm:affiliation>Division of Nephrology and Hypertension, University of Miami, Miller School of Medicine, Miami, FL, United States.</nlm:affiliation></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><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></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><nlm:affiliation>Department of Medicine, University of Chicago Medicine, Chicago, IL, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Butler, Javed" sort="Butler, Javed" uniqKey="Butler J" first="Javed" last="Butler">Javed Butler</name><affiliation><nlm:affiliation>Stony Brook Heart Institute, Stony Brook University School of Medicine, Stony Brook, NY, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Kosiborod, Mikhail" sort="Kosiborod, Mikhail" uniqKey="Kosiborod M" first="Mikhail" last="Kosiborod">Mikhail Kosiborod</name><affiliation><nlm:affiliation>Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Berman, Lance" sort="Berman, Lance" uniqKey="Berman L" first="Lance" last="Berman">Lance Berman</name><affiliation><nlm:affiliation>Relypsa, Redwood City, CA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Mebazaa, Alexandre" sort="Mebazaa, Alexandre" uniqKey="Mebazaa A" first="Alexandre" last="Mebazaa">Alexandre Mebazaa</name><affiliation><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></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><nlm:affiliation>ZS Pharma, Coppell, TX, United States.</nlm:affiliation></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><nlm:affiliation>Institute of Investigation and Hypertension Unit, Hospital 12 de Octubre, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Stockbridge, Norman" sort="Stockbridge, Norman" uniqKey="Stockbridge N" first="Norman" last="Stockbridge">Norman Stockbridge</name><affiliation><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></affiliation></author><author><name sortKey="Thompson, Aliza" sort="Thompson, Aliza" uniqKey="Thompson A" first="Aliza" last="Thompson">Aliza Thompson</name><affiliation><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></affiliation></author><author><name sortKey="Wittes, Janet" sort="Wittes, Janet" uniqKey="Wittes J" first="Janet" last="Wittes">Janet Wittes</name><affiliation><nlm:affiliation>Statistics Collaborative, Inc., Washington, D.C., United States.</nlm:affiliation></affiliation></author><author><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name><affiliation><nlm:affiliation>University of Michigan School of Medicine, Ann Arbor, MI, United States.</nlm:affiliation></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 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