Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial
Identifieur interne : 004495 ( Main/Exploration ); précédent : 004494; suivant : 004496Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial
Auteurs : Bertram Pitt [États-Unis] ; Lars Kober [Danemark] ; Piotr Ponikowski [Pologne] ; Mihai Gheorghiade [États-Unis] ; Gerasimos Filippatos [Grèce] ; Henry Krum [Australie] ; Christina Nowack [Allemagne] ; Peter Kolkhof [Allemagne] ; So-Young Kim [Allemagne] ; Faiez Zannad [France]Source :
- European Heart Journal [ 0195-668X ] ; 2013.
Abstract
Mineralocorticoid receptor antagonists (MRAs) improve outcomes in patients with heart failure and reduced left ventricular ejection fraction (HFrEF), but their use is limited by hyperkalaemia and/or worsening renal function (WRF). BAY 94-8862 is a highly selective and strongly potent non-steroidal MRA. We investigated its safety and tolerability in patients with HFrEF associated with mild or moderate chronic kidney disease (CKD).
This randomized, controlled, phase II trial consisted of two parts. In part A, the safety and tolerability of oral BAY 94-8862 [2.5, 5, or 10 mg once daily (q.d.)] was assessed in 65 patients with HFrEF and mild CKD. In part B, BAY 94-8862 (2.5, 5, or 10 mg q.d., or 5 mg twice daily) was compared with placebo and open-label spironolactone (25 or 50 mg/day) in 392 patients with HFrEF and moderate CKD. BAY 94-8862 was associated with significantly smaller mean increases in serum potassium concentration than spironolactone (0.04–0.30 and 0.45 mmol/L, respectively,
In patients with HFrEF and moderate CKD, BAY 94-8862 5–10 mg/day was at least as effective as spironolactone 25 or 50 mg/day in decreasing biomarkers of haemodynamic stress, but it was associated with lower incidences of hyperkalaemia and WRF.
Url:
DOI: 10.1093/eurheartj/eht187
PubMed: 23713082
PubMed Central: 3743070
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial</title><author><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name><affiliation wicri:level="1"><nlm:aff id="af1"><institution>University of Michigan School of Medicine</institution>,<addr-line>Ann Arbor, MI</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kober, Lars" sort="Kober, Lars" uniqKey="Kober L" first="Lars" last="Kober">Lars Kober</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Heart Centre, Rigshospitalet, University of Copenhagen</institution>,<addr-line>Copenhagen</addr-line>,<country>Denmark</country></nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Medical University, Clinical Military Hospital</institution>,<addr-line>Wroclaw</addr-line>,<country>Poland</country></nlm:aff><country xml:lang="fr">Pologne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gheorghiade, Mihai" sort="Gheorghiade, Mihai" uniqKey="Gheorghiade M" first="Mihai" last="Gheorghiade">Mihai Gheorghiade</name><affiliation wicri:level="1"><nlm:aff id="af4"><institution>Center for Cardiovascular Innovation, Northwestern University Feinberg School of 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Cardiology</addr-line>,<institution>Université de Lorraine</institution>,<addr-line>Nancy</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">23713082</idno><idno type="pmc">3743070</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3743070</idno><idno type="RBID">PMC:3743070</idno><idno type="doi">10.1093/eurheartj/eht187</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">002461</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002461</idno><idno type="wicri:Area/Pmc/Curation">002311</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002311</idno><idno type="wicri:Area/Pmc/Checkpoint">001893</idno><idno type="wicri:explorRef" wicri:stream="Pmc" 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Arbor, MI</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kober, Lars" sort="Kober, Lars" uniqKey="Kober L" first="Lars" last="Kober">Lars Kober</name><affiliation wicri:level="1"><nlm:aff id="af2"><institution>Heart Centre, Rigshospitalet, University of Copenhagen</institution>,<addr-line>Copenhagen</addr-line>,<country>Denmark</country></nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name><affiliation wicri:level="1"><nlm:aff id="af3"><institution>Medical University, Clinical Military Hospital</institution>,<addr-line>Wroclaw</addr-line>,<country>Poland</country></nlm:aff><country xml:lang="fr">Pologne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gheorghiade, Mihai" sort="Gheorghiade, Mihai" uniqKey="Gheorghiade M" first="Mihai" last="Gheorghiade">Mihai Gheorghiade</name><affiliation wicri:level="1"><nlm:aff id="af4"><institution>Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine</institution>,<addr-line>Chicago, IL</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Filippatos, Gerasimos" sort="Filippatos, Gerasimos" uniqKey="Filippatos G" first="Gerasimos" last="Filippatos">Gerasimos Filippatos</name><affiliation wicri:level="1"><nlm:aff id="af5"><addr-line>Heart Failure Unit, Department of Cardiology</addr-line>,<institution>Attikon University Hospital</institution>,<addr-line>Athens</addr-line>,<country>Greece</country></nlm:aff><country xml:lang="fr">Grèce</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Krum, Henry" sort="Krum, Henry" uniqKey="Krum H" first="Henry" last="Krum">Henry Krum</name><affiliation wicri:level="1"><nlm:aff id="af6"><addr-line>Department of Epidemiology and Preventive Medicine</addr-line>,<institution>Centre of Cardiovascular Research and Education in Therapeutics, Monash University</institution>,<addr-line>Melbourne, VIC</addr-line>,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Nowack, Christina" sort="Nowack, Christina" uniqKey="Nowack C" first="Christina" last="Nowack">Christina Nowack</name><affiliation wicri:level="1"><nlm:aff id="af7"><addr-line>Global Clinical Development</addr-line>,<institution>Bayer Pharma AG</institution>,<addr-line>Wuppertal</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kolkhof, Peter" sort="Kolkhof, Peter" uniqKey="Kolkhof P" first="Peter" last="Kolkhof">Peter Kolkhof</name><affiliation wicri:level="1"><nlm:aff id="af8"><addr-line>Cardiology Research, Global Drug Development</addr-line>,<institution>Bayer Pharma AG</institution>,<addr-line>Wuppertal</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kim, So Young" sort="Kim, So Young" uniqKey="Kim S" first="So-Young" last="Kim">So-Young Kim</name><affiliation wicri:level="1"><nlm:aff id="af9"><institution>Bayer Vital GmbH, Bayer HealthCare</institution>,<addr-line>Leverkusen</addr-line>,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name><affiliation wicri:level="1"><nlm:aff id="af10"><addr-line>INSERM, Centre d'investigation clinique 9501 and Unit 961, CHU Department of Cardiology</addr-line>,<institution>Université de Lorraine</institution>,<addr-line>Nancy</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">European Heart Journal</title><idno type="ISSN">0195-668X</idno><idno type="eISSN">1522-9645</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Aims</title><p>Mineralocorticoid receptor antagonists (MRAs) improve outcomes in patients with heart failure and reduced left ventricular ejection fraction (HFrEF), but their use is limited by hyperkalaemia and/or worsening renal function (WRF). BAY 94-8862 is a highly selective and strongly potent non-steroidal MRA. We investigated its safety and tolerability in patients with HFrEF associated with mild or moderate chronic kidney disease (CKD).</p></sec><sec><title>Methods and results</title><p>This randomized, controlled, phase II trial consisted of two parts. In part A, the safety and tolerability of oral BAY 94-8862 [2.5, 5, or 10 mg once daily (q.d.)] was assessed in 65 patients with HFrEF and mild CKD. In part B, BAY 94-8862 (2.5, 5, or 10 mg q.d., or 5 mg twice daily) was compared with placebo and open-label spironolactone (25 or 50 mg/day) in 392 patients with HFrEF and moderate CKD. BAY 94-8862 was associated with significantly smaller mean increases in serum potassium concentration than spironolactone (0.04–0.30 and 0.45 mmol/L, respectively, <italic>P</italic> < 0.0001–0.0107) and lower incidences of hyperkalaemia (5.3 and 12.7%, respectively, <italic>P</italic> = 0.048) and WRF. BAY 94-8862 decreased the levels of B-type natriuretic peptide (BNP), amino-terminal proBNP, and albuminuria at least as much as spironolactone. Adverse events related to BAY 94-8862 were infrequent and mostly mild.</p></sec><sec><title>Conclusion</title><p>In patients with HFrEF and moderate CKD, BAY 94-8862 5–10 mg/day was at least as effective as spironolactone 25 or 50 mg/day in decreasing biomarkers of haemodynamic stress, but it was associated with lower incidences of hyperkalaemia and WRF.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Zannad, F" uniqKey="Zannad F">F Zannad</name></author><author><name sortKey="Mcmurray, Jj" uniqKey="Mcmurray J">JJ McMurray</name></author><author><name sortKey="Krum, H" uniqKey="Krum H">H Krum</name></author><author><name sortKey="Van Veldhuisen, Dj" uniqKey="Van Veldhuisen D">DJ van Veldhuisen</name></author><author><name sortKey="Swedberg, K" uniqKey="Swedberg K">K Swedberg</name></author><author><name sortKey="Shi, H" uniqKey="Shi H">H Shi</name></author><author><name sortKey="Vincent, J" uniqKey="Vincent J">J 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uniqKey="Krum H">H Krum</name></author><author><name sortKey="Ponikowski, P" uniqKey="Ponikowski P">P Ponikowski</name></author><author><name sortKey="Nowack, C" uniqKey="Nowack C">C Nowack</name></author><author><name sortKey="Kolkhof, P" uniqKey="Kolkhof P">P Kolkhof</name></author><author><name sortKey="Kim, Sy" uniqKey="Kim S">SY Kim</name></author><author><name sortKey="Zannad, F" uniqKey="Zannad F">F Zannad</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Pitt, B" uniqKey="Pitt B">B Pitt</name></author><author><name sortKey="Anker, Sd" uniqKey="Anker S">SD Anker</name></author><author><name sortKey="Bushinsky, Da" uniqKey="Bushinsky D">DA Bushinsky</name></author><author><name sortKey="Kitzman, Dw" uniqKey="Kitzman D">DW Kitzman</name></author><author><name sortKey="Zannad, F" uniqKey="Zannad F">F Zannad</name></author><author><name sortKey="Huang, Iz" uniqKey="Huang I">IZ Huang</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Mak, G" uniqKey="Mak G">G Mak</name></author><author><name sortKey="Murphy, Nf" uniqKey="Murphy N">NF Murphy</name></author><author><name sortKey="Ali, A" uniqKey="Ali A">A Ali</name></author><author><name sortKey="Walsh, A" uniqKey="Walsh A">A Walsh</name></author><author><name sortKey="O Loughlin, C" uniqKey="O Loughlin C">C O'Loughlin</name></author><author><name sortKey="Conlon, C" uniqKey="Conlon C">C Conlon</name></author><author><name sortKey="Mccaffrey, D" uniqKey="Mccaffrey D">D McCaffrey</name></author><author><name sortKey="Ledwidge, M" uniqKey="Ledwidge M">M Ledwidge</name></author><author><name sortKey="Mcdonald, K" uniqKey="Mcdonald K">K McDonald</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Pitt, B" uniqKey="Pitt B">B Pitt</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Nishizaka, Mk" uniqKey="Nishizaka M">MK 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Kolkhof</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Lentini, S" uniqKey="Lentini S">S Lentini</name></author><author><name sortKey="Kimmeskamp Kirschbaum, N" uniqKey="Kimmeskamp Kirschbaum N">N Kimmeskamp-Kirschbaum</name></author><author><name sortKey="Wensing, G" uniqKey="Wensing G">G Wensing</name></author><author><name sortKey="Heinig, R" uniqKey="Heinig R">R Heinig</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Zannad, F" uniqKey="Zannad F">F Zannad</name></author><author><name sortKey="Mcmurray, Jj" uniqKey="Mcmurray J">JJ McMurray</name></author><author><name sortKey="Drexler, H" uniqKey="Drexler H">H Drexler</name></author><author><name sortKey="Krum, H" uniqKey="Krum H">H Krum</name></author><author><name sortKey="Van Veldhuisen, Dj" uniqKey="Van Veldhuisen D">DJ van Veldhuisen</name></author><author><name sortKey="Swedberg, K" uniqKey="Swedberg K">K Swedberg</name></author><author><name sortKey="Shi, H" uniqKey="Shi H">H Shi</name></author><author><name sortKey="Vincent, J" uniqKey="Vincent J">J Vincent</name></author><author><name sortKey="Pitt, B" uniqKey="Pitt B">B Pitt</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Pitt, B" uniqKey="Pitt B">B Pitt</name></author><author><name sortKey="Remme, W" uniqKey="Remme W">W Remme</name></author><author><name sortKey="Zannad, F" uniqKey="Zannad F">F Zannad</name></author><author><name sortKey="Neaton, J" uniqKey="Neaton J">J Neaton</name></author><author><name sortKey="Martinez, F" uniqKey="Martinez F">F Martinez</name></author><author><name sortKey="Roniker, B" uniqKey="Roniker B">B Roniker</name></author><author><name sortKey="Bittman, R" uniqKey="Bittman R">R Bittman</name></author><author><name sortKey="Hurley, S" uniqKey="Hurley S">S Hurley</name></author><author><name sortKey="Kleiman, J" uniqKey="Kleiman J">J Kleiman</name></author><author><name sortKey="Gatlin, M" uniqKey="Gatlin M">M Gatlin</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Danemark</li><li>France</li><li>Grèce</li><li>Pologne</li><li>États-Unis</li></country></list><tree><country name="États-Unis"><noRegion><name sortKey="Pitt, Bertram" sort="Pitt, Bertram" uniqKey="Pitt B" first="Bertram" last="Pitt">Bertram Pitt</name></noRegion><name sortKey="Gheorghiade, Mihai" sort="Gheorghiade, Mihai" uniqKey="Gheorghiade M" first="Mihai" last="Gheorghiade">Mihai Gheorghiade</name></country><country name="Danemark"><noRegion><name sortKey="Kober, Lars" sort="Kober, Lars" uniqKey="Kober L" first="Lars" last="Kober">Lars Kober</name></noRegion></country><country name="Pologne"><noRegion><name sortKey="Ponikowski, Piotr" sort="Ponikowski, Piotr" uniqKey="Ponikowski P" first="Piotr" last="Ponikowski">Piotr Ponikowski</name></noRegion></country><country name="Grèce"><noRegion><name sortKey="Filippatos, Gerasimos" sort="Filippatos, Gerasimos" uniqKey="Filippatos G" first="Gerasimos" last="Filippatos">Gerasimos Filippatos</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Krum, Henry" sort="Krum, Henry" uniqKey="Krum H" first="Henry" last="Krum">Henry Krum</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Nowack, Christina" sort="Nowack, Christina" uniqKey="Nowack C" first="Christina" last="Nowack">Christina Nowack</name></noRegion><name sortKey="Kim, So Young" sort="Kim, So Young" uniqKey="Kim S" first="So-Young" last="Kim">So-Young Kim</name><name sortKey="Kolkhof, Peter" sort="Kolkhof, Peter" uniqKey="Kolkhof P" first="Peter" last="Kolkhof">Peter Kolkhof</name></country><country name="France"><noRegion><name sortKey="Zannad, Faiez" sort="Zannad, Faiez" uniqKey="Zannad F" first="Faiez" last="Zannad">Faiez Zannad</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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