In-hospital initiation of angiotensin receptor-neprilysin inhibition in acute heart failure: the PREMIER trial
The efficacy and safety of early sacubitril/valsartan (Sac/Val) initiation after acute heart failure (AHF) has not been demonstrated outside North America. The present study aimed to evaluate the effect of in-hospital Sac/Val therapy initiation after an AHF episode on N-terminal pro-B-type natriuret...
Gespeichert in:
| Veröffentlicht in: | European heart journal 2024-11, Vol.45 (42), p.4482-4493 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 4493 |
|---|---|
| container_issue | 42 |
| container_start_page | 4482 |
| container_title | European heart journal |
| container_volume | 45 |
| creator | Tanaka, Atsushi Kida, Keisuke Matsue, Yuya Imai, Takumi Suwa, Satoru Taguchi, Isao Hisauchi, Itaru Teragawa, Hiroki Yazaki, Yoshiyuki Moroi, Masao Ohashi, Koichi Nagatomo, Daisuke Kubota, Toru Ijichi, Takeshi Ikari, Yuji Yonezu, Keisuke Takahashi, Naohiko Toyoda, Shigeru Toshida, Tsutomu Suzuki, Hiroshi Minamino, Tohru Nogi, Kazutaka Shiina, Kazuki Horiuchi, Yu Tanabe, Kengo Hachinohe, Daisuke Kiuchi, Shunsuke Kusunose, Kenya Shimabukuro, Michio Node, Koichi |
| description | The efficacy and safety of early sacubitril/valsartan (Sac/Val) initiation after acute heart failure (AHF) has not been demonstrated outside North America. The present study aimed to evaluate the effect of in-hospital Sac/Val therapy initiation after an AHF episode on N-terminal pro-B-type natriuretic peptide (NT-proBNP) level in Japanese patients.
This was an investigator-initiated, multicentre, prospective, randomized, open-label, blinded-endpoint pragmatic trial. After haemodynamic stabilization within 7 days after hospitalization, eligible inpatients were allocated to switch from angiotensin-converting enzyme inhibitor or angiotensin receptor blocker to Sac/Val (Sac/Val group) or to continue angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (control group). The primary efficacy endpoint was the 8-week proportional change in geometric means of NT-proBNP levels.
A total of 400 patients were equally randomized, and 376 (median age 75 years, 31.9% women, de novo heart failure rate 55.6%, and median left ventricular ejection fraction 37%) were analysed. The per cent changes in NT-proBNP level geometric means at Weeks 4/8 were -35%/-45% (Sac/Val group) and -18%/-32% (control group), and their group ratio (Sac/Val vs. control) was 0.80 (95% confidence interval 0.68-0.94; P = .008) at Week 4 and 0.81 (95% confidence interval 0.68-0.95; P = .012) at Week 8, respectively. In the pre-specified subgroup analyses, the effects of Sac/Val were confined to patients with a left ventricular ejection fraction < 40% and were more evident in those in sinus rhythm and taking mineralocorticoid receptor antagonists. No adverse safety signal was evident.
In-hospital Sac/Val therapy initiation in addition to contemporary recommended therapy triggered a greater NT-proBNP level reduction in Japanese patients hospitalized for AHF. These findings may expand the evidence on Sac/Val therapy in this clinical situation outside North America.
ClinicalTrial.gov (NCT05164653) and Japan Registry of Clinical Trials (jRCTs021210046). |
| doi_str_mv | 10.1093/eurheartj/ehae561 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11544311</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3099805962</sourcerecordid><originalsourceid>FETCH-LOGICAL-c282t-f1c990008d5ca32c68c515b7d3114940c104238166c47c61e33883b388a4548e3</originalsourceid><addsrcrecordid>eNpVUU1PGzEQtVArCLQ_gAvysZcFz_oDu5eqQmmJRNUKtVJvluPMskYbO7W9SPz7biBEcJnRzLx570mPkFNg58AMv8Ax9-hyvb_A3qFUcEBmINu2MUrId2TGwMhGKf33iByXcs8Y0wrUITnipgUpOcxIXMSmT2UTqhtoiKEGV0OKNHXUxbuQKsYSIs3ocVNTbiJuchget7sQ-7AMT-hpcn6sSJ_s0M6FYcz4mdYe6a_b-Y_F_JbWHNzwgbzv3FDw466fkD_f5r-vrpubn98XV19vGt_qtjYdeGO2dlfSO956pb0EubxccQBhBPPARMs1KOXFpVeAnGvNl1NxQgqN_IR8eebdjMs1rjzGmt1gJ-9rlx9tcsG-vcTQ27v0YAGkEJPKxPBpx5DTvxFLtetQPA6Di5jGYjkzRjNpVDtB4RnqcyolY7fXAWa3Qdl9UHYX1PRz9trg_uMlGf4fnBeUTQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3099805962</pqid></control><display><type>article</type><title>In-hospital initiation of angiotensin receptor-neprilysin inhibition in acute heart failure: the PREMIER trial</title><source>Oxford University Press Journals All Titles (1996-Current)</source><source>MEDLINE</source><creator>Tanaka, Atsushi ; Kida, Keisuke ; Matsue, Yuya ; Imai, Takumi ; Suwa, Satoru ; Taguchi, Isao ; Hisauchi, Itaru ; Teragawa, Hiroki ; Yazaki, Yoshiyuki ; Moroi, Masao ; Ohashi, Koichi ; Nagatomo, Daisuke ; Kubota, Toru ; Ijichi, Takeshi ; Ikari, Yuji ; Yonezu, Keisuke ; Takahashi, Naohiko ; Toyoda, Shigeru ; Toshida, Tsutomu ; Suzuki, Hiroshi ; Minamino, Tohru ; Nogi, Kazutaka ; Shiina, Kazuki ; Horiuchi, Yu ; Tanabe, Kengo ; Hachinohe, Daisuke ; Kiuchi, Shunsuke ; Kusunose, Kenya ; Shimabukuro, Michio ; Node, Koichi</creator><creatorcontrib>Tanaka, Atsushi ; Kida, Keisuke ; Matsue, Yuya ; Imai, Takumi ; Suwa, Satoru ; Taguchi, Isao ; Hisauchi, Itaru ; Teragawa, Hiroki ; Yazaki, Yoshiyuki ; Moroi, Masao ; Ohashi, Koichi ; Nagatomo, Daisuke ; Kubota, Toru ; Ijichi, Takeshi ; Ikari, Yuji ; Yonezu, Keisuke ; Takahashi, Naohiko ; Toyoda, Shigeru ; Toshida, Tsutomu ; Suzuki, Hiroshi ; Minamino, Tohru ; Nogi, Kazutaka ; Shiina, Kazuki ; Horiuchi, Yu ; Tanabe, Kengo ; Hachinohe, Daisuke ; Kiuchi, Shunsuke ; Kusunose, Kenya ; Shimabukuro, Michio ; Node, Koichi</creatorcontrib><description>The efficacy and safety of early sacubitril/valsartan (Sac/Val) initiation after acute heart failure (AHF) has not been demonstrated outside North America. The present study aimed to evaluate the effect of in-hospital Sac/Val therapy initiation after an AHF episode on N-terminal pro-B-type natriuretic peptide (NT-proBNP) level in Japanese patients.
This was an investigator-initiated, multicentre, prospective, randomized, open-label, blinded-endpoint pragmatic trial. After haemodynamic stabilization within 7 days after hospitalization, eligible inpatients were allocated to switch from angiotensin-converting enzyme inhibitor or angiotensin receptor blocker to Sac/Val (Sac/Val group) or to continue angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (control group). The primary efficacy endpoint was the 8-week proportional change in geometric means of NT-proBNP levels.
A total of 400 patients were equally randomized, and 376 (median age 75 years, 31.9% women, de novo heart failure rate 55.6%, and median left ventricular ejection fraction 37%) were analysed. The per cent changes in NT-proBNP level geometric means at Weeks 4/8 were -35%/-45% (Sac/Val group) and -18%/-32% (control group), and their group ratio (Sac/Val vs. control) was 0.80 (95% confidence interval 0.68-0.94; P = .008) at Week 4 and 0.81 (95% confidence interval 0.68-0.95; P = .012) at Week 8, respectively. In the pre-specified subgroup analyses, the effects of Sac/Val were confined to patients with a left ventricular ejection fraction < 40% and were more evident in those in sinus rhythm and taking mineralocorticoid receptor antagonists. No adverse safety signal was evident.
In-hospital Sac/Val therapy initiation in addition to contemporary recommended therapy triggered a greater NT-proBNP level reduction in Japanese patients hospitalized for AHF. These findings may expand the evidence on Sac/Val therapy in this clinical situation outside North America.
ClinicalTrial.gov (NCT05164653) and Japan Registry of Clinical Trials (jRCTs021210046).</description><identifier>ISSN: 0195-668X</identifier><identifier>ISSN: 1522-9645</identifier><identifier>EISSN: 1522-9645</identifier><identifier>DOI: 10.1093/eurheartj/ehae561</identifier><identifier>PMID: 39215531</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Acute Disease ; Aged ; Aged, 80 and over ; Aminobutyrates - therapeutic use ; Angiotensin Receptor Antagonists - therapeutic use ; Angiotensin-Converting Enzyme Inhibitors - therapeutic use ; Biphenyl Compounds - therapeutic use ; Drug Combinations ; Fast Track – Clinical Research ; Female ; Heart Failure - drug therapy ; Hospitalization - statistics & numerical data ; Humans ; Male ; Middle Aged ; Natriuretic Peptide, Brain - blood ; Natriuretic Peptide, Brain - metabolism ; Neprilysin - antagonists & inhibitors ; Peptide Fragments - blood ; Prospective Studies ; Tetrazoles - therapeutic use ; Treatment Outcome ; Valsartan</subject><ispartof>European heart journal, 2024-11, Vol.45 (42), p.4482-4493</ispartof><rights>The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.</rights><rights>The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c282t-f1c990008d5ca32c68c515b7d3114940c104238166c47c61e33883b388a4548e3</cites><orcidid>0000-0001-7835-7665 ; 0000-0002-4909-754X ; 0000-0002-0183-2541 ; 0000-0001-9037-0010 ; 0000-0003-3352-7661 ; 0000-0002-2534-0939</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39215531$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tanaka, Atsushi</creatorcontrib><creatorcontrib>Kida, Keisuke</creatorcontrib><creatorcontrib>Matsue, Yuya</creatorcontrib><creatorcontrib>Imai, Takumi</creatorcontrib><creatorcontrib>Suwa, Satoru</creatorcontrib><creatorcontrib>Taguchi, Isao</creatorcontrib><creatorcontrib>Hisauchi, Itaru</creatorcontrib><creatorcontrib>Teragawa, Hiroki</creatorcontrib><creatorcontrib>Yazaki, Yoshiyuki</creatorcontrib><creatorcontrib>Moroi, Masao</creatorcontrib><creatorcontrib>Ohashi, Koichi</creatorcontrib><creatorcontrib>Nagatomo, Daisuke</creatorcontrib><creatorcontrib>Kubota, Toru</creatorcontrib><creatorcontrib>Ijichi, Takeshi</creatorcontrib><creatorcontrib>Ikari, Yuji</creatorcontrib><creatorcontrib>Yonezu, Keisuke</creatorcontrib><creatorcontrib>Takahashi, Naohiko</creatorcontrib><creatorcontrib>Toyoda, Shigeru</creatorcontrib><creatorcontrib>Toshida, Tsutomu</creatorcontrib><creatorcontrib>Suzuki, Hiroshi</creatorcontrib><creatorcontrib>Minamino, Tohru</creatorcontrib><creatorcontrib>Nogi, Kazutaka</creatorcontrib><creatorcontrib>Shiina, Kazuki</creatorcontrib><creatorcontrib>Horiuchi, Yu</creatorcontrib><creatorcontrib>Tanabe, Kengo</creatorcontrib><creatorcontrib>Hachinohe, Daisuke</creatorcontrib><creatorcontrib>Kiuchi, Shunsuke</creatorcontrib><creatorcontrib>Kusunose, Kenya</creatorcontrib><creatorcontrib>Shimabukuro, Michio</creatorcontrib><creatorcontrib>Node, Koichi</creatorcontrib><title>In-hospital initiation of angiotensin receptor-neprilysin inhibition in acute heart failure: the PREMIER trial</title><title>European heart journal</title><addtitle>Eur Heart J</addtitle><description>The efficacy and safety of early sacubitril/valsartan (Sac/Val) initiation after acute heart failure (AHF) has not been demonstrated outside North America. The present study aimed to evaluate the effect of in-hospital Sac/Val therapy initiation after an AHF episode on N-terminal pro-B-type natriuretic peptide (NT-proBNP) level in Japanese patients.
This was an investigator-initiated, multicentre, prospective, randomized, open-label, blinded-endpoint pragmatic trial. After haemodynamic stabilization within 7 days after hospitalization, eligible inpatients were allocated to switch from angiotensin-converting enzyme inhibitor or angiotensin receptor blocker to Sac/Val (Sac/Val group) or to continue angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (control group). The primary efficacy endpoint was the 8-week proportional change in geometric means of NT-proBNP levels.
A total of 400 patients were equally randomized, and 376 (median age 75 years, 31.9% women, de novo heart failure rate 55.6%, and median left ventricular ejection fraction 37%) were analysed. The per cent changes in NT-proBNP level geometric means at Weeks 4/8 were -35%/-45% (Sac/Val group) and -18%/-32% (control group), and their group ratio (Sac/Val vs. control) was 0.80 (95% confidence interval 0.68-0.94; P = .008) at Week 4 and 0.81 (95% confidence interval 0.68-0.95; P = .012) at Week 8, respectively. In the pre-specified subgroup analyses, the effects of Sac/Val were confined to patients with a left ventricular ejection fraction < 40% and were more evident in those in sinus rhythm and taking mineralocorticoid receptor antagonists. No adverse safety signal was evident.
In-hospital Sac/Val therapy initiation in addition to contemporary recommended therapy triggered a greater NT-proBNP level reduction in Japanese patients hospitalized for AHF. These findings may expand the evidence on Sac/Val therapy in this clinical situation outside North America.
ClinicalTrial.gov (NCT05164653) and Japan Registry of Clinical Trials (jRCTs021210046).</description><subject>Acute Disease</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Aminobutyrates - therapeutic use</subject><subject>Angiotensin Receptor Antagonists - therapeutic use</subject><subject>Angiotensin-Converting Enzyme Inhibitors - therapeutic use</subject><subject>Biphenyl Compounds - therapeutic use</subject><subject>Drug Combinations</subject><subject>Fast Track – Clinical Research</subject><subject>Female</subject><subject>Heart Failure - drug therapy</subject><subject>Hospitalization - statistics & numerical data</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Natriuretic Peptide, Brain - blood</subject><subject>Natriuretic Peptide, Brain - metabolism</subject><subject>Neprilysin - antagonists & inhibitors</subject><subject>Peptide Fragments - blood</subject><subject>Prospective Studies</subject><subject>Tetrazoles - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Valsartan</subject><issn>0195-668X</issn><issn>1522-9645</issn><issn>1522-9645</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUU1PGzEQtVArCLQ_gAvysZcFz_oDu5eqQmmJRNUKtVJvluPMskYbO7W9SPz7biBEcJnRzLx570mPkFNg58AMv8Ax9-hyvb_A3qFUcEBmINu2MUrId2TGwMhGKf33iByXcs8Y0wrUITnipgUpOcxIXMSmT2UTqhtoiKEGV0OKNHXUxbuQKsYSIs3ocVNTbiJuchget7sQ-7AMT-hpcn6sSJ_s0M6FYcz4mdYe6a_b-Y_F_JbWHNzwgbzv3FDw466fkD_f5r-vrpubn98XV19vGt_qtjYdeGO2dlfSO956pb0EubxccQBhBPPARMs1KOXFpVeAnGvNl1NxQgqN_IR8eebdjMs1rjzGmt1gJ-9rlx9tcsG-vcTQ27v0YAGkEJPKxPBpx5DTvxFLtetQPA6Di5jGYjkzRjNpVDtB4RnqcyolY7fXAWa3Qdl9UHYX1PRz9trg_uMlGf4fnBeUTQ</recordid><startdate>20241108</startdate><enddate>20241108</enddate><creator>Tanaka, Atsushi</creator><creator>Kida, Keisuke</creator><creator>Matsue, Yuya</creator><creator>Imai, Takumi</creator><creator>Suwa, Satoru</creator><creator>Taguchi, Isao</creator><creator>Hisauchi, Itaru</creator><creator>Teragawa, Hiroki</creator><creator>Yazaki, Yoshiyuki</creator><creator>Moroi, Masao</creator><creator>Ohashi, Koichi</creator><creator>Nagatomo, Daisuke</creator><creator>Kubota, Toru</creator><creator>Ijichi, Takeshi</creator><creator>Ikari, Yuji</creator><creator>Yonezu, Keisuke</creator><creator>Takahashi, Naohiko</creator><creator>Toyoda, Shigeru</creator><creator>Toshida, Tsutomu</creator><creator>Suzuki, Hiroshi</creator><creator>Minamino, Tohru</creator><creator>Nogi, Kazutaka</creator><creator>Shiina, Kazuki</creator><creator>Horiuchi, Yu</creator><creator>Tanabe, Kengo</creator><creator>Hachinohe, Daisuke</creator><creator>Kiuchi, Shunsuke</creator><creator>Kusunose, Kenya</creator><creator>Shimabukuro, Michio</creator><creator>Node, Koichi</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7835-7665</orcidid><orcidid>https://orcid.org/0000-0002-4909-754X</orcidid><orcidid>https://orcid.org/0000-0002-0183-2541</orcidid><orcidid>https://orcid.org/0000-0001-9037-0010</orcidid><orcidid>https://orcid.org/0000-0003-3352-7661</orcidid><orcidid>https://orcid.org/0000-0002-2534-0939</orcidid></search><sort><creationdate>20241108</creationdate><title>In-hospital initiation of angiotensin receptor-neprilysin inhibition in acute heart failure: the PREMIER trial</title><author>Tanaka, Atsushi ; Kida, Keisuke ; Matsue, Yuya ; Imai, Takumi ; Suwa, Satoru ; Taguchi, Isao ; Hisauchi, Itaru ; Teragawa, Hiroki ; Yazaki, Yoshiyuki ; Moroi, Masao ; Ohashi, Koichi ; Nagatomo, Daisuke ; Kubota, Toru ; Ijichi, Takeshi ; Ikari, Yuji ; Yonezu, Keisuke ; Takahashi, Naohiko ; Toyoda, Shigeru ; Toshida, Tsutomu ; Suzuki, Hiroshi ; Minamino, Tohru ; Nogi, Kazutaka ; Shiina, Kazuki ; Horiuchi, Yu ; Tanabe, Kengo ; Hachinohe, Daisuke ; Kiuchi, Shunsuke ; Kusunose, Kenya ; Shimabukuro, Michio ; Node, Koichi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c282t-f1c990008d5ca32c68c515b7d3114940c104238166c47c61e33883b388a4548e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Acute Disease</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Aminobutyrates - therapeutic use</topic><topic>Angiotensin Receptor Antagonists - therapeutic use</topic><topic>Angiotensin-Converting Enzyme Inhibitors - therapeutic use</topic><topic>Biphenyl Compounds - therapeutic use</topic><topic>Drug Combinations</topic><topic>Fast Track – Clinical Research</topic><topic>Female</topic><topic>Heart Failure - drug therapy</topic><topic>Hospitalization - statistics & numerical data</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Natriuretic Peptide, Brain - blood</topic><topic>Natriuretic Peptide, Brain - metabolism</topic><topic>Neprilysin - antagonists & inhibitors</topic><topic>Peptide Fragments - blood</topic><topic>Prospective Studies</topic><topic>Tetrazoles - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Valsartan</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tanaka, Atsushi</creatorcontrib><creatorcontrib>Kida, Keisuke</creatorcontrib><creatorcontrib>Matsue, Yuya</creatorcontrib><creatorcontrib>Imai, Takumi</creatorcontrib><creatorcontrib>Suwa, Satoru</creatorcontrib><creatorcontrib>Taguchi, Isao</creatorcontrib><creatorcontrib>Hisauchi, Itaru</creatorcontrib><creatorcontrib>Teragawa, Hiroki</creatorcontrib><creatorcontrib>Yazaki, Yoshiyuki</creatorcontrib><creatorcontrib>Moroi, Masao</creatorcontrib><creatorcontrib>Ohashi, Koichi</creatorcontrib><creatorcontrib>Nagatomo, Daisuke</creatorcontrib><creatorcontrib>Kubota, Toru</creatorcontrib><creatorcontrib>Ijichi, Takeshi</creatorcontrib><creatorcontrib>Ikari, Yuji</creatorcontrib><creatorcontrib>Yonezu, Keisuke</creatorcontrib><creatorcontrib>Takahashi, Naohiko</creatorcontrib><creatorcontrib>Toyoda, Shigeru</creatorcontrib><creatorcontrib>Toshida, Tsutomu</creatorcontrib><creatorcontrib>Suzuki, Hiroshi</creatorcontrib><creatorcontrib>Minamino, Tohru</creatorcontrib><creatorcontrib>Nogi, Kazutaka</creatorcontrib><creatorcontrib>Shiina, Kazuki</creatorcontrib><creatorcontrib>Horiuchi, Yu</creatorcontrib><creatorcontrib>Tanabe, Kengo</creatorcontrib><creatorcontrib>Hachinohe, Daisuke</creatorcontrib><creatorcontrib>Kiuchi, Shunsuke</creatorcontrib><creatorcontrib>Kusunose, Kenya</creatorcontrib><creatorcontrib>Shimabukuro, Michio</creatorcontrib><creatorcontrib>Node, Koichi</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tanaka, Atsushi</au><au>Kida, Keisuke</au><au>Matsue, Yuya</au><au>Imai, Takumi</au><au>Suwa, Satoru</au><au>Taguchi, Isao</au><au>Hisauchi, Itaru</au><au>Teragawa, Hiroki</au><au>Yazaki, Yoshiyuki</au><au>Moroi, Masao</au><au>Ohashi, Koichi</au><au>Nagatomo, Daisuke</au><au>Kubota, Toru</au><au>Ijichi, Takeshi</au><au>Ikari, Yuji</au><au>Yonezu, Keisuke</au><au>Takahashi, Naohiko</au><au>Toyoda, Shigeru</au><au>Toshida, Tsutomu</au><au>Suzuki, Hiroshi</au><au>Minamino, Tohru</au><au>Nogi, Kazutaka</au><au>Shiina, Kazuki</au><au>Horiuchi, Yu</au><au>Tanabe, Kengo</au><au>Hachinohe, Daisuke</au><au>Kiuchi, Shunsuke</au><au>Kusunose, Kenya</au><au>Shimabukuro, Michio</au><au>Node, Koichi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>In-hospital initiation of angiotensin receptor-neprilysin inhibition in acute heart failure: the PREMIER trial</atitle><jtitle>European heart journal</jtitle><addtitle>Eur Heart J</addtitle><date>2024-11-08</date><risdate>2024</risdate><volume>45</volume><issue>42</issue><spage>4482</spage><epage>4493</epage><pages>4482-4493</pages><issn>0195-668X</issn><issn>1522-9645</issn><eissn>1522-9645</eissn><abstract>The efficacy and safety of early sacubitril/valsartan (Sac/Val) initiation after acute heart failure (AHF) has not been demonstrated outside North America. The present study aimed to evaluate the effect of in-hospital Sac/Val therapy initiation after an AHF episode on N-terminal pro-B-type natriuretic peptide (NT-proBNP) level in Japanese patients.
This was an investigator-initiated, multicentre, prospective, randomized, open-label, blinded-endpoint pragmatic trial. After haemodynamic stabilization within 7 days after hospitalization, eligible inpatients were allocated to switch from angiotensin-converting enzyme inhibitor or angiotensin receptor blocker to Sac/Val (Sac/Val group) or to continue angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (control group). The primary efficacy endpoint was the 8-week proportional change in geometric means of NT-proBNP levels.
A total of 400 patients were equally randomized, and 376 (median age 75 years, 31.9% women, de novo heart failure rate 55.6%, and median left ventricular ejection fraction 37%) were analysed. The per cent changes in NT-proBNP level geometric means at Weeks 4/8 were -35%/-45% (Sac/Val group) and -18%/-32% (control group), and their group ratio (Sac/Val vs. control) was 0.80 (95% confidence interval 0.68-0.94; P = .008) at Week 4 and 0.81 (95% confidence interval 0.68-0.95; P = .012) at Week 8, respectively. In the pre-specified subgroup analyses, the effects of Sac/Val were confined to patients with a left ventricular ejection fraction < 40% and were more evident in those in sinus rhythm and taking mineralocorticoid receptor antagonists. No adverse safety signal was evident.
In-hospital Sac/Val therapy initiation in addition to contemporary recommended therapy triggered a greater NT-proBNP level reduction in Japanese patients hospitalized for AHF. These findings may expand the evidence on Sac/Val therapy in this clinical situation outside North America.
ClinicalTrial.gov (NCT05164653) and Japan Registry of Clinical Trials (jRCTs021210046).</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>39215531</pmid><doi>10.1093/eurheartj/ehae561</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0001-7835-7665</orcidid><orcidid>https://orcid.org/0000-0002-4909-754X</orcidid><orcidid>https://orcid.org/0000-0002-0183-2541</orcidid><orcidid>https://orcid.org/0000-0001-9037-0010</orcidid><orcidid>https://orcid.org/0000-0003-3352-7661</orcidid><orcidid>https://orcid.org/0000-0002-2534-0939</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0195-668X |
| ispartof | European heart journal, 2024-11, Vol.45 (42), p.4482-4493 |
| issn | 0195-668X 1522-9645 1522-9645 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_11544311 |
| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE |
| subjects | Acute Disease Aged Aged, 80 and over Aminobutyrates - therapeutic use Angiotensin Receptor Antagonists - therapeutic use Angiotensin-Converting Enzyme Inhibitors - therapeutic use Biphenyl Compounds - therapeutic use Drug Combinations Fast Track – Clinical Research Female Heart Failure - drug therapy Hospitalization - statistics & numerical data Humans Male Middle Aged Natriuretic Peptide, Brain - blood Natriuretic Peptide, Brain - metabolism Neprilysin - antagonists & inhibitors Peptide Fragments - blood Prospective Studies Tetrazoles - therapeutic use Treatment Outcome Valsartan |
| title | In-hospital initiation of angiotensin receptor-neprilysin inhibition in acute heart failure: the PREMIER trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-08T21%3A55%3A47IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=In-hospital%20initiation%20of%20angiotensin%20receptor-neprilysin%20inhibition%20in%20acute%20heart%20failure:%20the%20PREMIER%20trial&rft.jtitle=European%20heart%20journal&rft.au=Tanaka,%20Atsushi&rft.date=2024-11-08&rft.volume=45&rft.issue=42&rft.spage=4482&rft.epage=4493&rft.pages=4482-4493&rft.issn=0195-668X&rft.eissn=1522-9645&rft_id=info:doi/10.1093/eurheartj/ehae561&rft_dat=%3Cproquest_pubme%3E3099805962%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3099805962&rft_id=info:pmid/39215531&rfr_iscdi=true |