An Exploratory Study of Dapagliflozin for the Attenuation of Albuminuria in Patients with Heart Failure and Type 2 Diabetes Mellitus (DAPPER)
Background and Aims Sodium-dependent glucose transporter-2 (SGLT-2) inhibitors, which are anti-diabetic drugs, reportedly decrease the incidence of cardiovascular events in high-risk patients with cardiovascular diseases, and thus chronic heart failure (CHF). SGLT-2 inhibitors also decrease albuminu...
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| Veröffentlicht in: | Cardiovascular drugs and therapy 2018-04, Vol.32 (2), p.183-190 |
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| creator | Yoshihara, Fumiki Imazu, Miki Hamasaki, Toshimitsu Anzai, Toshihisa Yasuda, Satoshi Ito, Shin Yamamoto, Haruko Hashimura, Kazuhiko Yasumura, Yoshio Mori, Kiyoshi Watanabe, Masataka Asakura, Masanori Kitakaze, Masafumi |
| description | Background and Aims
Sodium-dependent glucose transporter-2 (SGLT-2) inhibitors, which are anti-diabetic drugs, reportedly decrease the incidence of cardiovascular events in high-risk patients with cardiovascular diseases, and thus chronic heart failure (CHF). SGLT-2 inhibitors also decrease albuminuria in patients with type 2 diabetes mellitus (T2D). Since albuminuria is a biomarker of not only chronic kidney disease but also cardiovascular events, we hypothesized that, among T2D patients with CHF, SGLT-2 inhibitors will decrease the extent of albuminuria and also improve CHF concomitantly.
Methods
DAPPER (UMIN000025102) is a multicenter, randomized, open-labeled, parallel-group, standard treatment-controlled study, which is designed to evaluate whether dapagliflozin, one of the SGLT-2 inhibitors, decreases albuminuria in T2D patients with CHF and exerts cardioprotective effects on the failing heart. The patients are randomized to either of the dapagliflozin (5 or 10 mg, once daily orally) or control group (administration of anti-diabetic drugs administered other than SGLT 2 inhibitors). The estimated number of patients that need to be enrolled is 446 in total (223 in each group). The primary objective is the changes in the urinary albumin-to-creatinine ratio from the baseline after 2-year treatment. The key secondary objectives are (1) the safety of dapagliflozin and (2) the cardiovascular and renal efficacies of dapagliflozin.
Conclusion and Perspectives
DAPPER study investigates whether dapagliflozin decreases albuminuria and exerts beneficial effects on the failing heart in T2D patients. (UMIN000025102). |
| doi_str_mv | 10.1007/s10557-018-6782-1 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2019469688</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2019469688</sourcerecordid><originalsourceid>FETCH-LOGICAL-c372t-77924923a49070f9c3c3f89e4414d3b7dc50f124b5c60b4c9061bacb808cf513</originalsourceid><addsrcrecordid>eNp1kctu1DAUhi0EokPhAdggS2zKIsW3xPEy6kwvUhEjmH3kOHbrKmMHX1SGd-Cd8XTaIiGxOovznf_80gfAe4xOMUL8c8SornmFcFs1vCUVfgEWuOa04oThl2CBBEEVJag5Am9ivEPlRoj2NTgiom4FrukC_O4cXP2cJx9k8mEHv6c87qA3cClneTNZM_lf1kHjA0y3GnYpaZdlst7toW4a8ta6HKyEhVqXhXYpwnubbuGlliHBc2mnHDSUboSb3awhgUsrB510hF_0NNmUIzxZduv16tunt-CVkVPU7x7nMdicrzZnl9X114urs-66UpSTVHEuCBOESiYQR0YoqqhphWYMs5EOfFQ1MpiwoVYNGpgSqMGDVEOLWmVqTI_BySF2Dv5H1jH1WxtVKSOd9jn2BGHBGtG0bUE__oPe-RxcKfdAoabmjBUKHygVfIxBm34OdivDrseo36vqD6r6oqrfq-r3JT48Judhq8fniyc3BSAHIJaVu9Hh7-v_p_4B4pedww</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2019065744</pqid></control><display><type>article</type><title>An Exploratory Study of Dapagliflozin for the Attenuation of Albuminuria in Patients with Heart Failure and Type 2 Diabetes Mellitus (DAPPER)</title><source>MEDLINE</source><source>SpringerLink</source><creator>Yoshihara, Fumiki ; Imazu, Miki ; Hamasaki, Toshimitsu ; Anzai, Toshihisa ; Yasuda, Satoshi ; Ito, Shin ; Yamamoto, Haruko ; Hashimura, Kazuhiko ; Yasumura, Yoshio ; Mori, Kiyoshi ; Watanabe, Masataka ; Asakura, Masanori ; Kitakaze, Masafumi</creator><creatorcontrib>Yoshihara, Fumiki ; Imazu, Miki ; Hamasaki, Toshimitsu ; Anzai, Toshihisa ; Yasuda, Satoshi ; Ito, Shin ; Yamamoto, Haruko ; Hashimura, Kazuhiko ; Yasumura, Yoshio ; Mori, Kiyoshi ; Watanabe, Masataka ; Asakura, Masanori ; Kitakaze, Masafumi ; DAPPER investigators and study coordinators ; on behalf of the DAPPER investigators and study coordinators</creatorcontrib><description>Background and Aims
Sodium-dependent glucose transporter-2 (SGLT-2) inhibitors, which are anti-diabetic drugs, reportedly decrease the incidence of cardiovascular events in high-risk patients with cardiovascular diseases, and thus chronic heart failure (CHF). SGLT-2 inhibitors also decrease albuminuria in patients with type 2 diabetes mellitus (T2D). Since albuminuria is a biomarker of not only chronic kidney disease but also cardiovascular events, we hypothesized that, among T2D patients with CHF, SGLT-2 inhibitors will decrease the extent of albuminuria and also improve CHF concomitantly.
Methods
DAPPER (UMIN000025102) is a multicenter, randomized, open-labeled, parallel-group, standard treatment-controlled study, which is designed to evaluate whether dapagliflozin, one of the SGLT-2 inhibitors, decreases albuminuria in T2D patients with CHF and exerts cardioprotective effects on the failing heart. The patients are randomized to either of the dapagliflozin (5 or 10 mg, once daily orally) or control group (administration of anti-diabetic drugs administered other than SGLT 2 inhibitors). The estimated number of patients that need to be enrolled is 446 in total (223 in each group). The primary objective is the changes in the urinary albumin-to-creatinine ratio from the baseline after 2-year treatment. The key secondary objectives are (1) the safety of dapagliflozin and (2) the cardiovascular and renal efficacies of dapagliflozin.
Conclusion and Perspectives
DAPPER study investigates whether dapagliflozin decreases albuminuria and exerts beneficial effects on the failing heart in T2D patients. (UMIN000025102).</description><identifier>ISSN: 0920-3206</identifier><identifier>EISSN: 1573-7241</identifier><identifier>DOI: 10.1007/s10557-018-6782-1</identifier><identifier>PMID: 29589153</identifier><language>eng</language><publisher>New York: Springer US</publisher><subject>Albuminuria - diagnosis ; Albuminuria - epidemiology ; Albuminuria - prevention & control ; Antidiabetics ; Benzhydryl Compounds - therapeutic use ; Beta blockers ; Biomarkers ; Cardiology ; Cardiovascular diseases ; Creatinine ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - diagnosis ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - epidemiology ; Diabetic Nephropathies - diagnosis ; Diabetic Nephropathies - epidemiology ; Diabetic Nephropathies - prevention & control ; Drugs ; Glucose transporter ; Glucosides - therapeutic use ; Health risk assessment ; Health risks ; Heart diseases ; Heart failure ; Heart Failure - diagnosis ; Heart Failure - drug therapy ; Heart Failure - epidemiology ; Heart Failure - physiopathology ; Humans ; Inhibitors ; Japan - epidemiology ; Medicine ; Medicine & Public Health ; Multicenter Studies as Topic ; Original Article ; Patients ; Randomization ; Randomized Controlled Trials as Topic ; Risk Factors ; Risk groups ; Sodium ; Sodium-Glucose Transporter 2 Inhibitors - therapeutic use ; Time Factors ; Treatment Outcome</subject><ispartof>Cardiovascular drugs and therapy, 2018-04, Vol.32 (2), p.183-190</ispartof><rights>Springer Science+Business Media, LLC, part of Springer Nature 2018</rights><rights>Cardiovascular Drugs and Therapy is a copyright of Springer, (2018). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-77924923a49070f9c3c3f89e4414d3b7dc50f124b5c60b4c9061bacb808cf513</citedby><cites>FETCH-LOGICAL-c372t-77924923a49070f9c3c3f89e4414d3b7dc50f124b5c60b4c9061bacb808cf513</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10557-018-6782-1$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10557-018-6782-1$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41467,42536,51298</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29589153$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yoshihara, Fumiki</creatorcontrib><creatorcontrib>Imazu, Miki</creatorcontrib><creatorcontrib>Hamasaki, Toshimitsu</creatorcontrib><creatorcontrib>Anzai, Toshihisa</creatorcontrib><creatorcontrib>Yasuda, Satoshi</creatorcontrib><creatorcontrib>Ito, Shin</creatorcontrib><creatorcontrib>Yamamoto, Haruko</creatorcontrib><creatorcontrib>Hashimura, Kazuhiko</creatorcontrib><creatorcontrib>Yasumura, Yoshio</creatorcontrib><creatorcontrib>Mori, Kiyoshi</creatorcontrib><creatorcontrib>Watanabe, Masataka</creatorcontrib><creatorcontrib>Asakura, Masanori</creatorcontrib><creatorcontrib>Kitakaze, Masafumi</creatorcontrib><creatorcontrib>DAPPER investigators and study coordinators</creatorcontrib><creatorcontrib>on behalf of the DAPPER investigators and study coordinators</creatorcontrib><title>An Exploratory Study of Dapagliflozin for the Attenuation of Albuminuria in Patients with Heart Failure and Type 2 Diabetes Mellitus (DAPPER)</title><title>Cardiovascular drugs and therapy</title><addtitle>Cardiovasc Drugs Ther</addtitle><addtitle>Cardiovasc Drugs Ther</addtitle><description>Background and Aims
Sodium-dependent glucose transporter-2 (SGLT-2) inhibitors, which are anti-diabetic drugs, reportedly decrease the incidence of cardiovascular events in high-risk patients with cardiovascular diseases, and thus chronic heart failure (CHF). SGLT-2 inhibitors also decrease albuminuria in patients with type 2 diabetes mellitus (T2D). Since albuminuria is a biomarker of not only chronic kidney disease but also cardiovascular events, we hypothesized that, among T2D patients with CHF, SGLT-2 inhibitors will decrease the extent of albuminuria and also improve CHF concomitantly.
Methods
DAPPER (UMIN000025102) is a multicenter, randomized, open-labeled, parallel-group, standard treatment-controlled study, which is designed to evaluate whether dapagliflozin, one of the SGLT-2 inhibitors, decreases albuminuria in T2D patients with CHF and exerts cardioprotective effects on the failing heart. The patients are randomized to either of the dapagliflozin (5 or 10 mg, once daily orally) or control group (administration of anti-diabetic drugs administered other than SGLT 2 inhibitors). The estimated number of patients that need to be enrolled is 446 in total (223 in each group). The primary objective is the changes in the urinary albumin-to-creatinine ratio from the baseline after 2-year treatment. The key secondary objectives are (1) the safety of dapagliflozin and (2) the cardiovascular and renal efficacies of dapagliflozin.
Conclusion and Perspectives
DAPPER study investigates whether dapagliflozin decreases albuminuria and exerts beneficial effects on the failing heart in T2D patients. (UMIN000025102).</description><subject>Albuminuria - diagnosis</subject><subject>Albuminuria - epidemiology</subject><subject>Albuminuria - prevention & control</subject><subject>Antidiabetics</subject><subject>Benzhydryl Compounds - therapeutic use</subject><subject>Beta blockers</subject><subject>Biomarkers</subject><subject>Cardiology</subject><subject>Cardiovascular diseases</subject><subject>Creatinine</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - diagnosis</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - epidemiology</subject><subject>Diabetic Nephropathies - diagnosis</subject><subject>Diabetic Nephropathies - epidemiology</subject><subject>Diabetic Nephropathies - prevention & control</subject><subject>Drugs</subject><subject>Glucose transporter</subject><subject>Glucosides - therapeutic use</subject><subject>Health risk assessment</subject><subject>Health risks</subject><subject>Heart diseases</subject><subject>Heart failure</subject><subject>Heart Failure - diagnosis</subject><subject>Heart Failure - drug therapy</subject><subject>Heart Failure - epidemiology</subject><subject>Heart Failure - physiopathology</subject><subject>Humans</subject><subject>Inhibitors</subject><subject>Japan - epidemiology</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Multicenter Studies as Topic</subject><subject>Original Article</subject><subject>Patients</subject><subject>Randomization</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Risk Factors</subject><subject>Risk groups</subject><subject>Sodium</subject><subject>Sodium-Glucose Transporter 2 Inhibitors - therapeutic use</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0920-3206</issn><issn>1573-7241</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNp1kctu1DAUhi0EokPhAdggS2zKIsW3xPEy6kwvUhEjmH3kOHbrKmMHX1SGd-Cd8XTaIiGxOovznf_80gfAe4xOMUL8c8SornmFcFs1vCUVfgEWuOa04oThl2CBBEEVJag5Am9ivEPlRoj2NTgiom4FrukC_O4cXP2cJx9k8mEHv6c87qA3cClneTNZM_lf1kHjA0y3GnYpaZdlst7toW4a8ta6HKyEhVqXhXYpwnubbuGlliHBc2mnHDSUboSb3awhgUsrB510hF_0NNmUIzxZduv16tunt-CVkVPU7x7nMdicrzZnl9X114urs-66UpSTVHEuCBOESiYQR0YoqqhphWYMs5EOfFQ1MpiwoVYNGpgSqMGDVEOLWmVqTI_BySF2Dv5H1jH1WxtVKSOd9jn2BGHBGtG0bUE__oPe-RxcKfdAoabmjBUKHygVfIxBm34OdivDrseo36vqD6r6oqrfq-r3JT48Judhq8fniyc3BSAHIJaVu9Hh7-v_p_4B4pedww</recordid><startdate>20180401</startdate><enddate>20180401</enddate><creator>Yoshihara, Fumiki</creator><creator>Imazu, Miki</creator><creator>Hamasaki, Toshimitsu</creator><creator>Anzai, Toshihisa</creator><creator>Yasuda, Satoshi</creator><creator>Ito, Shin</creator><creator>Yamamoto, Haruko</creator><creator>Hashimura, Kazuhiko</creator><creator>Yasumura, Yoshio</creator><creator>Mori, Kiyoshi</creator><creator>Watanabe, Masataka</creator><creator>Asakura, Masanori</creator><creator>Kitakaze, Masafumi</creator><general>Springer US</general><general>Springer Nature B.V</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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7Z</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20180401</creationdate><title>An Exploratory Study of Dapagliflozin for the Attenuation of Albuminuria in Patients with Heart Failure and Type 2 Diabetes Mellitus (DAPPER)</title><author>Yoshihara, Fumiki ; Imazu, Miki ; Hamasaki, Toshimitsu ; Anzai, Toshihisa ; Yasuda, Satoshi ; Ito, Shin ; Yamamoto, Haruko ; Hashimura, Kazuhiko ; Yasumura, Yoshio ; Mori, Kiyoshi ; Watanabe, Masataka ; Asakura, Masanori ; Kitakaze, Masafumi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-77924923a49070f9c3c3f89e4414d3b7dc50f124b5c60b4c9061bacb808cf513</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Albuminuria - diagnosis</topic><topic>Albuminuria - epidemiology</topic><topic>Albuminuria - prevention & control</topic><topic>Antidiabetics</topic><topic>Benzhydryl Compounds - therapeutic use</topic><topic>Beta blockers</topic><topic>Biomarkers</topic><topic>Cardiology</topic><topic>Cardiovascular diseases</topic><topic>Creatinine</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, Type 2 - diagnosis</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - epidemiology</topic><topic>Diabetic Nephropathies - diagnosis</topic><topic>Diabetic Nephropathies - epidemiology</topic><topic>Diabetic Nephropathies - prevention & control</topic><topic>Drugs</topic><topic>Glucose transporter</topic><topic>Glucosides - therapeutic use</topic><topic>Health risk assessment</topic><topic>Health risks</topic><topic>Heart diseases</topic><topic>Heart failure</topic><topic>Heart Failure - diagnosis</topic><topic>Heart Failure - drug therapy</topic><topic>Heart Failure - epidemiology</topic><topic>Heart Failure - physiopathology</topic><topic>Humans</topic><topic>Inhibitors</topic><topic>Japan - epidemiology</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Multicenter Studies as Topic</topic><topic>Original Article</topic><topic>Patients</topic><topic>Randomization</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Risk Factors</topic><topic>Risk groups</topic><topic>Sodium</topic><topic>Sodium-Glucose Transporter 2 Inhibitors - therapeutic use</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yoshihara, Fumiki</creatorcontrib><creatorcontrib>Imazu, Miki</creatorcontrib><creatorcontrib>Hamasaki, Toshimitsu</creatorcontrib><creatorcontrib>Anzai, Toshihisa</creatorcontrib><creatorcontrib>Yasuda, Satoshi</creatorcontrib><creatorcontrib>Ito, Shin</creatorcontrib><creatorcontrib>Yamamoto, Haruko</creatorcontrib><creatorcontrib>Hashimura, Kazuhiko</creatorcontrib><creatorcontrib>Yasumura, Yoshio</creatorcontrib><creatorcontrib>Mori, Kiyoshi</creatorcontrib><creatorcontrib>Watanabe, Masataka</creatorcontrib><creatorcontrib>Asakura, Masanori</creatorcontrib><creatorcontrib>Kitakaze, Masafumi</creatorcontrib><creatorcontrib>DAPPER investigators and study coordinators</creatorcontrib><creatorcontrib>on behalf of the DAPPER investigators and study coordinators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biochemistry Abstracts 1</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Cardiovascular drugs and therapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yoshihara, Fumiki</au><au>Imazu, Miki</au><au>Hamasaki, Toshimitsu</au><au>Anzai, Toshihisa</au><au>Yasuda, Satoshi</au><au>Ito, Shin</au><au>Yamamoto, Haruko</au><au>Hashimura, Kazuhiko</au><au>Yasumura, Yoshio</au><au>Mori, Kiyoshi</au><au>Watanabe, Masataka</au><au>Asakura, Masanori</au><au>Kitakaze, Masafumi</au><aucorp>DAPPER investigators and study coordinators</aucorp><aucorp>on behalf of the DAPPER investigators and study coordinators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>An Exploratory Study of Dapagliflozin for the Attenuation of Albuminuria in Patients with Heart Failure and Type 2 Diabetes Mellitus (DAPPER)</atitle><jtitle>Cardiovascular drugs and therapy</jtitle><stitle>Cardiovasc Drugs Ther</stitle><addtitle>Cardiovasc Drugs Ther</addtitle><date>2018-04-01</date><risdate>2018</risdate><volume>32</volume><issue>2</issue><spage>183</spage><epage>190</epage><pages>183-190</pages><issn>0920-3206</issn><eissn>1573-7241</eissn><abstract>Background and Aims
Sodium-dependent glucose transporter-2 (SGLT-2) inhibitors, which are anti-diabetic drugs, reportedly decrease the incidence of cardiovascular events in high-risk patients with cardiovascular diseases, and thus chronic heart failure (CHF). SGLT-2 inhibitors also decrease albuminuria in patients with type 2 diabetes mellitus (T2D). Since albuminuria is a biomarker of not only chronic kidney disease but also cardiovascular events, we hypothesized that, among T2D patients with CHF, SGLT-2 inhibitors will decrease the extent of albuminuria and also improve CHF concomitantly.
Methods
DAPPER (UMIN000025102) is a multicenter, randomized, open-labeled, parallel-group, standard treatment-controlled study, which is designed to evaluate whether dapagliflozin, one of the SGLT-2 inhibitors, decreases albuminuria in T2D patients with CHF and exerts cardioprotective effects on the failing heart. The patients are randomized to either of the dapagliflozin (5 or 10 mg, once daily orally) or control group (administration of anti-diabetic drugs administered other than SGLT 2 inhibitors). The estimated number of patients that need to be enrolled is 446 in total (223 in each group). The primary objective is the changes in the urinary albumin-to-creatinine ratio from the baseline after 2-year treatment. The key secondary objectives are (1) the safety of dapagliflozin and (2) the cardiovascular and renal efficacies of dapagliflozin.
Conclusion and Perspectives
DAPPER study investigates whether dapagliflozin decreases albuminuria and exerts beneficial effects on the failing heart in T2D patients. (UMIN000025102).</abstract><cop>New York</cop><pub>Springer US</pub><pmid>29589153</pmid><doi>10.1007/s10557-018-6782-1</doi><tpages>8</tpages></addata></record> |
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| subjects | Albuminuria - diagnosis Albuminuria - epidemiology Albuminuria - prevention & control Antidiabetics Benzhydryl Compounds - therapeutic use Beta blockers Biomarkers Cardiology Cardiovascular diseases Creatinine Diabetes Diabetes mellitus Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - diagnosis Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - epidemiology Diabetic Nephropathies - diagnosis Diabetic Nephropathies - epidemiology Diabetic Nephropathies - prevention & control Drugs Glucose transporter Glucosides - therapeutic use Health risk assessment Health risks Heart diseases Heart failure Heart Failure - diagnosis Heart Failure - drug therapy Heart Failure - epidemiology Heart Failure - physiopathology Humans Inhibitors Japan - epidemiology Medicine Medicine & Public Health Multicenter Studies as Topic Original Article Patients Randomization Randomized Controlled Trials as Topic Risk Factors Risk groups Sodium Sodium-Glucose Transporter 2 Inhibitors - therapeutic use Time Factors Treatment Outcome |
| title | An Exploratory Study of Dapagliflozin for the Attenuation of Albuminuria in Patients with Heart Failure and Type 2 Diabetes Mellitus (DAPPER) |
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