{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T01:19:30Z","timestamp":1780449570635,"version":"3.54.1"},"reference-count":26,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"21","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circulation"],"published-print":{"date-parts":[[2022,5,24]]},"abstract":"<jats:sec>\n            <jats:title>Background:<\/jats:title>\n            <jats:p>Dapagliflozin improved heart failure and kidney outcomes in patients with type 2 diabetes (T2DM) with or at high risk for atherosclerotic cardiovascular disease in the DECLARE-TIMI 58 trial (Dapagliflozin Effect on Cardiovascular Events \u2013 Thrombolysis in Myocardial Infarction 58). Here, the aim was to analyze the efficacy and safety of dapagliflozin stratified according to baseline systolic blood pressure (SBP).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>The DECLARE-TIMI 58 trial randomly assigned patients with T2DM and either previous atherosclerotic cardiovascular disease or atherosclerotic cardiovascular disease risk factors to dapagliflozin or placebo. Patients were categorized by baseline SBP levels: &lt;120, 120 to 129, 130 to 139, 140 to 159, and \u2265160 mm Hg (normal, elevated, stage 1, stage 2, and severe hypertension, respectively). Efficacy outcomes of interest were hospitalization for heart failure and a renal-specific composite outcome (sustained decrease in estimated glomerular filtration rate by 40%, progression to end-stage renal disease, or renal death). Safety outcomes included symptoms of volume depletion, lower extremity amputations, and acute kidney injury.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>\n              The trial comprised 17 160 patients; mean age, 64.0\u00b16.8 years; 37.4% women; median duration of T2DM, 11 years; 40.6% with prevalent cardiovascular disease. Overall, dapagliflozin reduced SBP by 2.4 mm Hg (95% CI, 1.9\u20132.9;\n              <jats:italic>P<\/jats:italic>\n              &lt;0.0001) compared with placebo at 48 months. The beneficial effects of dapagliflozin on hospitalization for heart failure and renal outcomes were consistent across all baseline SBP categories, with no evidence of modification of treatment effect (\n              <jats:italic>P<\/jats:italic>\n              <jats:sub>interactions<\/jats:sub>\n              =0.28 and 0.52, respectively). Among normotensive patients, the hazard ratios were 0.66 (95% CI, 0.42\u20131.05) and 0.39 (95% CI, 0.19\u20130.78), respectively, for hospitalization for heart failure and the renal-specific outcome. Events of volume depletion, amputation, and acute kidney injury did not differ with dapagliflozin overall or within any baseline SBP group.\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions:<\/jats:title>\n            <jats:p>In patients with T2DM with or at high atherosclerotic cardiovascular disease risk, dapagliflozin reduced risk for hospitalization for heart failure and renal outcomes regardless of baseline SBP, with no difference in adverse events of interest at any level of baseline SBP. These results indicate that dapagliflozin provides cardiorenal benefits in patients with T2DM at high atherosclerotic cardiovascular disease risk independent of baseline blood pressure.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Registration:<\/jats:title>\n            <jats:p>\n              URL:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">https:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              ; Unique identifier: NCT01730534.\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circulationaha.121.058103","type":"journal-article","created":{"date-parts":[[2022,5,5]],"date-time":"2022-05-05T09:00:21Z","timestamp":1651741221000},"page":"1581-1591","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":26,"title":["Efficacy and Safety of Dapagliflozin in Type 2 Diabetes According to Baseline Blood Pressure: Observations From DECLARE-TIMI 58 Trial"],"prefix":"10.1161","volume":"145","clinical-trial-number":[{"clinical-trial-number":"nct01730534","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4639-1003","authenticated-orcid":true,"given":"Remo H.M.","family":"Furtado","sequence":"first","affiliation":[{"name":"Academic Research Organization, Hospital Israelita Albert Einstein, Sao Paulo, Brazil (R.H.M.F.)."},{"name":"Instituto do Coracao (InCor), Hospital das Clinicas da Faculdade de Medicina, Universidade de Sao Paulo, Brazil (R.H.M.F., J.C.N.)."},{"name":"TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women\u2019s Hospital Heart and Harvard Medical School, Boston, MA (R.H.M.F., E.L.G., S.A.M., D.L.B., M.S.S., S.D.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0209-4453","authenticated-orcid":true,"given":"Itamar","family":"Raz","sequence":"additional","affiliation":[{"name":"Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (I.R.A.C., O.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8541-264X","authenticated-orcid":true,"given":"Erica L.","family":"Goodrich","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women\u2019s Hospital Heart and Harvard Medical School, Boston, MA (R.H.M.F., E.L.G., S.A.M., D.L.B., M.S.S., S.D.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabina A.","family":"Murphy","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women\u2019s Hospital Heart and Harvard Medical School, Boston, MA (R.H.M.F., E.L.G., S.A.M., D.L.B., M.S.S., S.D.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1278-6245","authenticated-orcid":true,"given":"Deepak L.","family":"Bhatt","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women\u2019s Hospital Heart and Harvard Medical School, Boston, MA (R.H.M.F., E.L.G., S.A.M., D.L.B., M.S.S., S.D.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1040-6229","authenticated-orcid":true,"given":"Lawrence A.","family":"Leiter","sequence":"additional","affiliation":[{"name":"Li Ka Shing Knowledge Institute, St. Michael\u2019s Hospital, University of Toronto, ON, Canada (L.A.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6412-7989","authenticated-orcid":true,"given":"Darren K.","family":"McGuire","sequence":"additional","affiliation":[{"name":"Division of Cardiology, University of Texas Southwestern Medical Center and Parkland Health and Hospital System, Dallas (D.K.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2839-8404","authenticated-orcid":true,"given":"John P.H.","family":"Wilding","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular and Metabolic Medicine, University of Liverpool, United Kingdom (J.P.H.W.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Aylward","sequence":"additional","affiliation":[{"name":"South Australian Health and Medical Research Institute, Flinders University and Medical Centre, Adelaide (P.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony J","family":"Dalby","sequence":"additional","affiliation":[{"name":"Life Fourways Hospital, Randburg, Republic of South Africa (A.J.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikael","family":"Dellborg","sequence":"additional","affiliation":[{"name":"Sahlgrenska Academy, University of Gothenburg, Sweden (M.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Doina","family":"Dimulescu","sequence":"additional","affiliation":[{"name":"Carol Davila University of Medicine and Pharmacy, Bucharest, Romania (D.D.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9680-3689","authenticated-orcid":true,"given":"Jos\u00e9 C.","family":"Nicolau","sequence":"additional","affiliation":[{"name":"Instituto do Coracao (InCor), Hospital das Clinicas da Faculdade de Medicina, Universidade de Sao Paulo, Brazil (R.H.M.F., J.C.N.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthonius J.M.","family":"Oude Ophuis","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands (A.J.M.O.O.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7830-9994","authenticated-orcid":true,"given":"Avivit","family":"Cahn","sequence":"additional","affiliation":[{"name":"Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (I.R.A.C., O.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ofri","family":"Mosenzon","sequence":"additional","affiliation":[{"name":"Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Israel (I.R.A.C., O.M.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingrid","family":"Gause-Nilsson","sequence":"additional","affiliation":[{"name":"BioPharmaceuticals R&amp;D, AstraZeneca Gothenburg, M\u00f6lndal, Sweden (I.G.-N., A.M.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Maria","family":"Langkilde","sequence":"additional","affiliation":[{"name":"BioPharmaceuticals R&amp;D, AstraZeneca Gothenburg, M\u00f6lndal, Sweden (I.G.-N., A.M.L.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0691-3359","authenticated-orcid":true,"given":"Marc S.","family":"Sabatine","sequence":"additional","affiliation":[{"name":"TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women\u2019s Hospital Heart and Harvard Medical School, Boston, MA (R.H.M.F., E.L.G., S.A.M., D.L.B., M.S.S., 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