{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,8]],"date-time":"2026-05-08T17:26:40Z","timestamp":1778261200234,"version":"3.51.4"},"reference-count":45,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2016,5,12]],"date-time":"2016-05-12T00:00:00Z","timestamp":1463011200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1U54\u2010GM\u2010104940"],"award-info":[{"award-number":["1U54\u2010GM\u2010104940"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2016,8]]},"abstract":"\n Aim<\/jats:title>\n \n To evaluate the long\u2010term efficacy, safety and tolerability of dapagliflozin versus placebo added to usual care in patients with type 2 diabetes mellitus (\n T2DM<\/jats:styled-content>\n ) and cardiovascular disease (\n CVD<\/jats:styled-content>\n ).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Data were pooled from two phase\n III<\/jats:styled-content>\n studies (\n NCT<\/jats:styled-content>\n 01031680 and\n NCT<\/jats:styled-content>\n 01042977) in high\u2010risk patients (N = 1887) with\n T2DM<\/jats:styled-content>\n and\n CVD<\/jats:styled-content>\n treated with dapagliflozin (10 mg\/day) or placebo. Patients completing the double\u2010blind treatment studies (24 weeks) entered one or two sequential double\u2010blind, long\u2010term (\n LT<\/jats:styled-content>\n ) extensions of 28 (\n LT1<\/jats:styled-content>\n ; n = 1649) and 52 (\n LT2<\/jats:styled-content>\n ; n = 568) weeks.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Baseline and\n CVD<\/jats:styled-content>\n characteristics were similar in the two groups. Patients entering\n LT1<\/jats:styled-content>\n and\n LT2<\/jats:styled-content>\n on dapagliflozin maintained a greater mean reduction in glycated haemoglobin (\n HbA1c<\/jats:styled-content>\n ) versus placebo at 52 weeks [\n LT1<\/jats:styled-content>\n , \u22120.58% (95% confidence interval \u22120.68, \u22120.49)] and 104 weeks [\n LT2<\/jats:styled-content>\n , \u22120.35% (95% confidence interval \u22120.59, \u22120.12)]. Mean body weight and systolic blood pressure (\n SBP<\/jats:styled-content>\n ) reductions versus placebo were maintained in patients entering\n LT1<\/jats:styled-content>\n (52 weeks; \u22122.23 kg and \u22123.25 mmHg, respectively) and\n LT2<\/jats:styled-content>\n (104 weeks; \u22123.16 kg and \u22122.03 mmHg, respectively). Patients on dapagliflozin had a better three\u2010item composite endpoint of clinical benefit (glycaemia, weight and\n SBP<\/jats:styled-content>\n ) compared with placebo at week 24 (\n LT1<\/jats:styled-content>\n , 10.1% vs. 1.1%) and week 104 (\n LT2<\/jats:styled-content>\n , 6.7% vs. 1.4%). Genital and urinary tract infections were more frequent with dapagliflozin than with placebo. Events of hypoglycaemia, renal impairment\/failure and volume depletion were similar between groups.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n The long\u2010term efficacy of dapagliflozin to maintain reductions in\n HbA1c<\/jats:styled-content>\n ,\n SBP<\/jats:styled-content>\n and body weight over 2 years, together with its tolerability profile, make dapagliflozin an appropriate option in high\u2010risk patients with\n T2DM<\/jats:styled-content>\n and\n CVD<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/dom.12666","type":"journal-article","created":{"date-parts":[[2016,3,24]],"date-time":"2016-03-24T03:22:45Z","timestamp":1458789765000},"page":"766-774","source":"Crossref","is-referenced-by-count":33,"title":["Long\u2010term maintenance of efficacy of dapagliflozin in patients with type 2 diabetes mellitus and cardiovascular disease"],"prefix":"10.1111","volume":"18","author":[{"given":"L. A.","family":"Leiter","sequence":"first","affiliation":[{"name":"Division of Endocrinology and Metabolism, Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical Science St Michael's Hospital, University of Toronto Toronto ON Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W. T.","family":"Cefalu","sequence":"additional","affiliation":[{"name":"Pennington Biomedical Research Center Louisiana State University Baton Rouge LA USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"T. W. A.","family":"de Bruin","sequence":"additional","affiliation":[{"name":"Research & Development AstraZeneca Gaithersburg MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J.","family":"Xu","sequence":"additional","affiliation":[{"name":"Biometrics and Informatics AstraZeneca Gaithersburg MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S.","family":"Parikh","sequence":"additional","affiliation":[{"name":"Global Medical Affairs\u2010CV and Metabolism AstraZeneca Gaithersburg MD USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"E.","family":"Johnsson","sequence":"additional","affiliation":[{"name":"Research & Development AstraZeneca Gothenburg M\u00f6lndal Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"I.","family":"Gause\u2010Nilsson","sequence":"additional","affiliation":[{"name":"Research & Development AstraZeneca Gothenburg M\u00f6lndal Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,5,12]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.2147\/DMSO.S51325"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.292.20.2495"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0889-8529(05)70219-X"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.317.7160.713"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.317.7160.703"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1096-9136(199708)14:3 3.0.CO;2-1"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4615-1321-6_6"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-141-6-200409210-00007"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)60794-7"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0806470"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-014-3460-0"},{"key":"e_1_2_7_13_1","unstructured":"Farxiga [prescribing information]. AstraZeneca Pharmaceuticals LP Wilmington DE 2015."},{"key":"e_1_2_7_14_1","unstructured":"European Medicines Agency.Forxiga summary of product characteristics.2015. Available from URL:http:\/\/ec.europa.eu\/health\/documents\/community\u2010register\/2012\/20121112124487\/anx_124487_en.pdf. 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Available from URL:http:\/\/diabetes.teithe.gr\/UsersFiles\/entypa\/STANDARDS%20OF%20MEDICAL%20CARE%20IN%20DIABETES%202015.pdf. Accessed 10 September 2015."},{"key":"e_1_2_7_28_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2011-2260"},{"key":"e_1_2_7_29_1","unstructured":"CefaluW LeiterL JohnssonE SuggJ Gause\u2010NilssonI. Safety and efficacy of dapagliflozin in patients with T2DM and cardiovascular disease receiving loop diuretics.Presented at American Diabetes Association (ADA) 75th Annual Scientific Session Boston 5\u20139 June2015. Poster 1216\u2010P."},{"key":"e_1_2_7_30_1","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/943162"},{"key":"e_1_2_7_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/dom.12226"},{"key":"e_1_2_7_32_1","unstructured":"Clinicaltrials.gov.A pragmatic trial to evaluate the comparative effectiveness between dapagliflozin and standard of care in type 2 diabetes patients (DECIDE Study). Study NCT02616666 10 February2016. 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