PMID- 30920851 OWN - NLM STAT- MEDLINE DCOM- 20190723 LR - 20210504 IS - 1744-7666 (Electronic) IS - 1465-6566 (Linking) VI - 20 IP - 9 DP - 2019 Jun TI - Dapagliflozin and cardiovascular outcomes: anything else to DECLARE? PG - 1087-1090 LID - 10.1080/14656566.2019.1598970 [doi] AB - Individuals with type 2 diabetes mellitus (T2DM) have increased cardiovascular risk with regulatory agencies requiring cardiovascular outcome trials (CVOTs) for the approval of new antidiabetic drugs. Areas covered: In this paper, the authors critically discuss the background, trial design, results and implications of a recent CVOT [NCT01730534; DECLARE-TIMI 58 study], which demonstrated that dapagliflozin was non-inferior to placebo in terms of major adverse cardiovascular events, and superior for the occurrence of hospitalization for heart failure (HF) and composite renal endpoints, thus confirming the cardiovascular benefit of sodium-glucose co-transporter-2 (SGLT2) inhibitors. No statistically-significant effects were found for amputations, fractures, and stroke (debated safety issues having emerged in previous CVOTs). Expert opinion: DECLARE-TIMI 58 is the longest (4.2 years of follow up), largest (>17,000 participants) and most inclusive (only 41% of individuals with established atherosclerotic cardiovascular disease) CVOT raising the debate towards SGLT2 inhibitor therapy in primary prevention and the potential use of these drugs also in patients with HF without T2DM and other subpopulations. FAU - Raschi, Emanuel AU - Raschi E AD - a Pharmacology Unit, Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy. FAU - Poluzzi, Elisabetta AU - Poluzzi E AD - a Pharmacology Unit, Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy. FAU - Marchesini, Giulio AU - Marchesini G AD - b Unit of Metabolic Diseases & Clinical Dietetics, Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy. FAU - De Ponti, Fabrizio AU - De Ponti F AD - a Pharmacology Unit, Department of Medical and Surgical Sciences , University of Bologna , Bologna , Italy. LA - eng PT - Journal Article DEP - 20190328 PL - England TA - Expert Opin Pharmacother JT - Expert opinion on pharmacotherapy JID - 100897346 RN - 0 (Benzhydryl Compounds) RN - 0 (Glucosides) RN - 0 (Sodium-Glucose Transporter 2 Inhibitors) RN - 1ULL0QJ8UC (dapagliflozin) MH - Benzhydryl Compounds/pharmacology/*therapeutic use MH - Cardiovascular Diseases/*drug therapy MH - Glucosides/pharmacology/*therapeutic use MH - Humans MH - Sodium-Glucose Transporter 2 Inhibitors/pharmacology/*therapeutic use OTO - NOTNLM OT - Dapagliflozin OT - cardiovascular outcome trial OT - heart failure OT - major adverse cardiovascular events OT - sodium-glucose co-transporter-2 inhibitor OT - type 2 diabetes EDAT- 2019/03/29 06:00 MHDA- 2019/07/25 06:00 CRDT- 2019/03/29 06:00 PHST- 2019/03/29 06:00 [pubmed] PHST- 2019/07/25 06:00 [medline] PHST- 2019/03/29 06:00 [entrez] AID - 10.1080/14656566.2019.1598970 [doi] PST - ppublish SO - Expert Opin Pharmacother. 2019 Jun;20(9):1087-1090. doi: 10.1080/14656566.2019.1598970. Epub 2019 Mar 28.