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trial powered to test noninferiority of sem-\naglutide for the purpose of regulatory ap-proval (257). In this study, 3,297 peoplewith type 2 diabetes were randomized to\nreceive once-weekly semaglutide (0.5 mg\nor 1.0 mg) or placebo for 2 years. The pri-mary outcome (the first occurrence of car-\ndiovascular death, nonf... | [
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diovascular death, nonfatal MI, or nonfatal\nstroke) occurred in 108 individuals (6.6%)\nin the semaglutide group vs. 146 individu-als (8.9%) in the placebo group (HR 0.74[95% CI 0.58– 0.95]; P<0.001). More indi-\nviduals discontinued treatment in the sem-\naglutide group because of adverse events, | [
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aglutide group because of adverse events,\nmainly gastrointestinal. The cardiovasculareffects of the oral formulation of semaglu-tide compared with placebo have been\nassessed in Peptide Innovation for Early\nDiabetes Treatment (PIONEER) 6, a preap-proval trial designed to rule out an unac-ceptable increase in cardiova... | [
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(257). In this trial of 3,183 people with\ntype 2 diabetes and high cardiovascularrisk followed for a median of 15.9 months,oral semaglutide was noninferior to pla-cebo for the primary composite outcome\nof cardiovascular death, nonfatal MI, or\nnonfatal stroke (HR 0.79 [95% CI 0.57 –\n1.11]; P<0.001 for noninferiority... | [
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1.11]; P<0.001 for noninferiority) (257).\nThe cardiovascular effects of this formula-\ntion of semaglutide will be further tested\nin a large, longer-term outcomes trial.\nThe Harmony Outcomes trial random-\nized 9,463 people with type 2 diabetesand cardiovascular disease to once-weekly\nsubcutaneous albiglutide or ma... | [
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subcutaneous albiglutide or matching pla-\ncebo, in addition to their standard care(258). Over a median duration of 1.6 years,\nthe GLP-1 receptor agonist reduced the | [
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the GLP-1 receptor agonist reduced the\nrisk of cardiovascular death, MI, or stroketo an incidence rate of 4.6 events per100 person-years in the albiglutide groupvs. 5.9 events in the placebo group (HR0.78, P= 0.0006 for superiority) (258).\nThis agent is not currently available forclinical use.\nThe Researching Cardio... | [
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The Researching Cardiovascular Events\nWith a Weekly Incretin in Diabetes(REWIND) trial was a randomized, double-blind, placebo-controlled trial that assessedthe effect of the once-weekly GLP-1 recep-tor agonist dulaglutide versus placebo on\nmajor adverse cardiovascular events in\n/C249,990 people with type 2 diabetes... | [
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/C249,990 people with type 2 diabetes at\nrisk for cardiovascular events or with a his-tory of cardiovascular disease (259). Studyparticipants had a mean age of 66 yearsand a mean duration of diabetes of\n/C2410 years. Approximately 32% of partici-\npants had history of atherosclerotic cardio- | [
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pants had history of atherosclerotic cardio-\nvascular events at baseline. After a medianfollow-up of 5.4 years, the primary com-posite outcome of nonfatal MI, nonfatalstroke, or death from cardiovascular\ncauses occurred in 12.0% and 13.4% of | [
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causes occurred in 12.0% and 13.4% of\nparticipants in the dulaglutide and pla-cebo treatment groups, respectively(HR 0.88 [95% CI 0.79 –0.99]; P= 0.026).\nThese findings equated to incidence rates\nof 2.4 and 2.7 events per 100 person-years,respectively. The results were consistent\nacross the subgroups of individuals ... | [
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across the subgroups of individuals with\nand without history of CV events. All-causemortality did not differ between groups(P= 0.067).\nThe Evaluation of Lixisenatide in\nAcute Coronary Syndrome (ELIXA) trial\nstudied the once-daily GLP-1 receptor\nagonist lixisenatide on cardiovascular | [
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agonist lixisenatide on cardiovascular\noutcomes in people with type 2 diabe-tes who had had a recent acute coro-nary event (261). A total of 6,068people with type 2 diabetes with a re-cent hospitalization for MI or unstableangina within the previous 180 days\nwere randomized to receive lixisena- | [
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were randomized to receive lixisena-\ntide or placebo in addition to standardcare and were followed for a medianof/C242.1 years. The primary outcome of\ncardiovascular death, MI, stroke, orhospitalization for unstable angina oc-\ncurred in 406 individuals (13.4%) in | [
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curred in 406 individuals (13.4%) in\nthe lixisenatide group vs. 399 (13.2%)in the placebo group (HR 1.2 [95% CI0.89– 1.17]), which demonstrated the\nnoninferiority of lixisenatide to placeboS204 Cardiovascular Disease and Risk Management Diabetes Care Volume 47, Supplement 1, January 2024\n©AmericanDiabetesAssociation | [
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(P<0.001) but did not show superiority\n(P= 0.81).\nThe Exenatide Study of Cardiovascu-\nlar Event Lowering (EXSCEL) trial also\nreported results with the once-weekly\nGLP-1 receptor agonist extended-release | [
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GLP-1 receptor agonist extended-release\nexenatide and found that major adversecardiovascular events were numericallylower with use of extended-release exe-natide compared with placebo, although\nthis difference was not statistically signif-\nicant (261). A total of 14,752 peoplewith type 2 diabetes (of whom 10,782[73.... | [
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disease) were randomized to receive\nextended-release exenatide 2 mg orplacebo and followed for a median of3.2 years. The primary end point of\ncardiovascular death, MI, or stroke oc-\ncurred in 839 individuals (11.4%; 3.7events per 100 person-years) in the ex-enatide group and in 905 individuals(12.2%; 4.0 events per ... | [
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years) in the placebo group (HR 0.91\n[95% CI 0.83 –1.00]; P<0.001 for non-\ninferiority), but exenatide was not supe-rior to placebo with respect to the\nprimary end point ( P= 0.06 for superi-\nority). However, all-cause mortality was\nlower in the exenatide group (HR 0.86[95% CI 0.77 –0.97]). The incidence of | [
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acute pancreatitis, pancreatic cancer,medullary thyroid carcinoma, and seri-ous adverse events did not differ signi fi-\ncantly between the two groups.\nIn summary, there are now numerous\nlarge randomized controlled trials re-porting statistically signi ficant reduc- | [
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tions in cardiovascular events for threeof the FDA-approved SGLT2 inhibitors(empagli flozin, canagli flozin, and dapa-\ngliflozin, with lesser bene fits seen with\nertugli flozin) and four FDA-approved\nGLP-1 receptor agonists (liraglutide, al-biglutide [although that agent was re-\nmoved from the market for business | [
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moved from the market for business\nreasons], semaglutide [lower risk ofcardiovascular events in a moderate-sized clinical trial but one not powered\nas a cardiovascular outcomes trial],\nand dulaglutide). Meta-analyses of thetrials reported to date suggest thatGLP-1 receptor agonists and SGLT2 in-hibitors reduce risk ... | [
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major adverse cardiovascular events to a\ncomparable degree in people with type 2diabetes and established ASCVD (262,263).SGLT2 inhibitors also reduce risk of heart\nfailure hospitalization and progression of | [
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failure hospitalization and progression of\nkidney disease in people with establishedASCVD, multiple risk factors for ASCVD, oralbuminuric kidney disease (264,265). Inpeople with type 2 diabetes and estab-\nlished ASCVD, multiple ASCVD risk factors,\nor diabetic kidney disease, an SGLT2 in-hibitor with demonstrated car... | [
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lar bene fit is recommended to reduce\nthe risk of major adverse cardiovascular\nevents and/or heart failure hospitaliza-\ntion. In people with type 2 diabetes and\nestablished ASCVD or multiple risk factorsfor ASCVD, a GLP-1 receptor agonist with\ndemonstrated cardiovascular bene fiti s | [
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demonstrated cardiovascular bene fiti s\nrecommended to reduce the risk of ma-jor adverse cardiovascular events. For\nmany individuals, use of either an SGLT2i n h i b i t o ro raG L P - 1r e c e p t o ra g o n i s tt o\nreduce cardiovascular risk is appropriate.\nEmerging data suggest that use of bothclasses of drugs w... | [
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cardiovascular and kidney outcomes ben-\nefit; thus, combination therapy with an\nSGLT2 inhibitor and a GLP-1 receptor ag-\nonist may be considered to provide the\ncomplementary outcomes bene fits asso-\nciated with these classes of medication.\nEvidence to support such an approach\nincludes findings from AMPLITUDE-O | [
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includes findings from AMPLITUDE-O\n(Effect of Efpeglenatide on Cardiovascular\nOutcomes), an outcomes trial of people\nwith type 2 diabetes and either cardio-\nvascular or kidney disease plus at least\none other risk factor randomized to theinvestigational GLP-1 receptor agonist ef-\npeglenatide or placebo (266). Rando... | [
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peglenatide or placebo (266). Randomiza-\ntion was strati fied by current or potential\nuse of SGLT2 inhibitor therapy, a class ul-timately used by >15% of the trial par-\nticipants. Over a median follow-up of 1.8\nyears, efpeglenatide therapy reduced the\nrisk of incident major adverse cardiovas- | [
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risk of incident major adverse cardiovas-\ncular events by 27% and of a compositerenal outcome event by 32%. Importantly,\nthe effects of efpeglenatide did not vary\nby use of SGLT2 inhibitors, suggesting that\nthe bene ficial effects of the GLP-1 recep-\ntor agonist were independent of those\nprovided by SGLT2 inhibito... | [
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provided by SGLT2 inhibitor therapy (267).\nEfpeglenatide is currently not approved by\nthe FDA for use in the U.S.\nPrevention and Treatment of Heart\nFailure\nPrevention of Symptomatic Heart Failure\nACE Inhibitors/ARBs and b-Blockers. Early\nprimary prevention strategies and treat-\nment of associated risk factors r... | [
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ment of associated risk factors reduce in-\ncident, symptomatic heart failure andshould include lifestyle intervention with\ndiet, physical activity, weight control, andsmoking cessation (268 –271). The vast\nmajority of incident heart failure is pre- | [
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0.03719178959727287,
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majority of incident heart failure is pre-\nceded by hypertension; up to 91% of allnew heart failure development in theFramingham cohort occurred in people\nwith a previous diagnosis of hypertension\n(272). Therefore, management of hyper-tension constitutes a key goal in peoplewith diabetes and stage A or B heart fail- | [
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-... |
ure. For example, in the UKPDS trial, in-\ntensive blood pressure control in peoplewith type 2 diabetes reduced the risk forheart failure by 56% (273). Similarly, inthe SPRINT trial, intensive treatment of\nhypertension decreased the risk for de-\nvelopment of incident heart failure by36% (274). As discussed in the\nHY... | [
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HYPERTEN-\nSION/BLOOD PRESSURE CONTROL section above,\nuse of ACE inhibitors or ARBs is the pre-ferred treatment strategy for manage-ment of hypertension in people withdiabetes, particularly in the presence ofalbuminuria or coronary artery disease.\nPeople with diabetes and stage B heart | [
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People with diabetes and stage B heart\nfailure who remain asymptomatic buthave evidence of structural heart disease,including history of MI, acute coronary\nsyndrome, or left ventricular ejection frac-\ntion (LVEF) #40%, should be treated\nwith ACE inhibitors/ARBs plus b-blockers\naccording to current treatment guidel... | [
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according to current treatment guidelines\n(210). In the landmark Studies of Left\nVentricular Dysfunction (SOLVD) study, inwhich 15% of people had diabetes, treat-ment with enalapril reduced incidentheart failure in people with asymptomatic\nleft ventricular dysfunction by 20% (275). | [
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left ventricular dysfunction by 20% (275).\nIn the Survival and Ventricular Enlarge-ment (SAVE) study, which enrolled asymp-tomatic people with reduced LVEF after\nMI, including 23% people with diabetes, | [
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MI, including 23% people with diabetes,\ntreatment with captopril reduced the de-velopment of heart failure by 37% (276).Subsequent retrospective analyses fromboth trials revealed that concomitant use\nofb-blockers was associated with de-\ncreased risk of progression to symptom- | [
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creased risk of progression to symptom-\natic heart failure (277,278). The CarvedilolPost-Infarct Survival Control in Left Ven-\ntricular Dysfunction (CAPRICORN) study\nrandomized people with a history of MIand reduced LVEF to treatment with car-vedilol (279). Approximately half of thestudy participants were asymptomat... | [
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and 23% of study participants had a his-\ntory of diabetes. Treatment with carvedi-lol reduced mortality by 23%, and therewas a 14% risk reduction for heart failure\nhospitalization. Finally, in the Reversal of\nVentricular Remodeling With Toprol-XLdiabetesjournals.org/care Cardiovascular Disease and Risk Management S2... | [
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(REVERT) trial, in which 45% of the peo-\nple enrolled had diabetes, metoprololimproved adverse cardiac remodeling inasymptomatic individuals with an LVEF<40% and mild left ventricular dilatation\n(280).\nSGLT Inhibitors. As reviewed in detail in | [
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(280).\nSGLT Inhibitors. As reviewed in detail in\nthe following section, SGLT2 inhibitorsconstitute a key treatment approach toreduce cardiovascular disease and heartfailure outcomes in people with diabe-tes. People with type 2 diabetes and\nincreased cardiovascular risk or estab- | [
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increased cardiovascular risk or estab-\nlished cardiovascular disease should betreated with an SGLT2 inhibitor to pre-vent the development of incident heartfailure. This includes people with type 2diabetes and asymptomatic stage B heart\nfailure. In the EMPA-REG OUTCOME trial, | [
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failure. In the EMPA-REG OUTCOME trial,\nonly 10% of study participants had aprior history of heart failure, and treat-ment with empagli flozin reduced the rel-\native risk for hospitalization from heartfailure by 35% (11). In the CANVAS Pro-gram, hospitalization from heart failure\nwas reduced by 33% in people allocate... | [
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0.015110949985682964,
0.0... |
was reduced by 33% in people allocated\nto canagli flozin, and only 14% of individu-\nals enrolled had a prior history of heartfailure (12). In the DAPA-HF study, only10% of study participants had a priorhistory of heart failure, and dapagli flozin | [
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0.04999760538339615,
0.013996230438351631,
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0.012... |
reduced cardiovascular mortality andhospitalization for heart failure by 17%,which was consistent across multiplestudy subgroups regardless of a prior his-tory of heart failure (249). Finally, in theEffect of Sotagli flozin on Cardiovascular\nand Renal Events in Participants With\nType 2 Diabetes and Moderate Renal | [
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0.03... |
Type 2 Diabetes and Moderate Renal\nImpairment Who Are at CardiovascularRisk (SCORED) trial, randomization to theSGLT1/2 inhibitor sotagli flozin reduced the\nprimary outcome of death from cardiovas-cular causes, hospitalizations for heart fail-\nure, and urgent visits for heart failure in | [
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0.00931... |
ure, and urgent visits for heart failure in\npeople with type 2 diabetes, CKD, and riskfor cardiovascular disease (281). Therefore,SGLT inhibitor treatment is recommendedin asymptomatic people with type 2 dia-betes at risk or with established cardiovas-\ncular disease to prevent incident heart\nfailure and hospitalizat... | [
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failure and hospitalization from heartfailure.\nFinerenone. Finerenone is a nonsteroidal\nMRA and has recently been studied in\npeople with diabetes and diabetic kid-\nney disease, including the Finerenonein Reducing Kidney Failure and DiseaseProgression in Diabetic Kidney Disease\n(FIDELIO-DKD) and the Ef ficacy and | [
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0.02535492368042469,
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0.... |
(FIDELIO-DKD) and the Ef ficacy and\nSafety of Finerenone in Subjects With\nType 2 Diabetes Mellitus and the Clini-cal Diagnosis of Diabetic Kidney Disease(FIGARO-DKD) studies. In FIDELIO-DKD,finerenone was compared with placebo\nfor the primary outcome of kidney fail-ure, a sustained decrease of at least40% in the eGFR ... | [
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death from renal causes in people with\ntype 2 diabetes and diabetic kidneydisease (282). A prespeci fied secondary\noutcome was death from cardio-vascular causes, nonfatal MI, nonfatalstroke, or hospitalization for heart fail-ure, which was reduced by 13% in thefinerenone group. The incidence of | [
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heart failure hospitalization occurredless in the finerenone-treated group,\nand only 7.7% of study participantshad a prior history of heart failure. Inthe FIGARO-DKD trial, finerenone re-\nduced the primary outcome of deathfrom cardiovascular causes, nonfatalMI, nonfatal stroke, or hospitalizationfor heart failure (HR 0... | [
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0.76–0.98]; P= 0.03) in people with\ntype 2 diabetes and diabetic kidney\ndisease (240). Only 7.8% of all partici-pants had a prior history of heartfailure, and the incidence of hospitali-zation for heart failure was reduced inthefinerenone-allocated treatment arm\n(HR 0.71 [95% CI 0.56– 0.90]). Owing to\nthese observat... | [
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0.02... |
these observations, treatment with fi-\nnerenone is recommended in peoplewith type 2 diabetes and diabetic kidneydisease to reduce the risk of progressionfrom stage A heart failure to symptom-atic incident heart failure.\nTreatment of Symptomatic Heart\nFailure\nIn general, current guideline-directed | [
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Failure\nIn general, current guideline-directed\nmedical therapy for a history of MI andsymptomatic stage C and D heart failurein people with diabetes is similar tothat for people without diabetes. Atthese advanced stages of heart failure,a collaborative approach with a cardio-\nvascular specialist is recommended. The | [
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0... |
vascular specialist is recommended. The\ntreatment recommendations are de-tailed in current 2022 American HeartAssociation/American College of Cardi-ology/Heart Failure Society of Americaguidelines for the management of heartfailure (210).Glucose-Lowering Medications and\nHeart Failure: Discussion of HeartFailure Outco... | [
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0.027752747759222984,
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0.0634003... |
Heart Failure: Discussion of HeartFailure Outcomes\nData on the effects of glucose-lowering\nagents on heart failure outcomes have\ndemonstrated that thiazolidinedioneshave a strong and consistent relation-ship with increased risk of heart failure\n(283–285). Therefore, thiazolidinedione\nuse should be avoided in peopl... | [
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0.025671973824501038,
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0.06901223957538605,
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0.0... |
use should be avoided in people with\nsymptomatic heart failure. Restrictions\nto use of metformin in people with\nmedically treated heart failure were re-moved by the FDA in 2006 (286). Obser-\nvational studies of people with type 2\ndiabetes and heart failure suggest thatmetformin users have better outcomesthan indiv... | [
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0.016823846846818924,
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0.015225183218717575,
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0.1409444659948349,
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0.10889548808336258,
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hyperglycemic agents (287); however,\nno randomized trial of metformin ther-apy has been conducted in people with\nheart failure. Metformin may be used\nfor the management of hyperglycemiain people with stable heart failure as\nlong as kidney function remains within\nthe recommended range for use (288).\nRecent studies... | [
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0.08837029337882996,
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Recent studies examining the rela-\ntionship between DPP-4 inhibitors and\nheart failure have had mixed results.\nThe Saxagliptin Assessment of VascularOutcomes Recorded in Patients with Di-\nabetes Mellitus –Thrombolysis in Myo-\ncardial Infarction 53 (SAVOR-TIMI 53)\nstudy showed that individuals treatedwith the DPP-... | [
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0.017339833080768585,
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0.17719003558158875,
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0.003943074494600296,
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0.00032350103720091283,
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more likely to be hospitalized for heart\nfailure than those given placebo (3.5%vs. 2.8%, respectively) (289). However,\nthree other cardiovascular outcomes\ntrials—Examination of Cardiovascular Out-\ncomes with Alogliptin versus Standard of\nCare (EXAMINE) (290), Trial Evaluating | [
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0.01576242782175541,
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0.1235053613781929,
0.06102732941508293,
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0.040611907839775085,
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-0.0088... |
Care (EXAMINE) (290), Trial Evaluating\nCardiovascular Outcomes with Sitagliptin(TECOS) (291), and the Cardiovascular\nand Renal Microvascular Outcome Study\nWith Linagliptin (CARMELINA) (292) —did\nnotfind a signi ficant increase in risk of\nheart failure hospitalization with DPP-4\ninhibitor use compared with placebo. ... | [
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0.18156594038009644,
0.023864801973104477,
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0.025426555424928665,
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inhibitor use compared with placebo. No\nincreased risk of heart failure hospitaliza-tion has been identi fied in the cardiovas-\ncular outcomes trials of the GLP-1receptor agonists lixisenatide, liraglutide,semaglutide, exenatide once weekly,\nalbiglutide, or dulaglutide compared\nwith placebo ( Table 10.3 B) (255,256,... | [
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0.1269012689590454,
0.07308470457792282,
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0.002533105667680502,
0.07387340813875198,
-0.037936657667160034,
0.02104... |
with placebo ( Table 10.3 B) (255,256,\n259– 261).\nReduced incidence of heart failure\nhas been observed with the use ofSGLT2 inhibitors (11,247,249). In EMPA-REGS206 Cardiovascular Disease and Risk Management Diabetes Care Volume 47, Supplement 1, January 2024\n©AmericanDiabetesAssociation | [
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... |
OUTCOME, the addition of empaglifl ozin to\nstandard care led to a signi ficant 35% re-\nduction in hospitalization for heart failure\ncompared with placebo (11). Although themajority of individuals in the study did not\nhave heart failure at baseline, this bene fit\nwas consistent in individuals with and with- | [
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was consistent in individuals with and with-\nout a history of heart failure (13). Similarly,in CANVAS and DECLARE-TIMI 58, there\nwere 33% and 27% reductions in hospi-\ntalization for heart failure, respectively,with SGLT2 inhibitor use versus pla-cebo (12,249). Additional data from the\nCREDENCE trial with canagli flo... | [
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CREDENCE trial with canagli flozin showed\na3 9 %r e d u c t i o ni nh o s p i t a l i z a t i o nf o r\nheart failure, and 31% reduction in thecomposite of cardiovascular death orhospitalization for heart failure, in a dia-\nbetic kidney disease population with\nalbuminuria (UACR >300– 5,000 mg/g)\n(247). These combine... | [
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(247). These combined findings from four\nlarge outcomes trials of three different\nSGLT2 inhibitors are highly consistent and\nclearly indicate robust bene fits of SGLT2\ninhibitors in the prevention of heartfailure hospitalizations. The EMPA-REG\nOUTCOME, CANVAS, DECLARE-TIMI 58, | [
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OUTCOME, CANVAS, DECLARE-TIMI 58,\nand CREDENCE trials suggested, but didnot prove, that SGLT2 inhibitors wouldbe bene ficial in the treatment of people\nwith established heart failure. More re-\ncently, the placebo-controlled DAPA-HF\ntrial evaluated the effects of dapagli flozin | [
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trial evaluated the effects of dapagli flozin\non the primary outcome of a compositeof worsening heart failure or cardiovascu-\nlar death in individuals with New York\nHeart Association (NYHA) class II, III, or IVh e a r tf a i l u r ea n da ne j e c t i o nf r a c t i o no f40% or less. Of the 4,744 trial partici- | [
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pants, 45% had a history of type 2 diabe-\ntes. Over a median of 18.2 months, thegroup assigned to dapagli flozin treatment\nhad a lower risk of the primary outcome(HR 0.74 [95% CI 0.65 –0.85]), lower risk\noffirst worsening heart failure event (HR\n0.70 [95% CI 0.59– 0.83]), and lower risk | [
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0.70 [95% CI 0.59– 0.83]), and lower risk\nof cardiovascular death (HR 0.82 [95% CI0.69–0.98]) compared with placebo. The\neffect of dapagli flozin on the primary out-\ncome was consistent regardless of thepresence or absence of type 2 diabetes(14).\nEMPEROR-Reduced assessed the ef-\nfects of empagli flozin 10 mg once da... | [
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fects of empagli flozin 10 mg once daily\nversus placebo on a primary compositeoutcome of cardiovascular death or hos-pitalization for worsening heart failure\nin a population of 3,730 individuals | [
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in a population of 3,730 individuals\nwith NYHA class II, III, or IV heart failureand an ejection fraction of 40% or less(253). At baseline, 49.8% of participantshad a history of diabetes. Over a me-dian follow-up of 16 months, those inthe empagli flozin-treated group had a\nreduced risk of the primary outcome\n(HR 0.75... | [
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(HR 0.75 [95% CI 0.65 –0.86]; P<0.001)\nand fewer total hospitalizations for heart\nfailure (HR 0.70 [95% CI 0.58 –0.85]; P<\n0.001). The effect of empagli flozin on the\nprimary outcome was consistent irrespec-tive of diabetes diagnosis at baseline. Therisk of a prespeci fied renal composite\noutcome (chronic dialysis, ... | [
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outcome (chronic dialysis, renal trans-\nplantation, or a sustained reduction in\neGFR) was lower in the empagli flozin\ng r o u pt h a ni nt h ep l a c e b og r o u p( 1 . 6 %i nthe empagli flozin group vs. 3.1% in the pla-\ncebo group; HR 0.50 [95% CI 0.32– 0.77]).\nEMPEROR-Preserved, a randomized | [
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EMPEROR-Preserved, a randomized\ndouble-blinded placebo-controlled trialof 5,988 adults with NYHA functionalclass I –IV chronic HFpEF (LVEF >40%),\nevaluated the ef ficacy of empagli flozin\n10 mg daily versus placebo on top ofstandard of care on the primary out-come of composite cardiovascular death\nor hospitalization ... | [
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or hospitalization for heart failure (242).\nApproximately 50% of subjects had type 2diabetes at baseline. Over a median of26.2 months, there was a 21% reduction(HR 0.79 [95% CI 0.69 –0.90]; P<0.001)\nof the primary outcome. The effects ofempagli flozin were consistent in people\nwith or without diabetes (242).\nIn the ... | [
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In the DELIVER trial, 6,263 individuals\nwith heart failure and an ejection frac-\ntion>40% were randomized to receive\neither dapagli flozin or placebo (252).\nThe primary outcome of a composite\nof worsening heart failure, de fined as | [
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of worsening heart failure, de fined as\nhospitalization or urgent visit for heartfailure, or cardiovascular death was re-duced by 18% in individuals treatedwith dapagli flozin compared with pla-\ncebo (HR 0.82 [95% CI 0.73 –0.92]; P<\n0.001). Approximately 44% of individu-als randomized to either dapagli flozin or | [
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placebo had type 2 diabetes, and results\nwere consistent regardless of the pres-\nence of type 2 diabetes.\nA large recent meta-analysis (293) of\ndata from EMPEROR-Reduced, EMPEROR-Preserved, DAPA-HF, DELIVER, and the\nEffect of Sotagli flozin on Cardiovascular\nEvents in Patients With Type 2 Diabetes | [
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Events in Patients With Type 2 Diabetes\nPost Worsening Heart Failure (SOLOIST-WHF) trial included 21,947 individualsand demonstrated reduced risk for the\ncomposite of cardiovascular death or hos-\npitalization for heart failure, cardiovasculardeath, first hospitalization for heart failure,\nand all-cause mortality. Th... | [
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and all-cause mortality. The findings on\nthe studied end points were consistent inboth trials of heart failure with mildly re-duced or preserved ejection fraction and\nin all five trials combined. Collectively,\nthese studies indicate that SGLT2 inhibi-\ntors reduce the risk for heart failure hospi-talization and cardio... | [
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wide range of people with heart failure.\nIn addition to the hospitalization and\nmortality bene fit in people with heart\nfailure, several recent analyses have\naddressed whether SGLT2 inhibitor treat-\nment improves clinical stability and func- | [
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ment improves clinical stability and func-\ntional status in individuals with heartfailure. In 3,730 individuals with NYHAclass II –IV heart failure with an ejection\nfraction of #40%, treatment with empa-\ngliflozin reduced the combined risk of | [
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0.079... |
gliflozin reduced the combined risk of\ndeath, hospitalization for heart failure, oran emergent/urgent heart failure visitrequiring intravenous treatment and re-\nduced the total number of hospitalizations\nfor heart failure requiring intensive care, avasopressor or positive inotropic drug, ormechanical or surgical inte... | [
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0.00882955826818943,
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0.0294... |
In addition, individuals treated with empa-\ngliflozin were more likely to experience\nan improvement in NYHA functional class(294). In people hospitalized for acute de\nnovo or decompensated chronic heart fail-\nure, initiation of empagli flozin treatment | [
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0.051... |
ure, initiation of empagli flozin treatment\nduring hospitalization reduced the primaryoutcome of a composite of death fromany cause, number of heart failure events\nand time to first heart failure event, or a\n5-point or greater difference in change\nfrom baseline in the Kansas City Cardio-myopathy Questionnaire Total S... | [
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Score (295). Furthermore, PRESERVED-\nHF, a multicenter study (26 sites in theU.S.), showed that dapagli flozin treat-\nment leads to signifi cant improvement in | [
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ment leads to signifi cant improvement in\nboth symptoms and physical limitation aswell as objective measures of exercisefunction in people with chronic HFpEF,regardless of diabetes status (251). Fi-nally, canaglifl ozin improved heart failure | [
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symptoms assessed using the KansasCity Cardiomyopathy Questionnaire To-tal Symptom Score, irrespective of LVEFor the presence of diabetes (296).\nTherefore, in people with type 2 diabe-\ntes and established HFpEF or HFrEF, anSGLT2 inhibitor with proven bene fiti n\nthis patient population is recommended\nto reduce the r... | [
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to reduce the risk of worsening heart fail-\nure and cardiovascular death. In addition,an SGLT2 inhibitor is recommended indiabetesjournals.org/care Cardiovascular Disease and Risk Management S207\n©AmericanDiabetesAssociation | [
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0.000... |
this patient population to improve symp-\ntoms, physical limitations, and quality oflife. The bene fits seen in this patient pop-\nulation likely represent a class effect, andthey appear unrelated to glucose lower-\ning, given comparable outcomes in peo-\nple with heart failure with and withoutdiabetes.\nSotagliflozin | [
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ple with heart failure with and withoutdiabetes.\nSotagliflozin\nSotagli flozin, a dual SGLT1 and SGLT2 in-\nhibitor, was recently approved by theFDA in the U.S. to reduce the risk ofcardiovascular death, hospitalization forheart failure, and urgent heart failure\nin people with heart failure or type 2 | [
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... |
in people with heart failure or type 2\ndiabetes, CKD, and other cardiovascularrisk factors. This drug is distinct fromother SGLT inhibitors, as it lowers glu-\ncose via delayed glucose absorption in\nthe gut via inhibition of the cotrans-porter SGLT1 in addition to increasingurinary glucose excretion; however, it is | [
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0.007318723946809769,
0.05875547230243683,
-0.03587451949715614,
-0.01... |
not currently approved by the FDA for\nglycemic management of type 1 ortype 2 diabetes. Sotagli flozin was evalu-\nated in the SCORED trial (281) andSOLOIST-WHF trial (297). A total of\n10,584 people with type 2 diabetes,\nCKD, and additional cardiovascular riskwere enrolled in SCORED and random-ized to sotagli flo z i n... | [
0.058362625539302826,
0.003971961326897144,
-0.09553678333759308,
0.05375628173351288,
0.049969762563705444,
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0.002829040866345167,
0.09026144444942474,
-0.09799492359161377,
0.0223... |
(uptitrated to 400 mg once daily if toler-ated) or placebo. SCORED ended earlydue to a lack of funding; thus, changesto the prespeci fied primary end points\nwere made prior to unblinding to accom-modate a lower-than-anticipated numberof end point events. The primary endpoint of the trial was the total number of | [
0.036192383617162704,
0.04247532784938812,
-0.04327263683080673,
0.020504815503954887,
0.02198066934943199,
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0.0410102941095829,
-0.018019314855337143,
-0.02887... |
deaths from cardiovascular causes, hospi-\ntalizations for heart failure, and urgentvisits for heart failure. After a median of16 months of follow-up, the rate of pri-mary end point events was reduced with\nsotagli flozin (5.6 events per 100 patient-\nyears in the sotagli flozin group and 7.5\nevents per 100 patient-year... | [
-0.01673208735883236,
0.04822321608662605,
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-0.053860314190387726,
-0.... |
events per 100 patient-years in the pla-\ncebo group [HR 0.74; [95% CI 0.63– 0.88];\nP<0.001]). Sotagli flozin also reduced\nthe risk of the secondary end point of to-tal number of hospitalizations for heartfailure and urgent visits for heart failure\n(3.5% in the sotagli flozin group and 5.1%\nin the placebo group [HR 0... | [
0.050595592707395554,
0.05886244401335716,
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0.004025391768664122,
0.040713101625442505,
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0.028745925053954124,
0.03903896361589432,
-0.0515570305287838,
0.0201517... |
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