Table.
Key Studies Relevant to the Primary Prevention of HF in Patients With Type 2 Diabetes Mellitus
| Study Name (Trial Registration Number) | Study Design and Intervention | Overall Trial Population | N (%) Without Baseline HF | HF Hospitalization Events During Follow-Up Among Patients Without Baseline HF | Effect on HF Hospitalization Among Patients Without Baseline HF* |
|---|---|---|---|---|---|
| Studies of natriuretic peptide screening | |||||
| STOP-HF () | Randomized, controlled trial of BNP screening versus usual primary care | Age >40 y and history of CV disease or CV risk factors | 1374 (100) | 21 | OR, 0.48 (95% CI, 0.20–1.20) |
| PONTIAC () | Randomized, controlled trial of treatment in cardiac outpatient clinic for up-titration of RAAS inhibitors and β-blockers plus care in a diabetes mellitus care unit versus care in diabetes mellitus care unit alone | T2DM, NT-proBNP >125 pg/mL, and no known CV disease | 300 (100) | 8 | HR, 0.14 (95% CI, 0.02–1.14) |
| Studies of SGLT-2 inhibitors | |||||
| EMPA-REG OUTCOME () | Randomized, controlled trial of empagliflozin versus placebo | T2DM and established CV disease | 6314 (89.9) | 143 | HR, 0.59 (95% CI, 0.43–0.82) |
| CANVAS (; ) | Randomized, controlled trial of canagliflozin versus placebo | T2DM and history of symptomatic CV disease or age ≥50 y with CV risk factors | 8681 (85.6) | 243 (overall trial population) | Overall trial population: HR, 0.67 (95% CI, 0.52–0.87) P for interaction by baseline HF status=0.47 (non-HF subgroup; HR, 0.79 [95% CI, 0.57–1.09]) |
| CVD-REAL () | Observational propensity-matched study of initiation of SGLT-2 inhibitor versus initiation of other glucose-lowering therapy | T2DM | 299 583 (96.9) | 961 (overall trial population) | Overall trial population: HR, 0.61 (95% CI, 0.51–0.73) |
BNP indicates B-type natriuretic peptide; CANVAS, Canagliflozin Cardiovascular Assessment Study; CV, cardiovascular; CVD-REAL, Comparative Effectiveness of Cardiovascular Outcomes in New Users of SGLT-2 Inhibitors; EMPA-REG OUTCOME, Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients–Removing Excess Glucose; HF, heart failure; HR, hazard ratio; NT-proBNP, N-terminal pro–B-type natriuretic peptide; OR, odds ratio; PONTIAC, NT-proBNP Guided Primary Prevention of CV Events in Diabetic Patients; RAAS, renin-angiotensin-aldosterone system; SGLT-2, sodium-glucose cotransporter 2; STOP-HF, St. Vincent’s Screening to Prevent Heart Failure; and T2DM, type 2 diabetes mellitus.
Data reflect risk of HF hospitalization among patients without baseline HF, unless otherwise specified.