Table 1:
Baseline characteristics of the pooled STEP-HFpEF and STEP-HFpEF DM populations
| Semaglutide group (n=573) | Placebo group (n=572) | |
|---|---|---|
| Age, years | 70 (62–74) | 69·0 (62–75) |
| Sex | ||
| Female | 277 (48%) | 293 (51%) |
| Male | 296 (52%) | 279 (49%) |
| Race* | ||
| White | 506 (88%) | 520 (91%) |
| Asian | 45 (8%) | 31 (5%) |
| Black or African American | 21 (4%) | 18 (3%) |
| Other | 1 (<1%) | 3 (1%) |
| Ethnicity* | ||
| Hispanic or Latino | 53 (9%) | 59 (10%) |
| Not Hispanic or Latino | 520 (91%) | 513 (90%) |
| Weight, kg | 104·4 (92·0–119·0) | 103·1 (90·5–118·5) |
| BMI | ||
| Median, kg/m² | 37·0 (33·6–41·3) | 36·9 (33·4–41·5) |
| <35 kg/m²† | 197 (34%) | 203 (35%) |
| ≥35 kg/m² | 376 (66%) | 369 (65%) |
| Waist circumference, cm | 120·2 (111·8–129·5) | 119·0 (111·0–129·0) |
| Blood pressure, mm Hg | ||
| Systolic | 133·0 (123·0–144·0) | 134·5 (123·0–144·0) |
| Diastolic | 78·0 (71·0–85·0) | 78·0 (70·0–84·0) |
| NT-proBNP, pg/mL | 443·6 (237·6–997·9) | 500·7 (232·6–1059·7) |
| C-reactive protein, mg/L | 3·8 (1·8–7·6) | 3·4 (1·7–8·4) |
| Left ventricular ejection fraction | ||
| Median | 57% (50–60) | 56% (50–60) |
| ≥45% to <50%‡ | 94 (16%) | 97 (17%) |
| ≥50% to <60% | 234 (41%) | 240 (42%) |
| ≥60% | 245 (43%) | 235 (41%) |
| KCCQ-CSS | 59·9 (44·3–72·9) | 58·3 (40·6–71·9) |
| 6-min walk distance, m | 295·0 (230·0–368·1) | 294·3 (215·0–367·0) |
| Hospitalisation for heart failure within previous year | 91 (16%) | 102 (18%) |
| Comorbidities at screening | ||
| Atrial fibrillation | 252 (44%) | 266 (47%) |
| Hypertension | 471 (82%) | 488 (85%) |
| Coronary artery disease | 132 (23%) | 114 (20%) |
| Obstructive sleep apnoea | 58 (10%) | 61 (11%) |
| New York Heart Association functional class | ||
| Class II | 406 (71%) | 379 (66%) |
| Class III | 166 (29%) | 192 (34%) |
| Class IV | 1 (<1%) | 1 (<1%) |
| Concomitant medications | ||
| β blockers | 458 (80%) | 470 (82%) |
| Any diuretic | 453 (79%) | 472 (83%) |
| Loop diuretics | 344 (60%) | 358 (63%) |
| Mineralocorticoid receptor antagonists | 194 (34%) | 190 (33%) |
| Thiazides | 82 (14%) | 93 (16%) |
| ACE inhibitors, ARBs, or ARNIs | 445 (78%) | 454 (79%) |
| ARNIs | 32 (6%) | 26 (5%) |
| Biguanides (ie, metformin) | 240 (42%) | 212 (37%) |
| Sulfonylureas | 57 (10%) | 51 (9%) |
| SGLT2 inhibitors | 115 (20%) | 106 (19%) |
| DPP-4 inhibitors | 55 (10%) | 37 (6%) |
| Insulins | 53 (9%) | 75 (13%) |
Data are n (%) or median (IQR) and are for the full analysis set, which included 1145 of the 1146 randomly assigned participants (the set excludes one participant who was randomly assigned in error). Percentages might not total to 100% because of rounding. ACE=angiotensin-converting enzyme. ARBs=angiotensin II receptor blockers. ARNIs=angiotensin receptor–neprilysin inhibitors. KCCQ-CSS=Kansas City Cardiomyopathy Questionnaire Clinical Summary Score.
Race or ethnic group were reported by the investigators based on the participants’ perception of their race or ethnicity
All participants had a BMI of at least 30 kg/m².
Includes one participant with a left ventricular ejection fraction of 33%.