Table 2.
Clinical efficacy in the heart failure health status, glycemic control, anthropometric characteristics, treatment de-intensification, laboratory variables, and safety.
| Variables | Baseline (n = 136) | 3 months’ follow-up (n = 127) | 6 months’ follow-up (n = 125) | 12 months’ follow-up (n = 124) |
|---|---|---|---|---|
| HF health status | ||||
| KCCQ total symptom score | 59.0 ± 24.1 | 68.9 ± 25.1* | 75.5 ± 27.5† | 79.7 ± 28.4† |
| NYHA functional class I II III |
0 81 (59.6%) 55 (40.4%) |
0 88 (69.3%) *39 (30.7%)* |
6 (4.8%) 94 (75.2%)† 25 (20.0%)† |
7 (5.6%) 97 (78.2%)† 20 (16.2%)† |
| NT-proBNP (pg/mL) | 969.5 ± 653.5 | 738.8 ± 553.4* | 610.9 ± 424.5† | 577.4 ± 322.1† |
| Glycemic control | ||||
| Fasting blood glucose (mg/dL) | 154.9 ± 50.0 | 140.4 ± 42.2† | 121.5 ± 38.4‡ | 117.0 ± 33.2‡ |
| HbA1c (%) | 8.1 ± 1.4 | 7.3 ± 1.2* | 7.0 ± 1.1† | 6.7 ± 1.0† |
| Patients with HbA1c <7% | 22 (16.2) | 45 (35.4%)* | 66 (52.8%)‡ | 80 (64.5%)‡ |
| Anthropometric characteristics | ||||
| Body weight (kg) | 97.8 ± 19.7 | 92.8 ± 16.7* | 87.1 ± 14.4† | 85.1 ± 13.2‡ |
| Body Mass Index (kg/m2) | 36.6 ± 7.2 | 33.9 ± 6.5* | 30.9 ± 4.9† | 29.5 ± 4.3‡ |
| Body Mass Index ≥30 | 136 (100.0%) | 103 (81.1%)* | 80 (64.0%)† | 61 (49.2%)‡ |
| Waist circumference (cm) | 133.3 ± 19.1 | 119.1 ± 15.2* | 108.8 ± 12.7† | 102.9 ± 10.0† |
| SBP (mmHg) | 130.9 ± 12.3 | 122.4 ± 11.1 | 119.2 ± 10.4* | 118.4 ± 10.0* |
| DBP (mmHg) | 72.5 ± 13.6 | 71.5 ± 12.8 | 69.1 ± 9.9 | 68.4 ± 8.9 |
| Heart rate (bpm) | 75.1 ± 12.6 | 72.4 ± 10.2 | 70.2 ± 8.9 | 69.7 ± 8.2 |
| Treatment de-intensification | ||||
| Number of daily antidiabetic agents | 3.5 ± 1.2 | 2.5 ± 0.9* | 2.4 ± 0.9* | 2.2 ± 0.8* |
| Basal insulin | 86 (63.2%) | 70 (55.1%)* | 48 (38.4%)‡ | 40 (32.3%)‡ |
| Basal insulin dose (Units/day) | 39.0 ± 21.8 | 32.9 ± 18.5* | 24.6 ± 11.0† | 20.2 ± 8.9‡ |
| Insulin combinations | 16 (13.8%) | 9 (7.1%)* | 1 (0.8%)† | 0† |
| Laboratory variables | ||||
| Creatinine (mg/dL) | 1.2 ± 0.5 | 1.2 ± 0.5 | 1.3 ± 0.5 | 1.3 ± 0.5 |
| EGFR (ml/min/1.73 m2) | 56.8 ± 22.4 | 55.9 ± 21.2 | 56.4 ± 22.8 | 57.7 ± 22.9 |
| Uric acid (mg/dL) | 7.7 ± 5.0 | 7.1 ± 4.8 | 6.8 ± 3.8 | 6.7 ± 3.5 |
| Hematocrit (%) | 41.7 ± 5.5 | 43.0 ± 5.8 | 43.6 ± 6.3 | 43.7 ± 6.4 |
| LDL cholesterol (mg/dL) | 78.4 ± 28.5 | 77.4 ± 24.5 | 70.7 ± 21.1 | 71.5 ± 21.2 |
| HDL cholesterol (mg/dL) | 40.4 ± 9.5 | 39.8 ± 9.1 | 41.1 ± 10.5 | 43.1 ± 12.0 |
| Total cholesterol (mg/dL) | 158.7 ± 39.2 | 159.9 ± 39.5 | 147.6 ± 40.0 | 151.4 ± 44.4 |
| Triglycerides (mg/dL) | 203.9 ± 60.0 | 197.3 ± 56.4 | 200.5 ± 58.1 | 207.4 ± 59.1 |
| Urinary albumin/creatinine ratio (mg/g) | 52.4 ± 47.8 | 46.4 ± 40.8* | 23.6 ± 12.8† | 13.4 ± 9.9‡ |
| Safety variablesa | ||||
| Adverse drug effects | – | 12 (9.4%) | 25 (20.0%) | 30 (24.2%) |
| Gastrointestinal disorder Nausea Vomiting Diarrhea |
– | 12 5 4 3 |
24 11 8 5 |
30 14 10 6 |
| Acute pancreatitis | – | 0 | 1 | 0 |
| Discontinuation of semaglutide | – | 9 (6.6%) | 11 (8.1%) | 12 (8.8%) |
| Major complicationa,b | ||||
| 3P-MACE | – | 0 | 2 (1.6%) | 6 (4.8%) |
| Emergency department visit because of HF | 69 (50.7%) | 20 (15.7%) | 30 (24.0%) | 49 (39.5%)* |
| Hospitalization Because of HF All-cause |
52 (38.2%) 12 (8.8%) |
10 (7.9%) 2 (1.6%) |
19 (15.2%) 3 (2.4%) |
34 (27.4%)* 5 (4.0%)* |
| Mortality Cardiovascular cause Noncardiovascular cause |
– |
0 0 |
0 0 |
2 (2.4%) 0 |
| HF hospitalization and cardiovascular mortality | – | 10 (7.9%) | 19 (15.2%) | 36 (29.0%) |
Continuous data are shown as means (standard deviations) and qualitative data as absolute value and percentages. Statistical significance was measured for the comparison of baseline and follow-up data.
DBP, diastolic blood pressure; EGFR, estimated glomerular filtration rate; HbA1c, glycated hemoglobin; HF, heart failure; KCCQ, Kansas City Cardiomyopathy Questionnaire; 3P-MACE, 3-Point major adverse cardiovascular event; NT-proBNP, N-terminal pro-brain natriuretic peptide; NYHA, New York Heart Association; SBP, systolic blood pressure
Cumulative data during the 12 months of follow-up are shown.
Data from one year before initiation (baseline) were compared with 3, 6, and 12 months’ follow-up.
*p<.05.
†p<.01.
‡p<.001.