Table 1.
Pooled baseline characteristics for the semaglutide trials
| CVOTsa | Glycemic efficacy trialsb | Overall | ||||
|---|---|---|---|---|---|---|
| Semaglutide | Placebo | Semaglutide | Comparatorc | Semaglutide | Comparatorc | |
| n = 3,239 | n = 3,241 | n = 7,269 | n = 3,896 | n = 10,508 | n = 7,137 | |
| CV risk score | −1.0 (0.6) | −0.9 (0.6) | −1.7 (0.6) | −1.7 (0.6) | −1.5 (0.7) | −1.4 (0.7) |
| Age, years | 65.3 (7.2) | 65.5 (7.4) | 57.5 (10.4) | 57.5 (10.6) | 59.9 (10.2) | 61.1 (10.1) |
| HbA1c, % | 8.4 (1.5) | 8.4 (1.6) | 8.2 (0.9) | 8.2 (0.9) | 8.3 (1.1) | 8.3 (1.2) |
| Smoking status, n (%) | ||||||
| Current smoker | 388 (12.0) | 367 (11.3) | 1,254 (17.3) | 667 (17.1) | 1,642 (15.6) | 1,034 (14.5) |
| Never smoked | 1,473 (45.5) | 1,457 (45.0) | 3,946 (54.3) | 2,153 (55.3) | 5,419 (51.6) | 3,610 (50.6) |
| Previous smoker | 1,378 (42.5) | 1,417 (43.7) | 2,069 (28.5) | 1,076 (27.6) | 3,447 (32.8) | 2,493 (34.9) |
| LDL-C, mmol/L | 2.2 (0.9) | 2.3 (0.9) | 2.7 (0.9) | 2.7 (0.9) | 2.6 (0.9) | 2.5 (0.9) |
| Pulse rate, bpm | 71.6 (11.1) | 71.5 (11.1) | 74.2 (10.5) | 74.3 (10.5) | 73.4 (10.7) | 73.0 (10.9) |
| Systolic BP, mmHg | 135.7 (17.5) | 135.5 (17.2) | 132.2 (14.7) | 132.3 (15.1) | 133.3 (15.7) | 133.8 (16.2) |
| Heart failured, n (%) | 564 (17.4) | 586 (18.1) | 349 (4.8) | 212 (5.4) | 913 (8.7) | 798 (11.2) |
| NYHA | ||||||
| Class Id | 91 (2.8) | 97 (3.0) | 155 (2.1) | 93 (2.4) | 246 (2.3) | 190 (2.7) |
| Class II | 404 (12.5) | 419 (12.9) | 177 (2.4) | 115 (3.0) | 581 (5.5) | 534 (7.5) |
| Class III | 69 (2.1) | 70 (2.2) | 17 (0.2) | 4 (0.1) | 86 (0.8) | 74 (1.0) |
| Prior ischemic heart disease, n (%) | 1,403 (43.3) | 1,430 (44.1) | 850 (11.7) | 491 (12.6) | 2,253 (21.4) | 1,921 (26.9) |
| Prior MI, n (%) | 1,091 (33.7) | 1,131 (34.9) | 307 (4.2) | 185 (4.7) | 1,398 (13.3) | 1,316 (18.4) |
| Prior stroke, n (%) | 363 (11.2) | 412 (12.7) | 199 (2.7) | 117 (3.0) | 562 (5.3) | 529 (7.4) |
| Insulin use, n (%) | 1,740 (53.7) | 1,722 (53.1) | 869 (12.0) | 374 (9.6) | 2,609 (24.8) | 2,096 (29.4) |
| eGFR,e ml/min/1.73 m2 | 75.0 (21.8) | 75.1 (22.1) | 94.8 (17.1) | 94.3 (17.9) | 88.7 (20.8) | 85.6 (22.1) |
Data are mean (SD) unless otherwise stated
aCVOTs included SUSTAIN 6 and PIONEER 6.
bGlycemic efficacy trials included SUSTAIN 1–5, the SUSTAIN Japanese trials, PIONEER 1–5 and PIONEER 7–10.
cComparators included placebo, sitagliptin, exenatide ER, insulin glargine, dulaglutide, liraglutide and empagliflozin; for details of the n, (%) and observation times for each comparator see Additional file 3: Appendix Table S3.
dThe PIONEER 6 trial did not capture data on subjects with NYHA Class I.
eeGFR was estimated using the Chronic Kidney Disease Epidemiology Collaboration formula.
BP blood pressure, bpm beats per minute, CV cardiovascular, CVOT cardiovascular outcomes trial, eGFR estimated glomerular filtration rate, exenatide ER exenatide extended release, HbA1c glycated hemoglobin, LDL-C low-density lipoprotein cholesterol, MI myocardial infarction, NHYA New York Heart Association, SD standard deviation