Table 2.
Meta-analysis and TSA results of different doses of TZP for AEs.
| Outcome | TZP arm (events/total) | Comparator arm (events/total) | I 2 | RR (95%CI) | TSA | RIS | Quality of evidence |
|---|---|---|---|---|---|---|---|
| TZP 10 mg vs. TZP 5 mg | |||||||
| Total AEs | 1,013/1,448 | 958/1,449 | 0 | 1.06 (1.01, 1.11) | No | 4,607 | Moderate |
| Serious AEs | 117/1,448 | 125/1,449 | 19 | 0.94 (0.74, 1.19) | No | 116,856 | Moderate |
| GI AEs | 292/641 | 252/646 | 0 | 1.17 (1.03, 1.33) | No | 1,792 | Moderate |
| MACE-4 | 21/807 | 22/803 | 0 | 0.96 (0.54, 1.70) | No | 416,265 | Moderate |
| Cardiovascular death | 1/797 | 5/799 | 17 | 0.27 (0.05, 1.66) | No | 5,751 | Moderate |
| Hypertension | 10/530 | 14/529 | 0 | 0.71 (0.32, 1.58) | No | 12,059 | Moderate |
| Cancer | 1/240 | 3/237 | 0 | 0.42 (0.06, 2.83) | No | 3,641 | Moderate |
| Hypoglycaemia (PG < 70 mg/dl) | 137/651 | 111/650 | 25 | 1.22 (1.00, 1.48) | No | 7,373 | Moderate |
| Hypoglycaemia (PG < 54 mg/dl) | 48/1,397 | 55/1,394 | 0 | 0.86 (0.60, 1.25) | No | 42,953 | Moderate |
| TZP 15 mg vs. TZP 5 mg | |||||||
| Total AEs | 1,062/1,461 | 958/1,449 | 25 | 1.10 (1.05, 1.15) | Yes | 2,216 | High |
| Serious AEs | 106/1,461 | 125/1,449 | 0 | 0.84 (0.65, 1.07) | No | 12,234 | Moderate |
| GI AEs | 296/644 | 252/646 | 71 | 1.28 (0.95, 1.74) | No | 8,862 | Low |
| MACE-4 | 13/817 | 22/803 | 0 | 0.59 (0.30, 1.14) | No | 5,029 | Moderate |
| Cardiovascular death | 4/808 | 5/799 | 0 | 0.79 (0.21, 2.91) | No | 104,369 | Moderate |
| Hypertension | 13/532 | 14/529 | 0 | 0.93 (0.45, 1.92) | No | 21,984 | Moderate |
| Cancer | 0/241 | 3/237 | 0 | 0.25 (0.03, 2.17) | No | 1,258 | Moderate |
| Hypoglycaemia (PG <70 mg/dl) | 135/653 | 111/650 | 47 | 1.19 (0.98, 1.45) | No | 15,120 | Moderate |
| Hypoglycaemia (PG <54 mg/dl) | 60/1,408 | 55/1,394 | 0 | 1.07 (0.75, 1.51) | No | 129,242 | Moderate |
| TZP 15 mg vs. TZP 10 mg | |||||||
| Total AEs | 1,062/1,461 | 1,013/1,448 | 0 | 1.04 (0.99, 1.09) | No | 8,616 | Moderate |
| Serious AEs | 106/1,461 | 117/1,448 | 0 | 0.89 (0.70, 1.15) | No | 33,066 | Moderate |
| GI AEs | 296/644 | 292/641 | 18 | 1.01 (0.90, 1.14) | No | 686,030 | Moderate |
| MACE-4 | 13/817 | 21/807 | 0 | 0.60 (0.31, 1.19) | No | 6,313 | Moderate |
| Cardiovascular death | 4/808 | 1/797 | 0 | 2.96 (0.47, 18.77) | No | 7,202 | Moderate |
| Hypertension | 13/532 | 10/530 | 0 | 1.28 (0.58, 2.85) | No | 21,984 | Moderate |
| Cancer | 0/241 | 1/240 | 0 | 0.33 (0.01, 8.03) | No | 4,007 | Moderate |
| Hypoglycaemia (PG < 70 mg/dl) | 135/653 | 137/651 | 0 | 0.98 (0.81, 1.18) | No | 378,528 | Moderate |
| Hypoglycaemia (PG < 54 mg/dl) | 60/1,408 | 48/1,397 | 57 | 1.34 (0.69, 2.61) | No | 54,898 | Low |