Confirmed pancreatitis and pancreatic cancer events in the TECOS Study
. | Patients . | Events . | ||||
---|---|---|---|---|---|---|
Sitagliptin (n = 7,332) . | Placebo (n = 7,339) . | HR (95% CI) . | P . | Sitagliptin . | Placebo . | |
ITT analysis | ||||||
Acute pancreatitis | 23 (0.107) | 12 (0.056) | 1.93 (0.96–3.88) | 0.065 | 25 (0.113) | 17 (0.077) |
Severe | 4 | 0 | 4 | 0 | ||
Mild | 19 | 11 | 21 | 16 | ||
Unknown | 0 | 1 | 0 | 1 | ||
Pancreatic cancer | 9 (0.042) | 14 (0.066) | 0.66 (0.28–1.51) | 0.32 | ||
Per-protocol analysis | ||||||
Acute pancreatitis | 20 (0.104) | 11 (0.058) | 1.80 (0.86–3.76) | 0.12 | 21 (0.109) | 12 (0.063) |
Pancreatic cancer | 9 (0.047) | 10 (0.054) | 0.91 (0.37–2.25) | 0.85 | … | … |
. | Patients . | Events . | ||||
---|---|---|---|---|---|---|
Sitagliptin (n = 7,332) . | Placebo (n = 7,339) . | HR (95% CI) . | P . | Sitagliptin . | Placebo . | |
ITT analysis | ||||||
Acute pancreatitis | 23 (0.107) | 12 (0.056) | 1.93 (0.96–3.88) | 0.065 | 25 (0.113) | 17 (0.077) |
Severe | 4 | 0 | 4 | 0 | ||
Mild | 19 | 11 | 21 | 16 | ||
Unknown | 0 | 1 | 0 | 1 | ||
Pancreatic cancer | 9 (0.042) | 14 (0.066) | 0.66 (0.28–1.51) | 0.32 | ||
Per-protocol analysis | ||||||
Acute pancreatitis | 20 (0.104) | 11 (0.058) | 1.80 (0.86–3.76) | 0.12 | 21 (0.109) | 12 (0.063) |
Pancreatic cancer | 9 (0.047) | 10 (0.054) | 0.91 (0.37–2.25) | 0.85 | … | … |
Data are n (events per 100 patient-years of follow-up) or n, except where indicated. Some patients had more than 1 event.