Table 1

Investigator-reported and adjudication-confirmed pancreatitis in SAVOR-TIMI 53

Saxagliptin overall
(n = 8,280)Placebo overall
(n = 8,212)P value
(Fisher exact test)HR (95% CI)
Investigator-reported pancreatitis
 Patients with pancreatitis events33 (0.40)30 (0.37)0.801.09 (0.66–1.79)
 Number of events of pancreatitis35350.99 (0.90–1.10)
Adjudication-confirmed pancreatitis
 Patients with any pancreatitis event24 (0.29)21 (0.26)0.771.13 (0.63–2.06)
 Number of events of pancreatitis26251.03 (0.93–1.15)
 Patients with definite acute pancreatitis events17 (0.2)9 (0.1)0.171.88 (0.86–4.41)
 Patients with acute pancreatitis, definite or possible22 (0.3)16 (0.2)0.421.36 (0.72–2.64)
 Patients with chronic pancreatitis events2 (0.02)6 (0.07)0.180.33 (0.05–1.44)
Patients with any pancreatitis event*
 Duration of events (days)
  n2122
  Mean (SD)13.7 (28.3)38.5 (103.4)
  Median (minimum, maximum)7.0 (3.0, 135.0)12.0 (2.0, 494.0)
Action taken to study drug
 Not applicable4 (15.4)5 (20.0)
 Dose not changed16 (61.5)13 (52.0)
 Drug interrupted2 (7.7)1 (4.0)
 Drug withdrawn4 (15.4)6 (24.0)
Outcome of the AE
 Resolved21 (80.8)21 (84.0)
 Recovering3 (11.5)1 (4.0)
 Not resolved2 (7.7)1 (4.0)
 Resolved with sequelae01 (4.0)
 Fatal01 (4.0)
  • Data are n (%) unless otherwise indicated. HR and 95% CIs from a Poisson regression model.

  • *Summary is at the event level; denominator is the total number of events for each treatment group. Eight pancreatic cases missing data on duration of events.