Table 9

Select gastrointestinal and hypoglycemia adverse events: Predefined primary analysis, which excluded data after initiation of glycemic rescue therapy

Adverse Event

Incidence Rate per 100 Patient-years^†

Sitagliptin

100 mg

Non-exposed

Difference between Sitagliptin and Non-exposed (95% CI)*

Gastrointestinal disorders SOC

One or more select event (abdominal pain^‡, diarrhea, nausea, vomiting)

14.0

17.2

-2.9 (-4.8, -1.1)

Abdominal pain^‡

4.1

4.7

-0.7 (-1.7, 0.3)

Diarrhea

7.1

10.0

-2.5 (-3.9, -1.1)

Nausea

3.1

4.0

-0.7 (-1.6, 0.2)

Vomiting

1.9

1.9

0.0 (-0.6, 0.6)

Metabolism and nutrition disorders SOC

Hypoglycemia

4.9

11.7

-6.7 (-8.2, -5.3)

CI = confidence interval;

^†100 * (number of patients with ≥ 1 event/person years of follow-up time).

* Between-group difference and 95% CI based on stratified analysis. Positive differences indicate that the incidence rate for the sitagliptin group is higher than the incidence rate for the non-exposed group. "0.0" and "-0.0" represent rounding for values that are slightly greater and slightly less than zero, respectively.

^‡Abdominal pain includes abdominal pain, upper and lower abdominal pain, and abdominal and epigastric discomfort.

Williams-Herman et al. BMC Endocrine Disorders 2010 10:7   doi:10.1186/1472-6823-10-7