Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes

Table 6 Adverse events for which the 95% CI around the difference in incidence rates excludes 0 and the between-group difference is >0.2 incident events per 100 patient-years

Adverse Event	Incidence Rate per 100 Patient-years^†
	Sitagliptin 100 mg	Non-exposed	Difference between Sitagliptin and Non-exposed (95% CI)*
Sitagliptin > Non-exposed
Atrial fibrillation^‡	0.4	0.2	0.3 (0.0, 0.6)
Constipation	2.6	1.9	0.8 (0.1, 1.4)
Protein urine present^{^}	0.5	0.2	0.3 (0.0, 0.5)
Pain in extremity	2.8	2.1	0.7 (0.1, 1.4)
Dermatitis Contact	0.7	0.3	0.5 (0.1, 0.8)
Non-exposed > Sitagliptin
Diarrhea^#	6.9	9.6	-2.3 (-3.6, -1.0)
Fatigue	1.8	2.5	-0.6 (-1.3, -0.0)
Blood glucose decreased	0.5	1.0	-0.5 (-0.9, -0.1)
Blood glucose increased	2.3	3.6	-1.3 (-2.1, -0.6)
Blood triglycerides increased	0.5	0.8	-0.4 (-0.7, -0.0)
Hypoglycemia^#	5.2	12.1	-6.8 (-8.3, -5.5)
Sinus headache	0.1	0.3	-0.3 (-0.5, -0.1)

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.
^‡When atrial fibrillation and atrial flutter were combined, the between-group difference (95% CI) was 0.2 (-0.1, 0.5). Incidence rates for atrial flutter were 0.0 and 0.1 for the sitagliptin and the non-exposed groups, respectively, with a between-group difference [95% CI] of -0.1 (-0.3, -0.0).
^When albuminuria, microalbuminuria, albumin in urine present, protein urine present, and proteinuria were combined, the between-group difference (95% CI) was 0.1 (-0.2, 0.5).
^# For these events, see also Table 9 for the results of the predefined primary analysis which excludes data after initiation of glycemic rescue therapy.

ISSN: 1472-6823