Safety and tolerability of sitagliptin in patients with type 2 diabetes: a pooled analysis

BMC Endocrine Disorders

Table 5 Clinical adverse experiences for which the 95% confidence intervals around the difference in incidence rate exclude 0

Adverse Experience	Sitagliptin 100 mg n (%) (N = 3415)	Non-Exposed n (%) (N = 2724)	Difference in Sitagliptin and Non-Exposed, % (95% CI)*
Sitagliptin > Non-exposed
Atrial fibrillation^†	18 (0.5)	5 (0.2)	0.3 (0.0, 0.7)
Asthenia	19 (0.6)	6 (0.2)	0.3 (0.0, 0.7)
Chest discomfort	9 (0.3)	1 (0.0)	0.2 (0.0, 0.5)
Tooth abscess^‡	27 (0.8)	10 (0.4)	0.4 (0.0, 0.8)
Osteoarthritis	58 (1.7)	24 (0.9)	0.8 (0.2, 1.4)
Acne	7 (0.2)	0 (0)	0.2 (0.0, 0.4)
Dermatitis Contact	24 (0.7)	7 (0.3)	0.4 (0.1, 0.8)
Non-exposed > Sitagliptin
Bradycardia	0 (0)	4 (0.1)	-0.1 (-0.4, -0.0)
Goiter	1 (0.0)	6 (0.2)	-0.2 (-0.5, -0.0)
Change in bowel habit	0 (0)	4 (0.1)	-0.1 (-0.4, -0.0)
Blood glucose decreased	13 (0.4)	28 (1.0)	-0.6 (-1.1, -0.2)
Blood glucose increased	42 (1.2)	51 (1.9)	-0.6 (-1.3, -0.0)
Weight increased	12 (0.4)	20 (0.7)	-0.4 (-0.8, -0.0)
Hypoglycemia	117 (3.4)	296 (10.9)	-7.4 (-8.8, -6.1)
Sinus headache	3 (0.1)	12 (0.4)	-0.4 (-0.7, -0.1)
Prostatitis	3 (0.1)	9 (0.3)	-0.2 (-0.5, -0.0)
Balanitis	0 (0)	4 (0.1)	-0.1 (-0.4, -0.0)
Hyperkeratosis	0 (0)	8 (0.3)	-0.3 (-0.6, -0.1)

CI = confidence interval
*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 incidence rates were 0.5% and 0.3% for the sitagliptin and non-exposed groups, respectively (between-group difference [95% CI] = 0.3 [-0.1, 0.6]).
^‡When tooth abscess and tooth infection were combined, the incidence rates were 1.3% and 0.9% for the sitagliptin and non-exposed groups, respectively (between-group difference [95% CI] = 0.4 [-0.1, 1.0]).

ISSN: 1472-6823