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

Table 8 Serious adverse events irrespective of relationship to study drug that occurred at an incidence rate of ≥ 0.2 incident events per 100 patient-years in one or both groups

CI = confidence interval Adverse Event	Incidence Rate per 100 Patient-years^†
	Sitagliptin 100 mg	Non-exposed	Difference between Sitagliptin and Non-exposed (95% CI)*
Cardiac disorders SOC
Acute myocardial infarction	0.1	0.2	-0.1 (-0.3, 0.0)
Angina pectoris	0.2	0.1	0.1 (-0.1, 0.3)
Coronary artery disease	0.2	0.4	-0.2 (-0.5, 0.0)
Myocardial infarction	0.2	0.2	0.0 (-0.2, 0.2)
Myocardial ischemia	0.0	0.2	-0.2 (-0.4, -0.1)
General disorders and administration site conditions SOC
Non-cardiac chest pain	0.1	0.3	-0.1 (-0.4, 0.1)
Infections and Infestations SOC
Pneumonia	0.2	0.2	0.1 (-0.2, 0.3)
Neoplasms benign, malignant and unspecified SOC
Basal cell carcinoma	0.2	0.2	0.0 (-0.2, 0.2)
Breast cancer^‡	0.3	0.2	0.1 (-0.2, 0.5)
Prostate cancer^‡	0.2	0.2	-0.0 (-0.3, 0.3)
Nervous system disorders SOC
Cerebrovascular accident	0.1	0.2	-0.1 (-0.3, 0.1)
Transient ischemia attack	0.0	0.2	-0.1 (-0.3, 0.0)

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.
^‡ Gender-specific analyses for these adverse events. There were no reports of breast cancer in males.

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