International Journal of Endocrinology / 2014 / Article / Tab 2

Review Article

A Review on the Relationship between SGLT2 Inhibitors and Cancer

Table 2

Incidence rate ratio of malignancy by tumor type comparing dapagliflozin versus nondapagliflozin in 21 phase 2b and phase 3 clinical trials (dapagliflozin and control ).

Tumor originPatients with eventsIncidence rate ratio95% confidence interval

Overall1401.030.71, 1.51
Bladder105.17 0.68, 233.55
Breast (female only)152.470.64, 14.10
Pancreas81.840.31, 19.46
Prostate (male only)171.500.53, 5.35
Hepatobiliary30.920.04, 61.49
Thyroid and endocrine100.880.19, 4.46
Skin310.830.37, 1.91
Respiratory and mediastinal150.790.24, 2.81
Female reproductive (female only)40.740.05, 10.74
Metastases and site unspecified50.560.07, 8.96
Gastrointestinal100.510.13, 3.19
Renal tract50.400.03, 3.82
Blood/lymphatic70.370.05, 2.35
Musculoskeletal and soft tissue10.010,

Source: reference [20, 35]: data obtained from 21 phase 2b and 3 clinical trials, data cutoff date: Nov 4, 2013; a new case of bladder cancer found in an ongoing add-on to sulfonylurea and metformin phase 3 trial is not included. The incidence rate ratio with 95% CI including the case is 6.11 (0.827–272.00).