Abstract
The reimbursement database of the Taiwan’s National Health Insurance was used to evaluate oral cancer risk after sitagliptin use. Patients newly diagnosed of type 2 diabetes during 1999–2008 were recruited. A 1:1 propensity score matched-pair sample of 39195 ever users and 39195 never users were followed up until December 31, 2011. Cox regression incorporated with the inverse probability of treatment weighting using propensity score was used to estimate hazard ratios. Results showed that the overall hazard ratio was not statistically significant (0.956, 95% confidence interval: 0.652–1.401). However, in tertile analyses, the hazard ratio for the first (< 7.47 months), second (7.47–15.63 months) and third (> 15.63 months) tertile of cumulative duration was 1.563 (0.963–2.537), 1.236 (0.738–2.071) and 0.345 (0.164–0.725), respectively; and was 1.575 (0.963–2.575), 1.224 (0.738–2.033) and 0.347 (0.165–0.731), respectively, for the first (< 19,600 mg), second (19,600–42,200 mg) and third (> 42,200 mg) tertile of cumulative dose. Sensitivity analyses after excluding patients who developed any other cancer during follow-up did not change the results substantially. Additionally, the risk of oral diseases that may predispose to oral cancer (i.e., “gingival and periodontal diseases" and/or "oral mucosal lesions") paralleled the risk pattern of oral cancer, suggesting a possible explanation for the risk change of oral cancer related to sitagliptin. In conclusion, sitagliptin may reduce oral cancer risk when the cumulative duration is > 15.63 months or the cumulative dose is > 42,200 mg.
Highlights
Incretin-based therapies by using the oral form of dipeptidyl peptidase-4 (DPP-4) inhibitors have become a mainstay in the treatment of type 2 diabetes mellitus
The present study evaluated such risk after sitagliptin use in type 2 diabetes patients by using the reimbursement records in Taiwan’s National Health Insurance (NHI) database
When evaluating the distribution of the incident cases of oral cancer by the tertiles of cumulative duration and cumulative dose of sitagliptin therapy, there was a trend of decreasing incidence with longer duration or higher cumulative dose
Summary
Incretin-based therapies by using the oral form of dipeptidyl peptidase-4 (DPP-4) inhibitors have become a mainstay in the treatment of type 2 diabetes mellitus. Sitagliptin, probably the most commonly used DPP-4 inhibitor, was the first in the class approved for clinical use in 2006 [1]. There are some concerns on cancer risk related to the use of incretin-based therapies, especially for pancreatic cancer and thyroid cancer [1,2,3]. Some animal and in vitro studies suggested that sitagliptin inhibits the growth of colorectal cancer [1, 4]. A Japanese case report showed that sitagliptin treatment for 3 weeks dramatically regressed hepatocellular carcinoma in a patient with hepatitis. In a recent observational study, sitagliptin reduced the risk of prostate cancer [6]
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