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Incretin-based therapies and cancer risk: a review of recent literature safety data

Cristina Scavone, Liberata Sportiello*, Concetta Rafaniello, Sonia Fiorentino, Daniela Cimmaruta, Francesco Rossi and Annalisa Capuano

Type 2 diabetes mellitus represents almost 90–95% of all diabetes. In 2006 and in 2007, the pharmacological treatment of type 2 diabetes mellitus changed due to the introduction on the European market of the first GLP-1 receptor agonist, exenatide, and the first inhibitor of DPP-4, sitagliptin. These drugs act throughout the potentiation of incretin receptor signalling. Today, other 4 GLP-1 receptor agonists and 4 DPP-4i have obtained marketing approval. However as far as the safety of these drugs is concerned, some issues were recently raised regarding an increase in the risk of cancer. Therefore, in order to define the correlation between incretin-based therapies and the risk of cancer, a literature search was performed. Data was taken from recent pre-clinical and clinical studies in which tolerability of GLP-1 receptor agonists and DPP-4i and was evaluated. In total, data obtained from 38 preclinical and clinical studies was analysed. It was evident from these studies that the risk of cancer associated to incretin- based therapies was very low. Results demonstrated that in more than 80,000 patients treated with these drugs, little over 60 cases of cancer were diagnosed. Moreover, results from EXAMINE and SAVOR-TIMI53 trials showed that the number of malignancies in patients treated with inhibitors of DPP-4 was similar to number of cancer events occurring in patients in placebo groups. Data from pre-clinical studies also revealed encouraging results. Clearly, it is not a simple task to define the correlation between these drugs and the cancer risk especially as patients with type 2 diabetes already have a risk factor for cancer. According to the European Medicine Agency and Food and Drug Administration, it is important to continue monitoring the safety of patients treated with incretin-based therapies.