Pharmacokinetic and pharmacodynamic drug evaluation of tofogliflozin for the treatment of type 2 diabetes.

INTRODUCTION: Sodium-glucose co-transporter 2 (SGLT-2) inhibitors are a new class of drugs that are increasingly used for the management of type 2 diabetes mellitus (T2DM). Among these, tofogliflozin has recently received marketing approval in Japan.

AREAS COVERED: In this review, the authors summarize the pharmacokinetic and pharmacodynamic profile of tofogliflozin for the treatment of T2DM, and provide a rationale for its use in such patients.

EXPERT OPINION: Despite the very promising characteristics of tofogliflozin in improvement of glycemic and metabolic parameters, a number of issues await consideration. One important question relates to the manner in which tofogliflozin mediates metabolic changes. Additionally, safety issues, namely hypoglycemia, diabetic ketoacidosis, pollakiuria and polyuria, urinary and genital tract infections, and potential other adverse events, need to be better monitored by pharmacovigilance programs. Ultimately, although tofogliflozin seems a promising agent that physicians are likely to embrace with excitement in the T2DM therapeutic area, longer duration trials are expected to verify this speculation and to increase our experience.