Tofogliflozin safe, effective for type 2 diabetes mellitus
Tofogliflozin cuts glycated haemoglobin (HbA1c) and promotes weight loss in type 2 diabetes mellitus (T2DM) patients without posing substantial safety concerns, a new study has shown.
Researchers conducted a 3-year prospective, observational postmarketing study on 6,897 T2DM patients who were tofogliflozin-naïve at baseline but had been given 20 mg of the medication, to be taken once-daily. Disease course was the main outcome, described according to the parameters of HbA1c, fasting plasma glucose (FPG), adverse events (AEs) and adverse drug reactions (ADRs), among others.
HbA1c dropped from 8.00±1.48 percent to 7.31±1.22 percent at last observation carried forward (LOCF). This corresponded to a significant change of –0.70±1.31 percent (p<0.0001). This effect was only seen in those with baseline estimated glomerular filtration rate (eGFR) values ≥30 mL/min/1.73 m2. Baseline body mass index did not modify the effect of tofogliflozin on HbA1c.
There were other significant improvements in other efficacy indicators, such as FPG (mean change, –32.67±62.53 mg/dL; p<0.0001) and body weight (mean change, –2.95±4.40 kg; p<0.0001). Notably, the drop in body weight was stronger in those who had higher body mass index, while eGFR had no modifying effect.
In terms of safety, 952 ADRs were reported in the 6,712 patients, 103 of which were serious cases observed in 81 patients. Serious ADRs included nervous system disorders, cardiac disorders, and infections and infestations. Twelve deaths occurred, one of which, due to lung cancer, was deemed to be treatment-related.