Tofogliflozin safe, effective for seniors with T2DM
Tofogliflozin is safe and effective for elderly patients with type 2 diabetes mellitus (T2DM), regardless of insulin and oral antidiabetic drugs (OADs), reports a new Japan study.
Conducting a subanalysis of the J-STEP/EL* study, researchers evaluated the safety and efficacy of tofogliflozin in 1,497 elderly T2DM patients (mean age, 72.4±6.0 years; 52.4 percent female) who started the medication within the first 3 months of its launch.
A total of 271 patients reported adverse drug reactions (ADR), resulting in an incidence rate of 18.10 percent. There were 33 patients (2.20 percent) who experienced serious ADRs. Volume depletion-related ADRs were the most common (3.94 percent), followed by polyuria/pollakiuria (2.94 percent) and skin disorders (2.40 percent). The incidence rate of hypoglycaemia was 1.07 percent.
In terms of efficacy, researchers observed a significant drop in glycated haemoglobin (HbA1c) over time. From a baseline value of 7.64±1.35 percent, HbA1c decreased to 7.17±1.16 percent at the last observation. The mean change of –0.46±1.02 percent was statistically significant (p<0.001).
Efficacy of tofogliflozin did not meaningfully change according to the number of OADs. In those taking zero, one, two and ≥3 OADs, the mean change in HbA1c values from baseline were –0.34±0.91 percent, –0.42±1.06 percent, –0.56±1.03 percent and –0.50±1.07 percent, respectively (p<0.001 for all).
Similarly, insulin did not interfere with the effect of tofogliflozin, such that those taking the hormone showed a significant mean HbA1c change of –0.44±0.89 percent (p<0.001).
*Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients in an Observational Study of the Elderly