Empagliflozin effective as add-on to dual oral therapy
medwireNews: The sodium–glucose cotransporter 2 inhibitor empagliflozin significantly improves glycemic control in patients with type 2 diabetes who are already taking linagliptin and metformin, shows a randomized trial.
Average glycated hemoglobin (HbA1c) levels were the same in all treatment groups at baseline. But after 24 weeks of treatment, around twice as many patients assigned to take empagliflozin as placebo had reduced their levels to below 7.0%.
In all, 37.0% of the 109 patients taking empagliflozin 10 mg and 32.7% of the 110 taking empagliflozin 25 mg achieved this goal, compared with 17.0% of the 108 patients in the placebo group. The corresponding average changes in HbA1c levels by the end of treatment were 0.65% and 0.56% reductions compared with a 0.14% increase, with the between-group differences appearing within the first 6 weeks of treatment.
The HbA1c differences between the empagliflozin and placebo groups were statistically significant, but there were no differences between the two empagliflozin doses, which Eirik Søfteland (Haukeland University Hospital, Bergen, Norway) and study co-authors say is unexpected, given the dose-dependent effects reported in phase I and II trials.
All patients continued to take their previous metformin dose throughout the trial. They added the dipeptidyl peptidase 4 inhibitor linagliptin 5 mg for 16 weeks, and the 333 patients (of an initial 606) whose HbA1c levels remained above 7.0% continued to the empagliflozin/placebo phase of the trial.
Adverse events were no more common in the empagliflozin than placebo groups, and adverse events believed to relate to drug treatment occurred in 7.1–10.9% versus 5.5%. Four patients discontinued treatment due to adverse events, two of whom were in the placebo group. Confirmed hypoglycemia (plasma glucose ≤3.9 mmol/L and/or requiring assistance) occurred in just one patient in the placebo group and three in the empagliflozin 25 mg group.
Furthermore, patients taking empagliflozin experienced significant weight reductions, by 3.1 and 2.5 kg in the 10 mg and 25 mg groups, respectively, compared with 0.3 kg in the placebo group.
Linagliptin is “weight neutral,” the team notes in Diabetes Care. “Therefore, empagliflozin may provide a valuable treatment option as add-on therapy for patients with inadequate glycemic control with linagliptin and metformin, with the benefits of weight loss and a low risk of hypoglycemia.”
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