Real-world data confirm safety of dapagliflozin–metformin combo in T2DM

Using dapagliflozin and metformin together is well-tolerated and does not appear to cause additional safety concerns, according to a study involving Chinese patients with type 2 diabetes mellitus (T2DM) treated in routine clinical setting.

Researchers conducted a post hoc analysis of the large-scale real-world study DONATE, in which the safety of dapagliflozin was evaluated. The present analysis included 2,165 patients (mean age 51.7 years, 66.7 percent male, mean diabetes duration 8.6 years) who received metformin concomitantly. The mean fasting plasma glucose was 10.39 mmol/L, while the mean HbA1c was 9.10 percent. Common medical histories included hypertension (53.6 percent), hyperlipidaemia (41.2 percent), and hepatic steatosis (33.0 percent), among others.

Mean duration of treatment with dapagliflozin was 207.9 days, with all patients receiving the preferred once-daily dose. For metformin, the mean treatment duration was 1,132.3 days, with most patients taking the drug twice (45.5 percent) or thrice (38.5 percent) daily.

A total of 780 patients (36.0 percent) had at least one adverse event (AE), including 129 (6.0 percent) who had a serious AE (SAE) and 96 (4.4 percent) who had an AE leading to dapagliflozin discontinuation. The most frequent AEs were upper respiratory tract infection (4.0 percent), urinary tract infection (UTI, 2.1 percent), and constipation (1.5 percent). The most common AEs of special interest with dapagliflozin were UTI (2.3 percent), genital tract infection (1.5 percent), and hypoglycaemia (1.1 percent).

In the dapagliflozin and metformin dual-therapy subgroup, AE occurred in 26.7 percent of patients, serious AE in 2.5 percent, and AE leading to dapagliflozin discontinuation in 1.9 percent. These numbers were numerically lower than that in the total population and most other dual-therapy subgroups.