Abstract
Aims
Genital infections are associated with sodium glucose co-transporter 2 inhibitors
such as dapagliflozin. Since patients with Type 2 diabetes are at increased risk of
genital infections, and obesity is a risk factor for infections, obese patients with
Type 2 diabetes could be more susceptible to genital infections when treated with
sodium glucose co-transporter 2 inhibitors. This pooled dataset assessed the frequency
of genital infections according to baseline body mass index in patients treated with
dapagliflozin 10 mg.
Methods
Data were pooled from 13 studies of up to 24 weeks’ duration (dapagliflozin N=2 360;
placebo N=2 295). Frequency of genital infections was compared between three body
mass index subgroups (<30, ≥30−< 35 and ≥35 kg/m2).
Results
Genital infections were reported in 130 (5.5%) patients receiving dapagliflozin and
14 (0.6%) patients receiving placebo; none of which were serious. Genital infections
were more common in women (84/130 [64.6%]) than in men (46/130 [35.4%]) treated with
dapagliflozin. In the body mass index < 30, ≥ 30−< 35 and ≥ 35 kg/m2 dapagliflozin-treated subgroups, 38/882 (4.3%), 47/796 (5.9%) and 45/682 (6.6%) patients
presented with genital infections, respectively.
Conclusion
Although the frequency was low overall and relatively similar between subgroups, there
was a trend towards an increase in genital infections in patients with a higher body
mass index. This trend is unlikely to be clinically relevant or to affect suitability
of dapagliflozin as a treatment option for obese patients with Type 2 diabetes, but
rather should influence advice and counselling of overweight patients on prevention
and treatment of genital infections.
Key words
sodium glucose co-transporter 2 inhibitors - obesity - counselling
