Background: Empagliflozin, an oral antidiabetic drug, inhibits the sodium-glucose cotransporter 2 and promotes urinary glucose excretion. Six of the phase 3 studies assessed efficacy and safety, including health outcomes, of empagliflozin as monotherapy or in combination with other oral antidiabetic treatments.
Objective: Evaluate the effect of treatment on patient utility and health profiles (measured by the EQ-5D) and health care resource utilization (HCRU).
Methods: Descriptive analyses were performed for each individual trial and pooled across trials. Multivariable analyses were performed using linear mixed models for repeated measurements to account for the longitudinal data and significant baseline characteristics.
Results: The overall completion rate of the EQ-5D utility index and EQ-5D VAS at 24 weeks was above 90% in all treatment groups across trials. Patients’ utility and health profiles were high at baseline; most patients reported no problems with self-care [97% of empagliflozin; 96% of placebo]; the most commonly reported problem was pain/discomfort [35% of empagliflozin, 36% of placebo reported at least some problems]. After 24 weeks, adjusted for baseline covariates, there were few statistically significant differences between empagliflozin and placebo in patient utility (0.026, p=0.0268) and health profiles (3.4, p=0.0062) across trials. These differences were positive in three out of six trials in patient utility and in all trials in health profiles. For HCRU, the largest percentages of hospitalizations or outpatient visits were observed for general physician visits (~15%) and specialist visits (~10%) across treatment groups. Most of the resources used were not diabetes-related.
Conclusions: Differences in patient utility and health profiles between empagliflozin and placebo over 24 weeks were in general positive but small, which was not unexpected given that the majority of patients reported no problems at baseline. The percentage of patients with hospitalizations or outpatient visits was low with similar use reported among empagliflozin and placebo treatment groups.
