Abstract
Background It is unknown if initiation of a sodium-glucose cotransporter-2 inhibitor (SGLT-2i) is associated with changes in patient-reported health status outside of clinical trials. Methods and Results Using a prospective observational study design, adults with type 2 diabetes and cardiovascular disease were recruited from 14 US hospitals between November 2019 and December 2021 if they were new users of noninsulin antidiabetic medications. The primary outcome was change in 6-month diabetes treatment satisfaction. Secondary outcomes included diabetes-related symptom distress, diabetes-specific quality of life, and general health status for all patients and based on cardiovascular disease type. Inverse probability of treatment weight using propensity score was performed to compare outcome changes based on medication use. Of 887 patients (SGLT-2i: n=242) included in the inverse probability of treatment weight analyses, there was no difference in changes in treatment satisfaction in SGLT-2i users compared with other diabetes medication users (0.99 [95% CI, -0.14 to 2.13] versus 1.54 [1.08 to 2.00], P=0.38). Initiating an SGLT-2i versus other diabetes medications was associated with a greater reduction in ophthalmological symptoms (-3.09 [95% CI, -4.99 to -1.18] versus -0.38 [-1.54 to 0.77], P=0.018) but less improvement in hyperglycemia (1.08 [-2.63 to 4.79] versus -3.60 [-5.34 to -1.86], P=0.026). In subgroup analyses by cardiovascular disease type, SGLT-2i use was associated with a greater reduction in total diabetes symptom burden and neurological sensory symptoms in patients with heart failure. Conclusions Among patients with type 2 diabetes and cardiovascular disease, initiating an SGLT-2i was not associated with changes in diabetes treatment satisfaction, total diabetes symptoms, diabetes-specific quality of life, or general health status.