Worldwide approximately 463 million people (9.3%) have type 2 diabetes mellitus. The disease is progressive and is linked to dire complications including cardiovascular disease, chronic kidney disease, retinopathy, nephropathy, not to mention increased mortality. Mitigating such risk, complications and improving health outcomes remains a priority management of diabetes. SGLT-2 inhibitors are newer and more costly class of drugs used for type 2 diabetes, however, their comparative effectiveness research against alternative drug classes has been insufficiently conducted, in particular amongst varied study populations. This retrospective observational cohort study protocol aimed to estimate the effectiveness of SGLT2-inhibitors using hospital administrative database. A cohort of adult patient with type-2 diabetes and prescription use of SGLT-2 inhibitors and a separate adult cohort with type 2-diabetes prescribed DPP4-inhibitors will be included from King Abdullah University Hospital (KAUH) database. Patients will be followed up from index-date and clinical outcomes of interest will include safety measures (diabetic ketoacidosis, severe hypoglycemia, lower limb amputation, bone fracture) and efficacy measures (cardiovascular events, renal disease, cardiovascular related mortality). Propensity score matching will be adopted to manage bias due to confounding in the comparative analysis of outcomes between SGLT2 (intervention group) versus DPP4-i (comparator group). Multivariable Cox-proportional hazard regression analysis will be used to estimate the independent association between SGLT2i and the time-to event of outcomes compared to DPP4i. This study of comparative analysis of SGLT2 versus DPP4-i will provide evidence that can enable the possibility of mitigating medication related adverse effects.
Adan et al. (Mon,) studied this question.