MON-645 Association of Baseline Cardio-Metabolic Parameters on the Treatment Effects of Empagliflozin When Added to Metformin in Patients with T2D
Abstract
Abstract Sodium-glucose co-transporter-2 inhibitors (SGLT2i) are commonly used as 2nd-line therapy after metformin (MET) in patients with type 2 diabetes (T2D), and are now recommended in those with co-existing cardiovascular (CV) and/or chronic kidney disease (CKD). A better understanding of their clinical efficacy across the spectrum of cardio-metabolic characteristics may help to better individualize therapy. It was previously reported (Häring et al., Diabetes Care 2014) that empagliflozin (EMPA) 10 and 25 mg over 24 weeks vs placebo (PLB), when added to MET, led to clinically meaningful improvements in HbA1c, body weight (BW), and systolic blood pressure (SBP). We explored the magnitude of these effects across categories of baseline (BL) HbA1c, BW, and SBP, comparing EMPA 10 mg (n=217) and 25 mg (n=213) vs PLB (n=207) in the following subgroups: HbA1c 90 kg; and SBP 90 kg, respectively; interaction p: 0.075). Finally, EMPA significantly (p<0.05) lowered SBP vs PLB, but, in contrast, without significant differences across SBP categories (EMPA 10/25 mg: SBP <120 mg, -4.17 [±2.07]/-2.71 [±2.15]; SBP 120-<140, -4.35 [±1.48]/-4.98 [±1.49]; SBP ≥140, -4.28 [±2.38]/-6.29 [±2.33] mmHg; interaction p: 0.784). The number of patients reporting ≥1 adverse event (AE) was similar across treatment groups (PLB, 58.7%; EMPA 10 mg, 57.1%; EMPA 25 mg, 49.5%) and the AE profile was consistent with the drug’s established safety profile. Confirmed hypoglycemic AEs were reported in 0.5%, 1.8%,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 217 participants or records.
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