Abstract
BackgroundThe efficacy of ertugliflozin, a sodium–glucose cotransporter 2 inhibitor, for glycemic and blood pressure (BP) control has been demonstrated in phase 3 studies. To further evaluate the effects of ertugliflozin on BP and other hemodynamic parameters, an analysis was conducted on the pooled patient populations from these studies.MethodsThis was a post hoc analysis of data from three phase 3 studies (NCT01958671, NCT02033889, and NCT02036515) of adults with type 2 diabetes mellitus who received placebo, ertugliflozin 5 mg, or ertugliflozin 15 mg. Outcomes at 26 weeks were analyzed for the pooled population and according to relevant baseline factors, including BP.ResultsOf the 1544 patients included (placebo, n = 515; ertugliflozin 5 mg, n = 519; ertugliflozin 15 mg, n = 510), most (67.4–69.0%) had hypertension at baseline. Mean baseline BP was similar across treatment groups (placebo, 129.7/78.0 mmHg; ertugliflozin 5 mg, 131.0/78.4 mmHg; ertugliflozin 15 mg, 130.5/78.4 mmHg). At Week 26, placebo-adjusted least squares (LS) mean changes (95% confidence intervals [CI]) from baseline in systolic BP (SBP) were − 3.7 mmHg (− 5.1, − 2.3) for both ertugliflozin doses. Reductions were consistent across all baseline subgroups. At Week 26, more patients with a baseline SBP ≥ 130 mmHg had a SBP < 130 mmHg with ertugliflozin (38.7% both doses) than with placebo (24.0%), and more patients with a baseline SBP ≥ 140 mmHg attained a SBP < 140 mmHg with ertugliflozin (59.5% [5 mg] and 66.7% [15 mg]) than with placebo (43.8%). Placebo-adjusted LS mean changes (95% CI) in diastolic BP (DBP) with ertugliflozin 5 mg and 15 mg were − 1.8 mmHg (− 2.7, − 0.9) and − 1.6 mmHg (− 2.5, − 0.7), respectively, and in pulse rate were − 1.3 beats per minute (bpm) (− 2.2, − 0.3) and − 1.5 bpm (− 2.5, − 0.6), respectively. Greater reductions in pulse pressure, mean arterial pressure, and double product were observed with ertugliflozin than with placebo. Incidence of adverse event-related osmotic diuresis was low, but greater with ertugliflozin (2.9% [5 mg], 2.4% [15 mg]) than placebo (1.0%).ConclusionErtugliflozin treatment led to reductions in SBP, DBP, and pulse rate relative to placebo. Reductions in SBP were generally consistent across the subgroups evaluated.Trial registration NCT01958671; NCT02033889; NCT02036515
Highlights
The efficacy of ertugliflozin, a sodium–glucose cotransporter 2 inhibitor, for glycemic and blood pressure (BP) control has been demonstrated in phase 3 studies
In addition to characterizing the BPlowering effects of ertugliflozin, we evaluated the incidence of adverse events (AEs), including events related to osmotic diuresis and hypovolemia
67.8%, 69.0%, and 67.4% of patients had a history of hypertension in the placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg groups, respectively
Summary
The efficacy of ertugliflozin, a sodium–glucose cotransporter 2 inhibitor, for glycemic and blood pressure (BP) control has been demonstrated in phase 3 studies. For adults with T2DM, the American Diabetes Association advise a target systolic BP (SBP) < 140 mmHg and diastolic BP (DBP) < 90 mmHg [1], and the European Society of Cardiology recommend a target SBP < 140 mmHg and DBP < 80 mmHg [5]. In addition to improved glycemic control, clinically relevant reductions in BP in patients with T2DM have been observed with sodium–glucose cotransporter 2 (SGLT2) inhibitor treatment [10,11,12,13]. Beneficial effects on BP were observed in SGLT2 inhibitor CV outcomes studies [14,15,16,17,18]
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