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Table 4 Summary of overall safety and orthostatic blood pressure changes

From: Effect of ertugliflozin on blood pressure in patients with type 2 diabetes mellitus: a post hoc pooled analysis of randomized controlled trials

  Placebo (n = 515) Ertugliflozin 5 mg (n = 519) Ertugliflozin 15 mg (n = 510)
Any AE 263 (51.1) 236 (45.5) 257 (50.4)
Serious AE 15 (2.9) 17 (3.3) 12 (2.4)
Discontinuation due to AEa 9 (1.7) 12 (2.3) 7 (1.4)
Hypovolemia 9 (1.7) 4 (0.8) 5 (1.0)
Osmotic diuresis 5 (1.0) 15 (2.9) 12 (2.4)
Orthostatic change in SBP
 Baseline, n/m (%) 14/502 (2.8) 21/516 (4.1) 16/494 (3.2)
 Week 6, n/m (%) 16/477 (3.4) 16/493 (3.2) 17/476 (3.6)
 Week 26, n/m (%) 18/446 (4.0) 16/475 (3.4) 17/458 (3.7)
Orthostatic change in DBP
 Baseline, n/m (%) 72/502 (14.3) 80/516 (15.5) 81/494 (16.4)
 Week 6, n/m (%) 74/477 (15.5) 81/493 (16.4) 68/476 (14.3)
 Week 26, n/m (%) 65/446 (14.6) 82/475 (17.3) 75/458 (16.4)
  1. Data presented as number of patients (%). n is the number of patients with test results at that visit that met the predetermined criterion; m is the number of patients with at least one test result at that visit
  2. AE adverse event, DBP diastolic blood pressure, SBP systolic blood pressure
  3. aStudy medication withdrawn