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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 aStudy medication withdrawn