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Clinical Summary

Type 2 diabetes mellitus: effect of ertugliflozin on blood pressure

Takeaway

  • In patients with type 2 diabetes mellitus (T2DM), treatment with ertugliflozin 5 mg and 15 mg for 26 weeks was well tolerated and was associated with reductions in systolic blood pressure (SBP), diastolic BP (DBP) and pulse rate compared with placebo.
  • The SBP reduction was consistent across patient subgroups.

Why this matters

  • Findings demonstrate the benefits of ertugliflozin, a sodium–glucose cotransporter 2 inhibitor, on BP reduction.

Study design

  • Post hoc analysis of data from three phase 3, randomised, placebo-controlled studies (VERTIS MONO, VERTIS MET, VERTIS SITA2) included 1544 patients with T2DM who received placebo (n=515), ertugliflozin 5 mg (n=519) and ertugliflozin 15 mg (n=510).
  • Funding: Merck Sharp & Dohme Corp., and Pfizer Inc.

Key results

  • Placebo-adjusted least squares (LS) mean changes from baseline in SBP at week 26 were −3.7 mmHg (95% CI, −5.1 to −2.3) for both ertugliflozin doses.
  • Proportion of patients with SBP ≥130 mmHg at baseline who achieved SBP <130 mmHg at week 26 was higher in the ertugliflozin group (37.8% both doses vs 24.0% placebo).
  • Similarly, more patients with a baseline SBP ≥140 mmHg had a SBP <140 mmHg at week 26 with ertugliflozin (59.5% [5 mg] and 66.7% [15 mg]) vs 43.8% placebo).
  • Placebo-adjusted LS mean changes (95% CI) with ertugliflozin 5 mg and 15 mg were:
    • DBP (−1.8 mmHg [−2.7 to −0.9] and −1.6 mmHg [−2.5 to −0.7], respectively) and
    • Pulse rate (−1.3 beats per minute [bpm; −2.2 to −0.3] and −1.5 bpm [−2.5 to −0.6], respectively).
  • Incidence of adverse events related to osmotic diuresis was low, but higher in the ertugliflozin group compared with placebo (2.9% [5 mg], 2.4% [15 mg]) vs 1.0% placebo).

Limitations

  • Post hoc exploratory nature.

References


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