Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension - GMRx2_PCT

Dec 17, 2024
Font Size
A
A
A
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
George Medicines
Date Published:
12/02/2024
Original Posted Date:
12/17/2024
References

Contribution To Literature:

The GMRx2_PCT trial showed that a single-pill low-dose combination antihypertensive agent was effective at lowering BP compared with placebo.

Description:

The goal of the trial was to evaluate a single-pill low-dose combination antihypertensive agent compared with placebo among patients with hypertension.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Blinded

Patients with hypertension were randomized to telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg (1/4 dose group) (n = 113) vs. telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 m (1/2 dose group) (n = 119) vs. placebo (n = 63).

  • Total number of enrollees: 295
  • Duration of follow-up: 4 weeks
  • Mean patient age: 51 years
  • Percentage female: 56%
  • Percentage with diabetes: 7%

Inclusion criteria:

  • ≥18 years of age
  • Home systolic blood pressure (SBP) 130-154 mm Hg
  • Low cardiovascular risk

Principal Findings:

The primary efficacy outcome, change in home SBP at 4 weeks compared with placebo, was: -7.3 mm Hg in the 1/4 dose group and -8.2 mm Hg in the 1/2 dose group (p < 0.0001 for both groups).

The primary safety outcome, treatment discontinuation due to an adverse event, was: 0 in the 1/4 dose group, 5.1% in the 1/2 dose group, and 1.6% in the placebo group.

Secondary outcome:

Change in office systolic BP at 4 weeks compared with placebo was: -8.0 mm Hg in the 1/4 dose group and -9.5 mm Hg in the 1/2 dose group vs. (p < 0.0001 for both groups).

Interpretation:

Among patients with hypertension, a single-pill low-dose combination antihypertensive agent was effective at lowering SBP compared with placebo. The 1/4 dose and 1/2 dose groups were equally effective; however, there were slightly more treatment discontinuations due to an adverse event in the 1/2 dose group. The rationale for this trial was to try to maximize efficacy of antihypertensive drug therapy while minimizing adverse events.

References:

Rodgers A, Salam A, Schutte AE, et al. Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension. J Am Coll Cardiol 2024;84:2393-403.

Editorial Comment: Treating Hypertension With a Single (Combination) Pill: Changing the Paradigm. J Am Coll Cardiol 2024;84:2404-6.

Clinical Topics: Hypertension, Prevention

Keywords: Antihypertensive Agents, Blood Pressure, Hypotension


< Back to Listings