Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension - GMRx2

Nov 12, 2024
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
George Medicines
Date Published:
10/19/2024
Original Posted Date:
11/12/2024
References

Contribution To Literature:

The GMRx2 trial showed that a single-pill combination with three antihypertensive agents improves BP control compared with dual combinations of BP medications.

Description:

The goal of the trial was to evaluate a single-pill combination with three antihypertensive agents compared with dual combinations of blood pressure (BP) medications among patients with hypertension.

Study Design

  • Randomized
  • Parallel
  • Double-blind
  • Run-in phase

Patients with hypertension were randomized to telmisartan 20 mg with amlodipine 2.5 mg and indapamide 1.25 mg (GMRx2; n = 551) vs. telmisartan 20 mg and indapamide 1.25 mg (n = 276), vs. telmisartan 20 mg and amlodipine 2.5 (n = 282), vs. amlodipine 2.5 mg and indapamide 1.25 mg (n = 276). After a 6-week visit, doses were doubled.

  • Total number of enrollees: 1,385
  • Duration of follow-up: 12 weeks
  • Mean patient age: 59 years
  • Percentage female: 50%

Inclusion criteria:

  • ≥18 years of age
  • Systolic blood pressure (SBP) 140-179 mm Hg on no BP medications, or
  • SBP 130-170 mm Hg on one BP medication, or
  • SBP 120-160 mm Hg on two BP medications, or
  • SBP 110-150 mm Hg on three BP medications

Exclusion criteria:

  • Use of ≥4 BP medications
  • Contraindication to study medications
  • Cardiovascular disease
  • Uncontrolled diabetes
  • Chronic kidney disease
  • Secondary cause of hypertension

Principal Findings:

The primary outcome, mean home BP at 12 weeks, was 126 mm Hg in the telmisartan-amlodipine-indapamide group, which was 2.6 mm Hg lower than the telmisartan-indapamide group (p < 0.0001), 5.4 mm Hg lower than the telmisartan-amlodipine group (p < 0.0001), and 4.4 mm Hg lower than the amlodipine-indapamide group (p < 0.0001).

Secondary outcomes:

  • Treatment withdrawal due to an adverse event: 2% in the telmisartan-amlodipine-indapamide group, 1% in the telmisartan-indapamide group, 1% in the telmisartan-amlodipine group, and 1% in the amlodipine-indapamide group.

Interpretation:

Among patients with hypertension, a single-pill combination with three antihypertensive agents safely improves BP control compared with dual combinations of BP medications. This single-pill combination with three antihypertensive agents may represent a new therapeutic option for management of hypertension.

References:

Rodgers A, Salam A, Schutte AE, et al., on behalf of the GMRx2 Investigators. Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomized, double-blind, active-controlled, international clinical trial. Lancet 2024;404:1536-46.

Clinical Topics: Prevention, Hypertension

Keywords: Antihypertensive Agents, Hypertension


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