Low-dose 3-drug pill GMRx2 shows promise in lowering BP

The new antihypertensive low-dose, triple combination pill called GMRx2 was superior to dual therapies or placebo in reducing blood pressure (BP) in two phase 3, international trials, with no substantial difference in safety outcomes.

GMRx2 has a standard dose of 40 mg telmisartan, 5 mg amlodipine, and 2.5 mg indapamide and the planned indication is hypertension, including initial treatment. Prof. Anthony Rodgers (George Institute, Australia) discussed the results of two recent trials assessing the efficacy and safety of GMRx2 compared with placebo and 3 dual treatments [1].

In a placebo-controlled trial study (NCT04518306), 295 participants with home systolic BP between 130 and 154 mmHg were randomised 2:2:1 to 1/4 of the GMRx2 standard dose, 1/2 of the GMRx2 standard dose, or a placebo. After 4 weeks of therapy, the active arms were significantly more efficacious than placebo, with mean in-clinic reductions of systolic BP of -8 and diastolic BP of -4 for the lowest dose, and -10 and -5 for the higher dose. In total, none of the participants withdrew due to adverse events (AEs) in the lowest dose group, compared with 5% and 2% of the participants in the higher dose group and placebo group, respectively. According to Prof. Rodgers, the active agent was safe and tolerable, with hypotension (4–5%) and mild-to-moderate abnormal laboratory findings (8–10%) as the most common side effects.

An active-controlled trial (NCT04518293) started with a 4-week run-in period on 1/2 of the GMRx2 standard dose. Subsequently, 1,385 participants with a systolic BP between 110–154 mmHg were randomised 2:1:1:1 to 1/2 of the GMRx2 standard dose or 1 of 3 dual therapy regimens. After 6 weeks, all participants received the standard dose of the respective therapies. The primary endpoint was systolic BP at week 12. At week 12, GMRx2 outperformed all dual therapies with respect to systolic BP, with mean differences ranging between 2.5 and 5.4 mmHg (P<0.001 for all; see Figure). The rate of treatment withdrawals due to AEs was 2% in the GMRx2 arm and 1% in the other arms. “There were no apparent differences between the study arms with respect to safety,” commented Prof. Rodgers.

Figure: Home blood pressure over time by treatment group [1]



BP, blood pressure; SBP, systolic blood pressure.

The novel GMRx2 single 3-drug pill was superior to dual therapies and placebo in terms of lowering BP, without increasing toxicity.

Relevant reading:

• VERONICA: Improving BP control in Africa with a simple strategy (ESC 2024)

1. 
   
   1. Rodgers A, et al. GMRx2: single pill combination of telmisartan, amlodipine and indapamide to treat hypertension, including initial treatment: Two pivotal trials of novel low dose triple combination. HOTLINE 2, ESC Congress 2024, 30 Aug–02 Sept, London, UK.

Copyright ©2024 Medicom Medical Publishers



Posted on 7 November 20247 November 2024