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Introduction <p>FDA-approved GMRx2, a single-pill combination of telmisartan, amlodipine, and indapamide, has shown potential for improving blood pressure (BP) control.</p> Aim <p>We assessed the efficacy and safety of low-dose GMRx2 compared to placebo, or standard-care (monotherapy or dual therapy) in mild to moderate hypertension.</p> Methods <p>A meta-analysis of randomized controlled trials (RCTs) was conducted from PubMed, Embase, Cochrane, Scopus, and Web of Science from 2006 to June 2025. Random-effects model to pool mean difference (MD) for continuous outcomes and risk ratios (RR) for binary outcomes with 95% confidence intervals (CI). PROSPERO-ID: CRD420251108645</p> Results <p>Four RCTs involving 1999 patients were included. Compared with control, low-dose GMRx2 significantly reduced office systolic BP at 4–6&#xa0;weeks (MD −8.84&#xa0;mmHg, 95% CI [−11.27; −6.46]) and 12&#xa0;weeks (MD −5.52&#xa0;mmHg, 95% CI [−6.85; −4.18]). It also increased the proportion of patients achieving target office BP at 4–6&#xa0;weeks (66.7% vs. 50.2%, RR 1.20, 95% CI [1.08–1.43]) and 8–12&#xa0;weeks (75.6% vs. 59.5%, RR 1.15, 95% CI [1.05–1.26]). No significant differences were observed in serious adverse events (<i>P</i>= 0.77) or treatment discontinuation (<i>P</i>= 0.30). However, low-dose GMRx2 had a higher incidence of hypokalemia (9% vs. 7%, RR 1.40, 95% CI [1.04–1.90]) and hyponatremia (5% vs. 3.7%, RR 1.59, 95% CI [1.04–2.42]).</p> Conclusion <p>Low-dose GMRx2 provides superior BP reduction and a well-tolerated safety profile in patients with mild to moderate hypertension. Nonetheless, it may increase the risk of hypokalemia and hyponatremia. Larger and longer-term RCTs are warranted to confirm.</p> Graphical Abstract <p></p>

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Low-Dose Triple-Pill of Telmisartan, Amlodipine, and Indapamide for Initial Hypertension Treatment: A GRADE-Assessed Meta-analysis of Randomized Trials

  • 期刊论文

  • 发表日期：

    2025年11月12日

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  • Abdalhakim Shubietah,
  • Mohamed S. Elgendy,
  • Ahmed Emara,
  • Hamza A. Abdul-Hafez,
  • Ameer Awashra,
  • Ibrahim Elbably,
  • Mohamed Abuelazm,
  • Mohammed Mhanna

摘要

Introduction

FDA-approved GMRx2, a single-pill combination of telmisartan, amlodipine, and indapamide, has shown potential for improving blood pressure (BP) control.

Aim

We assessed the efficacy and safety of low-dose GMRx2 compared to placebo, or standard-care (monotherapy or dual therapy) in mild to moderate hypertension.

Methods

A meta-analysis of randomized controlled trials (RCTs) was conducted from PubMed, Embase, Cochrane, Scopus, and Web of Science from 2006 to June 2025. Random-effects model to pool mean difference (MD) for continuous outcomes and risk ratios (RR) for binary outcomes with 95% confidence intervals (CI). PROSPERO-ID: CRD420251108645

Results

Four RCTs involving 1999 patients were included. Compared with control, low-dose GMRx2 significantly reduced office systolic BP at 4–6 weeks (MD −8.84 mmHg, 95% CI [−11.27; −6.46]) and 12 weeks (MD −5.52 mmHg, 95% CI [−6.85; −4.18]). It also increased the proportion of patients achieving target office BP at 4–6 weeks (66.7% vs. 50.2%, RR 1.20, 95% CI [1.08–1.43]) and 8–12 weeks (75.6% vs. 59.5%, RR 1.15, 95% CI [1.05–1.26]). No significant differences were observed in serious adverse events (P= 0.77) or treatment discontinuation (P= 0.30). However, low-dose GMRx2 had a higher incidence of hypokalemia (9% vs. 7%, RR 1.40, 95% CI [1.04–1.90]) and hyponatremia (5% vs. 3.7%, RR 1.59, 95% CI [1.04–2.42]).

Conclusion

Low-dose GMRx2 provides superior BP reduction and a well-tolerated safety profile in patients with mild to moderate hypertension. Nonetheless, it may increase the risk of hypokalemia and hyponatremia. Larger and longer-term RCTs are warranted to confirm.

Graphical Abstract