Low-dose triple-pill of telmisartan, amlodipine, and indapamide for initial hypertension yreatment: A GRADE-assessed meta-analysis of randomized trials

Affiliations

Advocate Illinois Masonic Medical Center

Abstract

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.

Type

Article

PubMed ID

41222871

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