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

IF 2.9 Q2 PERIPHERAL VASCULAR DISEASE

High Blood Pressure & Cardiovascular Prevention Pub Date : 2026-01-01 Epub Date: 2025-11-12 DOI:10.1007/s40292-025-00751-8

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

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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.

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替米沙坦、氨氯地平和吲达帕胺低剂量三联片用于高血压初始治疗：一项随机试验的分级评估meta分析

简介：fda批准的GMRx2是替米沙坦、氨氯地平和吲达帕胺的单片组合，已显示出改善血压控制的潜力。目的：我们评估了低剂量GMRx2与安慰剂或标准治疗（单药或双药）治疗轻中度高血压的疗效和安全性。方法：对2006年至2025年6月PubMed、Embase、Cochrane、Scopus和Web of Science的随机对照试验（RCTs）进行meta分析。随机效应模型汇集连续结果的平均差异（MD）和二元结果的风险比（RR）， 95%置信区间（CI）。结果：纳入4项随机对照试验，共纳入1999例患者。与对照组相比，低剂量GMRx2显著降低了4-6周（MD -8.84 mmHg, 95% CI[-11.27; -6.46]）和12周（MD -5.52 mmHg, 95% CI[-6.85; -4.18]）的收缩压。它还增加了患者在4-6周达到目标办公室血压的比例（66.7% vs 50.2%, RR 1.20, 95% CI[1.08-1.43]）和8-12周（75.6% vs 59.5%, RR 1.15, 95% CI[1.05-1.26]）。严重不良事件（P= 0.77）和停药（P= 0.30）无显著差异。然而，低剂量GMRx2具有较高的低钾血症发生率（9%比7%，RR 1.40, 95% CI[1.04-1.90]）和低钠血症发生率（5%比3.7%,RR 1.59, 95% CI[1.04-2.42]）。结论：低剂量GMRx2在轻中度高血压患者中具有优越的降压效果和良好的耐受性安全性。然而，它可能会增加低钾血症和低钠血症的风险。需要更大规模和更长期的随机对照试验来证实。

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来源期刊

High Blood Pressure & Cardiovascular Prevention PERIPHERAL VASCULAR DISEASE-

CiteScore

5.70

自引率

3.30%

发文量

期刊介绍： High Blood Pressure & Cardiovascular Prevention promotes knowledge, update and discussion in the field of hypertension and cardiovascular disease prevention, by providing a regular programme of independent review articles covering key aspects of the management of hypertension and cardiovascular diseases. The journal includes: Invited ''State of the Art'' reviews. Expert commentaries on guidelines, major trials, technical advances.Presentation of new intervention trials design.''Pros and Cons'' or round tables on controversial issues.Statements on guidelines from hypertension and cardiovascular scientific societies.Socio-economic issues.Cost/benefit in prevention of cardiovascular diseases.Monitoring of healthcare systems.News and views from the Italian Society of Hypertension (including abstracts).All manuscripts are subject to peer review by international experts. Letters to the editor are welcomed and will be considered for publication.