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

Summary

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure (BP) control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to dual combinations.

Timeline

Start

2021-07-09

Primary completion

2023-08-11

Completion

2023-09-01

Outcome

Met primary endpoint

registry analysis (other test); GMRx2 vs Dual - TA; p <.0001; LS Means Difference -5.44 (95% CI -6.774 to -4.107); MIANALYZE procedure NCT04518293 ↗

registry analysis (other test); GMRx2 vs Dual - TI; p <.0001; LS Means Difference -2.49 (95% CI -3.723 to -1.251); MIANALYZE procedure NCT04518293 ↗

registry analysis (other test); GMRx2 vs Dual - AI; p <.0001; LS Means Difference -4.42 (95% CI -5.758 to -3.091); MIANALYZE procedure NCT04518293 ↗

Publications

• Rodgers A, Salam A, Schutte AE, Cushman WC, de Silva HA, Di Tanna GL, Grobbee DE, Narkiewicz K, Ojji DB, Poulter NR, Schlaich MP, Oparil S, Spiering W, Williams B, Wright JT Jr, Lakshman P, Uluwattage W, Hay P, Pereira T, Amarasena N, Ranasinghe G, Gianacas C, Shanthakumar M, Liu X, Wang N, Gnanenthiran SR, Whelton PK; 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 randomised, double-blind, active-controlled, international clinical trial. Lancet. 2024 Oct 19;404(10462):1536-1546. doi: 10.1016/S0140-6736(24)01744-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amlodipine	Other / unclassified	5 mg	Oral
Subject	Indapamide	Small molecule	2.5 mg	Oral
Subject	Telmisartan	Other / unclassified	40 mg	Oral

Indications