3-in-1 Blood Pressure Pill Reveals Significant Efficacy Over Standard Care in Recent Study
New research has revealed that a novel treatment plan, featuring a low-dose combination of three anti-hypertensive drugs in a single pill—termed GMRx2—far surpasses standard care in effectively lowering blood pressure among patients suffering from uncontrolled hypertension.
The findings from the ‘deliVERy of Optimal blood pressure coNtrol in AfrICA (VERONICA)-Nigeria’ trial, spearheaded by The George Institute for Global Health, were presented today at the European Society of Cardiology Congress 2024 and simultaneously published in the Journal of the American Medical Association (JAMA).
The GMRx2 regimen involves a once-daily pill combining telmisartan, amlodipine, and indapamide at quarter, half, or standard doses. In contrast, the standard care approach recommended by the Nigerian Ministry of Health begins with monotherapy, progressing to dual and triple combination therapy, in alignment with hypertension management guidelines common to many countries.
After six months of treatment, the GMRx2 group experienced an average reduction in home systolic blood pressure of 31 mmHg, compared to a 26 mmHg decrease in those receiving standard care. This 5.8 mmHg difference was found to be both clinically and statistically significant. Existing research indicates that every 5 mmHg reduction in systolic blood pressure correlates with a 10% decrease in major cardiovascular events, including stroke, heart attack, and heart failure.
Remarkably, one month into treatment, 81% of participants in the GMRx2 group achieved clinic-measured blood pressure control, compared to 55% in the standard care group. This trend continued at the six-month mark, with 82% of the GMRx2 group maintaining control, compared to 72% under standard care. Both treatment regimens were well tolerated, with no participants withdrawing due to adverse effects.
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Professor Dike Ojji, Head of the Cardiovascular Research Unit at the University of Abuja and principal investigator of the study, stated, “The triple pill still produced clinically meaningful reductions in blood pressure compared to standard care, even when standard care closely adhered to current guidelines and required more clinic visits.”
“In low-income countries, fewer than one in four treated individuals achieve blood pressure control, and in high-income settings, it’s only between 50% and 70%,” added Professor Ojji. “To see rates of over 80% in just one month is truly impressive.”
It is estimated that over a billion adults globally live with hypertension, with two-thirds residing in low- and middle-income countries. High blood pressure remains the leading risk factor for mortality, contributing to 10.8 million deaths annually. The hope is that this new treatment could significantly reduce cardiovascular disease rates, especially in regions with the highest burden.
GMRx2 is the flagship drug candidate of George Medicines, a late-stage biopharmaceutical company established to commercialize research from The George Institute for Global Health, addressing critical unmet needs in cardiometabolic disease treatment. Earlier this month, GMRx2 was submitted to the US Food and Drug Administration (FDA) for hypertension treatment approval.
Phase III data from two additional GMRx2 trials were also presented at the congress, demonstrating substantial tolerability and clinically relevant blood pressure reductions compared to placebo and dual combination therapy.
Professor Anthony Rodgers, Senior Professorial Fellow at The George Institute and Chief Medical Officer at George Medicines, remarked, “Our mission is to develop sustainable solutions that can improve the health of millions worldwide and alleviate strain on health systems. There is a global goal to achieve 80% blood pressure control among those treated, yet no country has managed this thus far. The VERONICA trial has shown the potential of this innovative strategy to meet this ambitious target.”
“There has been little innovation in this field, so it’s gratifying to witness years of research from The George Institute culminate in a novel treatment that addresses a significant unmet need using established medicines,” he added.
The VERONICA trial is funded by the Australian National Health and Medical Research Council.
