A novel combination of low doses of three anti-hypertensive drugs in a single pill, known as GMRx2, has proven superior to standard care in lowering blood pressure in patients with uncontrolled hypertension.
The results of the ‘deliVERy of Optimal blood pressure coNtrol in afrICA (VERONICA)-Nigeria’ trial, led by The George Institute for Global Health, were presented at the European Society of Cardiology Congress 2024 and published in the Journal of the American Medical Association (JAMA).
Comparing GMRx2 to Standard Care
The GMRx2 treatment plan involved a once-daily pill containing telmisartan, amlodipine, and indapamide at a quarter, half, or standard doses.
The standard care treatment plan recommended by the Nigerian Ministry of Health began with monotherapy, followed by dual and triple combination therapy.
After 6 months of treatment, home systolic blood pressure was 31mmHg lower in the GMRx2 group compared to 26 mmHg lower with standard care – a highly clinically and statistically significant difference of 5.8 mmHg.
Existing evidence shows that with every 5 mmHg reduction in systolic blood pressure, there is a 10% reduction in major cardiovascular events such as stroke, heart attack, and heart failure.
High Effectiveness in Diverse Populations
After just one month, 81% of participants in the GMRx2 group achieved clinic-measured blood pressure control versus 55% with standard care.
This improvement was sustained at six months with 82% achieving control in the GMRx2 group, compared with 72% under standard care.
The tolerability of both treatment plans was good, with no withdrawals due to adverse events.
Prof Dike Ojji, Head of the Cardiovascular Research Unit at the University of Abuja, Nigeria and study principal investigator, stated that “The triple pill still produced clinically meaningful reductions in blood pressure compared to standard care, even when standard care closely followed current guidelines and involved more clinic visits.”
“In low-income countries, fewer than one in four treated people achieve blood pressure control and in high-income settings, it is only between 50% and 70%, so to see rates of over 80% in just one month is impressive,” added Prof Ojji.
Potential Global Impact on Cardiovascular Health
Over a billion adults live with hypertension worldwide, with two-thirds living in low- and middle-income countries.
High blood pressure is the leading risk factor for mortality, accounting for 10.8 million deaths a year.
It is hoped this new treatment could have a big impact on reducing rates of cardiovascular disease, particularly in countries with the highest burden.
GMRx2 is the leading drug candidate of George Medicines, a late-stage, biopharmaceutical company established to commercialize the research of The George Institute for Global Health.
Earlier this month, GMRx2 was submitted to the US Food and Drug Administration (FDA) for the treatment of hypertension.
Positive Outcomes in Additional GMRx2 Trials
Phase III data from two additional GMRx2 trials were also presented at the congress, showing good tolerability and clinically relevant blood pressure reductions compared to placebo and dual combination therapy.
Prof Anthony Rodgers, Senior Professorial Fellow at The George Institute and Chief Medical Officer at George Medicines, stated that “Our mission is to develop sustainable solutions that can improve the health of millions of people worldwide and alleviate strain on health systems. There is a global goal to reach 80% blood pressure control among those treated, but no country has yet achieved this. With the VERONICA trial, we’ve shown the potential of this novel strategy to reach this ambitious target.”
“There has been little innovation in this field, so it’s rewarding to see many years of research by The George Institute culminate in a novel treatment using established medicines to address an unmet need,” he added.
The VERONICA trial is funded by the Australian National Health and Medical Research Council.