A novel low-dose, three-in-one combination pill, known as GMRx2, has demonstrated superior blood pressure control compared to standard care in a recent clinical trial conducted in Nigeria. The study, titled 'deliVERy of Optimal blood pressure coNtrol in afrICA (VERONICA)-Nigeria,' was presented at the European Society of Cardiology (ESC) Congress 2024 and simultaneously published in the Journal of the American Medical Association (JAMA).
GMRx2 Outperforms Standard Care
The GMRx2 treatment plan involves a once-daily pill containing telmisartan, amlodipine, and indapamide at quarter, half, or standard doses. In contrast, the standard care treatment plan, recommended by the Nigerian Ministry of Health, begins with monotherapy and progresses to dual and triple combination therapy, typical of hypertension guidelines in many countries.
After six months, home systolic blood pressure was 31 mmHg lower in the GMRx2 group compared to 26 mmHg lower in the standard care group. This 5.8 mmHg difference was clinically and statistically significant (p<0.0001). According to existing evidence, a 5 mmHg reduction in systolic blood pressure correlates with a 10% reduction in major cardiovascular events such as stroke, heart attack, and heart failure.
Rapid and Sustained Blood Pressure Control
Notably, after just one month, 81% of participants in the GMRx2 group achieved clinic-measured blood pressure control, compared to 55% in the standard care group. This improvement was sustained at six months, with 82% achieving control compared to 72% under standard care. Tolerability of both treatment plans was good, with no withdrawals due to adverse events.
Expert Commentary
Prof Dike Ojji, Head of the Cardiovascular Research Unit at the University of Abuja, Nigeria, and the study's principal investigator, stated, "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."
Prof Anthony Rodgers, Senior Professorial Fellow at The George Institute and Chief Medical Officer at George Medicines, added, "Our mission is to develop sustainable solutions that can improve the health of millions of people worldwide and alleviate strain on health systems... With the VERONICA trial, we've shown the potential of this novel strategy to reach this ambitious target."
Global Impact and Future Directions
With over a billion adults worldwide living with hypertension, and two-thirds residing in low- and middle-income countries, this new treatment could significantly reduce cardiovascular disease rates. GMRx2 is the leading drug candidate of George Medicines, a 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 hypertension treatment.
Phase III data from two additional GMRx2 trials, presented at the ESC Congress, also demonstrated good tolerability and clinically relevant blood pressure reductions compared to placebo and dual combination therapy. These trials tested GMRx2, in standard- and half-dose forms, against dual combinations of its component drugs. The trial’s primary efficacy outcome was the difference between GMRx2 and its comparators in home-measured BP change from randomization to week 12. The primary outcome was superiority of GMRx2 vs each of the three dual combinations for home systolic blood pressure reduction and each endpoint was met (p<0.0001).
Addressing Unmet Needs
Globally, most people treated for hypertension do not achieve sustained blood pressure (BP) control, primarily due to continued use of low efficacy regimens such as monotherapy. GMRx2 has been developed to meet this need.
Mark Mallon, Chief Executive Officer of George Medicines, said: “Subject to its review by regulators, GMRx2 would be the first medicine approved for the initial treatment of hypertension for over a decade, and could deliver profound results for patients globally, including in low- and middle-income countries whose populations carry a significant hypertension burden.”
