Innovative hypertension polypill study achieves “significant” outcomes

Three anti-hypertensive drugs combined in low doses into a single pill has been shown to be superior to standard care for lowering blood pressure in patients with uncontrolled hypertension. The oral treatment GMRx2 is biopharma George Medicines’ lead drug candidate. The once-daily, three-in-one pill contains telmisartan, amlodipine and indapamide at a quarter, half or standard doses. The results are based on the ‘deliVERy of Optimal blood pressure coNtrol in afrICA (VERONICA)-Nigeria’ trial.

Key outcomes from the hypertension (blood pressure) trial

Data from the study showed that after one month, 81 percent of participants treated with GMRx2 obtained clinic-measured blood pressure control. This was compared to 55 percent for individuals who received standard care, according to the study data. Participants who received standard care were initially given monotherapy, following by dual and triple combination therapy.

Furthermore, this improvement was sustained at six months. A total of 82 percent of participants gained control of their blood pressure, compared to 72 percent given standard care.

Notably, after six months, individuals given GMRx2 achieved home systolic blood pressure 31mmHg lower than standard care, this being 26 mmHg lower, respectively.

The researchers highlighted that the 5.8 mmHg difference in both treatment groups in the VERONICA was “highly clinically and statistically significant”.

Impact of the study results

“to see [participants achieve blood pressure control] rates of over 80 percent in just one month is impressive,” Professor Dike Ojji, Head of the Cardiovascular Research Unit at the University of Abuja, Nigeria and study principal investigator shared.

“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,” Professor Ojji explained.

“There is a global goal to reach 80 percent 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,” Professor Anthony Rodgers, Senior Professorial Fellow at The George Institute and Chief Medical Officer at George Medicines shared.

Therefore, the researchers anticipate that this new triple pill for controlling blood pressure “could have a big impact on reducing rates of cardiovascular disease, particularly in countries with the highest burden”.

George Medicines submitted GMRx2 as a treatment for hypertension for review earlier this month to the US Food and Drug Administration (FDA).

As well as the findings being presented at the European Society of Cardiology Congress (ESCC) 2024, the study was published in JAMA.