Scientists say that a game-changing treatment, a pill combining three blood pressure medications at ultra-low doses, has delivered promising results in a phase 3 clinical trial.
GMRx2, the novel treatment strategy, showed remarkable results in a part of the world where hypertension often strikes early and hits hard – sub-Saharan Africa – and could transform the fight against hypertension, which affects about a third of the world’s population, the researchers said.
Published in the Journal of the American Medical Association (JAMA), the findings suggest that the daily pill, combining low doses of three different anti-hypertensive medications, surpassed a current high-quality standard care treatment plan.
Hypertension, or high blood pressure, is a major health concern in sub-Saharan Africa, where it often strikes at younger ages and leads to more severe complications than in other parts of the world.
Researchers say the “triple-pill” strategy could be the key to effectively managing high BP in a region where less than 10% of treated patients typically achieve proper control.
“There is a global goal to reach 80% blood pressure control among those treated, but no country has yet achieved this,” said Professor Anthony Rodgers, senior professorial fellow at The George Institute and chief medical officer at George Medicines, the company developing the triple pill. “With the VERONICA trial, we’ve shown the potential of this novel strategy to reach this ambitious target.”
Rather than prescribing multiple blood pressure drugs separately, the new protocol combines telmisartan, amlodipine and indapamide into a single, once-daily pill – at doses lower than typically used.
The trial was carried out at hospital-based family medicine clinics in Nigeria, reports Studyfinds.org, where led by Professor Dike Ojji from the University of Abuja and Dr Abdul Salam from the George Institute India, it recruited black African adults with uncontrolled hypertension, who were either untreated or already receiving a single BP-lowering drug.
The trial compared GMRx2-based treatment protocol with existing, standard care protocol for six months. Half of the participants received GMRx2, the other half received the current high BP standard care treatment plan recommended by the Nigerian Ministry of Health, which starts with one medication and is followed by second and third drugs added as needed.
“This new paradigm is based on the evidence that at low doses, most benefits are maintained and most adverse effects avoided,” Rodgers said. “It is important to test any new paradigm against well implemented current practices.”
After a month, 81% achieve BP control
The scientists found that after only one month, 81% of study participants receiving the GMRx2 combination pill achieved clinic-measured BP control versus 55% following standard care for hypertension.
This improvement continued at six months, with 82% of the GMRx2 achieving control, compared with 72% receiving standard treatment.
“These were the results we were hoping for,” Rodgers told Medical News Today. “It is worth bearing in mind that ‘standard care’ in this trial was much better than average care: even in high income countries, such good results are rarely seen. So it was especially exciting to see the new strategy do even better.
“The main priority is to make this available to patients. We submitted to the FDA last month and plan to submit to other countries, including in Nigeria and elsewhere in Africa, as soon as possible. We see the next stage as implementation research, to guide the optimal ways to scale up this important innovation.”
Study details
Low-dose triple-pill vs standard-care protocols for hypertension treatment in Nigeria: a randomised clinical trial
Anthony Rodgers, Dike B. Ojji, Abdul Salam, Mahmoud U. Sani et al.
Published in JAMA Network on 31 August 2024
Key Points
Question
Among black African adults with hypertension, how effective and safe is a low-dose triple-pill protocol compared with standard-care protocol for lowering blood pressure?
Findings
In this randomised trial in Nigeria among 300 black patients with uncontrolled hypertension who were either untreated or receiving a single blood pressure–lowering drug, treatment with low-dose triple-pill protocol, compared with standard-care protocol, for six months significantly reduced home systolic blood pressure (by 5.8 mm Hg), with no increase in discontinuation of trial treatment due to adverse events.
Meaning
Compared with standard-care protocol, treatment with a low-dose triple-pill protocol can improve blood pressure lowering.
Abstract
Importance
With the high burden of hypertension in sub-Saharan Africa, there is a need for effective, safe and scalable treatment strategies.
Objective
To compare, among African adults, the effectiveness and safety of a novel low-dose triple-pill protocol compared with a standard-care protocol for blood pressure lowering.
Design and Setting
Randomised, parallel-group, open-label, multicentre trial conducted in public hospital–based family medicine clinics in Nigeria.
Participants
Black adults with uncontrolled hypertension (≥140/90 mm Hg) who were untreated or receiving a single blood pressure–lowering drug.
Interventions
Participants were randomly allocated to low-dose triple-pill or standard-care protocols. The triple-pill protocol involved a novel combination of telmisartan, amlodipine, and indapamide in triple one-quarter, one-half, and standard doses (ie, 10/1.25/0.625 mg, 20/2.5/1.25 mg, and 40/5/2.5 mg), with accelerated up-titration. The standard-care protocol was the Nigeria hypertension treatment protocol starting with amlodipine (5 mg).
Main Outcomes and Measures
The primary effectiveness outcome was the reduction in home mean systolic blood pressure, and the primary safety outcome was discontinuation of trial treatment due to adverse events, both from randomisation to month six.
Results
The first participant was randomised on July 19, 2022, and the last follow-up visit was on July 18, 2024. Among 300 randomised participants (54% female; mean age, 52 years; baseline mean home blood pressure, 151/97 mm Hg; and clinic blood pressure, 156/97 mm Hg), 273 (91%) completed the trial. At month 6, mean home systolic blood pressure was on average 31 mm Hg (95% CI, 28 to 33 mm Hg) lower in the triple-pill protocol group and 26 mm Hg (95% CI, 22 to 28 mm Hg) lower in the standard-care protocol group (adjusted difference, −5.8 mm Hg [95% CI, −8.0 to −3.6]; P < .001]). At month 6, clinic blood pressure control (<140/90 mm Hg) was 82% vs 72% (risk difference, 10% [95% CI, −2% to 20%]) and home blood pressure control (<130/80 mm Hg) was 62% vs 28% (risk difference, 33% [95% CI, 22% to 44%]) in the triple-pill compared with the standard-care protocol group; these were 2 of 21 prespecified secondary effectiveness end points. No participants discontinued trial treatment due to adverse events.
Conclusions and Relevance
Among black African adults with uncontrolled hypertension, a low-dose triple-pill protocol achieved better blood pressure lowering and control with good tolerability compared with the standard-care protocol.
See more from MedicalBrief archives:
Injection could replace drugs for high BP – British trial
Several low-dose drugs better for BP than one pill – Australian meta-analysis
Daily polypill instead of drug trio reduces CVD risk – SECURE randomised trial