Dr. Mustafa Lütfi Yavuz, Dr. Mehmet Aydoğan

Study Title: VERONICA-Nigeria - deliVERy of Optimal blood pressure coNtrol in Africa

Published at Conference: ESC - 2024

Link:  https://www.escardio.org/The-ESC/Press-Office/Press-releases/Combining-three-medicines-into-one-pill-reduces-blood-pressure-in-Black-African-adults-with-hypertension

Introduction:
Hypertension remains a significant public health challenge in Sub-Saharan Africa, with uncontrolled high blood pressure being a primary contributor to cardiovascular diseases. Despite existing therapeutic approaches, many patients fail to reach target blood pressure levels.

Objective:
This study aimed to compare the efficacy of a low-dose triple single-pill combination (GMRx2) with standard care protocols in managing uncontrolled hypertension among Black African adults in Nigeria.

Methods:
The VERONICA-Nigeria trial was an open-label, randomized controlled study conducted across three hospital-based family medicine clinics in Nigeria. A total of 300 Black African adults, with office systolic blood pressure (BP) between 140-179 mmHg and/or diastolic BP between 90-109 mmHg, who were either untreated or inadequately controlled on monotherapy, were enrolled. Participants were randomized in a 1:1 ratio into two groups: the GMRx2 group, receiving a low-dose combination of telmisartan, amlodipine, and indapamide, and the standard care group, treated according to Nigeria’s hypertension treatment protocol. The standard care group initiated treatment with amlodipine 5 mg, with subsequent addition of losartan and hydrochlorothiazide as necessary, and dose escalation continued until the target BP was achieved or referral to a specialist was required. The primary outcome was the change in mean systolic BP measured at home after 6 months. The effectiveness was evaluated based on BP control and its maintenance throughout the study period. Participants' BP was regularly monitored, and treatment doses were adjusted accordingly to achieve optimal BP control.

Results:
At six months, the mean home systolic BP reduction was 31 mmHg (95% CI, 28-33 mmHg) in the GMRx2 group, compared to a 26 mmHg reduction (95% CI, 22-28 mmHg) in the standard care group. Clinic BP control (<140/90 mmHg) was achieved in 82% of the GMRx2 group compared to 72% in the standard care group (RR 1.1; 95% CI, 1.0-1.3). Additionally, home BP control was achieved in 62% of the GMRx2 group versus 28% in the standard care group (RR 2.2; 95% CI, 1.6-2.9). Both groups had a serious adverse event rate of 1%, with no participants discontinuing treatment due to adverse effects.

Conclusion:
GMRx2 was found to be more effective in achieving blood pressure control in Black African adults compared to standard care, with a favorable safety profile. These findings suggest that GMRx2 could be considered a more effective option for hypertension management in this population compared to existing treatment strategies.

Commentary:
This study highlights the potential of new therapeutic strategies in managing hypertension, particularly in challenging patient populations. GMRx2, with its low-dose combination approach, offers superior outcomes compared to traditional methods, potentially redefining the current hypertension treatment paradigm. The findings indicate that GMRx2 may represent a significant advancement in the management of hypertension, especially in regions where achieving adequate BP control has been particularly difficult.