A low-dose triple single-pill combination-based protocol achieved better blood pressure (BP) control than a standard-care protocol in Black African Nigerian adults with uncontrolled hypertension, according to late-breaking research presented in a Hot Line session today at ESC Congress 2024.
"The burden of cardiovascular diseases in sub-Saharan Africa is rapidly increasing. Although high BP is a primary driver, only a very small fraction of people with hypertension are treated and in those who are treated, there is considerable therapeutic inertia, meaning they rarely achieve target BP levels. We hypothesised that the use of GMRx2, a low-dose triple single-pill combination, may overcome some of the barriers to uncontrolled hypertension. In the VERONICA-Nigeria trial, we found that GMRx2 achieved better BP control than standard care, with good tolerability in Black African adults," explained study presenter, Prof Dike Ojji from the University of Abuja, Nigeria.
The open-label VERONICA-Nigeria trial was conducted at three hospital-based family medicine clinics in Nigeria. Participants were Black African adults with uncontrolled hypertension (office systolic BP 140-179 mmHg and/or diastolic BP 90-109 mmHg) who were untreated (treatment naïve or currently untreated) or receiving BP-lowering monotherapy and considered to need initiation or intensification of BP-lowering therapy. Exclusion criteria included secondary hypertension, established cardiovascular disease and uncontrolled diabetes.
Participants randomised to the triple-pill group received once-daily GMRx2, which contains telmisartan, amlodipine and indapamide at one of three doses: one-quarter of standard doses (10 mg, 1.25 mg and 0.625 mg, respectively), one-half of standard doses (20 mg, 2.5 mg and 1.25 mg) or standard doses (40 mg, 5 mg and 2.5 mg). Doses were up titrated at clinic visits sequentially, aiming to quickly achieve sustained BP control (less than 135/85 mmHg). Adding telmisartan 40 mg plus amlodipine 5 mg and specialist referral were further options if the target was not met.
Participants randomised to the standard-care group were treated based on the Nigeria hypertension treatment protocol for primary care involving the following steps at monthly intervals to achieve target BP (less than 140/90 mmHg): amlodipine 5 mg, then amlodipine 5 mg and losartan 50 mg, then amlodipine 10 mg and losartan 100 mg, then amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide 25 mg, and finally referral to a specialist if target BP was still not achieved.
The primary effectiveness outcome was the change in home mean systolic BP from baseline at 6 months. The primary safety outcome was the percentage of participants who discontinued the trial treatment due to an adverse event over the 6-month trial period.
In total, 300 patients were randomised (1:1) to the GMR2x triple pill or to standard care. The mean age was 52 years and 54% were female. At baseline, mean home BP was 151/97 mmHg and mean clinic BP was 156/97 mmHg. In total, 62% of participants were untreated and 38% were taking one BP-lowering drug at baseline.
At 6 months, mean home systolic BP had reduced by 31 mmHg (95% confidence interval [CI] 28 to 33 mmHg) in the triple-pill group and reduced by 26 mmHg (95% CI 22 to 28 mmHg) in the standard-care group. The adjusted difference between the groups was significant in favour of the triple pill (−5.8 mmHg; 95% CI −3.6 to −8.0; p<0.001).
Clinic BP control (<140/90 mmHg) was better in the triple-pill group (82%) than in the standard-care group (72%; relative risk 1.1; 95% CI 1.0 to 1.3). Similarly, home BP control (<130/80 mmHg) was better in the triple-pill group (62%) than in the standard-care group (28%; relative risk 2.2; 95% CI 1.6 to 2.9).
No participants discontinued trial treatment due to adverse events. Serious adverse events occurred in 1% in each group.
The VERONICA-Nigeria trial is the first to evaluate a low-dose triple single-pill combination as initial or early therapy specifically in Black African patients. Hypertension can vary with race in terms of presentation and response to certain antihypertensives. We found that the effects of GMRx2 in Nigerian patients appeared consistent with those seen in broader populations, demonstrating excellent effectiveness, even when compared against a standard-care protocol that achieved much better results than usually seen in routine practice,"
Prof Dike Ojji from the University of Abuja, Nigeria
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