Abstract:
Background: A novel low-dose triple single-pill combination of antihypertensive drugs
(GMRx2) has demonstrated superior blood pressure (BP)-lowering efficacy compared
to placebo and dual combinations in short-term randomized double-blind trials.
Objectives: To evaluate the long-term BP-lowering efficacy and safety of GMRx2-
based treatment when used in normal clinical care.
Methods: After completing a four-week double-blind randomised phase, participants
from Sri Lanka and Nigeria were enrolled into an open-label extension phase (OLE)
with follow-up to one year. The OLE involved treatment and uptitration with GMRx2, of
¼, ½ and standard doses of telmisartan/amlodipine/indapamide (i.e., 10/1.25/0.625
mg, 20/2.5/1.25 mg and 40/5/2.5 mg), and add-on antihypertensive drugs if needed to target a home BP goal of <130/80 mm Hg. Home BP monitoring was continued
throughout the follow-up and six follow-up clinic visits were conducted. The primary
outcome was percentage of participants with home BP control (<130/80 mmHg) at
week 52.
Results: From 21 August 2023 to 20 August 2024, 50 participants participated in the
OLE, of whom 48 (96%) completed it. The mean age of participants was 49 years and
60% were female. Home and clinic mean BP at enrolment into OLE were 126/79 mmHg
and 131/83 mmHg, respectively. At one year, home BP control (<130/80 mmHg) was
60% and clinic BP control (<140/90 mmHg) was 88%. Home mean BP was reduced
to 121/78 mmHg after 4 weeks into the OLE and was 120/78 mmHg at one year. For
clinic BP, the corresponding values were 126/79 mmHg and 122/77 mmHg. None of
the participants discontinued trial treatment due to an adverse event.
Conclusions: In a population with mild-to-moderate hypertension, long-term therapy
with GMRx2-based treatment achieved high levels of BP control and was well tolerated.
Trial registration: NCT04518306.
