Long-Term Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination for the Treatment of Hypertension
Year: 2025
Type: article
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.
Source: Global Heart
DOI: 10.5334/gh.1481
Authors: Abdul Salam, H. Asita De Silva, Dike Ojji, A. P. De Silva, G. Galappatthy, P. Lakshman, T. Kumanan, G. Mayurathan, T. Pereira, M. Rahuman, G. Ranasinghe, L. Rasnayake, W. Uluwattage, G. R. Constantine, Thambyaiah Kandeepan, Mahmoud Umar Sani, Amit Kumar, Rashmi Pant, William C. Cushman, Gian Luca Di Tanna, Diederick Grobbee, Krzysztof Narkiewicz, Suzanne Oparil, Neil R. Poulter, Markus P. Schlaich, Aletta E. Schutte, Wilko Spiering, Bryan Williams, Jackson T. Wright, Jr., Chris Gianacas, Mathangi Shanthakumar, Xiaoqiu Liu, Ruth Freed, Paul K. Whelton, Anthony Rodgers
Institutions: Manipal Academy of Higher Education, UNSW Sydney, The George Institute for Global Health, University of Kelaniya, University of Abuja, National Hospital of Sri Lanka, Jaffna Teaching Hospital, Teaching Hospital Kandy, Aminu Kano Teaching Hospital, Bayero University Kano, The George Institute for Global Health, University of Tennessee Health Science Center, University of Applied Sciences and Arts of Southern Switzerland, Utrecht University, University Medical Center Utrecht, Gdańsk Medical University, University of Alabama at Birmingham, Imperial College London, The University of Western Australia, University College London, University Hospitals Cleveland Medical Center, Case Western Reserve University, Tulane University
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,300
OpenAlex ID: W4415733141