Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension

Anthony Rodgers; Abdul Salam; William Cushman; Asita de Silva; Gian Luca Di Tanna; Sonali R Gnanenthiran; Diederick Grobbee; Krzysztof Narkiewicz; Dike Ojji; Suzanne Oparil; Neil Poulter; Markus P Schlaich; Aletta E Schutte; Wilko Spiering; Bryan Williams; Jackson T Wright Jr; Paul Whelton

doi:10.5334/gh.1283

Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension

Glob Heart. 2024 Feb 14;19(1):18. doi: 10.5334/gh.1283. eCollection 2024.

Authors

Anthony Rodgers¹, Abdul Salam^{2

3}, William Cushman⁴, Asita de Silva⁵, Gian Luca Di Tanna⁶, Sonali R Gnanenthiran¹, Diederick Grobbee⁷, Krzysztof Narkiewicz⁸, Dike Ojji⁹, Suzanne Oparil¹⁰, Neil Poulter¹¹, Markus P Schlaich¹², Aletta E Schutte¹, Wilko Spiering⁷, Bryan Williams¹³, Jackson T Wright Jr¹⁴, Paul Whelton¹⁵

Affiliations

¹ The George Institute for Global Health, University of New South Wales, Australia.
² The George Institute for Global Health, University of New South Wales, India.
³ Prasanna School of Public Health, Manipal Academy of Higher Education, India.
⁴ University of Tennessee Health Science Center, USA.
⁵ University of Kelaniya, Sri Lanka.
⁶ University of Applied Sciences and Arts of Southern Switzerland, Switzerland.
⁷ University Medical Center Utrecht, Utrecht University, The Netherlands.
⁸ Medical University of Gdańsk, Poland.
⁹ University of Abuja, Nigeria.
¹⁰ University of Alabama at Birmingham, USA.
¹¹ Imperial College, London, UK.
¹² The University of Western Australia, Australia.
¹³ University College London, UK.
¹⁴ University Hospitals Cleveland Medical Center, Case Western Reserve University, USA.
¹⁵ Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, USA.

Abstract

Two recent large trials showed the potential of single pill combinations (SPCs) with ≥3 low-dose components among people with hypertension who were untreated or receiving monotherapy. In both trials, these 'hypertension polypills' were superior to usual care, achieving >80% BP control without increasing withdrawal due to side effects. However, there are no such products available for prescribers. To address this unmet need, George Medicines developed GMRx2 with telmisartan/amlodipine/indapamide in three strengths (mg): 10/1.25/0.625, 20/2.5/1.25; 40/5/2.5. Two pivotal trials are ongoing to support FDA submission for the treatment of hypertension, including initial treatment. These assess efficacy and safety of GMRx2 compared to: placebo, and each of the three possible dual combinations. Regulatory submissions are planned for 2024, with the aim of providing access to GMRx2 in developed and developing regions. Wider implementation of GMRx2-based treatment strategies will be guided by further research to inform access and appropriate scale up.

Keywords: blood pressure; fixed dose; hypertension; polypill; single pill combination.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antihypertensive Agents / therapeutic use
Blood Pressure
Humans
Hypertension* / drug therapy
Indapamide* / pharmacology
Indapamide* / therapeutic use
Treatment Outcome

Substances

Antihypertensive Agents
Indapamide

Grants and funding

The GMRx2 program is funded by George Medicines Pty Ltd (GM), which is partly owned by George Health Enterprises (GHE), the social enterprise arm of The George Institute for Global Health (TGI). GM has received investment from GHE, Brandon Capital, Bupa, and Federation Asset Management.