학술논문
Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension.
Document Type
Academic Journal
Author
Rodgers A; The George Institute for Global Health, University of New South Wales, Australia.; Salam A; The George Institute for Global Health, University of New South Wales, India.; Prasanna School of Public Health, Manipal Academy of Higher Education, India.; Cushman W; University of Tennessee Health Science Center, USA.; de Silva A; University of Kelaniya, Sri Lanka.; Di Tanna GL; University of Applied Sciences and Arts of Southern Switzerland, Switzerland.; Gnanenthiran SR; The George Institute for Global Health, University of New South Wales, Australia.; Grobbee D; University Medical Center Utrecht, Utrecht University, The Netherlands.; Narkiewicz K; Medical University of Gdańsk, Poland.; Ojji D; University of Abuja, Nigeria.; Oparil S; University of Alabama at Birmingham, USA.; Poulter N; Imperial College, London, UK.; Schlaich MP; The University of Western Australia, Australia.; Schutte AE; The George Institute for Global Health, University of New South Wales, Australia.; Spiering W; University Medical Center Utrecht, Utrecht University, The Netherlands.; Williams B; University College London, UK.; Wright JT Jr; University Hospitals Cleveland Medical Center, Case Western Reserve University, USA.; Whelton P; Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, USA.
Source
Publisher: Ubiquity Press Country of Publication: England NLM ID: 101584391 Publication Model: eCollection Cited Medium: Internet ISSN: 2211-8179 (Electronic) Linking ISSN: 22118160 NLM ISO Abbreviation: Glob Heart Subsets: MEDLINE
Subject
Language
English
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.
Competing Interests: Authors Anthony Rodgers, Abdul Salam, Sonali Gnanenthiran and Aletta E Schutte are employed at TGI, which holds an interest in GMRx2 via its ownership of George Health Enterprises. None of the TGI staff have a personal financial interest in GM. Professor Rodgers is seconded part-time to GM. TGI holds patents for ultra-low-dose fixed-dose combination products for the treatment of hypertension and diabetes, and Professor Rodgers is listed as one of the inventors (Granted: US 10,369,15; US 10,799,487; US 10,322,117; US 11,033,544; US 11,478,462; Pending: US 17/932,982; US 18/446,268; US 17/598,122; US 17/317,614; US 17/527,084; US 17/527,085; US 17/527,087). Professor Rodgers does not have a financial interest in these patents. None of the other authors have a financial interest in GM or have received funding for their independent contribution to the GMRx2 program. Aletta E Schutte has received consulting fees and/or speaker honoraria from Omron Healthcare, Aktiia, Medtronic, Servier, Abbott, Sanofi, Sun Pharmaceuticals, Novartis. She is supported by a Fellowship of the National Health and Medical Research Council of Australia (ID 2017504). Dike B. Ojji has received speaker honoraria from Novartis, AstraZeneca, Servier, Swipha and Boehringer for speaking at educational meetings. Krzysztof Narkiewicz has received speaker and consulting honoraria from Bausch Health, Berlin-Chemie/Menarini, Egis, Idorsia, Gedeon Richter, Gilead, Krka, Novo Nordisk, Polpharma, Recordati, Sandoz and Servier. Markus Schlaich has received consulting fees, and/or travel and research support from Medtronic, Abbott, ReCor, Novartis, Servier, Pfizer, and Boehringer-Ingelheim. He is the current president of Hypertension Australia and Treasurer of the World Hypertension League.
(Copyright: © 2024 The Author(s).)
Competing Interests: Authors Anthony Rodgers, Abdul Salam, Sonali Gnanenthiran and Aletta E Schutte are employed at TGI, which holds an interest in GMRx2 via its ownership of George Health Enterprises. None of the TGI staff have a personal financial interest in GM. Professor Rodgers is seconded part-time to GM. TGI holds patents for ultra-low-dose fixed-dose combination products for the treatment of hypertension and diabetes, and Professor Rodgers is listed as one of the inventors (Granted: US 10,369,15; US 10,799,487; US 10,322,117; US 11,033,544; US 11,478,462; Pending: US 17/932,982; US 18/446,268; US 17/598,122; US 17/317,614; US 17/527,084; US 17/527,085; US 17/527,087). Professor Rodgers does not have a financial interest in these patents. None of the other authors have a financial interest in GM or have received funding for their independent contribution to the GMRx2 program. Aletta E Schutte has received consulting fees and/or speaker honoraria from Omron Healthcare, Aktiia, Medtronic, Servier, Abbott, Sanofi, Sun Pharmaceuticals, Novartis. She is supported by a Fellowship of the National Health and Medical Research Council of Australia (ID 2017504). Dike B. Ojji has received speaker honoraria from Novartis, AstraZeneca, Servier, Swipha and Boehringer for speaking at educational meetings. Krzysztof Narkiewicz has received speaker and consulting honoraria from Bausch Health, Berlin-Chemie/Menarini, Egis, Idorsia, Gedeon Richter, Gilead, Krka, Novo Nordisk, Polpharma, Recordati, Sandoz and Servier. Markus Schlaich has received consulting fees, and/or travel and research support from Medtronic, Abbott, ReCor, Novartis, Servier, Pfizer, and Boehringer-Ingelheim. He is the current president of Hypertension Australia and Treasurer of the World Hypertension League.
(Copyright: © 2024 The Author(s).)