1. Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension
- Author
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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, and Paul Whelton
- Subjects
hypertension ,polypill ,blood pressure ,single pill combination ,fixed dose ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 ,Public aspects of medicine ,RA1-1270 - 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.
- Published
- 2024
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