학술논문

Rationale for a New Low-Dose Triple Single Pill Combination for the Treatment of Hypertension
Document Type
article
Source
Global Heart, Vol 19, Iss 1, Pp 18-18 (2024)
Subject
hypertension
polypill
blood pressure
single pill combination
fixed dose
Diseases of the circulatory (Cardiovascular) system
RC666-701
Public aspects of medicine
RA1-1270
Language
English
ISSN
2211-8179
60972971
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.