The GMRx2 clinical development program is conducting two pivotal phase III trials to evaluate the efficacy and safety of a novel low-dose triple single pill combination for the treatment of hypertension.
Does a low-dose triple single pill combination (telmisartan/amlodipine/indapamide) improve blood pressure control in patients with hypertension?
A novel low-dose triple single-pill combination of telmisartan, amlodipine, and indapamide is currently in pivotal trials to address the unmet need for early, effective hypertension management.
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.
Rodgers et al. (Mon,) conducted a other in Hypertension. GMRx2 (telmisartan/amlodipine/indapamide) vs. Dual combinations (telmisartan/amlodipine, telmisartan/indapamide, amlodipine/indapamide) or Placebo was evaluated on Difference in change in home mean SBP from randomization to week 12 (ACT) or week 4 (PCT). The GMRx2 clinical development program is conducting two pivotal phase III trials to evaluate the efficacy and safety of a novel low-dose triple single pill combination for the treatment of hypertension.