GMRx2 low-dose triple combination therapy reduced home systolic blood pressure at 4 weeks compared to placebo (placebo-corrected difference -8.2 mm Hg for 1/2 dose; 95% CI -5.2 to -11.3).
RCT (n=295)
Double-blind
2:2:1
Yes
Does a low-dose triple single-pill combination of telmisartan, amlodipine, and indapamide reduce home systolic blood pressure compared to placebo in adults with mild-to-moderate hypertension?
A novel low-dose triple single-pill combination of telmisartan, amlodipine, and indapamide provides clinically relevant blood pressure reductions with good tolerability compared to placebo in patients with mild-to-moderate hypertension.
Effect estimate: Placebo-corrected difference -7.3 mm Hg (1/4 dose) and -8.2 mm Hg (1/2 dose) (95% CI -4.5 to -10.2 (1/4 dose), -5.2 to -11.3 (1/2 dose))
BACKGROUND Single-pill combinations of 3 or more low-dose blood pressure (BP)-lowering drugs hold promise for initial or early treatment of hypertension. OBJECTIVES We conducted a placebo-controlled trial of a new single-pill combination containing low doses of telmisartan, amlodipine, and indapamide in 2 dose options to assess efficacy and safety. METHODS This international, randomized, double-blind, placebo-controlled, parallel-group trial enrolled adults with hypertension receiving 0 to 1 BP-lowering drugs. After a 2-week placebo run-in during which any BP-lowering medication was stopped, participants were eligible if home systolic BP (SBP) was 130 to 154 mm Hg. Participants were randomized in a 2:2:1 ratio to GMRx2 ¼ dose (telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg), GMRx2 ½ dose (telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg), or placebo. The primary efficacy outcome was difference in change in home SBP from randomization to week 4, and primary safety outcome was treatment discontinuation due to an adverse event. RESULTS From June 14, 2021 to October 18, 2023, a total of 295 participants (mean age: 51 years; 56% female) were randomized and 96% completed the trial. Baseline mean home BP was 139/86 mm Hg and clinic BP was 138/86 mm Hg after placebo run-in. The placebo-corrected least square mean differences in home SBP at Week 4 were -7.3 mm Hg (95% CI: -4.5 to -10.2) for GMRx2 ¼ dose and -8.2 mm Hg (95% CI: -5.2 to -11.3) for GMRx2 ½ dose; reductions for clinic BP were 8.0/4.0 and 9.5/4.9 mm Hg. At Week 4, clinic BP control (150 mmol/L or potassium 6.0 mmol/L. Serious adverse events were reported by 2 participants in the placebo and GMRx2 ½ groups and none in the GMRx2 ¼ group. CONCLUSIONS In a population with mild-to-moderate BP elevation, both dose versions of the novel low-dose triple single-pill combination showed good tolerability and clinically relevant BP reductions compared with placebo. (Efficacy and Safety of GRMx2 Compared to Placebo for the Treatment of Hypertension: NCT04518306).
Rodgers et al. (Sat,) conducted a rct in Hypertension (n=295). GMRx2 (telmisartan, amlodipine, and indapamide) vs. Placebo was evaluated on Difference in change in home systolic blood pressure from randomization to week 4 (Placebo-corrected difference -7.3 mm Hg (1/4 dose) and -8.2 mm Hg (1/2 dose), 95% CI -4.5 to -10.2 (1/4 dose), -5.2 to -11.3 (1/2 dose)). GMRx2 low-dose triple combination therapy reduced home systolic blood pressure at 4 weeks compared to placebo (placebo-corrected difference -8.2 mm Hg for 1/2 dose; 95% CI -5.2 to -11.3).