Journal of the American College of Cardiology: August,
2024
Single-pill combinations of 3 or
more low-dose blood pressure (BP)-lowering drugs hold promise for initial or
early treatment of hypertension.
The
Authors 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.
TAKE-HOME MESSAGE
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.
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 (<140/90 mm Hg) was 37%, 65%, and 70% for
placebo, GMRx2 ¼ dose, and GMRx2 ½ dose, respectively (both doses P < 0.001
vs placebo). Placebo, GMRx2-triple ¼, and GMRx2 ½ treatment discontinuation due
to an adverse event occurred in 1 (1.6%), 0, and 6 (5.1%), respectively; out of
normal range serum sodium or potassium was observed in 4 (6.3%), 12 (10.6%),
and 12 (10.1%), respectively, but no participant had a serum sodium
<130/>150 mmol/L or potassium <3.0/>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.
Comments
You must login to write comment