A NOVEL low-dose triple single-pill significantly reduced blood pressure (BP) compared with placebo in individuals with mild-to-moderate hypertension, showing good tolerability and clinical efficacy.
Hypertension is a leading cause of cardiovascular disease, and early treatment is critical to reducing associated risks. Single-pill combinations of low-dose antihypertensive agents offer potential benefits for initial treatment. This study investigated the efficacy and safety of two dose options of a new single-pill combination containing telmisartan, amlodipine, and indapamide compared with placebo. The trial aimed to provide evidence for improved BP control using this simplified treatment approach.
An international, randomised, double-blind, placebo-controlled trial enrolled 295 adults aged 51 years on average, 56% of whom were female. After a 2-week placebo run-in, participants with home systolic BP (SBP) of 130-154 mm Hg were randomised in a 2:2:1 ratio to receive either GMRx2 ¼ dose, GMRx2 ½ dose, or placebo for 4 weeks. The primary efficacy outcome was the change in home SBP, while safety outcomes included adverse event-related discontinuation and serum electrolyte abnormalities. Results showed significant placebo-corrected reductions in home SBP at 4 weeks of −7.3 mm Hg (GMRx2 ¼) and −8.2 mm Hg (GMRx2 ½), with clinic BP reductions of up to −9.5/−4.9 mm Hg. BP control rates in the clinic were 37% (placebo), 65% (¼ dose), and 70% (½ dose) (P < 0.001 for both doses vs placebo). Adverse event-related discontinuation rates were low, occurring in 1.6% (placebo), 0% (¼ dose), and 5.1% (½ dose), with no significant electrolyte derangements or serious adverse events in the lower dose group.
This study supports the clinical utility of a low-dose triple single-pill combination for initial hypertension treatment. The results highlight meaningful BP reductions and favourable tolerability, especially at the ¼ dose. Future research could explore long-term outcomes and the impact on cardiovascular events. In clinical practice, adopting such single-pill regimens may simplify hypertension management, improve adherence, and enhance patient outcomes.
Katrina Thornber, EMJ
Reference
Rodgers A et al. Efficacy and safety of a novel low-dose triple single-pill combination compared with placebo for initial treatment of hypertension. JACC. 2024;84(24):2393-403.
