Single-Pill Low-Dose Triple Combination Therapy vs Standard-Dose Monotherapy in Patients With Mild-to-Moderate Hypertension
Authors' conclusion
Single-pill LDC-ALC achieved BP reductions similar to those with amlodipine and greater than those with losartan monotherapy over 8 weeks, with similar short-term tolerability.
Study context
- Population
- Adults (≥19 years) with mild-to-moderate hypertension: Systolic blood pressure (SBP) 140 to <180 mm Hg and diastolic blood pressure (DBP) <110 mm Hg after 4-week placebo run-in
- Comparison
- Single-pill low-dose triple combination vs standard-dose monotherapy
- Primary endpoint
- SBP reduction, assessed first for noninferiority, then for superiority
- Follow-up
- Week 8
Methodological detailstwo phase III trials, HM-APOLLO-301 and HM-APOLLO-302, multicentre, double-blind, active-controlled, non-inferiority then superiority, South Korea, Study 301: May 2022-June 2023; Study 302: March-December 2024
- Two phase III trials, HM-APOLLO-301 and HM-APOLLO-302
- Multicentre
- Double-blind
- Active-controlled
- Non-inferiority then superiority
- South Korea
- Study 301: May 2022-June 2023; Study 302: March-December 2024
Primary result
As reported in the abstract
SBP reduction
Study 301: LDC-ALC
−19.1
least-squares mean change · mm Hg
Amlodipine
−19.9
least-squares mean change · mm Hg
Study 302: LDC-ALC
−19.9
least-squares mean change · mm Hg
Losartan
−16.4
least-squares mean change · mm Hg
Study 301: LDC-ALC vs Amlodipine: 95% CI −1.5 to 3.1; P = 0.495 · Study 302: LDC-ALC vs Losartan: 95% CI −6.6 to −0.2; P = 0.037
Further findings
DBP reduction and blood pressure (BP) control rate · week 8
- Study 301: similar DBP reduction and BP control rate vs amlodipine
- Study 302: greater DBP reduction and higher BP control rate vs losartan
Safety
| Outcome | LDC-ALC | Amlodipine | Losartan | |
|---|---|---|---|---|
| Adverse events · similar between groups | Not reported in the abstract | 13.9% | 3.3% | LDC-ALC: not reported in the abstract |
- Adverse events — Treatment withdrawals
- ≤1%
- Adverse events — Serious drug-related events
- 0
- Adverse events: Study 301: LDC-ALC 11.7%
- Adverse events: Study 302: LDC-ALC 6.4%
- Adverse events: Study 301: 11.7% vs 13.9%; Study 302: 6.4% vs 3.3%
Original publication
Single-Pill Low-Dose Triple Combination Therapy vs Standard-Dose Monotherapy in Patients With Mild-to-Moderate Hypertension. J Am Coll Cardiol. Published 11 February 2026. doi:10.
Summarised from the published abstract; every number is checked against it