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HypertensionRandomised controlled trial

Single-Pill Low-Dose Triple Combination Therapy vs Standard-Dose Monotherapy in Patients With Mild-to-Moderate Hypertension

J Am Coll CardiolPublished

  • Randomised controlled trials (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

Read the original article ↗

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

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

OutcomeLDC-ALCAmlodipineLosartan
Adverse events · similar between groupsNot reported in the abstract13.9%3.3%
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:10.1016/j.jacc.2025.12.028
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Summarised from the published abstract; every number is checked against it