HypertensionRandomised controlled trial
Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension
- Randomised controlled trial
- international
- double-blind
- placebo-controlled
- parallel-group
- 2:2:1 randomisation
Authors' conclusion
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.
Study context
- Population
- Adults with hypertension receiving 0 to 1 blood pressure (BP)-lowering drugs, home systolic BP (SBP) 130 to 154 mm Hg after 2-week placebo run-in96% completed
- Participants
- 295 adults
- Comparison
- Low-dose triple single-pill combination vs placebo
- Primary endpoint
- Difference in change in home SBP from randomization (primary safety: treatment discontinuation due to an adverse event)
- Follow-up
- Week 4
Primary result
As reported in the abstract
Home SBP, placebo-corrected least square mean difference
Least square mean difference, mm Hg
- GMRx2 ¼ dose
- −7.3 (95% CI −4.5 to −10.2)
- GMRx2 ½ dose
- −8.2 (95% CI −5.2 to −11.3)
Further findings
Clinic BP control (<140/90 mm Hg) · Week 4
- Clinic BP control (<140/90 mm Hg): both doses P < 0.001 vs placebo
Clinic BP reduction (placebo-corrected) · Week 4
- GMRx2 ¼ dose
- 8.0/4.0 mm Hg
- GMRx2 ½ dose
- 9.5/4.9 mm Hg
Safety
Out of normal range serum sodium or potassium
| Outcome | GMRx2 ¼ doseevents | GMRx2 ½ dose | Placebo |
|---|---|---|---|
| Treatment discontinuation due to an adverse event (primary safety outcome) | 0 | 5.1% | 1.6% |
| Serious adverse events | 0 | 2 events | 2 events |
- Out of normal range serum sodium or potassium: no participant had a serum sodium <130/>150 mmol/L or potassium <3.0/>6.0 mmol/L
Original publication
Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension. J Am Coll Cardiol. Published 31 August 2024. doi:10.1016/j.jacc.2024.08.025
Summarised from the published abstract; every number is checked against it