HypertensionRandomised controlled trial
Lorundrostat in Participants With Uncontrolled Hypertension and Treatment-Resistant Hypertension
- Randomised controlled trial
- phase 3
- 159 sites, 13 countries
Enrolled November 2023 to September 2024; last follow-up January 24, 2025
Authors' conclusion
The efficacy and safety of lorundrostat, an aldosterone synthase inhibitor, was demonstrated for lowering BP in adults with uncontrolled hypertension, including those with treatment-resistant hypertension.
Study context
- Population
- Adults with uncontrolled hypertension, including treatment-resistant hypertension, on 2 to 5 antihypertensive medications
- Participants
- 1,083 adults
- Comparison
- Lorundrostat vs placebo added to 2–5 antihypertensive medications
- Lorundrostat 50→100 mgn = 270
- Lorundrostat 50 mgn = 541
- Placebon = 272reference
- Primary endpoint
- Change in automated office SBP, lorundrostat 50 mg vs placebo
- Follow-up
- Week 6
Primary result
Change in automated office SBP
Least-squares mean difference
−9.1 mm Hg
95% CI −13.3 to −4.9
P < 0.001
By group
Pooled lorundrostat 50 mg
−16.9
least-squares mean change · 95% CI −19.0–-14.9 · mm Hg
Placebo
−7.9
least-squares mean change · 95% CI −11.5–-4.2 · mm Hg
As reported in the abstract
Safety
| Outcome | Lorundrostat 50→100 mg | Lorundrostat 50 mg | Placebo |
|---|---|---|---|
| Treatment discontinuation due to hyperkalemia / hyponatremia / reduced kidney function | |||
| Hyperkalemia | 1 (0.37%) | 2 (0.37%) | Not reported in the abstract |
| Hyponatremia | 1 (0.37%) | 2 (0.37%) | Not reported in the abstract |
| Reduced kidney function | 0 | 3 (0.56%) | Not reported in the abstract |
Hyponatremia, hyperkalemia, reduced kidney function
- Reported more often with lorundrostat vs placebo
Treatment-emergent adverse events
- TEAEs in all participants, mostly mild or moderate
- 49.9% (538/1078)
Original publication
Summarised from the published abstract; every number is checked against it