HypertensionRandomised controlled trial
Aldosterone Synthase Inhibition With Lorundrostat for Uncontrolled Hypertension
- Randomised controlled trial
- placebo-controlled
- dose-ranging
Randomised July 2021–June 2022; final follow-up September 2022
Authors' conclusion
Among individuals with uncontrolled hypertension, use of lorundrostat was effective at lowering blood pressure compared with placebo, which will require further confirmatory studies.
Study context
- Population
- Adults with uncontrolled hypertension taking ≥2 antihypertensive medications; initial cohort with suppressed plasma renin (PRA ≤1.0 ng/mL/h) and elevated plasma aldosterone (≥1.0 ng/dL), second cohort with PRA >1.0 ng/mL/h163 suppressed PRA + 37 not
- Participants
- 200 adults
- Comparison
- Lorundrostat vs placebo
- Primary endpoint
- Change in automated office SBP from baseline
- Follow-up
- Week 8
Primary result
As reported in the abstract
Change in office SBP (suppressed PRA) · 8 weeks
Lorundrostat 100 mg once daily
−14.1
mm Hg
Lorundrostat 50 mg once daily
−13.2
mm Hg
Lorundrostat 12.5 mg once daily
−6.9
mm Hg
Placebo
−4.1
mm Hg
Lorundrostat 25 mg twice daily
−10.1
mm Hg
Lorundrostat 12.5 mg twice daily
−13.8
mm Hg
Each group vs placeboLeast-squares mean difference, mm Hg (90% CI)P value
Lorundrostat 50 mg once daily
−9.6(−15.8 to −3.4)
P = 0.01Lorundrostat 100 mg once daily
−7.8(−14.1 to −1.5)
P = 0.04Further findings
| Outcome | Values |
|---|---|
| Change in SBP, participants without suppressed PRA (second cohort) | Lorundrostat 100 mg once daily decrease 11.4 (SD 2.5) mm Hg |
Change in SBP, participants without suppressed PRA (second cohort)
- Similar to reduction with same dose in suppressed PRA
Safety
Serum potassium >6.0 mmol/L
- Participants with increase, corrected with dose reduction or discontinuation
- 6
Cortisol insufficiency
- No instances
Original publication
Aldosterone Synthase Inhibition With Lorundrostat for Uncontrolled Hypertension. JAMA. Published 26 September 2023. doi:10.1001/jama.2023.16029
Summarised from the published abstract; every number is checked against it