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HypertensionRandomised controlled trial

RNA Interference With Zilebesiran for Mild to Moderate Hypertension

JAMAPublished

  • Randomised controlled trial
  • phase 2
  • double-blind
  • dose-ranging
  • placebo-controlled
  • 78 sites across 4 countries
Read the original article ↗

Authors' conclusion

In adults with mild to moderate hypertension, treatment with zilebesiran across a range of doses at 3-month or 6-month intervals significantly reduced 24-hour mean ambulatory SBP at month 3.

Study context

Population
Adults with mild to moderate hypertension (daytime mean ambulatory systolic BP (SBP) 135 to 160 mm Hg after antihypertensive washout)377 in full analysis set
Participants
394 adults
Comparison
Zilebesiran vs placebo
Primary endpoint
Between-group difference in least-squares mean (LSM) change from baseline in 24-hour mean ambulatory SBP
Follow-up
Month 3

Primary result

As reported in the abstract

24-hour mean ambulatory SBP change from baseline · 3 months

Zilebesiran 150 mg q6m

−7.3

change · 95% CI −10.3–-4.4 · mm Hg

Zilebesiran 300 mg

−10.0

change · 95% CI −12.0–-7.9 · mm Hg

Zilebesiran 600 mg q6m

−8.9

change · 95% CI −11.9–-6.0 · mm Hg

Placebo

6.8

change · 95% CI 3.6–9.9 · mm Hg

LSM difference, mm Hg (95% CI)P value
Zilebesiran 150 mg q6m vs Placebo
−14.1(−19.2 to −9.0)
P < 0.001
Zilebesiran 300 mg vs Placebo
−16.7(−21.2 to −12.3)
P < 0.001
Zilebesiran 600 mg q6m vs Placebo
−15.7(−20.8 to −10.6)
P < 0.001

Safety

Outcomezilebesiran, 150 mg, once every 6 monthszilebesiran, 300 mg, once every 3 months or every 6 monthszilebesiran, 600 mg, once every 6 monthsplacebo
Adverse events · 6 monthsNot reported in the abstractNot reported in the abstractNot reported in the abstract50.7%
Serious adverse events · 6 monthsNot reported in the abstractNot reported in the abstractNot reported in the abstract6.7%
Nonserious drug-related adverse events (mainly injection site reactions, mild hyperkalemia)Not reported in the abstractNot reported in the abstractNot reported in the abstract8.0%
  • Adverse events: Zilebesiran (all) 60.9%
  • Serious adverse events: Zilebesiran (all) 3.6%
  • Nonserious drug-related adverse events (mainly injection site reactions, mild hyperkalemia): Zilebesiran (all) 16.9%

Original publication

RNA Interference With Zilebesiran for Mild to Moderate Hypertension. JAMA. Published 5 March 2024. doi:10.1001/jama.2024.0728
Read the original article ↗PubMedCite RIS · BibTeX

Summarised from the published abstract; every number is checked against it