← PCSK9 inhibitors × lipids

TrialThe New England journal of medicine2020

Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol.

Kausik K Ray et al.PubMed ↗Publisher ↗

The primary results report of NCT03400800. Its numbers are set against the trial’s posted results below.

What the trial testedrandomised · 1,617 people · 2020

Randomised comparison

Lowered lipids

−53.8percentage points−56.2 to −51.3

As reported

difference −53.8 %, 95% CI −56.2 to −51.3

Randomised comparison

Lowered lipids

Doesn’t vote: the registry posted this outcome, and its result counts

−52.3percentage points−55.7 to −48.8

As reported

difference −52.3 %, 95% CI −55.7 to −48.8

Against the trial’s posted results

  • Same verdict as the posted result, different numberThis paper difference −52.3 (−55.7 to −48.8)Posted, primary outcome difference −53.5 (−56.7 to −50.4), p <0.0001Percentage Change in LDL-C From Baseline to Day 510Another analysis of the same outcome: a different population, model or data cut. The trial counts once.

Two numbers in the abstract

the abstract, start to end

… reduced LDL cholesterol levels by 52.3% (95% confidence interval [CI], 48.8 to 55.7) in the ORION-10 trial and by 49.9% (95% CI, 46.6 to 53.1) in the ORION-11 trial, with corresponding time-adjusted reductions of 53.8% (95% CI, 51.3 to 56.2) and …

← favours treatmentfavours comparator →
could be chance
Lipids
−52.3−55.7 to −48.8
Lipids
−53.8−56.2 to −51.3
PCSK9 inhibitorsLipids

PCSK9 inhibitors × lipidshelps?settled

unlikelylikely
0.930.93 without it
← favours treatmentfavours comparator →
this papermore certainless certain
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730 papers cite itlatest 60 shown

2020
…
2025
2026
this paperpooled ittrialcites it

5 trials

NCT03400800phase 31,617 enrolled2017this paper is its primary reportNCT06586684phase 440 enrolled2024NCT06865885phase 4100 enrolled2025NCT07581808phase 460 enrolled2026NCT03399370phase 31,561 enrolled2017
Full record →Abstract, authors, funding and every citing paper · PMID 32187462