← PCSK9 inhibitors × lipids

TrialThe New England journal of medicine2017

Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease.

Marc S Sabatine et al.PubMed ↗Publisher ↗

The primary results report of NCT01764633. Its numbers are set against the trial’s posted results below.

  • Evolocumablooks good hereLower composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization.Randomised, large.

What the trial testedrandomised · 27,564 people · 2017

Randomised vs placebo

Lowered composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization

Doesn’t vote: same as the registry's posted result, which counts instead

−15%−21% to −8%

evolocumab vs placebo

10 in 100 instead of 11

Bigger than 3 in 10 for cardiovascular events

As reported

HR 0.85, 95% CI 0.79–0.92

No range given

Reported lower least-squares mean percentage reduction in LDL cholesterol levels, no range given

−59.0percentage points

evolocumab vs placebo

As reported

difference −59.0 %, no interval

Against the trial’s posted results

  • Same as the trial’s posted resultThis paper HR 0.80 (0.73–0.88)Posted HR 0.80 (0.73–0.88), p < 0.0001Time to Cardiovascular Death, Myocardial Infarction, or Stroke
  • Same as the trial’s posted resultThis paper HR 0.85 (0.79–0.92)Posted, primary outcome HR 0.85 (0.79–0.92), p < 0.0001Time to Cardiovascular Death, Myocardial Infarction, Hospitalization for Unstable Angina, Stroke, or Coronary Revascularization

Who was studied, and how

27,564people with cardiovascular disease, in this paper

The trial randomly assignedassigned by chance

evolocumab
placebo

Lowered composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization−15%

Reported lower least-squares mean percentage reduction in LDL cholesterol levels, no range given−59.0

randomised

the abstract, start to end

… as compared with placebo, was 59%, from a median baseline value …

… vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], …

← favours treatmentfavours comparator →
could be chance
No interval given · direction only, strength unknown
Least-squares mean percentage reduction in LDL cholesterol levelsevolocumab vs placebo
−59.0
Composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularizationevolocumab vs placebo
HR 0.850.79–0.92
PCSK9 inhibitorsLipidsCardiovascular events

PCSK9 inhibitors × lipidshelps?settled

unlikelylikely
0.930.93 without it
← favours treatmentfavours comparator →
more certainless certain
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2,432 papers cite itlatest 60 shown

2017
…
2026
this paperpooled ittrialcites it

19 trials

Full record →Abstract, authors, funding and every citing paper · PMID 28304224