← PCSK9 inhibitors × cardiovascular events

TrialThe New England journal of medicine2017

Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients.

Paul M Ridker et al.PubMed ↗Publisher ↗

  • Bococizumablooks good hereFewer major cardiovascular events, no clear effect on major cardiovascular events, no clear effect on primary end point.Weak evidence: one subgroup.

What the trial testedrandomised · 27,438 people · 2017

One subgroup

May have reduced major cardiovascular events in higher-risk, longer-duration trial (baseline LDL cholesterol level ≥100 mg/dL, median follow-up 12 months)

−21%−35% to −3%

bococizumab vs placebo, in higher-risk, longer-duration trial (baseline LDL cholesterol level ≥100 mg/dL, median follow-up 12 months)

Bigger than 5 in 10 for cardiovascular events

As reported

HR 0.79, 95% CI 0.65–0.97

No range given

Reported lower LDL cholesterol levels, no range given

−59.0percentage points

bococizumab vs placebo

As reported

difference −59.0 percentage points, no interval · the paper's word: mean change from baseline in LDL cholesterol levels

Range includes no effect

No clear effect on major cardiovascular events

−1%−20% to +22%

bococizumab vs placebo, in lower-risk, shorter-duration trial (baseline LDL cholesterol level ≥70 mg/dL, median follow-up 7 months)

Smaller than almost all for cardiovascular events

As reported

HR 0.99, 95% CI 0.80–1.22

Range includes no effect

No clear effect on primary end point

−12%−24% to +2%

bococizumab vs placebo

Bigger than 2 in 10 for cardiovascular events

As reported

HR 0.88, 95% CI 0.76–1.02

+1 more in the walkthrough ↓

Who was studied, and how

27,438people with cardiovascular disease, in this paper

The trial randomly assignedassigned by chance

bococizumab
placebo

Reported lower LDL cholesterol levels, no range given−59.0

No clear effect on primary end point−12%

randomised

Among lower-risk, shorter-duration trial (baseline LDL cholesterol level ≥70 mg/dL, median follow-up 7 months), the trial randomly assignedassigned by chance

bococizumab
placebo

No clear effect on major cardiovascular events−1%

randomised

the abstract, start to end

… group, for a between-group difference of -59.0 percentage points (P<0.001) and a median reduction from baseline of 64.2% (P<0.001).

… and the placebo group (hazard ratio, 0.99; 95% confidence interval [CI], …

… patients, respectively (hazard ratio, 0.79; 95% CI, 0.65 to 0.97; P=0.02).

… end point in the combined trials was 0.88 (95% CI, 0.76 to 1.02; P=0.08).

← favours treatmentfavours comparator →
could be chance
No interval given · direction only, strength unknown
Mean change from baseline in LDL cholesterol levelsbococizumab vs placebo
−59.0
Median reduction from baseline in LDL cholesterol levelsbococizumab vs baseline
−64.2
Major cardiovascular eventsbococizumab vs placebo, in lower-risk, shorter-duration trial (baseline LDL cholesterol level ≥70 mg/dL, median follow-up 7 months)
HR 0.990.80–1.22
Major cardiovascular eventsbococizumab vs placebo, in higher-risk, longer-duration trial (baseline LDL cholesterol level ≥100 mg/dL, median follow-up 12 months)
HR 0.790.65–0.97
Primary end point (nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina requiring urgent revascularization, or cardiovascular death)bococizumab vs placebo
HR 0.880.76–1.02
PCSK9 inhibitorsLipidsCardiovascular events

PCSK9 inhibitors × cardiovascular eventshelps?settled

unlikelylikely
1.001.00 without it

PCSK9 inhibitors × lipidshelps?settled

unlikelylikely
0.930.93 without it
← favours treatmentfavours comparator →
this papermore certainless certain
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2 trials

NCT01975376phase 316,784 enrolled2013NCT01975389phase 310,564 enrolled2013
Full record →Abstract, authors, funding and every citing paper · PMID 28304242