Cochrane · systematic review · CD011748

PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease

Schmidt, AF, Carter, J-PL, Pearce, LS, et al. · Cochrane Database of Systematic Reviews · 2020 · Cochrane Library

Heart2 versionsAMSTAR 2: not assessed
SoF tableOnly the outcomes this review put in its Summary of Findings table are listed (the Cochrane Handbook caps them at about seven per comparison). Its other analyses are not shown here.
Questions
16
current version
GRADE rated
15
No studies
0
Included studies
NR
No studies 0 · 0%Ungraded 1 · 6.3%Very low 3 · 18.8%Low 4 · 25%Moderate 0 · 0%High 8 · 50%

Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.

Questions and results

Current version only

Alirocumab compared with placebo

Population: people at high risk of CVD (history of CVD or high LDL‐C despite treatment)
CD011748.PUB3 (current) · 4 questions
OutcomeEffectEvidenceStatus / GRADE
CVD
Alirocumab vs placebo
OR 0.87 [0.8, 0.94]10 studies · 23868 participantsHigh
All‐cause mortality
Alirocumab vs placebo
OR 0.83 [0.72, 0.96]12 studies · 24797 participantsHigh
Myocardial infarction
Alirocumab vs placebo
OR 0.86 [0.79, 0.94]9 studies · 23352 participantsHigh
Any stroke
Alirocumab vs placebo
OR 0.73 [0.58, 0.91]8 studies · 22835 participantsHigh

Evolocumab compared with placebo

Population: people at high risk of CVD (history of CVD or high LDL‐C despite treatment)
CD011748.PUB3 (current) · 4 questions
OutcomeEffectEvidenceStatus / GRADE
CVD
Evolocumab vs placebo
OR 0.84 [0.78, 0.91]3 studies · 29432 participantsHigh
All‐cause mortality
Evolocumab vs placebo
OR 1.04 [0.91, 1.19]3 studies · 29432 participantsHigh
Myocardial infarction
Evolocumab vs placebo
OR 0.72 [0.64, 0.82]3 studies · 29432 participantsHigh
Any stroke
Evolocumab vs placebo
OR 0.79 [0.65, 0.94]2 studies · 28531 participantsHigh

Alirocumab compared with ezetimibe and statins

Population: people at high risk of CVD (history of CVD or high LDL‐C despite treatment)
CD011748.PUB3 (current) · 4 questions
OutcomeEffectEvidenceStatus / GRADE
CVD
Alirocumab vs ezetimibe and statins
OR 1.37 [0.65, 2.87]3 studies · 1379 participantsLow
Downgraded: imprecision
All‐cause mortality
Alirocumab vs ezetimibe and statins
OR 0.51 [0.18, 1.4]5 studies · 1733 participantsLow
Downgraded: imprecision
Myocardial infarction
Alirocumab vs ezetimibe and statins
OR 1.45 [0.64, 3.28]5 studies · 1734 participantsLow
Downgraded: imprecision
Any stroke
Alirocumab vs ezetimibe and statins
OR 0.85 [0.13, 5.61]5 studies · 1734 participantsLow
Downgraded: imprecision

Evolocumab compared with ezetimibe and statins

Population: people at high risk of CVD (history of CVD or high LDL‐C despite treatment)
CD011748.PUB3 (current) · 4 questions
OutcomeEffectEvidenceStatus / GRADE
CVD
Evolocumab vs ezetimibe and statins
OR 0.66 [0.14, 3.04]1 study · 218 participantsVery low
Downgraded: risk of bias, imprecision
All‐cause mortality
Evolocumab vs ezetimibe and statins
OR 0.43 [0.14, 1.3]3 studies · 5223 participantsVery low
Downgraded: risk of bias, imprecision
Myocardial infarction
Evolocumab vs ezetimibe and statins
OR 0.66 [0.23, 1.85]3 studies · 5003 participantsVery low
Downgraded: risk of bias, imprecision
Any stroke
Evolocumab vs ezetimibe and statins
no estimate extracted2 studies · 3899 participantsUngraded

Summary of findings for PCSK9 compared with placebo

Population: people at high risk of cardiovascular disease (history of CVD or high LDL‐C despite treatment)
CD011748.PUB2 · 5 questions
OutcomeEffectEvidenceStatus / GRADE
LDL‐C reduction (LDL‐C)
Summary of findings for PCSK9 vs placebo
no estimate extracted8 studies · 4782 participantsModerate
Downgraded: risk of bias
Cardiovascular disease (CVD)
Summary of findings for PCSK9 vs placebo
OR 0.86 [0.8, 0.92]8 studies · 59294 participantsModerate
Downgraded: risk of bias, indirectness
All‐cause mortality (mortality)
Summary of findings for PCSK9 vs placebo
OR 1.02 [0.91, 1.14]12 studies · 60684 participantsModerate
Downgraded: risk of bias, indirectness
Any adverse events (adverse events)
Summary of findings for PCSK9 vs placebo
OR 1.08 [1.04, 1.12]13 studies · 61038 participantsLow
Downgraded: risk of bias, indirectness
CI: confidence interval
Summary of findings for PCSK9 vs placebo
no estimate extractedNRNo studies

Summary of findings for PCSK9 compared with ezetimibe

Population: people at high risk of cardiovascular disease (history of CVD or high LDL‐C despite treatment)
CD011748.PUB2 · 5 questions
OutcomeEffectEvidenceStatus / GRADE
LDL‐C reduction (LDL‐C)
Summary of findings for PCSK9 vs ezetimibe
no estimate extracted2 studies · 823 participantsModerate
Downgraded: risk of bias
Cardiovascular disease (CVD)
Summary of findings for PCSK9 vs ezetimibe
no estimate extractedNRNo studies
All‐cause mortality (mortality)
Summary of findings for PCSK9 vs ezetimibe
no estimate extractedNRNo studies
Any adverse events (adverse events)
Summary of findings for PCSK9 vs ezetimibe
no estimate extractedNRNo studies
CI: confidence interval
Summary of findings for PCSK9 vs ezetimibe
no estimate extractedNRNo studies

Summary of findings for PCSK9 compared with ezetimibe and statins

Population: people at high risk of cardiovascular disease (history of CVD or high LDL‐C despite treatment)
CD011748.PUB2 · 5 questions
OutcomeEffectEvidenceStatus / GRADE
LDL‐C reduction (LDL‐C)
Summary of findings for PCSK9 vs ezetimibe and statins
no estimate extracted5 studies · 5376 participantsModerate
Downgraded: risk of bias
Cardiovascular disease (CVD)
Summary of findings for PCSK9 vs ezetimibe and statins
OR 0.453 studies · 4770 participantsVery low
Downgraded: risk of bias
All‐cause mortality (mortality)
Summary of findings for PCSK9 vs ezetimibe and statins
no estimate extractedNRNo studies
Any adverse events (adverse events)
Summary of findings for PCSK9 vs ezetimibe and statins
OR 1.18 [1.05, 1.34]5 studies · 5376 participantsLow
Downgraded: risk of bias
CI: confidence interval
Summary of findings for PCSK9 vs ezetimibe and statins
no estimate extractedNRNo studies