Summary of findings 2.
PCSK9 Inhibitors compared to ezetimibe. | |||||||
Patient or population: people at high risk of cardiovascular disease (history of CVD or high LDL‐C despite treatment) Setting: outpatient care settings Intervention: PCSK9 monoclonal antibodies Comparison: ezetimibe | |||||||
Outcomes | Ilustrative comparative risk or mean (95% CI) | Relative effect (95%CI) | Mean difference (95% CI) | Number of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk or mean biomarker using ezetimibe* |
Corresponding risk or mean using PCSK9 inhibition† |
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LDL‐C reduction (LDL‐C) Follow up: 6 months | Mean LDL‐C reduction was ‐6.12 mean percentage change form baseline | Mean LDL‐C reduction in the intervention group was ‐36.32 (‐40.29 to ‐32.34) percentage change from baseline | ‐30.20% (‐34.18 to ‐26.23) in percentage reduction from baseline | 823 (2 RCTs) | ⊕⊕⊕⊝ MODERATEa | Negative is beneficial | |
Cardiovascular disease (CVD) | Cardiovascular disease risk was 64 per 1000 participants | Data unavailable | |||||
All‐cause mortality (mortality) | All‐cause mortality risk was 6 per 1000 participants | Data unavailable | |||||
Any adverse events (adverse events) | Risk of any adverse events was 692 per 1000 participants | Data unavailable | |||||
CI: confidence interval | |||||||
GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to the estimate of effect Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
aHigh risk of other biases. Downgrading one level because of "limitations in the design and implementation of available studies suggesting high likelihood of bias"
*Assumed risks or mean LDL‐C was based on the comparison arms of included trials
†Corresponding risk or mean was based on the risk difference reported in Table 7 or the mean difference in LDL‐C.