The quality of evidence is downgraded by study limitations (uncler allocation concealment).
A Cochrane review [Abstract] 1 included 26 studies with a total of 23 499 subjects. 25 studies compared ezetimibe plus statin versus statin alone or plus placebo, and one study compared ezetimibe plus fenofibrate versus fenofibrate alone.
Ezetimibe with statins reduced the risk of major adverse cardiovascular events (MACE), non-fatal myocardial infarction (MI) and non-fatal stroke compared with statins alone. Ezetimibe with statin or fenofibrate did not reduce all-cause mortality (table T1) or cardiovascular mortality (RR 1.00, 95% CI 0.89 to 1.12; 6 studies, n=19 457) compared to statin alone.
Adding ezetimibe to statins did not have significant effect on the risk of hepatopathy (RR 1.14, 95% CI 0.96 to 1.35; 4 studies, n=20 687), myopathy (RR 1.31, 95% CI 0.72 to 2.38; 3 studies, n=20 581) and rhabdomyolysis (RR 0.79, 95% CI 0.40 to 1.55; 2 studies, n=19 865). Little or no difference in the risk of cancer, gallbladder-related disease and discontinuation due to adverse events (RR 0.91, 95% CI 0.75 to 1.09; 10 studies, n=21 746) were observed between treatment groups.
Adding ezetimibe to statin or fenofibrate reduced the LDL-cholesterol, total cholesterol and triglyceride levels and increased the HDL-cholesterol levels, but most analyses included substantial heterogeneity.None of the included studies reported on health-related quality of life.
| Outcome | Relative effect (95% CI) | Assumed risk - control | Relative risk - intervention (95% CI) | Number of participants (studies) |
|---|---|---|---|---|
| *MACE defined as a composite outcome of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalisation for unstable angina, or coronary revascularisation procedures. | ||||
| All-cause mortality | RR 0.98(0.91 to 1.05) | 123 per 1000 | 120 per 1000(112 to 129) | 21 222(8 studies) |
| Major adverse cardiovascular events (MACE)* | RR 0.94(0.90 to 0.98) | 284 per 1000 | 267 per 1000(256 to 278) | 21 727(10 studies) |
| Myocardial infarction | RR 0.88(0.81 to 0.95) | 105 per 1000 | 92 per 1000(85 to 100) | 21 145(6 studies) |
| Stroke | RR 0.83(0.71 to 0.97) | 32 per 1000 | 27 per 1000(23 to 31) | 21 205(6 studies) |
The effects of ezetimibe monotherapy in preventing cardiovascular disease and all-cause mortality remain uncertain. Most participants in the included studies were diagnosed with atherosclerotic cardiovascular disease, and the evidence regarding the use of ezetimibe for primary prevention remains uncertain.
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