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Evidence summaries

Fibrates for Primary Prevention of Cardiovascular Disease

Fibrates appear to lower the risk for cardiovascular (CVD) and coronary events in primary prevention without increasing or decreasing overall mortality or non-CVD mortality, but the absolute treatment effects are modest (absolute risk reductions < 1%). Level of evidence: "B"

The quality of evidence is downgraded by study llimitations (high loss to follow-up).

Summary

A Cochrane review [Abstract] 1 included 6 studies with a total of 16 135 subjects. The mean age of participants varied between 47.3 and 62.3 years. Four studies included subjects with diabetes mellitus type 2 only. The mean treatment duration and follow-up of participants across studies was 4.8 years. Reporting of adverse effects was very limited, and discontinuation of therapy due to adverse effects was used as a proxy for adverse effects.

Fibrates compared to placebo in primary prevention of CVD

OutcomeRelative effect (95% CI)Assumed risk - PlaceboCorresponding risk - Fibrates (95% CI)Participants (studies)
CVD death, non-fatal MI, or non-fatal strokeRR 0.84 (0.79 to 0.96)62 per 100052 per 1000(49 to 59)16 135(6 studies)
CHD death or non-fatal MIRR 0.79 (0.68 to 0.92)46 per 100036 per 1000(31 to 42)16 135(6 studies)
Overall mortalityRR 1.01 (0.81 to 1.26)36 per 100036 per 1000(30 to 45)8 471(5 studies)
Non-CVD mortalityRR 1.01 (0.76 to 1.35)22 per 100022 per 1000(16 to 29)8 471(5 studies)
Discontinuation of therapy due to adverse effectsRR 1.38 (0.71 to 2.68)*261 per 1000360 per 1000(185 to 699)4 805(3 studies)
CVD = cardiovascular disease; MI = myocardial infarction; CHD = coronary heart disease; *) statistical heterogeneity I2 =74%
Patients treated with fibrates had a reduced risk for the combined primary outcome of cardiovascular disease (CVD) death, non-fatal myocardial infarction (MI), or non-fatal stroke and for the secondary endpoint of coronary heart disease (CHD) death or non-fatal MI (table T1) compared to patients on placebo. Overall mortality, non-CVD mortality, and discontinuation of therapy due to adverse effects were not different between the groups. Data on quality of life were not available from any study. Two studies that evaluated fibrates in the background of statins showed no benefits in preventing cardiovascular events.