Effective |
Emphasizes the absolute reductions in cardiovascular risk noted in the overall result of ACCORD-Lipid or any of its subgroup analyses. Focuses on the changes to surrogate endpoints, such a triglyceride and low density lipoprotein levels, as opposed to clinical endpoints |
“Although fenofibrate reduced triglyceride levels, there was only a small difference in mean HDL and no difference between LDL-C between groups, which could help to explain lack of benefit… Those subjects with residual atherogenic dyslipidemia as identified by an increased triglyceride level and low HDL-C had a significant 31% reduction in primary end point”1
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Mixed |
Emphasizes both the trials’ strengths and limitations. Includes favorable and unfavorable interpretations of ACCORD-Lipid |
“No significant differences between the two groups with respect to any secondary outcome was found, although there were some interesting subgroup analyses…. a possible interaction according to lipid subgroup, with a possible benefit for patients with both a high baseline triglyceride (TG) level and a low baseline level of high-density lipoprotein cholesterol (HDL-C).”2
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Ineffective |
Views ACCORD Lipid trial as an overwhelmingly negative result given failure to meet primary endpoint. Notes trend towards benefit among patients with high triglyceride and low high-density lipoprotein levels was not significant. |
“The results showed no difference between the 2 lipid arms in the primary or any of the secondary outcomes. One can conclude that in a setting of good glycemia, BP, and LDL control, a significant reduction in triglycerides and a small increase in HDL does not reduce CVD events in older patients with well-established diabetes.”3
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Recommendation for fibrate use in light of the ACCORD-Lipid trial |
Description |
Examples |
Supportive |
Any recommendation of fibrate use, either in the subpopulation of patients with high triglyceride and low high-density lipoprotein levels or any broader population |
“The subgroup analysis from the ACCORD Lipid study and similar findings support the combination use of statin with fibrates for cardiovascular risk reduction in high-risk patients with mixed dyslipidemia”4
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Neutral |
Notes insufficient evidence to make a recommendation about fenofibrate use or that further studies are required |
“These new findings suggest that further studies are needed to establish the effects of fenofibrate in the treatment of both macrovascular and microvascular complications of T2DM, albeit in specific groups”5
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Unsupportive |
Explains that fenofibrate has no role in cardiovascular risk reduction (n.b., recommendation of fenofibrate for prevention of pancreatitis among patients with very high levels of triglycerides does not preclude) |
“The findings of ACCORD, therefore, do not support the use of fenofibrate to reduce cardiovascular morbidity and mortality in patients with type II diabetics [sic] who are receiving statin therapy. Moreover, these results emphasize the hazards of assuming that improvements in surrogate end points, such as lipid levels, will translate into reductions in morbidity and mortality.”6
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