(2017) noted no significant differences in cognitive test results between fenofibrate and a statin versus a statin alone.[96] Secondary Prevention (Fibrate Added to Statin versus Statin Alone) In the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, 5,518 patients with DM who were receiving open-label simvastatin (80 mg) were randomized to receive fenofibrate or placebo for a mean of 4.7 years.[97] Approximately 36% of patients in each group had experienced a prior CVD event. The primary outcome of the first occurrence of non-fatal MI or stroke or death from CV causes was not different between groups and occurred in 2.2% of patients receiving fenofibrate versus 2.4% of those on placebo (HR: 0.92, 95% CI: 0.79 1.08, p=0.32). Underpowered prespecified subgroup analyses showed possible harm in women (increased CV events) while also showing some decrease in CV events for men with high TGs and low HDL-C.[97] Summary The Work Group determined the potential for harms outweighed potential benefits. Patient and provider values and preferences likely vary because some might use a statin/fenofibrate combination in the high TG, low HDL-C subgroup since benefits may be perceived to outweigh risks. Combination therapy entails a higher pill burden with associated decrements in adherence and additional cost for those with co-pays. Based on this data, the FDA removed the approval of combinations of statins with fenofibrate in 2016.[93] As this is a Reviewed, New-replaced recommendation, the Work Group systematically reviewed evidence related to this recommendation [90,94-96] and considered the evidence put forth in the 2014 CPG.[97] The Work Group s confidence in the quality of the fibrate evidence was low for primary prevention and moderate for secondary prevention. Compared to the niacin data (see Recommendation 15), the fibrate data was less robust and lower quality. 