[98] However, these findings were imprecise because of low event rates and the short follow-up (12 months), and the study was limited by high attrition. Evidence suggests a possibility of harm with bempedoic acid, with a non-significant trend toward higher CV (0.4% versus 0.1%) and all-cause mortality (0.9% versus 0.3%) in the treatment group compared to the placebo group. In Ray et al. (2019) there was no significant difference between placebo and bempedoic acid in CVD deaths and all-cause deaths. Adverse effects of bempedoic acid include potentially increased incidence of muscle pain (p=0.05) and gout (p <0.03), but with lower rates of new- onset or worsening DM (p=0.02).[98] Patient and provider values and preferences could not be determined since bempedoic acid was not on the market at the time of the systematic evidence review. Bempedoic acid received FDA approval in February 2020 and an ongoing clinical outcome trial will be completed in 2022. As a newly released drug, it has an uncertain safety profile and is expensive, compared to effective, safe, and low-priced statins. Given the adverse events and current lack of evidence in reducing CVD outcomes, patient and provider acceptability may be low. As this is a Reviewed, New-added recommendation, the Work Group systematically reviewed evidence related to this recommendation.[98] However, there were no systematic reviews or meta-analyses that studied bempedoic acid and our major outcomes of interest. The Work Group s confidence in the quality of the evidence was low. This recommendation is based on one RCT, Ray et al. (2019), which was limited by a short 12-month follow-up and a small number of events. The Work Group also considered the potential harm of adverse events. Patient values and preferences could not be estimated. 