Using the same methodology, only two trials included patients with risks between 6 12%, although these trials did include nearly 30,000 patients.[40-43] The Work Group decided to retain the 12% ten-year CV risk score as a threshold for recommending initiation of treatment with statins in primary prevention along with shared decision making within the 6 12% risk range from the 2014 VA/DoD Dyslipidemia CPG. The addition of patients with an LDL-C level >190 mg/dL is intended to include patients with possible familial hypercholesterolemia. In an analysis of the 20-year follow-up of the West of Scotland primary prevention trial, Vallejo-Vaz et al. (2017) demonstrated that patients with LDL-C levels >190 mg/dL treated with moderate-dose statins had significant 20-year reductions in CV mortality (3%) and all-cause mortality (5%), more than double the reductions in the population with lower initial LDL-C levels.[44] Thus, this study provided the first prospective evidence on the long-term benefit of moderate-dose statins. Diabetes is similarly maintained as an indication for statin therapy because a systematic review by de Vries et al. (2012) showed a 3% reduction in CV events in diabetics with moderate-dose statins for primary prevention Moderate-dose Statin Safety While there are known risks associated with the use of moderate-dose statins, most feel these risks are low and that the benefits of statins outweigh these risks in patients at risk for CVD.[40-42,46] It should be noted, however, that most randomized controlled trials (RCTs) of statins did not systematically assess for adverse events routinely. In a systematic review by Chou et al. (2016) of primary prevention RCTs reporting statin-induced adverse events, there was no increased risk for new-onset DM in patients treated with moderate-dose statins versus placebo (relative risk [RR]: 1.05, 95% CI: 0.91 1.2).