Purpose: AMG 145, a fully human monoclonal antibody to PCSK9, significantly reduced LDL-C levels in statin-intolerant patients in the GAUSS trial ([NCT01375764][1]). We report the relationship between pre-trial history of intolerance to statins and on-treatment therapeutic response, tolerability, and safety with AMG 145. Methods: This post-hoc intention-to-treat analysis included 157 patients aged 34-75 years who received 4 weekly subcutaneous administrations of AMG 145 or placebo. Participants, who had all failed standard statin therapy due to muscle-related side effects, were grouped according to their history of intolerance of one, two, or three or more statins prior to the study. Results: See Table 1. View this table: Table 1 Conclusion: Attempts at statin treatment increased with CVD risk but were not related to tolerability of AMG 145. LDL-C reductions appeared to diminish with the number of failed statins but were still comparable with reductions reported with the highest doses of the most effective statins. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01375764&atom=%2Fehj%2F34%2Fsuppl_1%2FP682.atom