2 trials have evaluated PCSK9 mAbs in patients reporting intolerance to 2 or more statins - GAUSS 3 (Nissen 2016) & ODYSSEY ALTERNATIVE (Moriarty 2015). In both trials, >75% could tolerate blinded atorvastatin 20 mg. Both trials elegantly illustrated the nocebo effect - with intolerance to placebo, PCSK-9 mAb and ezetimibe about he same as to atorvastatin 20 mg. There is also a placebo effect with PCK9 mAB - In ODYSSEY ALTERNATIVE, despite >20% intolerant to ezetimibe, alirocumab, atorvastatin 20 mg during the blinded phase, all were then treated with open label alirocumab. <5% had intolerable symptoms! This information can be diplomatically shared with patients: We know from clinical trials that 8 out of 10 patients who have symptoms during statin therapy can go back and take a good dose of statin that will protect against heart attack, stroke, and death. All of these strategies work: Discontinuation & rechallenge once symptoms resolve, patient choice of dose & interval, evaluation for underlying causes of myopathy (hypothyroidism, drug interactions, polymylagia rheumatica & other rheumatologic diseases, etc).
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