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    PCSK9 Inhibitors: A 5-Question Quiz


    Answer: D. A and B

    Overall, the two FDA-approved PCSK9 inhibitors are very well tolerated and there have been rare serious side effects. The mechanism of alirocumab and evolocumab is a humanized monoclonal antibody against PCSK9. Common side effects include injection site reactions and cold or flu and flu-like symptoms.  Serious side effect such as severe systemic allergic reactions/hypersesnitivity and hypersensitivity vasculitis, have been reported but are rare. Neurocognitive events were reported in 0.8% of patients treated with alirocumab and 0.7% of patients treated with placebo. Confusion or memory impairment were reported more frequently by those in the alirocumab group (0.2% for each) vs those in the placebo group (<0.1% for each). Liver-related disorders (primarily related to abnormalities in liver enzymes) were reported in 2.5% of alirocuman-treated patients and 1.8% of patients treated with placebo, leading to treatment discontinuation in 0.4% and 0.2% of patients, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with alirocumab vs 1.4% of patients treated with placebo.

    To date, despite thousands of patients being treated with monoclonal antibodies against PCSK9, there have been no significant unexpected adverse effects. Notably, no significant neurocognitive effects have emerged (a theoretical concern of achieving very low LDL concentrations) in a post-hoc analysis of the FOURIER randomized trial3 with another evolocumab.

    And here's one to keep you on your toes...

    Question 6.

    Payal Kohli, MD
    Payal Kohli, MD, is an attending cardiologist for Kaiser Permanente in Denver, Colorado.


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