Evolocumab in Hyperlipidemia

To the Editor: Given the recent statement by a Food and Drug Administration (FDA) official that approval of inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9) for the treatment of hyperlipidemia will not require clinical outcomes data,¹ the study by Blom et al. (May 8 issue)² on the durable effects of evolocumab in reducing the low-density lipoprotein (LDL) cholesterol level appears to be highly encouraging for its regulatory path to approval. Although this study was not designed to detect differences in cardiovascular outcomes, adverse events of interest³ regarding the efficacy of LDL cholesterol–lowering drugs were reported in four patients receiving . . .