Comparative Analysis of Adverse Drug Reactions of Evolocumab and Alirocumab Based on OpenFDA

doi:10.19803/j.1672-8629.2021.10.15

Abstract

Abstract: Objective To search the database of the US Food and Drug Administration public data open project (OpenFDA) for adverse drug reactions (ADR) of PCSK9 inhibitors evolocumab and alirocumab, and to compare and analyze the related ADR so as to provide reference for clinical rational use. Methods Using the API module in the interactive chart section of the ADR endpoint in OpenFDA database, the data on ADR reports of evolocumab and alirocumab harvested between January 1, 2004 and January 18, 2021 was retrieved. Results The number of ADR reports of evolocumab and alirocumab was 71 676 and 8 006, respectively. ADR reports of evolocumab mostly came from doctors, consumers and non-health professionals, compared with consumers, non-health professionals and other health professionals for alirocumab. Most of the ADR occurred in the United States. Female patients outnumbered male ones. Adults and the elderly made up the majority of the patients. The main indications for the drug were cardiovascular diseases. The dominating ADR related to elouzumab was pain at the injection site, and myalgia for alirocumab. The outcomes of most of these patients were unknown. Conclusion In the process of using evolocumab and alirocumab clinically, clinicians should be alert to the related ADR so as to promote the rational use of drugs.

Key words: adverse drug reaction, evolocumab, alirocumab, OpenFDA

CLC Number:

R994.11

LI Jiangfan, HU Ye, PANG Hongxian, ZHAO Dan, LI Xinru, WANG Xuhong. Comparative Analysis of Adverse Drug Reactions of Evolocumab and Alirocumab Based on OpenFDA[J]. Chinese Journal of Pharmacovigilance, 2021, 18(10): 965-968.

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