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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2024, Vol. 29 ›› Issue (7): 762-767.doi: 10.12092/j.issn.1009-2501.2024.07.005

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Analysis of hyperglycaemia adverse drug reactions of PCSK9 inhibitors and statins based on FAERS database

Analysis of hyperglycaemia adverse drug reactions of PCSK9 inhibitors and statins based on FAERS database   

  1. Department of Pharmacy, Beijing Jishuitan Hospital, Capital Medical Vniversity, Beijing 100035, China
  • Received:2024-03-01 Revised:2024-06-02 Online:2024-07-26 Published:2024-06-24

Abstract:

AIM: To compare the risk of hyperglycaemia with PCSK9 inhibitors versus statins, based on U.S. Food and Drug Administration Adverse Events Reporting System (FAERS). METHODS: The hyperglycaemia reports induced by "alirocumab", "evolocumab", "atorvastatin" and "rosuvastatin" were utilized as the first suspected drugs from the database of FAERS from 2016 to the third quarter of 2023. The report odd ratio (ROR) method was employed. RESULTS: Based on the FAERS database, the ROR (95% CI) for hyperglycaemia due to Alirocumab versus Atorvastatin and Rosuvastatin were 0.628(0.545, 0.724) and 0.307 (0.263, 0.357) , the ROR (95% CI) for hyperglycaemia due to Evolocumab were 0.817 (0.750, 0.889) and 0.399 (0.361, 0.441) , all generated no adverse reaction signals. The ROR (95% CI) for hyperglycaemia due to Alirocumab and Evolocumab versus all other drugs in FAERS were 1.488(1.315,1.682) and 1.934(1.845, 2.027), all generated adverse reaction signals, respectively. CONCLUSION: Based on the FAERS database, PCSK9 inhibitors have a lower risk of hyperglycemia than statins and deserve clinical attention.

Key words: PCSK9 inhibitors, adverse events reporting system, hyperglycaemia, signal mining

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