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Safety of Inclisiran: A Disproportionality Analysis from the EudraVigilance Database
Giuseppe Cicala1, Michelangelo Rottura1, Viviana Maria Gianguzzo2
1Department of Clinical and Experimental Medicine, University of Messina, 98125 Messina, Italy.
Pharmaceuticals (Basel, Switzerland)
|October 26, 2024
Summary
This study evaluated the real-world safety of inclisiran, a novel PCSK9 inhibitor, comparing it to PCSK9 antagonists. Inclisiran showed a similar safety profile but with increased reporting of myalgia and elevated LDL, requiring further investigation.
Area of Science:
- Pharmacovigilance
- Cardiovascular Pharmacology
- Drug Safety Evaluation
Background:
- Proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors have transformed lipid-lowering therapy.
- Inclisiran, a siRNA targeting PCSK9 mRNA, represents a novel approach to PCSK9 inhibition.
- Limited real-world safety data exists for inclisiran.
Purpose of the Study:
- To conduct a real-world safety evaluation of inclisiran.
- To compare the safety profile of inclisiran with PCSK9 antagonists (evolocumab and alirocumab).
Main Methods:
- Retrospective pharmacovigilance study using EudraVigilance data.
- Analysis of individual case safety reports (ICSRs) for inclisiran and PCSK9 antagonists.
- Descriptive and disproportionality analyses (Reporting Odds Ratio) were employed.
Main Results:
- Inclisiran was associated with increased reporting of myalgia (ROR: 2.43) and elevated low-density lipoprotein (ROR: 11.95) compared to PCSK9 antagonists.
- The most frequent adverse drug reactions for inclisiran were administration site conditions and investigations.
- A significant disproportionality for 'Drug ineffective' was also observed for inclisiran (ROR: 6.37).
Conclusions:
- The real-world safety profile of inclisiran is generally consistent with pre-commercial data.
- Observed differences in reporting, particularly for myalgia and elevated LDL, warrant further investigation.
- Continued real-world monitoring is essential to fully elucidate inclisiran's safety in diverse patient populations.
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