Association between atorvastatin and erectile dysfunction: a comprehensive analysis incorporating real-world pharmacovigilance and Mendelian randomization

Kaiqin Chen; Hesen Huang; Yongtai Chen; Weizhen He

doi:10.3389/fphar.2024.1382924

Association between atorvastatin and erectile dysfunction: a comprehensive analysis incorporating real-world pharmacovigilance and Mendelian randomization

Front Pharmacol. 2024 Apr 29:15:1382924. doi: 10.3389/fphar.2024.1382924. eCollection 2024.

Authors

Kaiqin Chen¹, Hesen Huang², Yongtai Chen³, Weizhen He¹

Affiliations

¹ Department of Neurosurgery, Xiang'an Hospital of Xiamen University, Xia Men, Fu Jian, China.
² Department of Otolaryngology-Head and Neck Surgery, Xiang'an Hospital of Xiamen University, Xia Men, Fu Jian, China.
³ Department of Hepatobiliary Surgery, The Affiliated Longyan First Hospital of Fujian Medical University, Longyan, Fujian, China.

Abstract

Background: Atorvastatin is a commonly prescribed medication for the prevention of cardiovascular diseases. Recent observational studies have suggested a potential association between atorvastatin use and the occurrence of Erectile Dysfunction (ED). In this study, we aimed to explore the relationship between atorvastatin and ED using real-world data from the FAERS database and employed Mendelian randomization to assess causality.

Methods: To evaluate the disproportionality of atorvastatin in relation to ED, we conducted several pharmacovigilance analyses, including odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence propagation neural network (BCPNN), and gamma-Poisson contractile apparatus (GPS). Additionally, we employed Mendelian randomization to investigate the causal relationship between atorvastatin and ED.

Results: Pharmacovigilance disproportionality analysis revealed a significant association between atorvastatin and ED, as indicated by the following results: ROR [3.707078559, 95% CI (3.33250349, 4.123756054)], PRR [3.702969038, χ2 (669.2853829)], IC [1.870490139, IC025 (1.702813857)], and EBGM [3.656567867, EBGM05 (3.28709656)]. Furthermore, the two-sample Mendelian randomization analysis provided evidence supporting a causal relationship between atorvastatin use and ED, with an inverse variance weighted estimate of β = 3.17 (OR = 23.91, p = 0.02 < 0.05).

Conclusion: Based on comprehensive analyses incorporating pharmacovigilance and Mendelian randomization, our findings suggest that atorvastatin use is associated with an increased risk of ED and indicate a causal relationship. These results emphasize the importance of considering potential adverse effects, such as ED, when prescribing atorvastatin for cardiovascular disease prevention. Further research and clinical monitoring are warranted to better understand the underlying mechanisms and develop appropriate strategies to mitigate this side effect.

Keywords: Mendelian randomization; adverse drug reaction; atorvastatin; erectile dysfunction; real-world data analysis.

Grants and funding

The author(s) declare that financial support was received for the research, authorship, and/or publication of this article. This work was supported by Guidance in Medical and Health Program of Xiamen, China (3502Z20224ZD1159), Guidance in Medical and Health Program of Xiamen, China (3502Z20224ZD1155).