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Purpose <p>Selective oestrogen receptor modulators (SERMs) are a standard treatment for breast cancer and osteoporosis. Alzheimer’s disease (AD) is a progressive neurodegenerative disorder that is a serious public health concern. This study aimed to identify potential pharmacovigilance signals related to dementia and AD for SERMs in menopausal and postmenopausal women.</p> Methods <p>To investigate this possible association, a disproportionality analysis was performed in VigiBase, the World Health Organization’s (WHO) global database of individual case safety reports (ICSRs). Disproportionality was quantified using the reporting odds ratio (ROR).</p> Results <p>We found risk of reporting dementia for tamoxifen [ROR = 1.74 (1.23–2.45)] and raloxifene [ROR = 1.63 (1.05–2.53)] and AD for raloxifene [ROR = 5.12 (3.26–8.05)]. No statistically significant association was detected for fulvestrant and bazedoxifene with dementia or AD. Most of the reports were severe and affected women over the age of 75. The latency of the reactions was predominantly long, suggesting that dementia is a late-onset reaction. The duration of treatment varied from a few months to more than three years, which may indicate that long-term exposure to SERMs is not necessary to develop dementia associated with these drugs.</p> Conclusion <p>Signals of disproportionate reporting have been observed between the incidence of dementia and AD with SERMs. There are conflicting results from the different studies that have been conducted on the relationship between these drugs and AD. More research is needed to find out what factors determine the risk of cognitive impairment associated with SERMs.</p>

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Selective oestrogen receptor modulators and Alzheimer´s disease: a real-world pharmacovigilance study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月18日

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  • María Teresa Yuste,
  • Elena Badillo,
  • Juan Sebastián Galecio,
  • Pedro Marín

摘要

Purpose

Selective oestrogen receptor modulators (SERMs) are a standard treatment for breast cancer and osteoporosis. Alzheimer’s disease (AD) is a progressive neurodegenerative disorder that is a serious public health concern. This study aimed to identify potential pharmacovigilance signals related to dementia and AD for SERMs in menopausal and postmenopausal women.

Methods

To investigate this possible association, a disproportionality analysis was performed in VigiBase, the World Health Organization’s (WHO) global database of individual case safety reports (ICSRs). Disproportionality was quantified using the reporting odds ratio (ROR).

Results

We found risk of reporting dementia for tamoxifen [ROR = 1.74 (1.23–2.45)] and raloxifene [ROR = 1.63 (1.05–2.53)] and AD for raloxifene [ROR = 5.12 (3.26–8.05)]. No statistically significant association was detected for fulvestrant and bazedoxifene with dementia or AD. Most of the reports were severe and affected women over the age of 75. The latency of the reactions was predominantly long, suggesting that dementia is a late-onset reaction. The duration of treatment varied from a few months to more than three years, which may indicate that long-term exposure to SERMs is not necessary to develop dementia associated with these drugs.

Conclusion

Signals of disproportionate reporting have been observed between the incidence of dementia and AD with SERMs. There are conflicting results from the different studies that have been conducted on the relationship between these drugs and AD. More research is needed to find out what factors determine the risk of cognitive impairment associated with SERMs.