Association of tibolone and dementia risk: a cohort study using Korean claims data

Abstract

Objective

Few studies have examined whether tibolone (TIB), a type of hormone replacement therapy widely used in Asia and Europe, affects dementia risk in postmenopausal women. Our study aims to investigate the association of TIB and dementia risk in Korean women aged 50–80 years.

Methods

A population-based longitudinal study was conducted using the Korean National Health Insurance Service claims database merged with national health examination data from 2002 to 2015. Among 13,110 participants, exposure to TIB was determined using the standardized defined daily dose (DDD) system from 2003 to 2007. Starting from 2007, participants were followed up for overall dementia, Alzheimer’s disease (AD) and vascular dementia (VD) until 2015. Cox proportional hazards regression was used to determine the adjusted hazard ratios (aHRs) and 95% confidence intervals (CIs) of dementia according to TIB use.

Results

TIB use was not significantly associated with the risk of total dementia (aHR = 1.040; 95% CI = 0.734–1.472; p = .827), AD (aHR = 0.949; 95% CI = 0.652–1.381; p = .785) and VD (aHR = 1.245; 95% CI = 0.631–2.457; p = .528).

Conclusions

Our results suggest that TIB use does not have a significant association with dementia risk. Further randomized controlled trials are necessary to elucidate the role of exogenous hormones in the development of dementia.

摘要

目的:很少有研究观察替勃龙(一种在亚洲和欧洲广泛使用的激素替代疗法)是否影响绝经后妇女的痴呆风险。我们的研究旨在调查年龄在50-80岁的韩国女性使用替勃龙和痴呆症的风险之间的关系。

方法:采用韩国国民健康服务数据库结合2002年至2015年的国民健康检查数据进行了一项基于人群的纵向研究。从2003年至2007年, 在13110名受试者中, 使用标准限定日剂量(DDD)系统测定了暴露于TIB的情况。从2007年开始, 参与者接受了全面的痴呆症、阿尔茨海默氏症(AD)和血管性痴呆(VD)随访, 直至2015年。根据替勃龙的使用, Cox比例风险回归用于确定痴呆的调整后风险比(aHRs)和95%置信区间(CIs)。

结果:替勃龙的使用与所有痴呆的风险没有显著相关性(aHR 1.04095%置信区间0.734–1.472；p =.827), 阿尔茨海默氏症(aHr 0.949；95%置信区间0.652–1.381；p= .785)和阿尔茨海默氏症(aHr 1.245；95%置信区间0.631–2.457；p=0.528)。

结论:我们的结果表明, 用替勃龙与患痴呆症的风险没有显著关联。需要进一步的随机对照试验来阐明外源激素在痴呆发展中的作用。

Keywords:

• Tibolone
• dementia
• Alzheimer’s disease
• Pharmacoepidemiological studies
• risk

Disclosure statement

No potential conflict of interest was reported by the author(s).