Recent Korean study has reported that tibolone use for hormone therapy in postmenopausal women is significantly associated with an increased risk of cardiovascular disease (CVD) [1], raising concerns in clinical practice. According to an analysis using national health insurance data, tibolone use was associated with a 38% higher risk of CVD compared to non-users, a pattern not observed with other hormone therapies. This increased risk was primarily attributed to a rise in stroke incidence. Subgroup analyses revealed a significant increase in CVD risk among women under the age of 60, whereas no such increase was observed in those aged 60 and above.
These findings appear to contrast with previous large-scale randomized controlled trials. For instance, Cummings et al. [2] reported that tibolone increased the risk of stroke compared to placebo, but the risk varied with age. Moreover, another randomized controlled trial by Kenemans et al. [3] found no increase in CVD risk associated with tibolone use compared to placebo. Methodological limitations inherent to studies utilizing health insurance data may partially explain the discrepancy. Additionally, given the relatively short median duration of tibolone use (23 months), the significant increase in CVD risk observed only in women in their 40s and 50s may reflect the inclusion of patients who are already at higher baseline risk.
In fact, another Korean study using national insurance data reported that long-term tibolone use in postmenopausal women aged 50 and older was associated with a decreased risk of stroke [4].
Although no large-scale prospective trials have yet been conducted with CVD as the primary endpoint in tibolone users, the current body of evidence suggests that, similar to other forms of menopausal hormone therapy, tibolone does not increase the risk of stroke in women younger than 60 or within 10 years of menopause. Stroke risk appears to increase with advancing age regardless of treatment.
In conclusion, the Korean Society of Menopause advises against overinterpreting the recent findings and reaffirms its current clinical guidelines: menopausal hormone therapy, including tibolone, does not increase the risk of stroke or other CVDs in women under the age of 60. We urge clinicians to continue following evidence-based treatment recommendations.
References
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