Tibolone 2.5mg tablets

BACKGROUND: Globally, dementia disproportionately affects women. Changes in circulating sex steroids over the menopause transition might contribute to this sex difference. Menopause hormone therapy (MHT) is recommended by the UK National Institute for Health and Care Excellence to manage menopausal symptoms, but whether MHT use affects dementia risk and how this association might vary by age at menopause is unclear. We aimed to assess whether MHT (vs no MHT) affects the risk of mild cognitive impairment or dementia in peri-menopausal or post-menopausal women, including those with premature ovarian insufficiency or early menopause (with normal cognition or mild cognitive impairment), and whether MHT type, duration, or age at initiation influence this risk. METHODS: We systematically searched MEDLINE via OVID, Embase via Elsevier, Cochrane via OVID, and PsycINFO via OVID for systematic reviews published between Jan 1, 2000, and Dec 19, 2024. As no existing review met our quality or scope criteria, we proceeded to conduct a systematic review and meta-analysis of primary studies published from Jan 1, 2000, to Oct 20, 2025. Eligible primary studies included randomised controlled trials (RCTs), non-randomised intervention studies, and prospective observational studies examining the association between MHT-including oestrogen-only MHT, combined MHT, testosterone, and tibolone-and incident mild cognitive impairment or dementia. Two reviewers independently screened studies, extracted data, and assessed risk of bias using RoB 2 and ROBINS-E, with certainty of evidence rated using GRADE. Meta-analyses pooled relative risk estimates in a random-effects model. The protocol was preregistered on PROSPERO (CRD42025639384). FINDINGS: Of 5914 records, ten studies (one RCT and nine observational studies) with a total of 1 016 055 participants were included. Certainty of evidence ranged from moderate to very low. No included studies examined testosterone or use in premature ovarian insufficiency. No significant association was found between MHT use and risk of mild cognitive impairment or dementia. Subgroup analyses by timing, duration, and type of MHT showed no significant effects. INTERPRETATION: This review found no evidence that MHT use either increases or decreases the risk of dementia in post-menopausal women. This reinforces current clinical guidance, that MHT prescription should be based on other perceived benefits and risks and not for dementia prevention. High-quality, long-term studies are needed to clarify the role of MHT and dementia risk, particularly regarding formulation, dose, route, timing, and duration of treatment, with a focus on women with premature ovarian insufficiency, early menopause, or mild cognitive impairment. FUNDING: The Public Health Agency of Canada.

Abstract licence: CC BY

Low bone mineral density (BMD) on postmenopausal women causes bone fragility and fracture risk. Tibolone seems to prevent bone loss. Therefore, this systematic review with meta-analysis synthesizes the tibolone effect on BMD percent change in lumbar spine (LS), femoral neck (FN), and total hip (TH) in postmenopausal women. Controlled trials that provided tibolone evidence on the efficacy of tibolone in preventing loss of BMD were included. Regarding the included studies, a pooled mean difference (MD) with 95% confidence intervals (95%CI) was estimated to determine the BMD percentage change. Eleven studies were identified and eight were included in the quantitative analysis. Tibolone at a dose of 2.5 mg increased BMD compared with non-active controls at 24 months in LS (MD 4.87%, 95%CI: 4.16-5.57, and MD 7.35%, 95%CI: 2.68-12.01); and FN (MD 4.85%, 95%CI: 1.55-8.15, and 4.21%, 95%CI: 2.99-5.42), with Hologic and Lunar scanners, respectively. No difference was observed when tibolone 2.5 mg dose was compared with estrogen therapy (ET) at 24 months, LS (MD -0.58%, 95%CI: -3.77-2.60), FN (MD -0.29%, 95%CI: -1.37-0.79), and TH (MD -0.12%, 95%CI: -2.28-2.53). Therefore, tibolone increases BMD in LS and FN compared to non-active controls, and there was no showed difference with ET.

Abstract licence: CC BY

Alzheimer's disease (AD) is a debilitating neurodegenerative disease characterised by the accumulation of amyloid-beta and tau in the brain, leading to the progressive loss of memory and cognition. The causes of its pathogenesis are still not fully understood, but some risk factors, such as age, genetics, and hormones, may play a crucial role. Studies show that postmenopausal women have a higher risk of developing AD, possibly due to the decrease in hormone levels, especially oestrogen, which may be directly related to a reduction in the activity of oestrogen receptors, especially beta (ERβ), which favours a more hostile cellular environment, leading to mitochondrial dysfunction, mainly affecting key processes related to transport, metabolism, and oxidative phosphorylation. Given the influence of hormones on biological processes at the mitochondrial level, hormone therapies are of clinical interest to reduce the risk or delay the onset of symptoms associated with AD. One drug with such potential is tibolone, which is used in clinics to treat menopause-related symptoms. It can reduce amyloid burden and have benefits on mitochondrial integrity and dynamics. Many of its protective effects are mediated through steroid receptors and may also be related to neuroglobin, whose elevated levels have been shown to protect against neurological diseases. Its importance has increased exponentially due to its implication in the pathogenesis of AD. In this review, we discuss recent advances in tibolone, focusing on its mitochondrial-protective effects, and highlight how valuable this compound could be as a therapeutic alternative to mitigate the molecular pathways characteristic of AD.

Abstract licence: CC BY

Tibolone, a selective tissue estrogenic activity regulator, is a synthetic steroid with distinct pharmacological and clinical characteristics in contrast to conventional menopausal hormone therapy. Tibolone induces estrogenic activity in the brain, vagina, and bone but remains inactive in the endometrium and breast. In particular, several studies have investigated whether tibolone usage increases the risk of breast cancer. This study aims to determine the effects of tibolone on the breast by focusing on the relation between tibolone use and breast cancer. Our investigation emphasizes recent studies, particularly those based on Asian populations.

Abstract licence: CC BY-NC