What is Tibella in a medical context?

Tibella (Tibolone) in Medical Context

Tibella (tibolone) is not a medication used for tuberculosis treatment or any other infectious disease; it is a synthetic steroid used for managing menopausal symptoms in women. Based on the available evidence, there appears to be confusion with tuberculosis medications in some of the provided references.

What is Tibolone (Tibella)?

• Tibolone is a synthetic steroid used for relieving climacteric (menopausal) symptoms and maintaining bone mineral density in postmenopausal women 1
• It has a tissue-specific mode of action that differs from conventional hormone replacement therapy (HRT) 1, 2
• Tibolone is quickly metabolized into its main active metabolites (3alpha and 3beta-OH) and a Delta4-metabolite, each with different receptor binding properties 1

Clinical Uses

• Relief of vasomotor symptoms (hot flushes, sweating episodes) in postmenopausal women 3, 4
• Treatment of vaginal dryness 3
• Prevention of postmenopausal bone loss 1, 2
• Improvement of sexual function in postmenopausal women 3, 4

Dosage

• Standard dose: 2.5 mg daily 3, 5
• Lower dose: 1.25 mg daily has shown similar efficacy with potentially better tolerability 3

Efficacy

• Reduces hot flushes by 78-90% after 24 weeks of treatment 3
• Reduces sweating episodes by 34-36% 3
• Reduces vaginal dryness by 44-51% 3
• Improves quality of sexual life compared to placebo 3, 4
• Maintains bone mineral density similar to estrogen therapy 1, 2

Side Effects and Safety Concerns

• Weight gain and/or bloating/edema (reported in 11.28% of women) 4
• Vaginal bleeding (reported in 12.69% of women) 4
• Breast symptoms (reported in 7.52% of women) 4
• Increased risk of breast cancer recurrence in women with a history of breast cancer (HR 1.40 [95% CI 1.14-1.70]) 5

Contraindications

• History of breast cancer 5
• Current or past history of thromboembolic disorders 2
• Undiagnosed vaginal bleeding 2
• Estrogen-dependent tumors 2

Clinical Pearls

• Tibolone has a unique tissue-specific action that provides estrogenic effects on bone and vaginal tissue while avoiding stimulation of breast and endometrial tissue 1
• It may have less effect on endometrial thickness compared to conventional HRT 3, 1
• The medication appears to have minimal impact on lipid profile and blood glucose levels 3
• In women with a history of breast cancer, tibolone significantly increases the risk of recurrence despite its effectiveness for vasomotor symptoms 5

Monitoring Recommendations

• Baseline and periodic assessment of cardiovascular risk factors 2
• Investigation of any unexpected vaginal bleeding 4
• Regular breast examinations and mammography according to age-appropriate guidelines 2