Tibolone (Livial®) enhances warfarin-induced anticoagulation in postmenopausal women
| Autor: | Jolanda Elbers, C. Hageluken, A. Wadham |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
medicine.medical_specialty
Norpregnenes medicine.drug_class Urology Tibolone Placebo General Biochemistry Genetics and Molecular Biology law.invention Double-Blind Method Estrogen Receptor Modulators Randomized controlled trial law medicine Humans International Normalized Ratio cardiovascular diseases Aged Prothrombin time Cross-Over Studies medicine.diagnostic_test business.industry Anticoagulant Warfarin Anticoagulants Obstetrics and Gynecology Drug Synergism Middle Aged Crossover study Blood Coagulation Factors Discontinuation Surgery Postmenopause Female business medicine.drug |
| Zdroj: | Maturitas. 56:94-100 |
| ISSN: | 0378-5122 |
| DOI: | 10.1016/j.maturitas.2006.06.010 |
| Popis: | Objective To investigate the potential drug interaction between tibolone and warfarin in healthy postmenopausal women. Methods and results The study was designed as a double-blind, randomized, placebo-controlled, two-way crossover study in postmenopausal women. After stabilization of the International Normalized Ratio (INR; a standardized prothrombin time, PT) between 1.4 and 2.0 with warfarin, subjects were randomized to receive either tibolone (2.5 mg/day) or placebo for 21 days. After a 7-day wash-out period (during which warfarin treatment was continued) the treatments were crossed over. Primary efficacy parameters were INR and coagulation Factors II, VII, VIIa and X (means of measurements at Days 18 and 20 and Days 46 and 48). Treatment with tibolone induced a statistically significant increase in INR (estimate of mean difference = 0.40; P = 0.002), and a statistically significant decrease in coagulation factors. Treatments were generally well tolerated and no clinically significant adverse events were observed. Conclusions Tibolone enhances warfarin-induced anticoagulation in postmenopausal women, as reflected by increases in INR and decreases in coagulation Factors II, VII, VIIa and X, compared to placebo. It is advisable to monitor for changes in coagulation status during (and after discontinuation of) simultaneous use of tibolone and warfarin. |
| Databáze: | OpenAIRE |
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