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Long-term quality of life and safety of a new tranexamic acid menorrhagia treatment

2010; Elsevier BV; Volume: 94; Issue: 4 Linguagem: Inglês

10.1016/j.fertnstert.2010.07.051

1556-5653

Ken Muse, Janet Gersten, Arthur Waldbaum, R. Garn Mabey, Andrea S. Lukes, Keith A. Moore,

Endometriosis Research and Treatment

OBJECTIVE: To determine the impact of treatment on a disease-specific measure and to evaluate long-term safety and tolerability of a novel, oral tranexamic acid formulation (TA, Lysteda™) in women with heavy menstrual bleeding (HMB).DESIGN: After a screening menstrual cycle, women (aged 18–49 years) with cyclic HMB received TA 3.9 g/day for up to 5 days per menstrual cycle during a maximum of 27 cycles in this multicenter, long-term, open-label study.MATERIALS AND METHODS: The Aberdeen (Ruta) Menorrhagia Clinical Outcome Questionnaire (AMCOQ) was administered during a baseline cycle and after treatment cycles 1, 2, 3, 6, 9, 12, and 15. The 15-item questionnaire provides an overall global score estimating the effect of menorrhagia on patients' perceived health status. In part, it sums general information about the woman's period, types, amount of sanitary products used, and the impact of HMB on her physical, social, and general functions. Safety was assessed by adverse event (AE) monitoring, physical examinations, vital sign monitoring, laboratory testing, ophthalmologic examinations, and 12-lead electrocardiography. Efficacy and safety analyses were performed on the intent-to-treat (ITT) population (all randomized patients who received at least 1 dose of study drug).RESULTS: The ITT population included 723 women with treatment of 10,213 menstrual cycles. Significant improvements from baseline in the AMCOQ global scores were observed at all evaluated cycles (P<.0001). The reduction in AMCOQ scores suggests a consistent improvement in HMB-impacted activities, which were maintained from the 1st through 15th cycle. TA was generally well tolerated; the majority of AEs were mild to moderate in severity. The frequency of treatment-related gastrointestinal AEs was low and no thrombotic or thromboembolic AEs occurred.CONCLUSION: Long-term treatment with this new TA formulation was well tolerated and ensured immediate and enduring improvement in quality of life in women with HMB. OBJECTIVE: To determine the impact of treatment on a disease-specific measure and to evaluate long-term safety and tolerability of a novel, oral tranexamic acid formulation (TA, Lysteda™) in women with heavy menstrual bleeding (HMB). DESIGN: After a screening menstrual cycle, women (aged 18–49 years) with cyclic HMB received TA 3.9 g/day for up to 5 days per menstrual cycle during a maximum of 27 cycles in this multicenter, long-term, open-label study. MATERIALS AND METHODS: The Aberdeen (Ruta) Menorrhagia Clinical Outcome Questionnaire (AMCOQ) was administered during a baseline cycle and after treatment cycles 1, 2, 3, 6, 9, 12, and 15. The 15-item questionnaire provides an overall global score estimating the effect of menorrhagia on patients' perceived health status. In part, it sums general information about the woman's period, types, amount of sanitary products used, and the impact of HMB on her physical, social, and general functions. Safety was assessed by adverse event (AE) monitoring, physical examinations, vital sign monitoring, laboratory testing, ophthalmologic examinations, and 12-lead electrocardiography. Efficacy and safety analyses were performed on the intent-to-treat (ITT) population (all randomized patients who received at least 1 dose of study drug). RESULTS: The ITT population included 723 women with treatment of 10,213 menstrual cycles. Significant improvements from baseline in the AMCOQ global scores were observed at all evaluated cycles (P<.0001). The reduction in AMCOQ scores suggests a consistent improvement in HMB-impacted activities, which were maintained from the 1st through 15th cycle. TA was generally well tolerated; the majority of AEs were mild to moderate in severity. The frequency of treatment-related gastrointestinal AEs was low and no thrombotic or thromboembolic AEs occurred. CONCLUSION: Long-term treatment with this new TA formulation was well tolerated and ensured immediate and enduring improvement in quality of life in women with HMB.