Efficacy and safety of oral tranexamic acid in women with heavy menstrual bleeding and fibroids.

AIM: To evaluate the efficacy and safety of oral, modified-release tranexamic acid in women with heavy menstrual bleeding and fibroids. MATERIALS & METHODS: This was a pooled analysis of two pivotal Phase III studies. Fibroids were evaluated by transvaginal ultrasonography. Menstrual blood loss (MBL) was measured via a validated alkaline hematin method. RESULTS: In women with and without fibroids, mean MBL was reduced compared with placebo across all treatment cycles (p < 0.001). Within the tranexamic acid group, more statistically significant (p < 0.001) reductions in MBL compared with placebo occurred in women with fibroids than in those without fibroids. Adverse events were similar between treatment groups. CONCLUSION: Tranexamic acid was well tolerated and reduced MBL in women with and without fibroids.

Daily menstrual blood loss and quality of life in women with heavy menstrual bleeding.

AIM: Excessive blood loss during menstruation is a major problem for women of reproductive age. Women who experience heavy menstrual bleeding (HMB) often present to physicians because of the subsequent negative impact HMB has on their daily lives and activities. The objective of this post-hoc analysis is to evaluate daily menstrual blood loss (MBL) in women with HMB and assess the relationship between daily MBL and women's perceptions of MBL, limitations in physical activities and limitations in social/leisure activities as measured by the Menorrhagia Impact Questionnaire. MATERIALS & METHODS: Data from two randomized, placebo-controlled studies of an oral tranexamic acid formulation in women with HMB were assessed. Daily MBLs and Menorrhagia Impact Questionnaire scores were evaluated for two pretreatment cycles and the first three tranexamic acid treatment cycles of each study. Effect-size analyses were not conducted. RESULTS & CONCLUSION: Highest daily MBLs occurred on days 2 and 3 of menstrual cycles. Women's perceptions of daily MBL were consistent with objective measures of MBL. Higher daily MBL was related to increased limitations in physical activities and limitations in social/leisure activities. Daily MBL values were consistent with women's perceptions of MBL. Reduced daily MBL was associated with improvements in health-related quality of life.

Tranexamic acid increases hemoglobin and ferritin levels in women with heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding (HMB) is the most common cause of iron deficiency anemia (IDA) in women. A novel, modified-release oral formulation of tranexamic acid (TA) designed to reduce gastrointestinal side effects was approved recently for treatment of HMB. We assessed improvements in objective laboratory measures of IDA in women with self-reported HMB who received long-term TA therapy. METHODS: Women enrolled in a long-term, open-label, multicenter study self-medicated with TA 3.9 g/day administered as 1.3 g orally up to three times daily for 5 days/menstrual cycle for 27 cycles. Oral iron therapy was required if serum hemoglobin (Hgb) levels decreased to <11 g/dL. RESULTS: A total of 723 women (mean age 38.3 years) were included in the intent-to-treat (ITT) population. Significant increases in mean serum Hgb and ferritin were observed throughout the study (p<0.01). Among 191 patients with low Hgb (<12 g/dL) at baseline, mean serum Hgb increased by ≥0.71 g/dL after the third cycle and all subsequent assessments (p<0.001). After 3 and 27 cycles, 34.1% and 45.7%, respectively, of patients with low Hgb at baseline shifted to within normal range, respectively. Among 233 patients with low ferritin (<10 ng/mL) at baseline, mean serum ferritin increased by >5.38 ng/mL after cycles 15 and 27. After 6 and 27 cycles, 35.2% and 58% of patients, respectively, with low ferritin levels at baseline shifted to within normal range. CONCLUSIONS: Long-term self-medication with this novel TA formulation improved Hgb and ferritin levels in women with self-reported HMB.

Safety of tranexamic acid in women with heavy menstrual bleeding: an open-label extension study.

AIMS: An open-label, extension clinical study was conducted to assess the safety of a novel, oral formulation of tranexamic acid (TA) in women with cyclic heavy menstrual bleeding. PATIENTS & METHODS: Eligible patients who completed either a three- or six-cycle double-blinded clinical trial of TA were offered enrollment into a study of nine cycles with TA (1.3 g orally three times/day for a maximum of 5 days per cycle). Safety was assessed by the incidence of treatment-emergent adverse events, ophthalmologic examinations and ECGs, among other evaluations. RESULTS: The most commonly reported treatment-emergent adverse events were menstrual discomfort (46.2%), headache (43.9%) and back pain (23.1%). A small proportion of participants (3.8%) reported ocular adverse events, but there was no evidence of ocular toxicity. No prothrombotic effects were observed. CONCLUSION: During nine menstrual cycles of treatment, this novel formulation of TA was well tolerated and exhibited a favorable safety profile supporting its use as a therapy for cyclic heavy menstrual bleeding.

A dose-response study of a novel, oral tranexamic formulation for heavy menstrual bleeding.

OBJECTIVE: We sought to assess the efficacy and safety of 2 dosing regimens of a novel, oral tranexamic acid formulation (Lysteda; Ferring Pharmaceuticals Inc, Parsippany, NJ) in women with cyclic heavy menstrual bleeding. STUDY DESIGN: This was a multicenter, double-blind, placebo-controlled, randomized, parallel-group trial for 3 menstrual cycles (n = 304). Women with mean menstrual blood loss (MBL) of ≥ 80 mL/cycle were randomized to receive either 1.95 g/d or 3.9 g/d of tranexamic acid or placebo for up to 5 days of menstrual bleeding. Primary efficacy endpoints were mean MBL reduction from baseline, mean MBL reductions that were considered "meaningful" by subjects, and mean MBL reductions from baseline > 50 mL/cycle. Adverse events (AEs) were also assessed. RESULTS: Only the 3.9 g/d group met all 3 primary efficacy endpoints. AEs did not significantly differ among the 3 groups. There were no serious study-related AEs. CONCLUSION: The 3.9-g/d dose met all 3 primary efficacy endpoints, whereas the 1.95 g/d dose met 2 primary efficacy endpoints. Both doses were well tolerated.