title: Tranexamic acid increases hemoglobin and ferritin levels in women with heavy menstrual bleeding.
abstract: 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.
authors.affiliation: Department of Obstetrics and Gynecology, University of Kentucky, Lexington, KY 40536, USA. muse@uky.edy
authors.forename: Ken
authors.initials: K
authors.lastname: Muse
authors.forename: R Garn
authors.initials: RG
authors.lastname: Mabey
authors.forename: Arthur
authors.initials: A
authors.lastname: Waldbaum
authors.forename: Janet K
authors.initials: JK
authors.lastname: Gersten
authors.forename: Tammie L
authors.initials: TL
authors.lastname: Adomako
mesh_terms: D000293:Adolescent; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy; D000933:Antifibrinolytic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use; D005293:Ferritins / Q000378:metabolism*; D006454:Hemoglobins / Q000378:metabolism*; D006801:Humans; D008595:Menorrhagia / Q000188:drug therapy*; D008875:Middle Aged; D014148:Tranexamic Acid / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000933:Antifibrinolytic Agents; D005290:Ferric Compounds; D006454:Hemoglobins; D014148:Tranexamic Acid; D005293:Ferritins