PRACTICE CHANGER
Offer tranexamic acid to patients with heavy menstrual bleeding. The extended-release formulation is effective and well tolerated.1
STRENGTH OF RECOMMENDATION
A: Based on 1 good-quality randomized controlled trial (RCT).
Lukes AS, Moore KA, Muse KN, et al. Tranexamic acid treatment for heavy menstrual bleeding: a randomized controlled trial. Obstet Gynecol. 2010;116:865-875.
ILLUSTRATIVE CASE
A 32-year-old woman comes to your office complaining of heavy, but regular, menstrual bleeding, accompanied by clots and heavy cramping that often leave her drained and unable to work. She has taken oral contraceptives in the past, but they caused nausea, and nonsteroidal anti-inflammatory drugs (NSAIDs) did not provide adequate symptom relief.
A pelvic ultrasound shows that the patient has normal endometrial thickness and no fibroids. Aside from surgical intervention or the placement of a hormonal intrauterine device (IUD), what can you offer her?
Heavy menstrual bleeding is a frequent problem, common enough to cause an estimated 10% to 30% of women of reproductive age to seek treatment.2-4 Often the bleeding is severe enough to adversely affect the patient’s social, physical, and emotional well-being.
Adverse effects, variable efficacy limit use of other treatments
Quantitatively defined as blood loss ≥80 mL per cycle, heavy menstrual bleeding can also be diagnosed based on a patient’s perception of menstrual blood loss and its effect on her daily life.5,6 NSAIDs, hormonal medications, the placement of a hormonal IUD, and surgical procedures are all treatment options, but potential adverse effects, contraindications, personal preference, and variable efficacy can limit their use.7
The fibrinolysis-blood loss link
Fibrinolytic activity in menstrual blood, leading to increasing blood loss, has prompted the evaluation of hemostatic agents as potential therapeutic options.8 Oral tranexamic acid decreases fibrinolysis, thereby reducing menstrual blood loss;9 however, gastrointestinal (GI) side effects limit the usefulness of immediate-release tranexamic acid.9,10
This formulation of tranexamic acid has been used in Europe for heavy menstrual bleeding. A Cochrane review published in 2000 included 4 studies that compared immediate-release tranexamic acid therapy with placebo. The meta-analysis found a significant reduction in mean blood loss compared with placebo (weighted mean difference [WMD]=-94.0 mL; 95% confidence interval [CI], -151.4 to -36.5) and a significant change in mean reduction of blood loss (WMD=-110.2 mL; 95% CI, -146.5 to -73.8) compared with baseline in the treatment group. However, only one of the studies measured perceived improvement in monthly menstrual blood loss, and its sample size was inadequate to provide a precise estimate of the effect (relative risk [RR] 2.5; 95% CI, 0.9-7.3).11
An extended-release option. Oral extended-release (ER) tranexamic acid (Lysteda), approved by the US Food and Drug Administration in 2009,12 reduces blood loss with fewer GI effects than immediate-release tranexamic acid. In the RCT detailed below, Lukes et al assessed the efficacy and safety of this new formulation.
STUDY SUMMARY: ER formulation reduces blood loss, boosts quality of life
The researchers conducted a multicenter, randomized, double-blind placebo-controlled study comparing the effect of ER tranexamic acid on reduction of menstrual blood flow compared with placebo.1 Reduction in menstrual blood loss >50 mL and a reduction in menstrual blood loss ≥36 mL (an amount previously established to be perceived as meaningful to women) were related primary outcomes. Improvements in limitations in social or leisure and physical activities and in self-perceived menstrual blood loss were secondary outcomes.