Tranexamic Acid Reduces Heavy Menstrual Bleeding
Washington, DC—Menorrhagia was effectively treated, and the effects were durable, in women who received oral tranexamic acid (TA) treatment in a phase 3, randomized, double-blind clinical trial reported at the ACOG 2011 annual meeting.
In a separate analysis of this study also presented at the meeting, the drug significantly reduced sleep interruptions in these women.
TA is a competitive plasmin inhibitor thought to reduce the excessive fibrino - lysis in the endometrium of women with heavy menstrual bleeding. The drug is the only oral nonhormonal prescription medication that is US Food and Drug Administration–approved specifically for menorrhagia.
“TA is an effective option for women with heavy menstrual bleeding,” said David Archer, MD, of Eastern Virginia Medical School in Norfolk. “The drug significantly reduced menstrual blood loss in this study.” The multicenter US study included 196 women (aged, 18-49 years) who had heavy menstrual bleeding, defined as blood loss >60 mL during the first pretreatment cycle, and mean baseline loss >80 mL, as measured by a validated alkaline hematin method.
The women were randomized in a 2:1 ratio to TA 1.3 g or to placebo 3 times daily for up to 5 days per menstrual cycle. Treatment was initiated at the onset of heavy bleeding and was continued for 6 cycles. Efficacy was determined by measuring menstrual bloodloss volume from all soiled sanitary products collected during the study.
Blood loss was significantly Reduced
Three fourths of each group completed the study; they were included in the intention-to-treat analysis of women who received at least 1 dose of study drug, had a baseline evaluation, and had sufficient daily primary efficacy data to construct 1 period of data after the first dose of study drug.
TA proved very effective in reducing blood loss, Dr Archer said. The women treated with TA had a significant 40% reduction in menstrual blood loss from baseline, amounting to 69.6 mL less blood. Those randomized to placebo also had a significant, although much smaller, 12.6-mL (8.2%) reduction.
The reductions in blood loss with TA were first observed during the first cycle and were maintained for 6 cycles. The improvement observed in the first cycle in the placebo arm was not maintained.
Fewer sleep Interruptions
“Women who experience heavy menstrual bleeding often present to a healthcare provider because of the subsequent negative impact on their daily lives and activities,” said Ken Muse, MD, of the University of Kentucky, who presented the data on the drug’s impact on sleep interruptions. “Sleep interruptions caused by waking in the night to change sanitary products are often an under-recognized consequence of cyclic heavy menstrual bleeding.”
Women in the TA group reported a significant reduction in the mean number of sleep interruptions compared with baseline and compared with the placebo group. The mean reduction was 0.99 with TA and 0.7 with placebo, Dr Muse reported.
The most common adverse events that were possibly related to treatment included headache, nausea, menstrual discomfort, and diarrhea. Three women from each arm withdrew from the study due to adverse events.
Gastrointestinal and ophthalmic events have been concerns with this drug, Dr Archer acknowledged, but in this study the incidence of such adverse events was similar for drugand placebo-treated patients.
“We believe that TA provides a good first-line, oral, non-hormonal and nonsurgical treatment option for cyclic heavy menstrual bleeding,” Dr Archer said.