Menorrhagia significantly, durably reduced with tranexamic acid

Menorrhagia Significantly, Durably Reduced With Tranexamic Acid

May 4, 2011 (Washington, DC) – Oral tranexamic acid (TA) significantly reduced menstrual blood loss in women with heavy menstrual bleeding, and blood loss reductions were durable throughout the 6 months of treatment in a phase 3, randomized, double-blind, placebo-controlled trial. The safety of TA was comparable to placebo.

Other options approved by the US Food and Drug Administration for heavy menstrual bleeding include hormonal treatments and surgery. Oral TA provides a first-line, oral, nonsurgical treatment option for women with heavy menstrual bleeding, according to the study authors here at the American Congress of Obstetricians and Gynecologists 59th Annual Clinical Meeting.

“TA is a good option for women with heavy menstrual bleeding,” said David Archer, MD, from the Eastern Virginia Medical School in Norfolk. Dr. Archer, one of he study’s investigators, was standing in for lead author of the poster, Andrea Lukes, MD, from Carolina Women’s Research and Wellness Center, in Durham, North Carolina, who was unable to attend the meeting.

Dr. Archer explained that heavy menstrual bleeders have increased amounts of endogenous plasminogen activators that cause clots to dissolve. “They just keep bleeding,” he noted. “It’s not life-threatening, but it is a social problem and can make women anxious. TA is an antifibrinolytic agent that makes the clot stronger.”

The study enrolled 196 women with heavy menstrual bleeding at 40 sites in the United States. Subjects were 18 to 49 years of age and were randomly assigned, in a 2:1 ratio, to TA 1.3 g or placebo 3 times a day for a maximum of 5 days per cycle. Treatment was initiated at the onset of heavy menstrual bleeding and was continued for 6 cycles. About 75% of women in both groups completed treatment as assigned. Baseline and demographic characteristics were similar

between treatment groups.

TA-treated women achieved significant reductions in menstrual blood loss from baseline (-69.6 mL [40.4%]; P < .0001). Subjects randomized to placebo also experienced significant decreases from baseline, but of a much smaller magnitude (-12.6 mL [8.2%]; P = .004).

Reductions in blood loss with TA occurred during the first treatment cycle and were maintained for 6 cycles; menstrual blood loss reductions observed in the placebo group at the first cycle were not durable, Dr. Archer noted.

TA was generally well tolerated. Serious adverse events occurred in 5 subjects: 2 in the TA group and 3 in the placebo group. Adverse events deemed of special interest before initiation of treatment included gastrointestinal (GI) and ophthalmic events. During the study, a similar percentage of subjects in the TA and placebo groups experienced GI events (31.6% vs 37.5%). Fewer subjects in the TA group than in the placebo group experienced ocular adverse events (5.98% vs 12.5%). No subject in the TA group experienced a thrombotic or thromboembolic event, whereas 1 subject in the placebo group did (deep vein thrombosis).

“TA has an excellent track record in Europe, and is probably the first choice for treatment of menorrhagia in the United Kingdom,” said Kevin Ault, MD, associate professor of obstetrics and gynecology at Emory University in Atlanta, Georgia.

Although Dr. Ault welcomes the availability of TA, he said its adoption depends on cost and whether it is on the formulary. “Georgia Medicaid does not pay for it,” he noted.

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Menorrhagia significantly, durably reduced with tranexamic acid