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05/14/2012 10:58 PM

tranexamic acid, LYSTEDA, reduces HEAVY MENSTRUAL

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Tranexamic Acid (Lysteda) Reduces Heavy Menstrual Flow

By Ed Susman, Contributing Writer, MedPage Today

Published: May 10, 2012

Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

Action Points

This study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Tranexamic acid therapy significantly reduced blood loss among women with menorrhagia compared with placebo treatment.

Point out that women less than 30 had the smallest decrease in menstrual blood loss from baseline at 41.7 mL, while women ages 45 and up had the largest decrease (82.8 mL) from baseline.

SAN DIEGO -- Tranexamic acid (Lysteda) therapy significantly reduced blood loss among women with menorrhagia compared with placebo treatment, researchers said here.

In an analysis of pooled results from two studies, women who were treated with 3.9 grams a day of tranexamic acid saw a reduction in heavy menstrual flow by 58.3 mL from baseline compared with women given a placebo (P<0.0001), reported Jeffrey Baker, MD, of Rosemark WomenCare Specialists in Idaho Falls, Idaho, and colleagues at the annual meeting of the American College of Obstetricians and Gynecologists.

In addition, within the treatment arm, younger women (less than 30) had the smallest decrease in menstrual blood loss from baseline at 41.7 mL, while women ages 45 and up had the largest decrease (82.8 mL) from baseline, they reported.

Tranexamic acid (Lysteda) is a non-hormonal medicine for treating heavy monthly bleeding.

It was first approved by the FDA in 1989 as an injection (Cyklokapron) to reduce bleeding during and following tooth extraction in patients with hemophilia.

The tablet formulation was approved in 2009 for menorrhagia.

In the two randomized, placebo-controlled studies, heavy menstrual bleeding was defined as bleeding of more than 80 mL during a menstrual cycle, and the enrolled women had bleeding of more than 150 mL during their menstrual cycles.

Normal menstrual blood flow is about 30 mL per cycle, Baker said.

The mean age of the women was 40 and two-thirds were white. They had experienced heavy menstrual bleeding for about a decade.

Menstrual blood loss was assessed by the alkaline hematin method. Baseline and post-treatment mean menstrual blood loss values were calculated for each participant, based on two baseline and the first three menstrual cycle blood loss measurements for each study.

Baker reported that the treatment with tranexamic acid was significantly better than placebo across a host of patient subgroups:

Age <30: blood flow reduction of 40 mL from baseline versus 10 mL with placebo

Ages 30 to <35: 60 mL reduction versus an increase of 2 mL with placebo

Ages 35 to <40: 65 mL reduction versus 8 mL with placebo

Ages 40 to <45: 70 mL reduction versus an increase of 1 mL with placebo

Age &#8805; 45: 82.8 mL reduction versus 1 mL with placebo

Women with fibroids who took tranexamic acid experienced a greater decrease in menstrual blood loss from baseline (78 mL) compared with women without fibroids (60 mL).

Body mass index at baseline did not considerably alter reductions in mean blood loss from baseline for the treatment arm.

Baker said the majority of adverse events in the tranexamic acid group were mild to moderate in severity, including headache, nausea, menstrual discomfort, upper respiratory infection, musculoskeletal pain, and myalgia.

"We determined in these studies that tranexamic acid was well tolerated when used up to 5 days during menstrual cycles and was consistent with the established safety profile," Baker said.

"Tranexamic acid adds an oral, non-hormonal, non-surgical alternative for intermittent use to the current limited options for the treatment of cyclic heavy menstrual bleeding."

Baker disclosed commercial interests with Ferring.

Co-authors disclosed commercial interests with Ferring Pharmaceuticals, Merck, Everett Laboratories, Teva, Warner Chilcott, Xanodyne, Roche, Becton Dickinson, Church & Dwight, Amneal Pharmaceuticals, Abbott Laboratories, Novo Nordisk, Bayer, Boehringer-Ingelheim, Medicis Pharmaceuticals, and Vermillion.

Primary source: American College of Obstetricians and Gynecologists

Source reference:

Baker J, et al "Analysis of tranexamic acid efficacy in women with heavy menstrual bleeding across patient types" ACOG 2012.

http://www.medpagetoday.com/MeetingCoverage/ACOGMeeting/ 32600?utm_content=&utm_medium=email& utm_campaign=DailyHeadlines&utm_source=

© 2012 Everyday Health, Inc. All rights reserved.

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