May 28, 2010 (San Francisco, California) — Women who took tranexamic acid (Lysteda, Ferring Pharmaceuticals) for heavy menstrual bleeding experienced significant improvements in quality of life after 3 cycles — and were more able to participate in social, leisure, physical, and social activities after taking the medication, said researchers here at the American Congress of Obstetricians and Gynecologists (ACOG) 58th Annual Clinical Meeting.
In several studies unveiled at the meeting, more than 70% of women who took the highest dose of tranexamic acid (3.9 g/day) responded to the medication.
Xanodyne Pharmaceuticals received approval from the US Food and Drug Administration (FDA) for the drug in late November 2009. Ferring Pharmaceuticals acquired Lysteda from Xanodyne Pharmaceuticals on May 10, 2010.
Tranexamic acid is the first nonhormonal product approved by the FDA for use in treating menorrhagia. It works by inhibiting fibrinolysis. “If you can block that activity within the endometrium, clots remain for a longer time, are more stable, and women bleed less,” said researcher Andrea Lukes, MD, from the Carolina Women’s Research and Wellness Center in Durham, North Carolina.
Tranexamic acid was first approved by the FDA in 1986 as an injection under the brand name Cyklokapron and has been used to prevent bleeding in patients with hemophilia after tooth extraction. Lysteda is a new oral formulation of tranexamic acid.
As many as 25% of women (3 million women of reproductive age) in the United States experience menorrhagia, often when there is no underlying medical condition. As part of its requirements for the approval of tranexamic acid, the FDA asked that clinical trials demonstrate a significant improvement in quality of life for women who take the drug, and that women perceive the drug as beneficial, Dr. Lukes noted.
In a multicenter double-blind placebo-controlled study, 294 women 18 to 49 years of age with heavy menstrual bleeding (defined as menstrual blood loss of greater than 80 mL per cycle averaged over 2 cycles) received a dose of 3.9 g/day of tranexamic acid, 1.9 g/day of tranexamic acid, or placebo for up to 5 days per cycle for 3 menstrual periods.
The Menorrhagia Impact Questionnaire (MIQ) was administered at baseline and after 3 treatment cycles. The MIQ assesses limitations in physical, social, and leisure activities, reductions in the ability to work inside or outside the home, and perceived mean blood loss reduction. Most of the women who participated in the study had experienced heavy menstrual periods for a significant length of time (mean, 10 to 12 years), Dr. Lukes said.
When the women were asked on the MIQ to rate the extent to which their menstrual bleeding limited their work outside and inside the home, on a scale of 1 to 5 (with 1 being “not at all” and 5 being “extremely” limiting), women taking tranexamic acid experienced a 1-point reduction in their restrictions, which was significantly more than those in the placebo group (P < .0001). When asked about how much their menstrual bleeding limited their social and leisure activities, women taking tranexamic acid experienced a similar drop in limitations after being on the drug for 3 cycles. The effect on quality of life was dose-dependent, however, with the greatest benefit seen in those receiving 3.9 g/day. This dose is now considered to be the standard dose for menorrhagia, Dr. Lukes said.
The researchers concluded that the MIQ is an important instrument for assessing treatments for heavy menstrual bleeding. “Future studies need to address women’s perspectives on these medications,” Dr. Lukes said.
“I think it’s important that both women and clinicians be aware of yet another option in terms of management of abnormal and heavy menstrual bleeding,” said Paula Hillard, MD, chief of the Division of Gynecologic Specialties in the Department of Obstetrics and Gynecology at Stanford University School of Medicine in California.
Dr. Hillard noted that a number of hormonal options, such as birth control pills and the progesterone-containing Intrauterine device (IUD), are quite useful in controlling menorrhagia. Hormonal medications can have adverse effects; however, the rates of significant adverse effects are actually quite low, especially for the progesterone IUD, she said. The most common adverse effects for women who took tranexamic acid in the studies presented at ACOG were headache, abdominal discomfort, menstrual discomfort, diarrhea, and nausea.
The combination of tranexamic acid and hormonal contraceptives can increase the risk for blood clots, stroke, and heart attack. However, for women who can’t take hormonal medications, such as those with migraines who are at increased risk of stroke from estrogen medications, tranexamic acid might be one alternative, Dr. Hillard said.
“It’s another option and options are good for management of a problem that can truly be life-changing for many women,” she said.
The studies were funded by Ferring Pharmaceuticals, Inc. Dr. Lukes reports receiving research support from Xanodyne, Interlace Medical, Merck, Bayer, Hologic, and Duramed; and speaker/consultant fees from Xanodyne, Bayer, Interlace Medical, Myriad, and Boehringer Ingelheim. Dr. Hillard has disclosed no relevant financial relationships.
American Congress of Obstetricians and Gynecologists (ACOG) 58th Annual Clinical Meeting: Presented May 17 and May 18, 2010.