09 December 2009

Women From Clinical Trial Sing The Praises Of Lysteda

Grand Rapids Press


It's certainly not an easy subject to talk about, but heavy menstrual bleeding can be debilitating for some women, and more than just a nuisance for others.

Rockford resident Karen Van Riper says her condition is so bad, she can't leave the house for several days each month.

Now, for the first time, hormone-free relief is on the way in form of a pill -- Lysteda -- just approved by the Food and Drug Administration after a two-year research clinical trial that included 100 West Michigan women like Van Riper.

"I'm a soccer mom; I'm a Girl Scout leader; I volunteer at my kids' school, but if my period happens, I can't do any of that," said Van Riper, 38. "It was incredibly life changing (to be on the drug)."

Female Pelvic Medicine & Urogynecology, an arm of Grand Rapids Michigan Women's Health group, was the largest participant in the study that led to Lysteda, also known as Tranexamic acid, being set to hit the market next spring.

Beth Rogers, the practice's research director and coordinator of the study in Grand Rapids, said the West Michigan women first participated in a blind trial in which some received the drug while others took a sugar pill. It was almost immediately obvious who was receiving the real thing, she said.

"These are women that always have to carry an extra set of clothing with them -- it was that bad," Rogers said. "These are women that their doctors told them, 'You know it's just part of being a woman.' And now they have another option."

The drug, manufactured by Kentucky-based Xanodyne Pharmaceuticals, works by stabilizing a protein that helps blood to clot. It is currently used to reduce and prevent bleeding following tooth extraction in patients with hemophilia, a hereditary disorder that prevents blood from clotting.

According to the FDA, about 3 million U.S. women of reproductive age suffer from the condition, known as menorrhagia.

Dr. Douglas Van Drie, who led the study in Grand Rapids, estimates about 20 percent to 30 percent of women have a period so heavy that it interferes with their life, causing severe anemia, pain, fatigue and embarrassing leaks.

Treating the condition with low-dose birth control pills is not an option for all women, and it's not always effective, he said.

"If you look back to the 1950s, probably a lot of these things were suffered silently," Van Drie said. "But with more women in the workplace, it's not practical."

Stephanie Chandler's heavy bleeding had led her to take vacation days once a month from her job at an area call center, consider filing for unpaid leave under a federal law, or even confining herself to the bathroom.

The 39-year-old Grand Rapids resident said she participated in the study because heavy bleeding has been a problem since she was a teenager and caused fatigue from dangerously low blood iron levels. Chandler said she has tried birth control and minor surgery and even considered a partial hysterectomy to relieve her symptoms.

"Taking (Lysteda) literally changed my life," she said.

No comments:

Post a Comment