The low participation among women in clinical trials for popular artery-clearing heart stent devices is among the key interests of a study by North Chicago-based drug and medical device-maker Abbott Laboratories.
Although the study could one day be a benefit to female cardiovascular health, it could also boost Abbott's future marketing efforts of its potentially lucrative stent device known as Xience. Increasingly, drug and medical device-makers are stepping up the marketing of health-care products to women.
Abbott this week enrolled the first patient in a clinical trial studying the safety and efficacy of Xience in women. Xience is a next-generation drug-coated stent Abbott submitted to the Food and Drug Administration in June for approval.
If approved, Xience could be on the U.S. market in the first half of next year, competing in a market valued at $6 billion worldwide, with most of those sales coming from the U.S. market dominated by the only two drug-coated stents sold here: Boston Scientific Corp.'s Taxus and Johnson & Johnson's Cypher.
Xience has thus far not shown the extent of clotting issues that Taxus and Cypher have, and therefore officials at Abbott believe Xience will be competitive as doctors opt for an alternative.
Stents of all kinds are implanted in both women and men, but health experts and devicemakers believe they have a long way to go in treatment of women, pointing to studies showing a higher death rate and incidence of heart disease.
The trial "has the potential to enhance access to therapy for women by increasing physicians' and women's awareness about cardiovascular disease," said Dr. Marie-Claude Morice, a consultant to Abbott and principal investigator of the trial from the Institute Jacques Cartier in Massy, France.
Although heart disease is often referred to as a "men's disease," the U.S. Centers for Disease Control and Prevention says women accounted for 51 percent of the total heart disease deaths in 2002.
Yet Abbott, citing industry statistics, says women receive only 33 percent of balloon angioplasty procedures, stents and bypass surgeries. "With more women dying of cardiovascular disease than men, it is tragic that women [make up] only 25 percent of participants in all heart-related research studies," Morice said.
The trial will look at myriad potential reasons why women do not participate in trials, as well as "specific aspects of women's health in relation to" heart disease, such as general awareness, referral patterns and hormonal menopausal status, Abbott said in a statement.
Abbott plans to enroll 2,000 women from about 100 sites in Europe, Asia, Canada and Latin America in the study.
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