Evista's heart effects deemed neutral

The osteoporosis drug raloxifene, sold as Evista, does not appear to have a beneficial or harmful effect on the occurrence of cardiovascular events in postmenopausal women who are at relatively low risk of these events, a new study suggests.

The impact of so-called "selective estrogen receptor modulators" such as Evista on heart disease outcomes in postmenopausal women is unclear, Dr. Kristine Ensrud from the University of Minnesota in Minneapolis, and colleagues point out in the American Journal of Cardiology.

Ensrud's team examined the effect of Evista on the incidence of serious cardiovascular events in 4,011 postmenopausal women with osteoporosis participating in the 4-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial and the 4-year follow-up Continuing Outcomes Relevant to Evista (CORE) trial.

The 8-year incidence of serious cardiovascular adverse events was similar between the Evista and placebo arms (5.5 percent versus 4.7 percent).

The same was true when coronary and cerebrovascular events were analyzed separately, and when cardiovascular events were analyzed in the 459 study subjects who were at increased risk for cardiovascular events.

It is worth noting, the authors say, that "neither the MORE nor CORE trial was designed to assess the effects of raloxifene on cardiovascular outcomes, and prospective trials with greater numbers of events are needed."

They say this is the focus "of the ongoing RUTH trial, a study of postmenopausal women with or at increased risk of coronary disease."

SOURCE: American Journal of Cardiology February 15, 2006.