The heart trial, nicknamed ‘Ruth’, evaluated the use of Evista (Raloxifene HCl) in a large-scale placebo-controlled study. Currently, Evista is not approved by the FDA for preventing or reducing the risk of cardiovascular disease or breast cancer.
The study included more than 10 thousand women from 26 countries who were followed for up to seven years. Analysis of the data revealed that Evista did not increase or decrease the risk heart attack. The treatment was however correlated with a decreased incidence of invasive breast cancer.
Evista use was linked to an increased incidence of stroke risk, although the overall occurrence was low. Women in the treatment group were also at a greater risk of venous thromboembolic events compared to placebo users. This finding is consistent with previous trials and is reflected in Evista’s current label.
“Because Evista did not prevent coronary events, we want to reinforce for physicians that Evista should not be prescribed for cardioprotection,” said Dr Alan Breier, vice president and chief medical officer at Lilly. “Physicians should be aware that the modest reduction of LDL, or ‘bad’ cholesterol, previously seen in Evista’s clinical trials and currently reflected in the label, did not translate into cardioprotection in the Ruth study.”
Breier said the company would submit an application for the FDA to review the drug’s potential for reducing the risk of invasive breast cancer in postmenopausal women.