Indianapolis, IN - Long-term therapy with raloxifene (Evista, Eli Lilly) didn't influence the risk of CVD but apparently protected against development of invasive breast cancer in a preliminary analysis from the large, placebo-controlled Raloxifene Use for the Heart (RUTH) study, according to a statement released by the drug's marketer. Raloxifene, a selective estrogen-receptor modulator currently available in the US for the treatment of osteoporosis, mimics many effects of estrogen.

RUTH encompassed more than 10 000 women from 26 countries who had heart disease or major CV risk factors and who were randomized to either 60-mg raloxifene daily or placebo. Enrollment ended in 2001, and follow-up has ranged up to seven years.

Summarizing the study's preliminary primary outcomes, the Lilly press release said that:

• Active therapy, compared with placebo, "did not increase or decrease" the composite end point of fatal MI, fatal coronary disease, or hospitalization for acute coronary syndromes."
• But it did "decrease the end point of invasive breast cancer compared with placebo."

As for the secondary end points:

• There were no differences in all-cause or CV mortality or in stroke rates between the two treatment arms.
• "However, there was an increase in stroke mortality, but the overall incidence was low."
• The risk of venous thromboembolic events was increased among actively treated women, a finding consistent with the drug's current labeling.

"Physicians should be aware that the modest reduction of low-density-lipoprotein cholesterol, previously seen in Evista's clinical trials and currently reflected in the label, did not translate into cardioprotection in the RUTH study," Lilly chief medical officer Dr Alan Breier is quoted as saying. The company will pursue with the US Food and Drug Administration a labeling addition based on the trial's breast-cancer findings.