Lilly: Study shows Evista does not prevent heart attack

By E. Janene Geiss

Philadelphia, April 12 - Eli Lilly and Co. said Wednesday that preliminary results from the Raloxifene Use for The Heart (RUTH) trial show that Evista did not prevent coronary events in patients with heart disease or at high risk for heart attack.

Because preliminary analyses of the study's two primary endpoints indicated that Evista did not increase or decrease the combined endpoint of non-fatal heart attack, fatal heart attack and hospitalized acute coronary syndrome, the company said it wanted to reinforce for physicians that Evista should not be prescribed for cardioprotection, officials said in a company news release.

"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," Alan Breier vice president and chief medical officer, said in the release.

The trial was a large-scale placebo-controlled study that investigated whether 60 mg daily dose of raloxifene Hcl would reduce the risk of coronary events like heart attack and the risk of invasive breast cancer in postmenopausal women with known heart disease or at high risk for heart attack.

Raloxifene Hcl is currently marketed in the United States as Evista for the prevention and treatment of osteoporosis in postmenopausal women. The drug is not approved by the Food and Drug Administration in the United States for preventing or reducing the risk of cardiovascular disease or breast cancer.

The study included more than 10,000 women from 26 countries who were followed for up to seven years. All women enrolled in the study had known heart disease or were at high risk for heart attack.

Preliminary results did show that Evista treatment decreased the endpoint of invasive breast cancer compared to a placebo, officials said.

The company said the new data on Evista's potential for reducing the risk of invasive breast cancer in postmenopausal women will be submitted to the FDA for review.

Results of secondary endpoints indicate that there was no difference in overall mortality or cardiovascular

mortality among women who took Evista compared to placebo.

Among women taking Evista, there was no difference in the overall number of strokes compared to a placebo. But, there was an increase in stroke mortality, but the overall incidence was low, officials said.

There was an increase in venous thromboembolic events for patients taking Evista, officials said. This is consistent with what has been observed in previous trials and is reflected in Evista's current label, officials said.

Trial investigators are preparing the results for publication, and the company is working with the FDA and other regulatory agencies to update Evista's product label.

Lilly is an Indianapolis, Ind., pharmaceutical company.

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