Lilly is stressing that Evista (raloxifene) should not be used for cardioprotection after preliminary trial results for the selective estrogen receptor modulator showed no impact on heart ailments, the company said April 12.

Results from the same study, however, support the company's supplemental NDA for a breast cancer indication, still on track for submission by the end of 2006, the company says.

[Editor's note: An earlier version of this story inadvertently mischaracterized Lilly's plans for disseminating the study information.]

Lilly's Phase III RUTH (Raloxifene Use for The Heart) trial studied use of Evista in 10,000 women - all known to have or be at high risk for heart disease - for seven years.

"Because Evista did not prevent coronary events, we want to reinforce for physicians that Evista should not be prescribed for cardioprotection," said VP-Medical Alan Breier.

Trial results showed that Evista failed primary endpoints related to cardiac events. In spite of reductions in "bad" cholesterol, the drug was not linked to any decrease in heart attack or hospitalized acute coronary syndrome.

"Physicians should be aware that the modest reduction of LDL, or 'bad' cholesterol, previously seen in Evista's clinicals and currently reflected in the label, did not translate into cardioprotection in the RUTH study," Breier added. The label links the drug to LDL cholesterol reductions of up to 10%.

Evista was approved in 1997 for treatment and prevention of post-menopausal osteoporosis.

The selective estrogen receptor modulator also showed no difference from placebo in secondary endpoints including overall mortality, cardiovascular mortality and stroke incidence.

The firm said it will immediately update its "important safety information" box on promotional materials. Lilly is also in discussions with FDA about including the new findings in the product's label.

The RUTH study met a second primary endpoint of decrease in invasive breast cancer, supporting the Lilly's goal to file an sNDA by the end of the year, the company said.

Lilly's sNDA for a breast cancer risk reduction indication hinges on a study by the National Surgical Adjuvant Breast and Bowel Project, which is testing raloxifene head-to-head against tamoxifen in the Study of Tamoxifen and Raloxifene (STAR). STAR data will likely be available at the end of April.

Lilly recently agreed to pay $36 mil. to settle charges from HHS related to alleged off-label promotion of Evista for the prevention and reduction in risk of breast cancer and reduction in cardiovascular risk (¹ Also see "Lilly Pleads Guilty To Off-Label Evista Promotion" - Pink Sheet, 21 December, 2005.).

-Todd Leeuwenburgh

Lilly's Evista Not Effective For Heart Disease, Preliminary Results Show

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