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Pharmaceutical industry

Raloxifene Use for The Heart (RUTH) Trial: Preliminary Results Announced by Eli Lilly and Company

Strategic Insights

— 2 min read

A large-scale placebo-controlled study, RUTH, has investigated the effect of a 60 mg daily dose of raloxifene HCl on the risk of coronary events and invasive breast cancer in postmenopausal women with known heart disease or at high risk for heart attack. The study included over 10,000 women from 26 countries followed for up to 7 years. Preliminary analyses revealed that raloxifene, marketed as Evista for osteoporosis prevention and treatment, did not significantly impact the combined endpoint of nonfatal heart attack, fatal heart attack, and hospitalized acute coronary syndrome compared to placebo. However, Evista treatment decreased the endpoint of invasive breast cancer compared to placebo.

Key Takeaways:

  • The RUTH trial, sponsored by Eli Lilly and Company, was a placebo-controlled study investigating raloxifene's effect on coronary events and invasive breast cancer in postmenopausal women.
  • The study included over 10,000 women from 26 countries followed for up to 7 years.
  • Preliminary analyses indicated no significant impact on the combined endpoint of nonfatal heart attack, fatal heart attack, and hospitalized acute coronary syndrome.
  • Evista treatment decreased the endpoint of invasive breast cancer compared to placebo.
  • There was no difference in overall mortality or cardiovascular mortality among women taking Evista compared to placebo.
  • The number of strokes among women taking Evista was similar to placebo, but there was an increase in stroke mortality.
  • Venous thromboembolic events (VTEs) increased among patients taking Evista, consistent with previous trials and the current Evista label.
  • The RUTH executive committee is working to complete data analyses for expedited publication, and Lilly is collaborating with regulatory agencies to update the product label.
  • Raloxifene, marketed as Evista, is currently not approved by the US FDA for preventing or reducing the risk of cardiovascular disease or breast cancer.

Statistics:

  • The study included over 10,000 women from 26 countries.
  • The women were followed for up to 7 years.
  • Preliminary analyses focused on the combined endpoint of nonfatal heart attack, fatal heart attack, and hospitalized acute coronary syndrome.
  • Evista treatment decreased the endpoint of invasive breast cancer by a significant margin.
  • There were [number] cases of VTEs in the Evista group compared to [number] in the placebo group.
  • The overall mortality rate among women taking Evista was [percentage] compared to [percentage] among placebo recipients.
  • The cardiovascular mortality rate among women taking Evista was [percentage] compared to [percentage] among placebo recipients.

Sources:

  • Eli Lilly and Company (LLY)
  • Raloxifene Use for The Heart (RUTH) trial
  • World Disease Weekly editors and staff
  • NewsRx.com
  • U.S. Food and Drug Administration (FDA)

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