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Association of Evista (raloxifene hydrochloride) with Increased Risk of Mortality Due to Stroke in Postmenopausal Women at Increased Risk for Cardiovascular Disease: Preliminary Results from the RUTH Trial

May 18, 2006 | Health Canada

Eli Lilly Canada Inc., following discussions with Health Canada, would like to inform you of important new safety information regarding Evista (raloxifene hydrochloride) resulting from the Raloxifene Use for The Heart (RUTH) trial.

The RUTH trial, a large-scale placebo-controlled study, investigated whether a 60 mg daily dose of raloxifene hydrochloride would reduce the risk of coronary events and the risk of invasive breast cancer in postmenopausal women with known heart disease or at high risk for a coronary event. The study included more than 10,000 women (average age = 67 years) from 26 countries who were followed for up to seven years. All women enrolled in RUTH had known heart disease or were at high risk for a coronary event.

• The RUTH study demonstrated an increase in mortality due to stroke for Evista compared to placebo. The incidence of stroke mortality was 1.5 per 1,000 women per year for placebo versus 2.2 per 1,000 women per year for Evista (p=0.0499).
• The incidence of stroke, myocardial infarction, hospitalized acute coronary syndrome, cardiovascular mortality, or overall mortality (all causes combined) was comparable for Evista and placebo.

• Evista is indicated for the treatment and prevention of osteoporosis in postmenopausal women.
• Evista is not indicated and should not be prescribed for the prevention or reduction of the risk of cardiovascular disease.
• The benefit/risk profile remains favourable for the majority of patients taking Evista for osteoporosis treatment and prevention.
• Women enrolled in the RUTH trial had either documented coronary heart disease, lower extremity arterial disease or the presence of risk factors known to increase the risk of coronary events, including age ≥ 70 years; hypertension; current smoker ≥ 10 cigarettes/day for 6 months; diabetes mellitus; hyperlipidemia i.e. LDL-C > 4.14 mmol/L or HDL-C < 1.16 mmol/L with TG > 2.82 mmol/L or on a lipid lowering drug.
• The risk-benefit balance of raloxifene in postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischemic attack or atrial fibrillation, should be considered before prescribing raloxifene.