Yourlawyer.com (Evista News)

Raloxifene averts breast cancer, at a risk

Thu, 13 Jul 2006 00:00:00 -0700

Women with heart disease or a high risk for it would trade one set of odds for another if they took the drug raloxifene to try to prevent breast cancer, a new study suggests. The drug helped prevent cancer, but raised the risk of blood clots and fatal strokes. It also didn't lower the risk of death, hospitalization or heart attack, as some had hoped it would.

Doctors have been testing this drug as an alternative to tamoxifen for preventing breast cancer and as a way to lower heart disease risks.

Based on the new study's results, "most people would decline taking raloxifene" unless they have a high risk of breast cancer, said Dr. Linda Vahdat, director of breast cancer research at Weill Cornell Medical College.

Dr. Marisa Weiss, a Philadelphia breast cancer specialist who founded the consumer Web site breastcancer.org, agreed.

"The cardiac benefit wasn't there. The side effects were," and breast cancer is more treatable than life-threatening blood clots and strokes, she said.

Neither doctor took part in the study, which involved 10,101 postmenopausal women in the United States and 25 other countries. Results were published in Thursday's New England Journal of Medicine.

Many of the authors consult or work for Indianapolis-based Eli Lilly & Co., which makes raloxifene and paid for the study. The drug is sold as Evista for treating the bone disease osteoporosis, but the company is seeking approval to market it for breast cancer prevention.

A similar drug, tamoxifen, has long been used to prevent breast cancers whose growth is fueled by the hormone estrogen. A big federal study reported last month that raloxifene was equally effective at preventing the most serious types of breast cancer and with fewer side effects, although some doctors disagree on how large the differences in side effects really are.

That study, called STAR, directly compared the two drugs in women at higher-than-usual risk of developing breast cancer. The new study involved a different group of women those at high risk of heart problems and tested whether raloxifene was better than dummy pills at reducing breast cancer and heart-related risks.

Participants either had clogged arteries or multiple heart risk factors, such as advanced age, diabetes, smoking, high blood pressure or high cholesterol. About 40 percent also had elevated risk of breast cancer, mostly because of their age, but this was not the main reason they were in this study their heart risk was.

Roughly half were given daily raloxifene pills and the others, dummy pills. Neither they nor their doctors knew who was taking what.

After an average of five years on the pills, deaths and major heart problems were about the same in both groups. Raloxifene users had one-third fewer cases of breast cancer and about half the number of invasive breast cancers benefits seen previously.

However, 59 of the 5,044 raloxifene users had fatal strokes; only 39 of the 5,057 on dummy pills did, translating to a 49 percent greater risk for those taking the drug.

Blood clots in veins, which can be life-threatening if they travel to the lungs, formed in 103 women on raloxifene but only 71 of the others.

The "moderate" breast cancer prevention benefits "do not seem to justify the risks" of raloxifene for women already prone to heart problems, Marcia Stefanick, a disease prevention researcher at Stanford School of Medicine, wrote in an editorial in the medical journal.

However, the murky results make it important for women to talk about risks with their doctors, said Dr. Lori Mosca, one of the authors and director of preventive cardiology at New York Presbyterian Hospital in New York.

"Even though the study overall appears to be a wash, it's important that every woman understand that the tipping point for her may be different. Every woman has a unique risk for breast cancer, for cardiovascular disease," she said.

None of this changes tamoxifen's status as the drug of choice for breast cancer prevention before menopause. Raloxifene's safety and effectiveness in that situation is unknown.

Drug increases risk of stroke death for some women

Fri, 26 May 2006 00:00:00 -0700

Post-menopausal women taking a popular osteoporosis drug are at increased danger of dying from a stroke if they have heart disease or are at high risk of a heart attack, Health Canada warns.

In a large-scale trial of 10,000 post-menopausal women with heart problems in 26 countries, the drug raloxifene, marketed as Evista, increased the risk of stroke death from 1.5 per thousand women to 2.2, it said yesterday.

The drug received widespread publicity last month after a second trial found that for post-menopausal women at high risk of getting breast cancer, it reduced the risk without the serious side effects of tamoxifen.

But the stroke risk prompted Health Canada and the drug maker, Eli Lilly, to post the new warning and advise patients taking Evista to consult their doctors.

In 1999, another drug trial found that it increased the risk of developing life-threatening blood clots in the legs or lungs by seven women in every 10,000 taking the drug.

More than 42 million prescriptions for Evista have been filled around the world to protect against bone fractures since it was first approved in 1997.

"It's confusing, but you have to be wary about using new drugs," said Joel Lexchin, a healthy policy professor at York University.

"New drugs often have unexpected side effects associated with them and we need to be cautious about recommendations for their use early on unless you're looking at a disease where the mortality rate is so high that something is better than nothing."

Drug companies rely on so-called blockbuster medications that can earn $1 billion or more worldwide and are always searching for new uses for the same drug, which is where the side effects show up, he said. "That's what you're seeing with Evista."

Alan Cassels of the University of Victoria's school of health information said warnings about side effects are never included in the product information patients receive with the drugs.

"It drives me nuts," he said. "That's information women need to know. Health Canada has been dragging its feet for years on making it mandatory. Women are not getting good information."

But David Juurlink, a drug safety specialist at Sunnybrook and Women's College Health Sciences Centre, said the new stroke risk is small and women shouldn't overreact.

The drug trial looked at multiple bad outcomes and the only one where there was an increase was in stroke-related deaths, he said.

But women who are at very high risk of stroke or who have had mini strokes should talk to their doctor.

Eli Lilly is continuing to evaluate the data with health regulatory bodies and worked rapidly to communicate the early results, a spokeswoman said.

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

Thu, 18 May 2006 00:00:00 -0700

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.

Important Considerations for Health Care Professionals:

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.

Evista Stroke Lawyer Side Effects Lawsuit

Thu, 18 May 2006 00:00:00 -0700

Evista Stroke Side Effects

On May 18, 2006, Health Canada and Eli Lilly Canada issued a new safety warning for the drug Evista concerning an increased risk of death due to stroke in postmenopausal women who are at increased risk of cardiovascular disease. This risk was discovered during the RUTH clinical trial which examined the use for Evista for cardiovascular disease. Evista was approved by the FDA on November 24, 1998 for the treatment and prevention of osteoporosis in postmenopausal women.

RUTH (Raloxifene Use for The Heart) Study Revealed Risk of Stroke
The RUTH (Raloxifene Use for The Heart) trial was an extensive placebo study that examined whether a 60 mg daily dose of Evista (Generic: raloxifene hydrochloride) would cut the danger of coronary events and the risk of invasive breast cancer in postmenopausal women who already had heart disease or were at an elevated risk for a coronary episode. The study was made up of more than 10,000 women (average age: 67 years) from 26 countries who were trailed for up to seven years. Every woman enrolled in RUTH had known heart disease or were at high risk for a coronary event. The trial found an increase in death as a result of stroke for Evista compared to the placebo. The rate 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.

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