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Head-to-head comparison of osteoporosis drugs: alendronate vs. raloxifene.

NEW ORLEANS -- Once-weekly Fosamax produced a twofold greater increase in bone mineral density than daily Evista after 1 year of treatment in a head-to-head trial sponsored by Merck, which markets alendronate as Fosamax.

The study did not address fracture rates, a fact that Eli Lilly, maker of Evista (raloxifene), criticized in a written statement issued in response to the study, which was presented at the annual meeting of the American College of Obstetricians and Gynecologists.

"Bone mineral density change with drug therapy is a poor predictor of fracture reduction. What are needed are true fracture outcome trials," the company said in the statement.

The Efficacy of Fosamax vs. Evista Comparison Trial (EFFECT), was a double-blind, randomized, 1-year trial involving 456 postmenopausal women. All patients had osteoporosis as defined by a bone mineral density (BMD) score of at least 2 standard deviations below normal, said Dr. Risa Kagan, principal, author of the study and co-medical director of the Foundation for Osteoporosis Research and Education in Oakland, Calif.

Patients were randomized to receive either once-weekly Fosamax (70 mg) and daily placebo, or daily Evista (60 mg) and once-weekly placebo.

Results showed that for the primary end point--percent change in BMD at the lumbar spine--patients on Fosamax had a greater increase (4.4% vs. 1.9%).

The Fosamax group also had greater increases in total hip BMD (2% vs. 1%) and BMD at the hip trochanter (3.2% vs. 1.8%).

The percentage of patients either maintaining or increasing BMD at the lumbar spine was 94% in the Fosamax group and 75% in the Evista group.

Although she did not provide details, Dr. Kagan said the adverse events reported were similar for both groups.

The study did not measure fracture rates and would have had to be much longer to do so, she said, adding that BMD or T-score is a good predictor of fracture risk.

"There's definitely something called bone quality that's very important to help us predict future risk of fracture, but we don't have any good assessment right now of bone quality. For now, I have to say that T-scores are the best surrogate marker for looking at future risk of fracture. That's better than looking at cholesterol levels as predictors of heart attacks," she told this newspaper.

According to the Lilly statement, the only head-to-head fracture-prevention trial is the Lilly-sponsored Evista Alendronate Comparison (EVA), which is designed to compare Evista and Fosamax in terms of fracture reduction (primary end point) and potential effects in the breast and heart (secondary end points).

EVA is an ongoing 5-year, head-to-head, multicenter, randomized, double-blind study that will include 3,000 post menopausal women at approximately 150 sites in the United States, Canada, and Puerto Rico.

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Title Annotation:Women's Health
Author:Johnson, Kate
Publication:Family Practice News
Article Type:Product/Service Evaluation
Geographic Code:1USA
Date:Aug 1, 2003
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