MAY 15, 2005
VOLUME 2 NO. 9
 

MORE help on the way for menopausal women

Raloxifene strengthens minds as well as bones


If Alice had stayed in Wonderland long enough to collect her pension cheque from the Queen of Hearts, she may have sadly ended up like the Mad Hatter. One-third of women over the age of 65 develop dementia, with Alzheimer's disease being the most common form.

But there's new hope for these women — a study reports that taking raloxifene may have improved Alice's odds of dodging dementia. The selective estrogen receptor modulator (SERM) used for the prevention and treatment of osteoporosis might help keep both brains and bones healthy.

"Women receiving 120mg/day of raloxifene had a 33% lower risk of mild cognitive impairment," according to the authors of a multicentre trial funded by Eli-Lilly and published in the April issue of the American Journal of Psychiatry.

The randomized, placebo-controlled Multiple Outcomes of Raloxifene Evaluation (MORE) trial was designed primarily to study vertebral fractures and bone mineral density. As a secondary endpoint, the researchers evaluated the incidence of mild cognitive impairment and dementia as declining serum estrogen levels following menopause may contribute to Alzheimer's disease in older women.

Meta-analyses of observational studies have shown a 30% risk reduction for developing dementia in women receiving postmenopausal estrogen therapy, but until now the findings in large randomized trials have been less impressive.

Along with her colleagues, Dr Kristine Yaffe at the University of California, San Francisco, selected 7,705 postmenopausal women with osteoporosis for the main study. Of those, 7,023 were screened for dementia at the outset of the trial.

Participants were divided equally among the three treatment groups: 120mg or 60mg raloxifene daily or placebo. All of the women were also asked to take 500mg calcium and 400 - 600IU vitamin D daily. During the three-year study period, clinical and cognitive assessments were repeated annually. Women who developed cognitive impairment were kept in the study and monitored for continuing decline.

MAKE NO BONES ABOUT IT
At the end of the study, the 5,386 women who remained were again tested for dementia. Researchers found "while treatment with 120mg/day of raloxifene reduced the risk of mild cognitive impairment, there was no significant benefit from treatment with the lower dose of 60mg/day." However, both 60mg and 120mg raloxifene daily were effective for osteoporosis.

The researchers suggest that higher doses of raloxifene are needed to achieve therapeutic concentrations of the drug in the brain. Although there's no doubt that this SERM shows promise, the authors caution that they can't determine whether 120mg/day of raloxifene prevented mild cognitive impairment or delayed its onset.

Given that mild impairment frequently progresses, even a delay in onset would provide precious time to those with the condition and to their caregivers. And with the prevalence of Alzheimer's disease expected to quadruple over the next 45 years, this drug could give thousands of Canadian women a chance to improve their odds of staying physically and mentally fit.

Am J Psychiatry Apr, 2005;162(4):683-90

 

 

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