Originally published as JCO Early Release 10.1200/JCO.2008.21.0716 on September 21 2009

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Effects of Tamoxifen and Raloxifene on Memory and Other Cognitive Abilities: Cognition in the Study of Tamoxifen and Raloxifene

From the Division of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC; Departments of Psychiatry and Psychology, University of Illinois at Chicago, Chicago IL; Laboratory of Personality and Cognition, Gerontology Research Center, National Institute on Aging, National Institutes of Health, Baltimore, MD; and Department of Clinical Cancer Prevention, The University of Texas M. D. Anderson Cancer Center, University of Texas, Houston, TX.

Corresponding author: Claudine Legault, PhD, Department of Biostatistical Sciences, Wake Forest University School of Medicine, Medical Center Blvd, Winston-Salem, NC 27157; e-mail: clegault{at}wfubmc.edu.

Purpose To compare the effects of two selective estrogen receptor modulators, tamoxifen and raloxifene, on global and domain-specific cognitive function.

Patients and Methods The National Surgical Adjuvant Breast and Bowel Project's Study of Tamoxifen and Raloxifene (STAR) study was a randomized clinical trial of tamoxifen 20 mg/d or raloxifene 60 mg/d in healthy postmenopausal women at increased risk of breast cancer. The 1,498 women who were randomly assigned in STAR were age 65 years and older, were not diagnosed with dementia, and were enrolled onto the Cognition in the Study of Tamoxifen and Raloxifene (Co-STAR) trial, beginning 18 months after STAR enrollment started. A cognitive test battery modeled after the one used in the Women's Health Initiative Study of Cognitive Aging (WHISCA) was administered. Technicians were centrally trained to administer the battery and recertified every 6 months. Analyses were conducted on all participants and on 273 women who completed the first cognitive battery before they started taking their medications.

Results Overall, there were no significant differences in adjusted mean cognitive scores between the two treatment groups across visits. There were significant time effects across the three visits for some of the cognitive measures. Similar results were obtained for the subset of women with true baseline measures.

Conclusion Tamoxifen and raloxifene are associated with similar patterns of cognitive function in postmenopausal women at increased risk of breast cancer. Future comparisons between these findings and patterns of cognitive function in hormone therapy and placebo groups in WHISCA should provide additional insights into the effects of tamoxifen and raloxifene on cognitive function in older women.

See accompanying editorial on page 5119

Written on behalf of the Co-STAR Study.

Supported by the National Institute on Aging Grant No. NO1-AG-2106 and in part by the Intramural Research Program, National Institute on Aging, National Institutes of Health (Co-STAR); supported by Public Health Service Grants No. U10-CA-37377, U10-CA-69974, U10CA-12027, and U10CA-69651 from the National Cancer Institute, the Department of Health and Human Services, AstraZeneca, and Eli Lilly (STAR).

Presented in part at the Alzheimer's Association International Conference on Alzheimer's Disease, July 26-31, 2008, Chicago, IL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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