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      Exemestane Reduces HDL Levels in Patients With Low Risk Early Breast Cancer: Presented at ASCO

      By Ed Susman

      NEW ORLEANS, LA -- June 8, 2004 -- Researchers examining the effect that treatment with the aromatase inactivator exemestane has on circulating lipids have found that the drug reduces levels of high density lipoproteins (HDL) cholesterol in patients with low-risk, early breast cancer.

      "Exemestane causes a modest but significant 9% drop in HDL-cholesterol after 2 years of therapy," reported Lars Krag, MD, Sentralsjukehuset i Rogaland, Stavanger, Norway.

      However, in his poster presentation here June 5th at the American Society of Clinical Oncology 40th Annual Meeting, Dr. Krag said that the drop in HDL-cholesterol might not be meaningful clinically in light of other blood lipid changes seen in patients treated with this agent, although those differences did not reach statistical significance.

      Dr. Krag and colleagues compared the changes to lipid profiles in 73 patients treated with exemestane and 74 patients given placebo, who were recruited into a trial that was primarily designed to look at bone metabolism. In addition to bone measurements, the researchers also measured blood levels of lipids, homocysteine, and coagulation patterns.

      Patients all had histologically proven breast cancer or ductal carcinoma in situ at stage T1 and were node negative. They were postmenopausal and had good performance status.

      At 24 months, there was 6% drop in total cholesterol among the exemestane patients compared with a 5% drop in cholesterol level among placebo patients. There was a 9% drop in HDL-cholesterol in exemestane group compared with a 2% increase in HDL-cholesterol level in the placebo group. There was a 6% drop in low-density lipoprotein cholesterol in both groups. The exemestane group had a 3% decrease in triglycerides compared with a 1% drop among placebo patients. Homocysteine levels increased by 18% among exemestane patients compared with 12% in placebo patients. Coagulation factors did not change in either group.

      "Exemestane's effect on HDL-cholesterol suggests that further long-term follow-up is necessary for cardiovascular morbidity and mortality in all studies assessing aromatase inhibitors and inactivators in early breast cancer patients," Dr. Krag said.


      [Presentation title: Lipid and Coagulation Profile in Postmenopausal Women With Early Breast Cancer at Low Risk Treated With Exemestane: A Randomized, Placebo-Controlled Study. Abstract 650]



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