The tibolone - breast cancer link
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Menopause is an annoying and potential life altering occurrence for women. With the extended length of the signs and symptoms, to the range of intensity between the well established 34 symptoms of menopause, women are always trying to find their “magic bullet” to keep the symptoms manageable. However one drug that was hailed as a treatment for menopause symptoms and for the use to prevent osteoporosis in women is now stopped because of its increased risk for breast cancer. The study that showed this risk was hated six months early due to the seriousness of the issue. All the study findings were published in
The Lancet.
Tibolone, also known by the brand name of Livial, isn’t in the United States. The synthetic steroid was approved in ninety other countries for the use in the treatment of menopause symptoms and was approved in fifty-five countries for the use in the prevention of osteoporosis. The drug was made to act like progesterone and estrogen and had previously been thought not to have the breast cancer risk associated with estrogen and progesterone hormone replacement therapies that are on the market today.
The study was made up of 3,100 women all with past breast cancer surgeries. They were given a placebo drug or was given 2.5mg of tibolone. Approximately 1,556 of the women were given the real drug and 15.2% of those had a breast cancer recurrence. The placebo group (who numbered 1,542) only had 10.7% of breast cancer recurrence. That equaled to a 40% increased risk, too high for Professor Peter Kenemans of the VU University Medical Center in the Netherlands who said the drug should not be prescribed to any woman. Adding to the risk, 70% of the recurrences of breast cancer were distant metastases. Distant metastases is normally fatal.
The authors of the study were quoted as saying "There are insufficient data to establish the safety of tibolone in women who have had breast cancer and do not require or have finished adjuvant therapy."
This is not the first study to find that Tibolone, or Livial, had issues. There was a study done in the United States the summer of 2008 that showed that those women 60 or older that took the drug were over twice as likely to have a stroke on the drug than with a placebo. This finding made the stroke study halt early as well and was published in the New England Journal of Medicine.