Evista side effects, dose, 60 mg, medication for postmenopausal women
July 2 2015 by
Ray Sahelian, M.D.


Evista (raloxifene) is a prescription medication that has been proposed to be a better choice than tamoxifen (Nolvadex, and others) for prevention of breast cancer in high-risk postmenopausal women. However, new research indicates that the cardiovascular side effects of Evista may outweigh its potential benefits in breast cancer prevention.


Evista for Breast Cancer prevention?

Women with heart disease or a high risk for it would trade one set of odds for another if they took the drug Evista to try to prevent breast cancer. Reloxifene helps prevent cancer, but raise the risk of blood clots and fatal strokes. Evista also doesn't lower the risk of death, hospitalization or heart attack. Doctors have been testing Evista as an alternative to tamoxifen for preventing breast cancer and as a way to lower heart disease risks.The results of the study, which involved 10,101 postmenopausal women in the United States and 25 other countries were published in the July, 2006 issue of the New England Journal of Medicine. Many of the authors consult or work for Indianapolis-based Eli Lilly & Co., which makes Evista and paid for the study. The drug is sold as Evista for treating the bone disease osteoporosis, but the company is seeking approval to market it for breast cancer prevention. A similar drug, tamoxifen, has long been used to prevent breast cancers whose growth is fueled by the hormone estrogen. A big federal study reported in June, 2006 that Evista was equally effective at preventing the most serious types of breast cancer and with fewer side effects, although some doctors disagree on how large the differences in side effects really are. That study, called STAR, directly compared the two drugs in women at higher-than-usual risk of developing breast cancer. The new study involved a different group of women -- those at high risk of heart problems -- and tested whether Evista was better than dummy pills at reducing breast cancer and heart-related risks. Participants either had clogged arteries or multiple heart risk factors, such as advanced age, diabetes, smoking, high blood pressure or high cholesterol. About 40 percent also had elevated risk of breast cancer, mostly because of their age, but this was not the main reason they were in this study -- their heart risk was. Roughly half were given daily Evista pills and the others, dummy pills. After an average of five years on the pills, deaths and major heart problems were about the same in both groups. Evista users had one-third fewer cases of breast cancer and about half the number of invasive breast cancers -- benefits seen previously. It appears that the moderate breast cancer prevention benefits do not seem to justify the risks of Evista for women already prone to heart problems.


Evista Research

Patient-reported symptoms and quality of life during treatment with tamoxifen or Evista for breast cancer prevention: the NSABP Study of Tamoxifen and Evista (STAR) P-2 trial.
JAMA. 2006. Land SR, Wickerham DL, Costantino JP, Ritter MW, Vogel VG, Lee M, Pajon ER, Wade JL, Lockhart JB Jr, Wolmark N, Ganz PA. National Surgical Adjuvant Breast and Bowel Project (NSABP) Operations and Biostatistical Centers, Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pa
Tamoxifen has been approved for breast cancer risk reduction in high-risk women, but how Evista compares with tamoxifen is unknown. To compare the differences in patient-reported outcomes, quality of life [QOL], and symptoms in Study of Tamoxifen and Evista (STAR) participants by treatment assignment. No significant differences existed between the tamoxifen and Evista groups in patient-reported outcomes for physical health, mental health, and depression, although the tamoxifen group reported better sexual function. Although mean symptom severity was low among these postmenopausal women, those in the tamoxifen group reported more gynecological problems, vasomotor symptoms, leg cramps, and bladder control problems, whereas women in the Evista group reported more musculoskeletal problems, dyspareunia, and weight gain.


Menopause. 2014 Feb 24. Diary of hot flashes reported upon occurrence: results of a randomized double-blind study of raloxifene, placebo, and paroxetine. This trial examined diaries of hot flash events reported upon occurrence to assess the test/retest reliability of the diaries and their ability to measure treatment effects on hot flash frequency and severity. Forty-two postmenopausal women (aged ≥40 y; 5-50 hot flashes/wk) were randomized (3:3:1) to placebo, raloxifene 60 mg, or paroxetine 20 mg daily for 12 weeks. Diaries of hot flash frequency and severity were evaluated at 1-week intervals (twice before study treatment and thrice during study treatment). Measures of hot flash frequency and severity show acceptable test/retest reliability between screening and baseline. Reductions in vasomotor symptoms by raloxifene are numerically less than those seen with placebo, but no statistically significant treatment differences have been documented in this small study. The large effect of placebo and the significant reduction in vasomotor symptoms by paroxetine are consistent with other studies.


Interaction with herbs, vitamins, supplements
Drug Metab Dispos. 2015. Milk Thistle Constituents Inhibit Raloxifene Intestinal Glucuronidation: a Potential Clinically Relevant Natural Product-Drug Interaction.