Evista - raloxifene hydrochloride

What is Evista?

Evista is a medicine that contains the active substance raloxifene hydrochloride. It is available as white oval tablets (60 mg).

What is Evista used for?

Evista is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women after menopause. Evista has been shown to significantly reduce vertebral (spine) fractures but not hip (hip) fractures. ).
The medicine can only be obtained with a prescription.

How is Evista used?

The recommended dose for adult women and elderly women is one tablet per day with or without meals. Calcium and vitamin D supplements are generally recommended for women with reduced dietary calcium intake. Evista is intended for long-term use.

How does Evista work?

Osteoporosis occurs when enough new bone is not produced to replace what is naturally consumed. Bones become progressively thinner and brittle and more prone to breakage (fractures). Osteoporosis is more common in postmenopausal women. when levels of the female hormone estrogen decrease: estrogen slows down the breakdown of bones and makes them less prone to fracture.
The active substance in Evista, raloxifene, is a selective estrogen receptor modulator (SERM) and acts as an agonist of the estrogen receptor (a substance that stimulates the estrogen receptor) in some tissues of the body. Raloxifene has the same effect as estrogen on bone, but has no effect on the breast or uterus.

How has Evista been studied?

Evista has been studied in four main studies in the treatment and prevention of osteoporosis.
Three osteoporosis prevention studies included 1,764 women who took Evista or a placebo (a dummy treatment) for two years. In these studies, bone density was measured. In the fourth study, the effects of Evista were compared to those of Evista. of a placebo in the treatment of osteoporosis in 7,705 women for four years. The main measure of effectiveness was the number of women who experienced vertebral (spine) fractures during the study.

What benefit has Evista shown during the studies?

Evista was more effective than placebo in preventing and treating osteoporosis.
In the prevention of osteoporosis, women who received Evista reported a 1.6% increase in hip and spine bone density over two years, while those who received placebo reported a decrease of 0. 8%.
In the treatment of osteoporosis, Evista was more effective than placebo in reducing the number of vertebral fractures. Over four years, compared to placebo, Evista reduced the number of vertebral fractures by 46% in women with osteoporosis and 32% in women with osteoporosis associated with the presence of a fracture. Evista showed no effect on hip fractures.

What is the risk associated with Evista?

The most common side effects with Evista (seen in more than 1 in 10 patients) are vasodilation (hot flashes) and flu-like symptoms. For the full list of side effects reported with Evista, see the Package Leaflet.
Evista must not be used in women who:

  1. I am able to have children;
  2. have, or have had, problems with blood clots, including deep vein thrombosis and pulmonary embolism (blood clots in the lungs);
  3. have liver disease, severe kidney problems, unexplained uterine bleeding or cancer of the endometrium (cancer of the lining of the uterus).

Evista must not be used in people who are hypersensitive (allergic) to raloxifene or any of the other ingredients.

Why has Evista been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Evista was shown to be effective in the prevention and treatment of osteoporosis, with no effect on the breast and uterus. The Committee decided that Evista's benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women. The Committee recommended that Evista be given marketing authorization.

Other information about Evista:

On 5 August 1998 the European Commission issued a "Marketing Authorization" for Evista, valid throughout the European Union. The "Marketing Authorization" was renewed on 5 August 2003 and 5 August 2008. The the holder of the marketing authorization is Daiichi Sankyo Europe GmbH.
For the full version of Evista's EPAR, click here.

Last update of this summary: 01-2009.


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