What is Optruma?
Optruma is a medicine that contains the active substance raloxifene hydrochloride. It is available as white oval tablets (60 mg).
What is Optruma used for?
Optruma is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women after menopause. Optruma has been shown to significantly reduce vertebral (spine) fractures, but not femoral (hip) fractures.
The medicine can only be obtained with a prescription.
How is Optruma used?
The recommended dose for adult women and the elderly is one tablet a day with meals or between meals. Generally calcium and vitamin D supplements are recommended in women with reduced dietary calcium intake. Optruma is intended for long-term use.
How does Optruma work?
Osteoporosis arises when new bone is not produced in sufficient quantity to replace what is naturally consumed. The bones become progressively thin and fragile and more prone to breakage (fractures). Osteoporosis is more common in postmenopausal women when levels of the female estrogen hormone decrease: estrogen slows bone degradation and makes it less prone to fracture.
The active ingredient in Optruma, raloxifene, is a selective estrogen receptor modulator (SERM) and acts as an estrogen receptor agonist (a substance that stimulates the estrogen receptor) in certain tissues of the body. Raloxifene has the same effect as estrogen on the bone, but has no effect on the breast or uterus.
How has Optruma been studied?
Optruma has been studied in four main studies in the treatment and prevention of osteoporosis.
Three osteoporosis prevention studies included 1, 764 women who took Optruma or a placebo (a dummy treatment) for two years. In these studies bone density was measured. In the fourth study, the effects of Optruma were compared with those 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 suffered vertebral (spine) fractures during the study.
What benefit has Optruma shown during the studies?
Optruma was more effective than placebo in preventing and treating osteoporosis.
In the prevention of osteoporosis, women who received Optruma reported a 1.6% increase in bone density of the hip and spine in two years, while those who received placebo reported a decrease of 0, 8%.
In the treatment of osteoporosis, Optruma was more effective than placebo in reducing the number of vertebral fractures. Over a four-year period, compared to placebo, Optruma reduced the number of vertebral fractures by 46% in women with osteoporosis and by 32% in women with osteoporosis associated with fracture. Optruma showed no effect on femoral fractures.
What is the risk associated with Optruma?
The most common side effects with Optruma (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms. For the full list of all side effects reported with Optruma, see the Package Leaflet.
Optruma should not be used in women who:
- I am able to have children;
- have, or have had, problems due to blood clots, including deep vein thrombosis and pulmonary embolism (blood clots in the lungs);
- have liver disease, severe kidney problems, unexplained uterine bleeding or endometrial carcinoma (cancer of the wall that lines the uterus).
Optruma should not be used in people who are hypersensitive (allergic) to raloxifene or any of the other ingredients.
Why has Optruma been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Optruma has been shown to be effective in the prevention and treatment of osteoporosis, with no effect on the breast or uterus. The Committee decided that Optruma's benefits are greater than its risks for the treatment and prevention of osteoporosis in post-menopausal women. The Committee recommended that Optruma be given marketing authorization.
More information on Optruma:
On 5 August 1998, the European Commission granted a marketing authorization valid throughout the European Union to Eli Lilly Nederland BV for a marketing authorization for Optruma. The marketing authorization was renewed on 5 August 2003 and 5 August 2008.
The full EPAR for Optruma can be found here.
Last update of this summary: 07-2008.
