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Raloxifene hikes bone density in women: Science News: "The drug raloxifene came on the market last year, prescribed mainly to counteract osteoporosis, or brittle-bone disease. Approved for use because tests had indicated that it inhibits bone loss, raloxifene nevertheless had not been shown to actually prevent fractures. Now, researchers report that raloxifene increases bone density of postmenopausal women and reduces their risk of backbone fractures by nearly half. Two-thirds of 7,705 women with osteoporosis, average age 67, received raloxifene over 3 years. The rest took an inert pill. Of women getting the drug, less than 6 percent suffered fractures of the vertebrae, compared with 10 percent in the other group. The raloxifene group showed fewer ankle breaks, but the number of other fractures in the body wasn't significantly different between the groups, the researchers report in the Aug. 18 JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION."
http://www.findarticles.com/cf_dls/m1200/10_156/55982954/p1/article.jhtml

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The Medical Literature on Raloxifene for Osteoporosis: American Family Physician: "Raloxifene is an antiestrogen labeled for the prevention of osteoporosis in postmenopausal women. Because data on raloxifene are rapidly accumulating, Khovidhunkit and Shoback reviewed the literature published in the past 18 years on raloxifene. Raloxifene has both estrogen-agonistic and estrogen-antagonistic properties: it acts as an estrogen antagonist on the uterus and breast, and as an estrogen agonist on bone and lipids. The term "selective estrogen receptor modulator" (SERM) has been coined to describe agents that interact with the estrogen receptor but have tissue-specific activities. SERMs compete with endogenous estrogens for binding to the receptor and may either activate or block estrogen activity. Studies suggest that raloxifene inhibits bone loss by reducing bone resorption through the same mechanism as estrogen. It does not have an anabolic action on the skeleton. One study of postmenopausal women showed that raloxifene in a dosage of 60 mg per day for two years increased bone mineral density by 1.2 percent at the femoral neck and by 1.6 percent at the spine and total hip. Total-body bone mass had increased by 1.4 percent. Raloxifene has been shown to have beneficial effects on lipid levels. A study of postmenopausal women demonstrated that 60 mg per day decreased the total cholesterol concentration by 6.4 percent and the LDL concentration by 10 to 12 percent. HDL cholesterol and triglycerides were unaffected. No reports indicate that raloxifene exerts some of the other favorable cardiovascular effects of estrogen. For example, the agent has not been reported to reduce arterial vasoconstriction produced by regulation of the generation of nitric oxide and other vasoactive peptides, to improve insulin and glucose metabolism, or to improve hepatic cholesterol metabolism. No data support the idea that raloxifene can reduce cardiovascular events in humans."
http://www.findarticles.com/cf_dls/m3225/11_59/55391727/p1/article.jhtml

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Raloxifene (Evista) overdose and contraindications: RxList: "Incidents of overdose in humans have not been reported. In an 8-week study of 63 postmenopausal women, a dose of raloxifene HCl 600 mg/day was safely tolerated. No mortality was seen after a single oral dose in rats or mice at 5000 mg/kg (810 times the human dose for rats and 405 times the human dose for mice based on surface area, mg/m2) or in monkeys at 1000 mg/kg (80 times the AUC in humans). There is no specific antidote for raloxifene. CONTRAINDICATIONS EVISTA is contraindicated in women who are or may become pregnant. EVISTA may cause fetal harm when administered to a pregnant woman. In rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred in rabbits at doses ³ 0.1 mg/kg (³ 0.04 times the human dose based on surface area, mg/m2), and hydrocephaly was observed in fetuses at doses ³10 mg/kg (³ 4 times the human dose based on surface area, mg/m2). In rat studies, retardation of fetal development and developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses ³ 1mg/kg (³0.2 times the human dose based on surface area, mg/m2). Treatment of rats at doses of 0.1 to 10 mg/kg (0.02 to 1.6 times the human dose based on surface area, mg/m2) during gestation and lactation produced effects that included delayed and disrupted parturition; decreased neonatal survival and altered physical development; sex-and age-specific reductions in growth and changes in pituitary hormone content; and decreased lymphoid compartment size in offspring. At 10 mg/kg, raloxifene disrupted parturition which resulted in maternal and progeny death and morbidity. Effects in adult offspring (4 months of age) included uterine hypoplasia and reduced fertility; however, no ovarian or vaginal pathology was observed. The patient should be apprised of the potential hazard to the fetus if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug. EVISTA is contraindicated in women with active or past history of venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis. EVISTA is contraindicated in women known to be hypersensitive to raloxifene or other constituents of the tablets."
http://www.rxlist.com/cgi/generic/raloxif_od.htm

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Raloxifene as a multifunctional medicine?: bmj.com: "Recent developments in the new endocrinology of selective oestrogen receptor modulators (SERMs) seem to have the potential to transform therapeutics. The emerging data on the multiple effects of raloxifene have generated great excitement that this might be the first multifunctional medicine. Raloxifene was developed for preventing osteoporosis and, like oestrogen, may reduce the risk of cardiovascular disease. In addition, raloxifene may reduce the incidence of breast cancer without increasing that of endometrial cancer. Selective oestrogen receptor modulators such as raloxifene introduce important new concepts for the physician, but how did we get to this point and what is the evidence to support the claims? The description of the target site specificity of tamoxifen and raloxifene opened the door for novel applications of the drugs originally known as non-steroidal antiestrogens. 1 2 Until then the drugs had been considered only as treatments for breast cancer,3 but then tamoxifen was advanced as a breast cancer preventive agent in high risk women.4 Tamoxifen would never have been acceptable as a preventive agent if it had had an antioestrogenic action on bone, resulting in an increased incidence of osteoporosis. The realisation that "antioestrogens" could not only block oestrogen action in the breast but also mimic oestrogen in bone 1 5 resulted in a paradigm shift for preventing breast cancer. Drugs could be developed for preventing osteoporosis, with the beneficial side effect of preventing breast cancer.3 The rationale for this strategy was based on the fact that half of the women who develop breast cancer have no identifiable risk factors,6 making a prevention strategy targeting high risk women7 an incomplete solution to the problem"
http://bmj.com/cgi/content/full/319/7206/331

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Special warnings while taking Raloxifene (Evista): Health Square: "Because of Evista's tendency to promote clots, you should not take it during long periods of immobilization such as recovery from surgery or prolonged bed rest, or for 72 hours beforehand. If you are scheduled for surgery, make sure the doctor is aware that you are taking Evista. For the same reason, if you are going on a trip where your movement will be restricted, make a point of periodically getting up and walking around. Evista is not needed prior to menopause and shouldn't be taken until menopause has passed. It has not been studied in premenopausal women and its use is not recommended. Use Evista with caution if you have congestive heart failure, a liver condition, or cancer. Be cautious, too, if you've had breast cancer in the past; the drug's effect in this situation is unknown. If you develop unusual uterine bleeding or breast problems while taking Evista, tell your doctor immediately. Evista will not cure hot flashes. (In fact, it may cause them.) Nevertheless, never combine Evista with estrogen hormones. If you've had a problem with high blood triglyceride levels when taking estrogen, Evista may cause the same problem. However, it tends to lower cholesterol levels by 6 to 11 percent"
http://www.healthsquare.com/newrx/evi1169.htm

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Before taking Raloxifene (Evista): Medline Plus: "In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For raloxifene, the following should be considered: Allergies--Tell your doctor if you have ever had any unusual or allergic reaction to raloxifene. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes. Pregnancy--Raloxifene is not recommended during pregnancy. Presently, raloxifene is to be used in postmenopausal women only. It has been shown to cause serious birth defects or other problems in animals. Be sure you have discussed this with your doctor. Breast-feeding--It is not known whether raloxifene passes into breast milk. However, raloxifene is not recommended during breast-feeding because it may cause unwanted effects in nursing babies. Presently, raloxifene is to be used in postmenopausal women only. Older adults--This medicine has been tested only in women past menopause and has not been shown to cause different side effects or problems in elderly people than it does in adults who have just gone through menopause. Other medicines--Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking raloxifene, it is especially important that your health care professional know if you are taking any of the following: Cholestyramine (e.g., Questran)--Cholestyramine can significantly reduce the absorption of raloxifene Estrogens, injection (e.g., Premarin) or Estrogens, oral (e.g., Premarin, Estrace, Estratab) or Estrogens, transdermal (e.g., Climara, Estrace, Vivelle)--Raloxifene should not be used with estrogens Warfarin (e.g., Coumadin)--Raloxifene may decrease the effect of warfarin, and the dose of warfarin may need to be adjusted when adding or stopping raloxifene"
U.S. National Library of Medicine
8600 Rockville Pike, Bethesda, MD 20894
custserv@nlm.nih.gov
http://www.nlm.nih.gov/medlineplus/druginfo/raloxifenesystemic203396.html

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Raloxifene clinical pharmacology: Nurses PDR: "Pregnancy Category: X Evista (Rx) Classification: Estrogen receptor modulator Action/Kinetics: Selective estrogen receptor modulator that reduces bone resorption and decreases overall bone turnover. Considered an estrogen antagonist that acts by combining with estrogen receptors. Has not been associated with endometrial proliferation, breast enlargement, breast pain, or increased risk of breast cancer. Also decreases total and LDL cholesterol levels. Absorbed rapidly after PO; significant first-pass effect. Excreted primarily in feces with small amounts excreted in urine. Uses: Prevention and treatment of osteoporosis in postmenopausal women. Not effective in reducing hot flashes or flushes associated with estrogen deficiency. Investigational: Reduce risk of breast cancer in postmenopausal women. Contraindications: In women who are or who might become pregnant, active or history of venous thromboembolic events (e.g., DVT, pulmonary embolism, retinal vein thrombosis). Use in premenopausal women, during lactation, or in pediatric clients. Concurrent use with systemic estrogen or hormone replacement therapy. Special Concerns: Use with caution with highly protein-bound drugs, including clofibrate, diazepam, diazoxide, ibuprofen, indomethacin, and naproxen. Effect on bone mass density beyond 2 years of treatment is not known. Side Effects: CV: Hot flashes, migraine. Body as a whole: Infection, flu syndrome, chest pain, fever, weight gain, peripheral edema. CNS: Depression, insomnia. GI: Nausea, dyspepsia, vomiting, flatulence, GI disorder, gastroenteritis. GU: Vaginitis, UTI, cystitis, leukorrhea, endometrial disorder. Respiratory: Sinusitis, pharyngitis, increased cough, pneumonia, laryngitis. Musculoskeletal: Arthralgia, myalgia, leg cramps, arthritis. Dermatologic: Rash, sweating."
http://www.nursespdr.com/members/database/ndrhtml/raloxifene.html

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Raloxifene (Evista) dosages: Medscape Druginfo: "For the prevention of osteoporosis in postmenopausal women, the usual dosage of raloxifene hydrochloride is 60 mg once daily. Higher dosages (e.g., 150 mg daily) have been used but have not been shown to provide additional clinically important benefit on bone health. The optimum duration of raloxifene therapy for the prevention of postmenopausal osteoporosis has not been established; experience with estrogen replacement suggests that therapy for the prevention of postmenopausal osteoporosis may require continuance into late life or indefinitely. Treatment in Postmenopausal Women. For the treatment of osteoporosis in postmenopausal women, the usual dosage of raloxifene hydrochloride is 60 mg once daily. Higher dosages (e.g., 120 mg daily) have been studied and have been associated with a lower incidence of vertebral fracture inwomen with one or more baseline fractures; higher dosage (i.e., 120 mg daily) have not been shown to provide additional benefit in women without baseline vertebral fractures. Dosage in Renal and Hepatic Impairment from AHFS DI™ The manufacturer makes no specific recommendations for raloxifene dosage adjustment in patients with renal impairment. Limited evidence from patients with cirrhosis (Child-Pugh class A) and total serum bilirubin concentrations of 0.6—2 mg/dL indicate that plasma concentrations of raloxifene are 2.5 times higher in such patients relative to plasma concentrations in patients with normal hepatic function. Raloxifene has not been evaluated in patients with hepatic impairment other than Child-Pugh class A or in long-term studies in patients with cirrhosis. The manufacturer currently makes no specific recommendation for adjustment of raloxifene dosage in patients with hepatic impairment. However, the drug is extensively metabolized in the liver and excreted principally in feces."
http://promini.medscape.com/drugdb/drug_uses_dosage.asp?DrugCode=1-16917&DrugName=EVISTA+ORAL&DrugType=1

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Drug information available form the makers of Raloxifene (Evista): Evista.com: "EVISTA has been shown to decrease the risk of fracture, and while preventing and treating osteoporosis in women who are past menopause, EVISTA also... Lowers cholesterol EVISTA lowers total cholesterol by about 7% and LDL (bad) cholesterol by about 11%. It does not change HDL (good) cholesterol. (The effect of EVISTA-induced reductions in total and LDL cholesterol on risk for cardiovascular disease is currently under study.) Does not increase the risk of breast or uterine cancer Women taking EVISTA had no increased risk of breast or uterine cancer in clinical studies Does not cause breast tenderness or vaginal bleeding Women taking EVISTA and women taking placebo (sugar pill) experienced no difference in breast tenderness or vaginal bleeding in clinical studies"
http://www.evista.com/about_evista/index.jsp

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