Osteoporosis drug Bazedoxifene - Conbriza
Osteoporosis drug Bazedoxifene - Conbrizahas been approved for use in the European Union. It is in FDA Phase 3 clinical trials in the United States.
In April 2009 Wyeth Pharmaceuticals announced that the European Commission has granted marketing authorization for Conbriza (bazedoxifene), a selective estrogen receptor modulator (SERM), for the treatment of postmenopausal osteoporosis in women at increased risk of fracture.
In the United States the drug is undergoing FDA Phase III Trial "A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women"
Research reports on the Osteoporosis drug Bazedoxifene An article by Kung, Chu and Xu published by Expert Opinion on Pharmacotherapy June 2009 the authors noted that this SERM has"demonstrated estrogen agonist effects on the skeleton and lipid metabolism but not on breast and uterine endometrium. . . . Phase III clinical studies have shown favorable effects on the skeleton without stimulation of endometrium and breast. Bazedoxifene prevents bone loss in postmenopausal women without osteoporosis and reduces vertebral fractures in women with postmenopausal osteoporosis.
In women at high risk of fracture with multiple risk factors, bazedoxifene reduces nonvertebral
fracture risk in post-hoc analysis. Bazedoxifene in combination with conjugated estrogens represents a new form of therapeutic agents for the treatment of postmenopausal symptoms and prevention of postmenopausal osteoporosis. Clinical trials with bazedoxifene/conjugated estrogens have shown beneficial effects on bone mineral density and bone turnover markers with improvement in vasomotor symptoms and little or no stimulation of breast and endometrium."
At the 20th 20th Annual North American Menopause Society Meeting in October 2009 offered reference to the Osteoporosis drug Bazedoxifene. It was noted that "Bazedoxifene 20 mg or bazedoxifene 40/20 mg daily was a safe, effective treatment for osteoporosis in postmenopausal women, according to phase 3 study results presented here.
Santiago Palacios, MD, director of the Palacios Institute in Madrid, Spain, and colleagues randomly assigned 7,492 postmenopausal women with osteoporosis to receive bazedoxifene (Conbriza, Wyeth) 20 mg or 40 mg daily, raloxifene (Evista, Lilly) 60 mg daily or placebo for three years.
Researchers enrolled 4,216 participants in an extension study (years four and five). The raloxifene group was discontinued in year four and women who received bazedoxifene 40 mg were transitioned to bazedoxifene 20 mg at the end of year four. Transvaginal ultrasound data were available for 176 women at baseline and at five years (bazedoxifene 20 mg, n=60; bazedoxifene 40/20 mg, n=58; placebo, n=58).
Overall safety and tolerability findings of the Osteoporosis drug Bazedoxifene at five years are encouraging and consistent with those seen in the three-year core study, according to the researchers.
Compared with placebo (n=6), fewer cases of endometrial carcinoma were reported in women assigned to bazedoxifene 20 mg (n=0) or bazedoxifene 40/20 mg (n=3; P=.05).
Mean change in endometrial thickness from baseline to five years was not significantly different between placebo, bazedoxifene 20 mg or bazedoxifene 40/20 mg. In addition, the number of cases of endometrial hyperplasia or endometrial thickness =5 mm was small and similar among all three groups.
The incidence for uterine bleeding, ovarian cysts and benign breast disease was similar among all groups; the number of women with breast cancer was similar with bazedoxifene 20 mg (n=10), bazedoxifene 40/20 mg (n=9) and placebo (n=10).
LDL effects of this drug
"In the osteoporosis study mentioned above, serum concentrations of low-density lipoprotein cholesterol decreased significantly compared with placebo at all doses of bazedoxifene, an effect similar to that of raloxifene.4 Serum concentrations of high-density lipoprotein (HDL) cholesterol were higher with bazedoxifene doses of 10 mg and 20 mg relative to placebo, but not with 40 mg where the trend was for a drop in HDL similar to placebo and raloxifene. Serum triglycerides also increased with bazedoxifene doses of 20 mg and 40 mg, with no reported cases of pancreatitis."
So, it could be that this drug could have dual uses: both for bone density and as a cholesterol loweringagent.
Side effects 0f the Osteoporosis drug Bazedoxifene
Side effects Researchers at the Department of Internal Medicine, Endocrine-Metabolic Sciences and Biochemistry, University of Siena, Italy published a study that included reference to side effects of the Osteoporosis drug Bazedoxifene.
Their abstract said that in their study, which compared bazedoxifene, raloxifene and a placebo, the most common reasons for discontinuation were similar in all three groups.
- The percentage of women who reported either worsening of preexisting hot flushes or whodeveloped any new hot flush during the course of the study was significantly higher with all doses of bazedoxifenecompared with placebo, and similar to that observed in the raloxifene group.
- Hot flushes were reported by 14.2% of womenrandomized to placebo,
- 19.6% to 24.1% of women randomized to bazedoxifene 10 mg to 40 mg,
- 18.6% randomized to raloxifene 60 mg.
- The incidence of leg cramps was also similar across all treatment groups and similar to placebo (9.3% to 12.1% for bazedoxifene, 11.9% for raloxifene, and 11.6% for placebo).
Four deaths were reported during the study and 2 deaths were reported after withdrawal or completion of the study, But 5 of these deaths were not considered to be related to treatment. One death in the bazedoxifene 40 mg group was attributed to a pulmonary embolism during a prolonged air flight 30 days after study completion, and was considered by the investigator to be possibly related to treatment.
Although no events of deep venous thrombosis occurred in the raloxifene group in this study, other larger studies of raloxifene have demonstrated a small increase in the incidence of deep venous thrombosis with raloxifene, similar to that seen with estrogen. Larger long-term studies should help clarify the magnitude of risk with bazedoxifene alone or combined with estrogen.
Press release Osteoporosis drug Bazedxifene (Conbbriza) approval for the European Union
NOTE: As additional information about the Osteoporosis drug Bazedoxifene becomes available, I shall make note of it in our monthly newsletter.
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