Vivelle-Dot® Makes a Significant Difference in Bone Mineral Density
Vivelle-Dot and Vivelle® are indicated for the treatment of the following conditions associated with menopause: moderate to severe vasomotor symptoms; moderate to severe symptoms of vulvar and vaginal atrophy; and the prevention of postmenopausal osteoporosis. When prescribed solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. Vivelle-Dot 0.025 mg/day is indicated for the prevention of postmenopausal osteoporosis only. When being prescribed solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis after non-estrogen medications have been carefully considered.
Results from a 2-year, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Vivelle in the prevention of PMO. 261 surgically or naturally postmenopausal women were randomized to apply the estradiol matrix transdermal system (0.025, 0.0375, 0.05, or 0.1 mg/day) or matching placebo twice a week for 2 years. Patients were given supplemental dietary calcium (1000 mg elemental calcium/day) but no supplemental vitamin D. Least squares means of percentage change from baseline. All randomized patients with at least 1 postbaseline assessment available, with last postbaseline observation carried forward.
- Doses as low as 0.025 mg/day proved beneficial to patients in preventing postmenopausal osteoporosis.
- The 0.025 mg/day dose was statistically significantly superior to placebo (P<0.05) in BMD at the anteroposterior lumbar spine.
- The 0.025 mg/day dose was statistically significantly superior to placebo (P<0.05) in BMD at the femoral neck at Week 104.
All Doses Studied Shown to be Effective in the Prevention of Postmenopausal Bone Loss1
Vivelle-Dot, the revised formulation with smaller system sizes, was shown to be bioequivalent to the original formulation, Vivelle, used in the clinical trials.
- All doses studied showed a statistically significant increase in BMD at the L1-L4 anteroposterior lumbar spine from baseline (P<0.05) at all time points, with the exception of the 0.05 mg/day dose at 6 months.
- All doses studied were statistically significantly superior to placebo (P<0.05) in BMD at the femoral neck at Week 104.
- The 0.1 mg/day dose was shown to be statistically significantly superior to placebo (P=0.023) in BMD at the lateral lumbar spine at Week 104.
Estrogens should not be used in women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer except in appropriately selected patients being treated for metastatic disease; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or history of these conditions; active or recent arterial thromboembolic disease; liver dysfunction or disease; or known or suspected pregnancy.
1When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis after non-estrogen medications have been carefully considered.
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