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Osteoporosis Prevention |
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Vivelle-Dot® Makes a Significant Difference in Bone Mineral Density
Vivelle-Dot and Vivelle® (estradiol transdermal system) are
indicated for the treatment of the following conditions associated with
menopause: moderate to severe menopause 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.
McKeever C, et al. An Estradiol Matrix Transdermal System for the Prevention of
Postmenopausal Bone Loss. Clinical Therapeutics. 2000;22:845-857.
Least square means of the percentage change from baseline in BMD of the
anteroposterior lumbar spine (L1-L4) at weeks 26, 52, 78 and 104 (intent to
treat population).
Results of the multicenter, randomized, placebo-controlled, parallel-group
study (0.025 mg/day subgroup + placebo, n=114). 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. Study was double blind with respect to treatment (active vs placebo)
but not to dose levels of active treatment (because of the differing sizes and
shapes of the patches). In addition to receiving the assigned treatment, the
100 nonhysterectomized women received 2.5 medroxyprogesterone acetate daily
throughout the study to reduce the likelihood of inducing endometrial
hyperplastic changes with estrogen treatment.
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Doses as low as 0.025 mg/day proved beneficial to patients in preventing
postmenopausal osteoporosis.1
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The 0.025 mg/day dose was statistically significantly superior to
placebo(P<0.05) in BMD at the anteroposterior lumbar spine.
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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 Loss.1
McKeever C, et al. An Estradiol Matrix Transdermal System for the Prevention of
Postmenopausal Bone Loss. Clinical Therapeutics. 2000;22:845-857.
Least square means of the percentage change from baseline in bone mineral
density (BMD) of the anteroposterior lumbar spine (L1-L4) at week 104 (intent
to treat population).
Vivelle-Dot, the revised formulation with smaller system sizes, was shown to be
bioequivalent to the original formulation, Vivelle, used in the clinical
trials.
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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.
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All doses studied were statistically significantly superior to
placebo(P<0.05) in BMD at the femoral neck at week 104.
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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.
See full prescribing information PDF.
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