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Premarin (0.3 mg, 0.45 mg, and 0.625 mg tablets) was shown to be statistically better than placebo at weeks 4 and 12 for relief of both the frequency and severity of moderate to severe vasomotor symptoms. Table 2 shows the adjusted mean number of hot flushes in the Premarin 0.3 mg, 0.45 mg, and 0.625 mg and placebo treatment groups over the initial 12-week period. TABLE 2. SUMMARY TABULATION OF THE NUMBER OF HOT FLUSHES PER DAY– MEAN VALUES AND COMPARISONS BETWEEN THE ACTIVE TREATMENT GROUPS AND THE PLACEBO GROUP: PATIENTS WITH AT LEAST 7 MODERATE TO SEVERE FLUSHES PER DAY OR AT LEAST 50 PER WEEK AT
BASELINE, LOCF
Treatment
(No. of Patients) ---------------No. of Hot Flushes/ Day ------------------ Text Continues Below
Time Period
(week)
Baseline
Mean ± SD
Observed
Mean ± SD
Mean
Change ± SD
p-Values
vs. Placebo a
0.625 mg CE
(n = 27)
4 12.29 ± 3.89 1.95 ± 2.77 -10.34 ± 4.73 < 0.001
12 12.29 ± 3.89 0.75 ± 1.82 -11.54 ± 4.62 < 0.001
0.45 mg CE
(n = 32)
4 12.25 ± 5.04 5.04 ± 5.31 -7.21 ± 4.75 < 0.001
12 12.25 ± 5.04 2.32 ± 3.32 -9.93 ± 4.64 < 0.001
0.3 mg CE
(n = 30)
4 13.77 ± 4.78 4.65 ± 3.71 -9.12 ± 4.71 < 0.001
12 13.77 ± 4.78 2.52 ± 3.23 -11.25 ± 4.60 < 0.001
Placebo
(n = 28)
4 11.69 ± 3.87 7.89 ± 5.28 -3.80 ± 4.71 -12
11.69 ± 3.87 5.71 ± 5.22 -5.98 ± 4.60 -a:
Based on analysis of covariance with treatment as factor and baseline as covariate. Effects on Vulvar and Vaginal Atrophy Results of vaginal maturation indexes at cycles 6 and 13 showed that the differences from placebo were statistically significant (p 0.001) for all treatment groups (conjugated estrogens alone and conjugated estrogens/ medroxyprogesterone acetate treatment groups). Effects on Bone Mineral Density Health and Osteoporosis, Progestin and Estrogen (HOPE) Study The HOPE study was a double-blind, randomized, placebo/ active-drug-controlled, multicenter study of healthy postmenopausal women with an intact uterus. Subjects (mean age 53.3 ± 4.9 years) were 2. 3 ± 0.9 years, on average, since menopause, and took one 600-mg tablet of elemental calcium (Caltrate) daily. Subjects were not given vitamin D supplements. They were treated with Premarin 0.625 mg, 0.45 mg, 0.3 mg, or placebo. Prevention of bone loss was assessed by measurement of bone mineral density (BMD), primarily at the anteroposterior lumbar spine (L2 to L4). Secondarily, BMD measurements of the total body, femoral neck, and trochanter were also analyzed. Serum osteocalcin, urinary calcium, and N-telopeptide were used as bone turnover markers (BTM) at cycles 6, 13, 19, and 26. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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