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Clinical Studies Effects on Vasomotor Symptoms In the first year of the Health and Osteoporosis, Progestin and Estrogen (HOPE) Study, a total of 2805 postmenopausal women (average age 53.3 ± 4.9 years) were randomly assigned to one of eight treatment groups, receiving either placebo or conjugated estrogens with or without medroxyprogesterone acetate. Efficacy for vasomotor symptoms was assessed during the first 12 weeks of treatment in a subset of symptomatic women (n = 241) who had at least 7 moderate to severe hot flushes daily or at least 50 moderate to severe hot flushes during the week before randomization. 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. Text Continues Below
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 ------------------ 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. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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