Premarin Clinical Pharmacology

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Premarin - Clinical Pharmacology [Conjugated Estrogens]

The analysis for the other 3 BMD endpoints yielded mean percent changes from baseline in femoral trochanter that were generally larger than those seen for L2 to L4 and changes in femoral neck and total body that were generally smaller than those seen for L2 to L4. Significant differences between groups indicated that each of the Premarin treatments was more effective than placebo for all 3 of these additional BMD endpoints.

With regard to femoral neck and total body, the active treatment groups all showed mean percent increases in BMD while placebo treatment was accompanied by mean percent decreases. For femoral trochanter, each of the Premarin dose groups showed a mean percent increase that was significantly greater than the small increase seen in the placebo group. The percent changes from baseline to final evaluation are shown in Table 3.

TABLE 3. PERCENT CHANGE IN BONE MINERAL DENSITY: COMPARISON BETWEEN ACTIVE AND PLACEBO GROUPS IN THE INTENT-TO-TREAT

POPULATION, LAST OBSERVATION CARRIED FORWARD
Region Evaluated
Treatment Group a
No. of
Subjects
Baseline (g/ cm 2 )
Mean ą SD
Change from Baseline (%)
Adjusted Mean ą SE
p-Value vs
Placebo
L2 to L4 BMD
0.625 83 1.17 ą 0.15 2.46 ą 0.37 < 0.001
0.45 91 1.13 ą 0.15 2.26 ą 0.35 < 0.001
0.3 87 1.14 ą 0.15 1.13 ą 0.36 < 0.001
Placebo 85 1.14 ą 0.14 -2.45 ą 0.36

TABLE 3. PERCENT CHANGE IN BONE MINERAL DENSITY: COMPARISON BETWEEN ACTIVE AND PLACEBO GROUPS IN THE INTENT-TO-TREAT
POPULATION, LAST OBSERVATION CARRIED FORWARD
Region Evaluated
Treatment Group a
No. of
Subjects
Baseline (g/ cm 2 )
Mean ą SD
Change from Baseline (%)
Adjusted Mean ą SE
p-Value vs
Placebo
Total Body BMD
0.625 84 1.15 ą 0.08 0.68 ą 0.17 < 0.001
0.45 91 1.14 ą 0.08 0.74 ą 0.16 < 0.001
0.3 87 1.14 ą 0.07 0.40 ą 0.17 < 0.001
Placebo 85 1.13 ą 0.08 -1.50 ą 0.17

Femoral Neck BMD
0.625 84 0.91 ą 0.14 1.82 ą 0.45 < 0.001
0.45 91 0.89 ą 0.13 1.84 ą 0.44 < 0.001
0.3 87 0.86 ą 0.11 0.62 ą 0.45 < 0.001
Placebo 85 0.88 ą 0.14 -1.72 ą 0.45