Nonhormonal Drug Eases Vasomotor Symptoms
The findings for number and severity of daily hot flashes and number of nighttime awakenings were similar to the results from the first study. The analysis also included a more detailed look at the effect of treatment on sleep. Women who received either the 100- or 150-mg dosage had significant increases in the number of minutes slept and in their self-reported sleep quality, compared with placebo patients, reported Dr. Sophie Olivier, senior director for clinical research and development at Wyeth.
This report included data on mood, based on the Profile of Mood States (POMS) questionnaire. The lower the POMS score, the better a person's mood, and a normal score is about 20 points or lower. At baseline, women in the combined study had an average score of about 27.
After 12 weeks of treatment, the POMS scores had dropped by an average of about 19 points in the women treated with desvenlafaxine, compared with an average fall of about 12 points among women in the placebo group, a significant difference.
The ability of desvenlafaxine treatment to improve the POMS score is likely due to a direct antidepressant effect of the drug and to a secondary effect mediated by reduced vasomotor symptoms and improved sleep quality, Dr. Olivier said.
The third study involved 508 women who were randomized to daily treatment with 100 mg desvenlafaxine, 2.5 mg tibolone, or placebo and were treated for 12 weeks. Tibolone (Xyvion), a synthetic hormone that is a selective estrogen-receptor modulator, is not approved for use in the United States but is approved for use in Europe and elsewhere. In this study, the 100-mg dosage of desvenlafaxine was not significantly different from placebo for reducing the frequency and severity of hot flashes and nighttime awakenings, and this dosage of desvenlafaxine was significantly worse than tibolone.
In an analysis that combined the efficacy data collected in all three studies, the 100-mg/day and 150-mg/day dosages were each significantly better than placebo for reducing vasomotor symptoms. In addition, treatment with these dosages of desvenlafaxine produced the full treatment effect within 7 days of the start of treatment. In contrast, in the placebo group, the full effect of treatment was not seen until 4 weeks had elapsed.
The safety analysis involved a total of 1,131 patients treated with desvenlafaxine, including 495 treated for at least 12 weeks with the 100-mg/day dosage and 336 women treated with 150 mg/day. This analysis included 612 women assigned to treatment with desvenlafaxine for 52 weeks, including 155 women on 100 mg/day and 157 assigned to 150 mg/day. The results showed that desvenlafaxine was generally safe and well tolerated, with an adverse effect profile similar to those of other SNRIs.
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The 100-mg/day dosage produced a drop in all three measures compared with placebo. DR. GASS
