Identifying meaningful differences in vasomotor symptoms among menopausal women

Abstract

In Brief Objective: First, to identify treatment satisfaction thresholds for interpreting treatment-related changes in vasomotor symptoms, and, second, to determine the doses of desvenlafaxine (DVS) (administered as desvenlafaxine succinate) that effectively provide relief of vasomotor symptoms considered important by menopausal women. Design: Efficacy and treatment satisfaction were assessed in 620 postmenopausal women with moderate to severe vasomotor symptoms participating in a double-blind, placebo-controlled trial and randomly assigned to placebo or 50, 100, 150, or 200 mg DVS. Number and severity of hot flushes and number of nighttime awakenings were recorded in daily diaries for 12 weeks of treatment. At week 12, responses to the Menopause Symptoms Treatment Satisfaction Questionnaire were compared with efficacy results. Results: Greater percentages of participants in the DVS groups reported being "satisfied" or "extremely satisfied" with daytime and nighttime control of hot flushes compared with placebo. The treatment satisfaction threshold, defined as the difference between the average reduction in vasomotor symptoms for women who were "neutral" versus "satisfied," was 1.64 for moderate to severe hot flushes and 0.42 for nighttime awakenings. Statistically significant reductions with 100, 150, and 200 mg DVS exceeded treatment satisfaction threshold results for at least one of these thresholds, and results with 100 mg DVS compared with placebo exceeded both treatment satisfaction thresholds. Conclusions: Among menopausal women with moderate to severe vasomotor symptoms, the treatment satisfaction thresholds that were meaningful to participants were 1.64 fewer moderate to severe hot flushes per day and 0.42 fewer nighttime awakenings per night. A dose of 100 mg DVS met both of these important vasomotor symptom change thresholds. This article addresses two important challenges in vasomotor symptom relief. First, it estimates a meaningful treatment satisfaction threshold for the reduction in the number and severity of hot flushes and nighttime awakenings for postmenopausal women with moderate to severe vasomotor symptoms, and, second, it suggests that a nonhormonal therapy (100 mg desvenlafaxine) can achieve these vasomotor symptom change thresholds in a double-blind, placebo-controlled trial