Background: Hot flashes are a major cause of morbidity among postmenopausal women, including many survivors of breast cancer. Hormone therapy decreases hot flashes but is not used as much as is has been because of toxicity concerns. Various new centrally acting agents have also been shown to decrease hot flashes. Aprepitan, a neurokinin-1 receptor antagonist, is a centrally active agent that might have the ability to decrease hot flashes. The objective of this pilot trial was to assess the potential efficacy and safety of aprepitant for the treatment of hot flashes in this patient population.
Patients and methods: Twenty-five postmenopausal women, aged >/= 45 years, who were experiencing bothersome hot flashes (>/= 14 times per week) for >/= 1 month, were included. During the baseline week, general demographic characteristics and hot flash and quality of life data were obtained. At the beginning of the second week, patients were given aprepitant 80 mg per day for 4 weeks. Information about hot flashes, quality of life, and toxicity was collected during these 4 weeks and compared with week 1.
Results: After treatment with aprepitant for 4 weeks (n = 21), mean hot flash scores (frequency times mean severity) were reduced by 17%, and mean hot flash frequencies were decreased by 15% (from the baseline week 1). There were no statistically significant differences from week 1 to week 5 for any of the patient-reported side effects or quality of life.
Conclusion: The decrease of hot flashes seen with aprepitant in this trial is less than what would be expected from the 20%-25% decrease often seen with a placebo. Thus, aprepitant does not appear to be an effective treatment for hot flashes. This study suggests that neurokinin receptors do not play a major role in mediating hot flashes.