(055) A RETROSPECTIVE ANALYSIS ON THE BENEFITS OF AN OVER-THE-COUNTER COMBINATION OF ASPIRIN, ACETAMINOPHEN, AND CAFFEINE (AAC) IN MENSTRUAL MIGRAINE

Abstract

Abstract Introduction • Migraine affects approximately 15% of the general population globally. It is an episodic headache disorder that produces a wide spectrum of pain and associated disability. • Women are 3 times more likely than men to experience migraine headache. More than 60% of women with migraine experience attacks that occur in association with the menstrual periods. • Although some women experience migraine exclusively during the perimenstrual period others have attacks both during the perimenstrual period and at other times of the month. Menstrual migraine is thought to be more severe and disabling and less responsive to non-drug treatments than is non-menstrual migraine Objective Since menstrual migraine is an important health issue for women, we wanted to examine whether AAC is more effective than placebo in relieving menstruation associated migraine and improving the quality of life (QoL) of patients. Methods The study population selected for this analysis were adapted from a pooled analysis of women associated with menstrual migraine [Clin Therapeutics 21(3) 475, 1999]. A total of 185 women with menstrual associated migraine, of which 85 took one dose of AAC (aspirin/acetaminophen/caffeine – 250 mg/250 mg/65 mg) and 100 took placebo were included in this study. The data was analyzed using SAS Windows version 9.4. All post-rescue medication severity scores were assigned either the baseline value or the last recorded value whichever was most severe. Post-rescue medication pain relief scores were classified as “no relief”. Results It was observed that the intensity of the headache pain was reduced to mild or none (1) within 30 min in 20% (AAC treated) vs (10% in placebo). Within 1 hour in 40% (AAC treated) vs (14% placebo) (p<=0.001) treated patients and the pain relief lasted for at least six hours. The quality of life (able to perform all or usual activities with minimal or no additional effort) also improved within 1 hour in 48.2% (AAC treated patients) vs 28% (placebo) (p<=0.005) and within 3 hour in 68.2% AAC treated patients vs 40% (placebo) (p<=0.001). In addition, in terms of relative change (%) difference, there was a 19% improvement in QoL with a 24.6% reduction in pain intensity within 1 hour. At 3 hours the QoL scores improved to 38.1% with a reduction in pain intensity of 41.1% that lasted till 6 hours in AAC treated patients vs placebo. Conclusions This post- hoc pooled analysis provides evidence that a single dose of AAC provides significant benefits in relieving menstrual migraine associated pain relief and improves quality of life of patients in their ability to perform usual activities with minimal or no additional effort. Disclosure Yes, this is sponsored by industry/sponsor: Haleon Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Haleon.