Comparisons between the

ICHD-2R criteria and the S-L 2006 criteria are summarized herein. The analysis involved baseline diary data from 2 phase 3 studies (PREEMPT 1 and PREEMPT 2) that recruited CM patients between January 2006 and July 2007 from 122 study centers see more in 6 countries (Canada, United States, Croatia, Switzerland, Germany, and United Kingdom). The number of patients enrolled in the 28-day screening baseline period and having sufficient diary data (ie, ≥20 days) for assessment was 2736. During the 28-day screening phase, patients used an interactive voice response system daily telephone diary to record their headache symptoms and acute headache medication use. Analyses to validate case definitions against the gold standards included measurements of sensitivity and specificity, Cohen’s kappa, positive predictive value (PPV), and negative predictive value (NPV). As the role of medication overuse within the diagnosis of CM differs among the case definitions, CM case definitions were stratified by medication overuse, which was defined as intake of simple analgesics on ≥15 days or of other

medication types or combination of types for ≥10 days, with intake ≥2 days/week from the category of overuse. Demographic profiles (Table 3) check details and headache characteristics (Table 4) were similar across CM diagnostic criteria. Mean age ranged from 38.1 to 41.9 years, with populations that did not include medication overuse (ICHD-3-MO = ICHD-2R and S-L TM-MO) having slightly lower estimates at 38.1 years. Body mass index was nearly identical among Epothilone B (EPO906, Patupilone) case definition populations. The vast majority of all populations were female and white. The headache characteristics of subjects

meeting the alternative diagnostic criteria features were strikingly similar (Table 4). No differences across CM diagnostic criteria were observed in mean frequency of headache days per 28 days. Headache episodes and migraines days were similar. For the definitions that did not exclude medication overuse, ≥64% of subjects met criteria for overuse. The mean age of onset of CM was within the second decade (mean age range of 20.8-21.9 years). Those with medication overuse were more likely to have tried a preventive medication. The vast majority (92.7-97.5%) were currently using acute medications. Triptans use varied based on whether medication overuse was exclusion for the case definition. Results of analyses to validate case definitions against the gold standards are summarized in Table 5. ICHD-3-MO = ICHD-2R (which do not allow for medication overuse in CM) are denoted as ICHD-3; ICHD-2R criteria, including those with and without medication overuse, as ICHD-3 ± MO; S-L criteria for TM (which allow for medication overuse in TM) as S-L TM ± MO; and S-L criteria for TM excluding those with medication overuse as S-L TM-MO.