{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T12:03:11Z","timestamp":1762084991337,"version":"build-2065373602"},"reference-count":40,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,10,24]],"date-time":"2023-10-24T00:00:00Z","timestamp":1698105600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["headachejournal.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Headache"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate an alternative method of defining acute treatment success in migraine by combining multiple indicators into a single dichotomous measure of success.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Migraine is characterized by a symptom complex; combining these features as a single endpoint may improve the measurement of treatment effects and better predict patient satisfaction with treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We used a confirmatory latent class model (LCM) with two latent classes interpreted as treatment success and treatment failure. Pooled data for placebo and ubrogepant 50\u2009mg from the ACHIEVE I and ACHIEVE II trials and data for ubrogepant 100\u2009mg from ACHIEVE I were used. LCM inputs included pre\u2010dose and 2\u2010h post\u2010dose measures of pain severity (0\u20133), the presence\/absence of associated symptoms (nausea, photophobia, and phonophobia [0 or 1]), and functional disability (0\u20133). All definitions were validated against satisfaction with study medication (SWSM) at 24\u2009h post\u2010dose; results were compared with 2\u2010hour pain freedom (2hPF).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>This pooled analysis included 2247 participants. At 2\u2009h post\u2010dose in the ubrogepant 50 and 100\u2009mg dose groups, 53.2% (472\/887) and 54.9% (246\/448) of participants, respectively, were classified as achieving treatment success using the LCM\u2010based approach, compared to 39.0% (356\/912) of participants in the placebo group. The results for treatment success using the 2hPF endpoint were 20.7% (184\/887) and 21.5% (96\/447) in the ubrogepant 50 and 100\u2009mg dose groups, respectively, compared to 12.7% (116\/912) for placebo. Using 24\u2010h SWSM as an external validator, the LCM approach sensitivity and correct classification rates were higher than for 2hPF.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The LCM approach led to higher rates of treatment success and greater separation between ubrogepant and placebo and was a more sensitive predictor of treatment satisfaction than the regulatory endpoint of 2hPF.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/head.14631","type":"journal-article","created":{"date-parts":[[2023,10,24]],"date-time":"2023-10-24T07:08:23Z","timestamp":1698131303000},"page":"1412-1422","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Evaluating therapeutic benefits of ubrogepant via latent class models: A post hoc exploratory analysis of the\n                    <scp>ACHIEVE I<\/scp>\n                    and\n                    <scp>ACHIEVE II<\/scp>\n                    trials"],"prefix":"10.1111","volume":"63","author":[{"given":"Charlie J.","family":"Iaconangelo","sequence":"first","affiliation":[{"name":"OPEN Health  Bethesda Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Serrano","sequence":"additional","affiliation":[{"name":"The Psychometrics Team  Sheridan Wyoming USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aubrey Manack","family":"Adams","sequence":"additional","affiliation":[{"name":"AbbVie  Irvine California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joel M.","family":"Trugman","sequence":"additional","affiliation":[{"name":"AbbVie  Madison New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard B.","family":"Lipton","sequence":"additional","affiliation":[{"name":"Albert Einstein College of Medicine  Bronx New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,10,24]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1146\/annurev-physiol-030212-183717"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102417738202"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/head.12499"},{"key":"e_1_2_13_5_1","unstructured":"REYVOW [package insert].Lilly USA;2020."},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s10194-019-0974-3"},{"key":"e_1_2_13_7_1","unstructured":"Ubrelvy [package insert].AbbVie;2023."},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1523\/JNEUROSCI.0373-15.2015"},{"key":"e_1_2_13_9_1","doi-asserted-by":"publisher","DOI":"10.1177\/0333102419828967"},{"volume-title":"Migraine: Developing Drugs for Acute Treatment. 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