{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,16]],"date-time":"2025-12-16T12:24:02Z","timestamp":1765887842852},"reference-count":34,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2016,11,26]],"date-time":"2016-11-26T00:00:00Z","timestamp":1480118400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Eisai Inc"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Obesity"],"published-print":{"date-parts":[[2017,1]]},"abstract":"<jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the effects of lorcaserin in patients with pre\u2010existing Food and Drug Administration (FDA)\u2010defined valvulopathy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This is a pooled, <jats:italic>post hoc<\/jats:italic> analysis of three Phase 3 studies. BLOOM and BLOSSOM patients were 18 to 65 years of age without diabetes and with a body mass index (BMI) of 27 to 29.9 kg\/m<jats:sup>2<\/jats:sup> and \u22651 weight<jats:bold>\u2010<\/jats:bold>related comorbidity or a BMI of 30 to 45 kg\/m<jats:sup>2<\/jats:sup>. BLOOM\u2010DM patients had a BMI of 27 to 45 kg\/m<jats:sup>2<\/jats:sup> and type 2 diabetes. Patients were treated with placebo, lorcaserin 10 mg once daily, or lorcaserin 10 mg twice daily. Serial echocardiographs were obtained at baseline and every 6 months.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Included patients (<jats:italic>N =<\/jats:italic> 169) had FDA\u2010defined valvulopathy at baseline and a week 52 echocardiogram. At week 52, 35.5% and 52.7% of patients experienced changes from baseline in aortic and mitral regurgitation, respectively. Numerically greater proportions of patients taking lorcaserin versus placebo had decreases in aortic (33.0% vs. 28.3%) or mitral (41.3% vs. 36.7%) regurgitation. Fewer patients taking lorcaserin versus placebo had increases in aortic (2.8% vs. 6.7%) or mitral (8.3% vs. 21.7%) regurgitation. No adverse event\u2010related discontinuation was due to a valve problem.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These data suggest that lorcaserin does not adversely affect valvular disease in patients with pre\u2010existing FDA\u2010defined valvulopathy.<\/jats:p><\/jats:sec>","DOI":"10.1002\/oby.21695","type":"journal-article","created":{"date-parts":[[2016,11,26]],"date-time":"2016-11-26T12:26:39Z","timestamp":1480163199000},"page":"39-44","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Effects of lorcaserin on pre\u2010existing valvulopathy: A pooled analysis of phase 3 trials"],"prefix":"10.1002","volume":"25","author":[{"given":"Neil J.","family":"Weissman","sequence":"first","affiliation":[{"name":"MedStar Health Research Institute Washington DC USA"},{"name":"Regulatory Science Georgetown University School of Medicine Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven R.","family":"Smith","sequence":"additional","affiliation":[{"name":"Center for the Metabolic Origins of Disease, Sanford Burnham Prebys Medical Discovery Institute Orlando Florida USA"},{"name":"Translational Research Institute for Metabolism and Diabetes, Florida Hospital Orlando Florida USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Randi","family":"Fain","sequence":"additional","affiliation":[{"name":"Mallinckrodt Pharmaceuticals Hampton New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nancy","family":"Hall","sequence":"additional","affiliation":[{"name":"Medical and Scientific Affairs Eisai Inc. Woodcliff Lake New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William R.","family":"Shanahan","sequence":"additional","affiliation":[{"name":"Anthera Pharmaceuticals, Inc Hayward California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,11,26]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuron.2008.09.033"},{"key":"e_1_2_6_3_1","volume-title":"BELVIQ (lorcaserin hydrochloride) US Prescribing Information","author":"Eisai Inc","year":"2014"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2261-3-5"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199809103391102"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.101.17.2071"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9343(02)01123-3"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1067\/mhj.2002.126733"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.102.23.2836"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp068265"},{"key":"e_1_2_6_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0163-7258(02)00234-6"},{"key":"e_1_2_6_12_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1550-8528.1999.tb00414.x"},{"key":"e_1_2_6_13_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-134-4-200102200-00008"},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199708283370901"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2011-1256"},{"key":"e_1_2_6_16_1","doi-asserted-by":"publisher","DOI":"10.1038\/oby.2012.66"},{"key":"e_1_2_6_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0909809"},{"key":"e_1_2_6_18_1","first-page":"1061","article-title":"Cardiac valvulopathy associated with exposure to fenfluramine or dexfenfluramine: U.S. Department of Health and Human Services interim public health recommendations, November 1997","volume":"46","year":"1997","journal-title":"MMWR Morb Mortal Wkly Rep"},{"key":"e_1_2_6_19_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCIMAGING.112.000128"},{"key":"e_1_2_6_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(14)61948-3"},{"key":"e_1_2_6_21_1","doi-asserted-by":"publisher","DOI":"10.3810\/pgm.2014.10.2817"},{"key":"e_1_2_6_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9149(98)01064-9"},{"key":"e_1_2_6_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0735-1097(98)00454-9"},{"key":"e_1_2_6_24_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199809103391103"},{"key":"e_1_2_6_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0894-7317(03)00335-3"},{"key":"e_1_2_6_26_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.100.21.2161"},{"key":"e_1_2_6_27_1","doi-asserted-by":"publisher","DOI":"10.1038\/oby.2005.241"},{"key":"e_1_2_6_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)60205-5"},{"key":"e_1_2_6_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)60888-4"},{"key":"e_1_2_6_30_1","doi-asserted-by":"publisher","DOI":"10.1038\/ijo.2013.120"},{"key":"e_1_2_6_31_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.107.133348"},{"key":"e_1_2_6_32_1","doi-asserted-by":"publisher","DOI":"10.1124\/mi.5.5.8"},{"key":"e_1_2_6_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharmthera.2005.12.004"},{"key":"e_1_2_6_34_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2014-3415"},{"key":"e_1_2_6_35_1","doi-asserted-by":"publisher","DOI":"10.1002\/oby.20309"}],"container-title":["Obesity"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Foby.21695","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/oby.21695","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,17]],"date-time":"2023-09-17T17:55:07Z","timestamp":1694973307000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/oby.21695"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,11,26]]},"references-count":34,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2017,1]]}},"alternative-id":["10.1002\/oby.21695"],"URL":"https:\/\/doi.org\/10.1002\/oby.21695","archive":["Portico"],"relation":{},"ISSN":["1930-7381","1930-739X"],"issn-type":[{"value":"1930-7381","type":"print"},{"value":"1930-739X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,11,26]]},"assertion":[{"value":"2016-06-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2016-09-08","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2016-11-26","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}