{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T21:14:57Z","timestamp":1761513297011,"version":"3.40.4"},"reference-count":30,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Imaging"],"published-print":{"date-parts":[[2013,7]]},"abstract":"<jats:sec><jats:title>Background\u2014<\/jats:title><jats:p>Lorcaserin is a selective 5-HT<jats:sub>2C<\/jats:sub>agonist evaluated for weight management in clinical trials. Echocardiographic monitoring was conducted to test the hypothesis that selective 5-HT<jats:sub>2C<\/jats:sub>agonism would avoid valvular heart disease.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and Results\u2014<\/jats:title><jats:p>Echocardiographic and weight change data from 5249 obese and overweight patients in 3 phase 3 trials were integrated. Treatment duration with 10 mg lorcaserin twice daily or placebo was 52 weeks. The proportions of patients who developed Food and Drug Administration\u2013defined valvulopathy (\u2265 mild aortic or \u2265 moderate mitral regurgitation) and changes in regurgitant grade at each heart valve were evaluated. Possible associations between weight or body mass index change and valvulopathy were explored. New valvulopathy was present in 2.04% of placebo and 2.37% of lorcaserin recipients at 52 weeks (risk difference, 0.33%; 95% confidence interval, \u22120.46 to 1.13; risk ratio, 1.16 [all patients with sufficient echocardiographic data, last-observation-carried-forward imputation] or 1.03 [patients who completed 52 weeks]). Changes in weight and body mass index were negatively associated with presence of valvulopathy at week 52 (<jats:italic>P<\/jats:italic>=0.02 and<jats:italic>P<\/jats:italic>=0.04, respectively); a 5% decrease in weight was associated with an odds ratio of 1.15 for Food and Drug Administration\u2013defined valvulopathy. Most changes in regurgitation were \u00b11 grade in both treatment groups at all heart valves.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions\u2014<\/jats:title><jats:p>In 3 prospective placebo-controlled trials with integrated data for 5249 patients, the rate of echocardiographic valvulopathy was similar with lorcaserin and placebo. Point estimates for risk ratios ranged from 1.03 to 1.16 and may be at least partially influenced by greater weight loss in the lorcaserin group than in the placebo group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration\u2014<\/jats:title><jats:p>URL:<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">http:\/\/www.clinicaltrials.gov<\/jats:ext-link>. Unique identifiers: NCT00395135, NCT00603291, NCT00603902.<\/jats:p><\/jats:sec>","DOI":"10.1161\/circimaging.112.000128","type":"journal-article","created":{"date-parts":[[2013,5,10]],"date-time":"2013-05-10T00:56:32Z","timestamp":1368147392000},"page":"560-567","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":58,"title":["Echocardiographic Assessment of Cardiac Valvular Regurgitation With Lorcaserin From Analysis of 3 Phase 3 Clinical Trials"],"prefix":"10.1161","volume":"6","author":[{"given":"Neil J.","family":"Weissman","sequence":"first","affiliation":[{"name":"From the MedStar Health Research Institute and Georgetown University, Washington, DC, (N.J.W.); Arena Pharmaceuticals, Inc, San Diego, CA (M.S., W.R.S.); University of North Carolina at Chapel Hill, NC (G.G.K.); Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Medical Research Institute, Orlando, FL (S.R.S.); and Christen M. Anderson Consulting, Encinitas, CA (C.M.A.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matilde","family":"Sanchez","sequence":"additional","affiliation":[{"name":"From the MedStar Health Research Institute and Georgetown University, Washington, DC, (N.J.W.); Arena Pharmaceuticals, Inc, San Diego, CA (M.S., W.R.S.); University of North Carolina at Chapel Hill, NC (G.G.K.); Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Medical Research Institute, Orlando, FL (S.R.S.); and Christen M. Anderson Consulting, Encinitas, CA (C.M.A.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary G.","family":"Koch","sequence":"additional","affiliation":[{"name":"From the MedStar Health Research Institute and Georgetown University, Washington, DC, (N.J.W.); Arena Pharmaceuticals, Inc, San Diego, CA (M.S., W.R.S.); University of North Carolina at Chapel Hill, NC (G.G.K.); Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Medical Research Institute, Orlando, FL (S.R.S.); and Christen M. Anderson Consulting, Encinitas, CA (C.M.A.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven R.","family":"Smith","sequence":"additional","affiliation":[{"name":"From the MedStar Health Research Institute and Georgetown University, Washington, DC, (N.J.W.); Arena Pharmaceuticals, Inc, San Diego, CA (M.S., W.R.S.); University of North Carolina at Chapel Hill, NC (G.G.K.); Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Medical Research Institute, Orlando, FL (S.R.S.); and Christen M. Anderson Consulting, Encinitas, CA (C.M.A.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William R.","family":"Shanahan","sequence":"additional","affiliation":[{"name":"From the MedStar Health Research Institute and Georgetown University, Washington, DC, (N.J.W.); Arena Pharmaceuticals, Inc, San Diego, CA (M.S., W.R.S.); University of North Carolina at Chapel Hill, NC (G.G.K.); Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Medical Research Institute, Orlando, FL (S.R.S.); and Christen M. Anderson Consulting, Encinitas, CA (C.M.A.)."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christen M.","family":"Anderson","sequence":"additional","affiliation":[{"name":"From the MedStar Health Research Institute and Georgetown University, Washington, DC, (N.J.W.); Arena Pharmaceuticals, Inc, San Diego, CA (M.S., W.R.S.); University of North Carolina at Chapel Hill, NC (G.G.K.); Translational Research Institute for Metabolism and Diabetes, Florida Hospital and the Sanford-Burnham Medical Research Institute, Orlando, FL (S.R.S.); and Christen M. 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