{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T19:35:13Z","timestamp":1777923313124,"version":"3.51.4"},"reference-count":78,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2012,9,6]],"date-time":"2012-09-06T00:00:00Z","timestamp":1346889600000},"content-version":"vor","delay-in-days":1771,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Obesity"],"published-print":{"date-parts":[[2007,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:italic>Introduction:<\/jats:italic> Observational cohort studies were conducted using prescription\u2010event monitoring (PEM) to examine the safety profiles of the anti\u2010obesity agents orlistat and sibutramine. Adverse events reported as case reports were also evaluated to determine whether these events were also identified by PEM.<\/jats:p><jats:p><jats:italic>Research Methods and Procedures:<\/jats:italic> Patients were identified from dispensed prescriptions written by general practitioners (GPs) in England for orlistat or sibutramine. Patient demographic and clinical event information, including reasons for stopping and adverse drug reactions, were requested on questionnaires posted to GPs at least 6 months after the first prescription for individual patients. Event incidence densities (IDs) (number of first reports of event\/1000 patient\u2010months treatment) were calculated for month 1 (ID<jats:sub>1<\/jats:sub>) and months 2\u20133 (ID<jats:sub>2\u20133<\/jats:sub>). Published case reports were identified by searching Medline and Embase.<\/jats:p><jats:p><jats:italic>Results:<\/jats:italic> The cohorts comprised 16,021 and 12,336 patients prescribed orlistat and sibutramine, respectively. Both cohorts had a median age of 45 years, and \u223c80% were female. The most common reason for stopping orlistat within 3 months was diarrhea (332 patients; 2.1% cohort), and for stopping sibutramine it was hypertension (203 patients; 1.6%). Clinical events significantly associated with taking orlistat were mainly gastrointestinal and those for sibutramine included central nervous system effects, nausea\/vomiting, palpitation, and sweating. We identified 8 published case reports for orlistat and 10 for sibutramine that had equivalent or similar events assessed as causally related in the PEM studies.<\/jats:p><jats:p><jats:italic>Conclusions:<\/jats:italic> The PEM studies highlighted different adverse event profiles for orlistat and sibutramine that were consistent with their distinct pharmacological mechanisms and other published information.<\/jats:p>","DOI":"10.1038\/oby.2007.323","type":"journal-article","created":{"date-parts":[[2008,7,17]],"date-time":"2008-07-17T22:54:10Z","timestamp":1216335250000},"page":"2712-2722","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":50,"title":["The Safety Profiles of Orlistat and Sibutramine: Results of Prescription\u2010Event Monitoring Studies in England"],"prefix":"10.1002","volume":"15","author":[{"given":"Michael J.","family":"Perrio","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lynda V.","family":"Wilton","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saad A. W.","family":"Shakir","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,9,6]]},"reference":[{"key":"e_1_2_7_2_2","volume-title":"Orlistat, Summary of Product Characteristics","author":"Roche Products Limited","year":"1998"},{"key":"e_1_2_7_3_2","volume-title":"Sibutramine, Summary of Product Characteristics","author":"Abbott Laboratories Limited","year":"2000"},{"key":"e_1_2_7_4_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199958040-00015"},{"key":"e_1_2_7_5_2","doi-asserted-by":"publisher","DOI":"10.2165\/00003495-199856060-00019"},{"key":"e_1_2_7_6_2","author":"Health Canada","journal-title":"Advisory: Health Canada investigates safety of Meridia (sibutramine)"},{"key":"e_1_2_7_7_2","author":"European Agency for the Evaluation of Medicinal Products","journal-title":"Committee for Proprietary Medicinal Products opinion following an article 31 referral: sibutramine"},{"key":"e_1_2_7_8_2","first-page":"203","volume-title":"Pharmacoepidemiology","author":"Shakir S. A. W.","year":"2005"},{"key":"e_1_2_7_9_2","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200528110-00002"},{"key":"e_1_2_7_10_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.329.7456.44"},{"key":"e_1_2_7_11_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.38701.399942.63"},{"key":"e_1_2_7_12_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.332.7539.488"},{"key":"e_1_2_7_13_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.332.7539.488-a"},{"key":"e_1_2_7_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)67483-1"},{"key":"e_1_2_7_15_2","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200629040-00001"},{"key":"e_1_2_7_16_2","doi-asserted-by":"publisher","DOI":"10.1002\/0470014199.ch7"},{"key":"e_1_2_7_17_2","doi-asserted-by":"publisher","DOI":"10.1002\/0470842555.ch3"},{"key":"e_1_2_7_18_2","volume-title":"International Ethical Guidelines for Biomedical Research Involving Human Subjects","author":"World Health Organization","year":"2002"},{"key":"e_1_2_7_19_2","volume-title":"Guidelines on the Practice of Ethical Research Involving Human Subjects","author":"Royal College of Physicians of London","year":"1996"},{"key":"e_1_2_7_20_2","author":"Multi\u2010Centre Research Ethics Committee","journal-title":"Guidance notes 2000: Appendix C-page 19"},{"key":"e_1_2_7_21_2","first-page":"9","volume-title":"Confidentiality: Protecting and Providing Information: Frequently Asked Questions","author":"General Medical Council","year":"2004"},{"key":"e_1_2_7_22_2","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ijo.0803323"},{"key":"e_1_2_7_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0168-8278(00)00042-8"},{"key":"e_1_2_7_24_2","doi-asserted-by":"publisher","DOI":"10.1177\/002580240204200405"},{"key":"e_1_2_7_25_2","first-page":"374","article-title":"Is Xenical hepatotoxic?","volume":"24","author":"Chistidas C.","year":"2000","journal-title":"Gastroenterol Clin Biol"},{"key":"e_1_2_7_26_2","first-page":"317","article-title":"A case of acute cholestatic hepatitis associated with orlistat","volume":"8","author":"Kim D. H.","year":"2002","journal-title":"Taehan Kan Hakhoe Chi"},{"key":"e_1_2_7_27_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.321.7253.87"},{"key":"e_1_2_7_28_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.10346"},{"key":"e_1_2_7_29_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1A452"},{"key":"e_1_2_7_30_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2133.2006.07220.x"},{"key":"e_1_2_7_31_2","doi-asserted-by":"publisher","DOI":"10.1017\/S1461145702003000"},{"key":"e_1_2_7_32_2","first-page":"129","article-title":"Case report: a mixt episode induced by sibutramine","volume":"13","author":"Eker M. C.","year":"2003","journal-title":"Klin Psikofarmacol Bul"},{"key":"e_1_2_7_33_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v63n0213a"},{"key":"e_1_2_7_34_2","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.159.10.1793-a"},{"key":"e_1_2_7_35_2","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.157.12.2057-a"},{"key":"e_1_2_7_36_2","doi-asserted-by":"publisher","DOI":"10.1590\/S1516-44462002000100009"},{"key":"e_1_2_7_37_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.329.7478.1316"},{"key":"e_1_2_7_38_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2006.02574.x"},{"key":"e_1_2_7_39_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-143-10-200511150-00030"},{"key":"e_1_2_7_40_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2133.2003.05413.x"},{"key":"e_1_2_7_41_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(01)06898-2"},{"key":"e_1_2_7_42_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.317.7151.119"},{"key":"e_1_2_7_43_2","first-page":"91","article-title":"Surveying general practitioners: does a low response rate matter?","volume":"47","author":"Templeton L.","year":"1997","journal-title":"Br J General Pract"},{"key":"e_1_2_7_44_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-142-7-200504050-00012"},{"key":"e_1_2_7_45_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1467-789X.2004.00125.x"},{"key":"e_1_2_7_46_2","article-title":"Long\u2010term pharmacotherapy for obesity and overweight","volume":"4","author":"Padwal R.","year":"2003","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_7_47_2","doi-asserted-by":"publisher","DOI":"10.3310\/hta6060"},{"key":"e_1_2_7_48_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2004.00372.x"},{"key":"e_1_2_7_49_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1463-1326.2002.00181.x"},{"key":"e_1_2_7_50_2","first-page":"222","article-title":"Comparison of metabolic effects of orlistat and sibutramine treatment in Type 2 diabetic obese patients","volume":"17","author":"Derosa G.","year":"2004","journal-title":"Diabetes Nutr Metab"},{"key":"e_1_2_7_51_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1463-1326.2004.00428.x"},{"key":"e_1_2_7_52_2","volume-title":"Orlistat, Summary of Product Characteristics","author":"Roche Products Limited","year":"2006"},{"key":"e_1_2_7_53_2","volume-title":"Sibutramine, Summary of Product Characteristics","author":"Abbott Laboratories Limited","year":"2006"},{"key":"e_1_2_7_54_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.322.7278.110"},{"key":"e_1_2_7_55_2","doi-asserted-by":"publisher","DOI":"10.1038\/oby.2003.152"},{"key":"e_1_2_7_56_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2004.02249.x"},{"key":"e_1_2_7_57_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(02)11911-8"},{"key":"e_1_2_7_58_2","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.24.3.602"},{"key":"e_1_2_7_59_2","first-page":"87","article-title":"Depression induced by orlistat (Xenical)","volume":"45","author":"Benazzi F.","year":"2000","journal-title":"Can J Psychiatry Rev Can Psychiatr"},{"key":"e_1_2_7_60_2","doi-asserted-by":"publisher","DOI":"10.1002\/art.10670"},{"key":"e_1_2_7_61_2","first-page":"712","article-title":"Caution when using oral contraceptive pills with Orlistat","volume":"2","author":"Peleg R.","year":"2000","journal-title":"Isr Med Assoc J"},{"key":"e_1_2_7_62_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clon.2005.05.001"},{"key":"e_1_2_7_63_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1C122"},{"key":"e_1_2_7_64_2","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.26.8.2471"},{"key":"e_1_2_7_65_2","doi-asserted-by":"publisher","DOI":"10.1345\/aph.1A353"},{"key":"e_1_2_7_66_2","doi-asserted-by":"publisher","DOI":"10.1053\/ajkd.2003.50061"},{"key":"e_1_2_7_67_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0041-1345(01)02829-9"},{"key":"e_1_2_7_68_2","doi-asserted-by":"publisher","DOI":"10.4158\/EP.8.2.124"},{"key":"e_1_2_7_69_2","doi-asserted-by":"publisher","DOI":"10.1007\/s002280050690"},{"key":"e_1_2_7_70_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-200011270-00026"},{"key":"e_1_2_7_71_2","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-200011270-00025"},{"key":"e_1_2_7_72_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM200004133421518"},{"key":"e_1_2_7_73_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v65n0507"},{"key":"e_1_2_7_74_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2003.11.060"},{"key":"e_1_2_7_75_2","doi-asserted-by":"publisher","DOI":"10.1034\/j.1600-6143.2003.00159.x"},{"key":"e_1_2_7_76_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.284.6311.249"},{"key":"e_1_2_7_77_2","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-134-4-200102200-00017"},{"key":"e_1_2_7_78_2","first-page":"253","article-title":"Rethinking case reports","volume":"170","author":"Hoffman J. R.","year":"1999","journal-title":"West J Med"},{"key":"e_1_2_7_79_2","doi-asserted-by":"publisher","DOI":"10.2165\/00002018-200629080-00001"}],"container-title":["Obesity"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1038%2Foby.2007.323","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1038\/oby.2007.323","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,31]],"date-time":"2023-10-31T08:14:38Z","timestamp":1698740078000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1038\/oby.2007.323"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2007,11]]},"references-count":78,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2007,11]]}},"alternative-id":["10.1038\/oby.2007.323"],"URL":"https:\/\/doi.org\/10.1038\/oby.2007.323","archive":["Portico"],"relation":{},"ISSN":["1930-7381","1930-739X"],"issn-type":[{"value":"1930-7381","type":"print"},{"value":"1930-739X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2007,11]]},"assertion":[{"value":"2012-09-06","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}