{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T23:41:10Z","timestamp":1790206870604,"version":"4.1.0"},"reference-count":24,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2006,8,16]],"date-time":"2006-08-16T00:00:00Z","timestamp":1155686400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2006,9]]},"abstract":"<jats:sec><jats:title>Summary<\/jats:title><\/jats:sec><jats:sec><jats:title>Background<\/jats:title><jats:p>In November 2002, alosetron HCl (Lotronex, GlaxoSmithKline Research Triangle Park, NC, USA) was re\u2010introduced to the US marketplace for women with severe diarrhoea\u2010predominant irritable bowel syndrome. In support of the re\u2010introduction, a risk management programme was implemented, which included a patient follow\u2010up study in which all users of alosetron could participate.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>We report on the methods used and the effectiveness of key elements of the risk management programme.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients voluntarily enroled in the study and completed questionnaires at baseline, after 5 and 10\u2003weeks, and quarterly thereafter. Questions focussed on patient eligibility, knowledge of risks and benefits, and adherence to the recommended programme elements for education, prescribing and dispensing.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between December 2002 and 2004, 4803 patients enrolled in the study, and &lt;3% were lost to follow\u2010up. The average follow\u2010up time was approximately 6\u2003months, and the response rate for each assessment was &gt;95%. A total of 90% of patients at baseline met the full clinical criteria recommended for the treatment. Patient adherence to the risk management programme was &gt;87%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Using the Lotronex risk management programme, patients met clinical criteria, were knowledgeable about treatment risks and benefits, and were adherent to the process elements of the programme. These patients seemed to engage in active dialogue with their physicians about symptoms and use of alosetron.<\/jats:p><\/jats:sec>","DOI":"10.1111\/j.1365-2036.2006.03031.x","type":"journal-article","created":{"date-parts":[[2006,8,16]],"date-time":"2006-08-16T09:21:33Z","timestamp":1155720093000},"page":"869-878","source":"Crossref","is-referenced-by-count":14,"title":["A patient follow\u2010up survey programme for alosetron: assessing compliance to and effectiveness of the risk management programme"],"prefix":"10.1111","volume":"24","author":[{"given":"D.","family":"MILLER","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"BENNETT","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"HOLLIS","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"TENNIS","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"COOK","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"ANDREWS","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2006,8,16]]},"reference":[{"key":"e_1_2_6_2_2","first-page":"38","article-title":"New developments in the treatment of irritable bowel syndrome","volume":"232","author":"De Schryver AM","year":"2000","journal-title":"Scand J Gastroenterol Suppl"},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/0016-5085(91)90275-P"},{"key":"e_1_2_6_4_2","doi-asserted-by":"publisher","DOI":"10.1097\/00004836-199912000-00009"},{"key":"e_1_2_6_5_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF01303162"},{"key":"e_1_2_6_6_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2003.01456.x"},{"key":"e_1_2_6_7_2","doi-asserted-by":"publisher","DOI":"10.1023\/A:1013208713670"},{"key":"e_1_2_6_8_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2005.02671.x"},{"key":"e_1_2_6_9_2","doi-asserted-by":"publisher","DOI":"10.18553\/jmcp.2004.10.4.299"},{"key":"e_1_2_6_10_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1572-0241.2003.07418.x"},{"key":"e_1_2_6_11_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.1999.00610.x"},{"key":"e_1_2_6_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)02033-X"},{"key":"e_1_2_6_13_2","doi-asserted-by":"publisher","DOI":"10.1136\/gut.52.5.671"},{"key":"e_1_2_6_14_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.2002.01372.x"},{"key":"e_1_2_6_15_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11938-003-0025-6"},{"key":"e_1_2_6_16_2","doi-asserted-by":"publisher","DOI":"10.1023\/A:1022209631047"},{"key":"e_1_2_6_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.bpg.2004.04.008"},{"key":"e_1_2_6_18_2","doi-asserted-by":"publisher","DOI":"10.1159\/000050687"},{"key":"e_1_2_6_19_2","volume-title":"Overweight Prevalence","author":"Centers for Disease Control and Prevention","year":"2003"},{"key":"e_1_2_6_20_2","doi-asserted-by":"publisher","DOI":"10.1331\/1544345041475670"},{"key":"e_1_2_6_21_2","doi-asserted-by":"publisher","DOI":"10.1592\/phco.22.12.1041.33611"},{"key":"e_1_2_6_22_2","volume-title":"Lotronex Alosetron Hydrochloride Tables Briefing Document for Drug Safety and Risk Management Committee","author":"GlaxoSmithLine"},{"key":"e_1_2_6_23_2","volume-title":"Drug Safety and Risk Management Advisory Committee (DSaRM) Committee Meeting","author":"Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research"},{"key":"e_1_2_6_24_2","volume-title":"Overview of the First Year Evaluation of the Isotretinoin Risk Management Program","author":"Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research"},{"key":"e_1_2_6_25_2","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1009"}],"container-title":["Alimentary Pharmacology &amp; 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