دورية أكاديمية

Mercaptopurine versus placebo to prevent recurrence of Crohn's disease after surgical resection (TOPPIC): a multicentre, double-blind, randomised controlled trial

التفاصيل البيبلوغرافية
العنوان: Mercaptopurine versus placebo to prevent recurrence of Crohn's disease after surgical resection (TOPPIC): a multicentre, double-blind, randomised controlled trial
المؤلفون: Mowat, Craig, Arnott, Ian, Cahill, Aiden, Smith, Malcolm, Ahmad, Tariq, Subramanian, Sreedhar, Travis, Simon, Morris, John, Hamlin, John, Dhar, Anjan, Nwokolo, Chuka, Edwards, Cathryn, Creed, Tom, Bloom, Stuart, Thomas, Linzi, Campbell, Simon, Lewis, Stephen J, Sebastian, Shaji, Sen, Sandip, Yousif, Mohamed, Lal, Simon, Hawkey, Chris, Murray, Charles, Cummings, Fraser, Goh, Jason, Lindsay, James O, Arebi, Naila, Potts, Lindsay, McKinley, Aileen J, Thomson, John M, Todd, John A, Collie, Mhairi, Dunlop, Malcolm G, Mowat, Ashley, Gaya, Daniel R, Winter, Jack, Naismith, Graham D, Ennis, Holly, Keerie, Catriona, Lewis, Steff, Prescott, Robin J, Kennedy, Nicholas A, Satsangi, Jack
بيانات النشر: Elsevier BV
سنة النشر: 2016
المجموعة: The University of Liverpool Repository
الوصف: Background Up to 60% of patients with Crohn's disease need intestinal resection within the first 10 years of diagnosis, and postoperative recurrence is common. We investigated whether mercaptopurine can prevent or delay postoperative clinical recurrence of Crohn's disease. Methods We did a randomised, placebo-controlled, double-blind trial at 29 UK secondary and tertiary hospitals of patients (aged >16 years in Scotland or >18 years in England and Wales) who had a confirmed diagnosis of Crohn's disease and had undergone intestinal resection. Patients were randomly assigned (1:1) by a computer-generated web-based randomisation system to oral daily mercaptopurine at a dose of 1 mg/kg bodyweight rounded to the nearest 25 mg or placebo; patients with low thiopurine methyltransferase activity received half the normal dose. Patients and their carers and physicians were masked to the treatment allocation. Patients were followed up for 3 years. The primary endpoint was clinical recurrence of Crohn's disease (Crohn's Disease Activity Index >150 plus 100-point increase in score) and the need for anti-inflammatory rescue treatment or primary surgical intervention. Primary and safety analyses were by intention to treat. Subgroup analyses by smoking status, previous thiopurines, previous infliximab or methotrexate, previous surgery, duration of disease, or age at diagnosis were also done. This trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN89489788) and the European Clinical Trials Database (EudraCT number 2006-005800-15). Findings Between June 6, 2008, and April 23, 2012, 240 patients with Crohn's disease were randomly assigned: 128 to mercaptopurine and 112 to placebo. All patients received at least one dose of study drug, and no randomly assigned patients were excluded from the analysis. 16 (13%) of patients in the mercaptopurine group versus 26 (23%) patients in the placebo group had a clinical recurrence of Crohn's disease and needed anti-inflammatory rescue ...
نوع الوثيقة: article in journal/newspaper
اللغة: English
العلاقة: Collapse authors list. Mowat, Craig, Arnott, Ian, Cahill, Aiden, Smith, Malcolm, Ahmad, Tariq, Subramanian, Sreedhar orcid:0000-0002-6483-1730 , Travis, Simon, Morris, John, Hamlin, John, Dhar, Anjan et al (show 33 more authors) , Nwokolo, Chuka, Edwards, Cathryn, Creed, Tom, Bloom, Stuart, Thomas, Linzi, Campbell, Simon, Lewis, Stephen J, Sebastian, Shaji, Sen, Sandip, Yousif, Mohamed, Lal, Simon, Hawkey, Chris, Murray, Charles, Cummings, Fraser, Goh, Jason, Lindsay, James O, Arebi, Naila, Potts, Lindsay, McKinley, Aileen J, Thomson, John M, Todd, John A, Collie, Mhairi, Dunlop, Malcolm G, Mowat, Ashley, Gaya, Daniel R, Winter, Jack, Naismith, Graham D, Ennis, Holly, Keerie, Catriona, Lewis, Steff, Prescott, Robin J, Kennedy, Nicholas A and Satsangi, Jack (2016) Mercaptopurine versus placebo to prevent recurrence of Crohn's disease after surgical resection (TOPPIC): a multicentre, double-blind, randomised controlled trial. LANCET GASTROENTEROLOGY & HEPATOLOGY, 1 (4). pp. 273-282.
DOI: 10.1016/s2468-1253(16)30078-4
الإتاحة: https://doi.org/10.1016/s2468-1253Test(16)30078-4
http://livrepository.liverpool.ac.uk/3031914Test/
رقم الانضمام: edsbas.B3036319
قاعدة البيانات: BASE