PMID- 28554266
OWN - NLM
STAT- MEDLINE
DCOM- 20180430
LR  - 20220409
IS  - 1502-7708 (Electronic)
IS  - 0036-5521 (Linking)
VI  - 52
IP  - 9
DP  - 2017 Sep
TI  - Tolerability profile of thiopurines in inflammatory bowel disease: a prospective 
      experience.
PG  - 981-987
LID - 10.1080/00365521.2017.1333626 [doi]
AB  - OBJECTIVES: The occurrence of thiopurine-related adverse events (AEs) may 
      complicate the management of patients with inflammatory bowel disease (IBD). We 
      aimed to evaluate the tolerability of thiopurines in a current IBD setting. 
      MATERIALS AND METHODS: All consecutive patients who started a treatment with 
      azathioprine (AZA) from January 2010 to March 2016 were entered in a 
      prospectively maintained database, and the AEs which led to the permanent 
      discontinuation of the drug were reported. RESULTS: Two hundred and fifty three 
      patients were included. Median total follow-up was 32 months (range: 0.2-75 
      months). At the end of the study, AZA was discontinued in 160 patients (63.2%). 
      The main reason leading to drug withdrawal was the occurrence of AEs (109/160 
      patients [68.1%]; cumulative incidence among the entire cohort: 43.1%). Overall, 
      the most frequent AEs leading to treatment withdrawal were nausea (31/253 
      patients, 12.3%) and subjective symptoms, i.e., poorly defined side effects such 
      as fatigue, headache and muscle pain (20/253 patients, 7.9%). Among the 109 
      AZA-intolerant patients, a switch to 6-mercaptopurine (6-MP) was performed in 44 
      cases (40.4%). At the end of follow-up, 6-MP was discontinued in 35/44 patients 
      (79.5%), mostly due to AEs (29/35 patients, 82.8%). Azathioprine-induced hepatic 
      and pancreatic toxicity was associated with male gender (p = .01 and p = .03, 
      respectively), and occurrence of nausea with Crohn's disease (p = .04). 
      CONCLUSIONS: Our real-life prospective cohort showed the higher cumulative 
      incidence of thiopurine withdrawal due to AEs reported to date. Switching from 
      AZA to 6-MP was often ineffective.
FAU - Macaluso, Fabio Salvatore
AU  - Macaluso FS
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
FAU - Renna, Sara
AU  - Renna S
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
FAU - Maida, Marcello
AU  - Maida M
AD  - b Gastroenterology and Endoscopy Unit , "Villa Sofia-Cervello" Hospital , Palermo 
      , Italy.
FAU - Dimarco, Mariangela
AU  - Dimarco M
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
FAU - Sapienza, Chiara
AU  - Sapienza C
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
FAU - Affronti, Marco
AU  - Affronti M
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
FAU - Orlando, Emanuele
AU  - Orlando E
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
FAU - Rizzuto, Giulia
AU  - Rizzuto G
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
FAU - Orlando, Rosalba
AU  - Orlando R
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
FAU - Ventimiglia, Marco
AU  - Ventimiglia M
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
FAU - Cottone, Mario
AU  - Cottone M
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
FAU - Orlando, Ambrogio
AU  - Orlando A
AD  - a Di.Bi.M.I.S., Division of Internal Medicine , "Villa Sofia-Cervello" Hospital, 
      University of Palermo , Palermo , Italy.
LA  - eng
PT  - Journal Article
DEP - 20170529
PL  - England
TA  - Scand J Gastroenterol
JT  - Scandinavian journal of gastroenterology
JID - 0060105
RN  - 0 (Immunosuppressive Agents)
RN  - E7WED276I5 (Mercaptopurine)
RN  - MRK240IY2L (Azathioprine)
SB  - IM
MH  - Adult
MH  - Azathioprine/*adverse effects/therapeutic use
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/*adverse effects/therapeutic use
MH  - Inflammatory Bowel Diseases/*drug therapy
MH  - Italy
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Mercaptopurine/therapeutic use
MH  - Middle Aged
MH  - Nausea/epidemiology
MH  - Prospective Studies
OTO - NOTNLM
OT  - 6-Mercaptopurine
OT  - adverse events
OT  - azathioprine
OT  - safety
OT  - thiopurines
EDAT- 2017/05/31 06:00
MHDA- 2018/05/01 06:00
CRDT- 2017/05/31 06:00
PHST- 2017/05/31 06:00 [pubmed]
PHST- 2018/05/01 06:00 [medline]
PHST- 2017/05/31 06:00 [entrez]
AID - 10.1080/00365521.2017.1333626 [doi]
PST - ppublish
SO  - Scand J Gastroenterol. 2017 Sep;52(9):981-987. doi: 
      10.1080/00365521.2017.1333626. Epub 2017 May 29.