PMID- 18175075
OWN - NLM
STAT- MEDLINE
DCOM- 20080612
LR  - 20220801
IS  - 1590-1874 (Print)
IS  - 1590-1874 (Linking)
VI  - 28
IP  - 6
DP  - 2007 Dec
TI  - Azathioprine. Safety profile in multiple sclerosis patients.
PG  - 299-303
LID - 10.1007/s10072-007-0842-9 [doi]
AB  - Azathioprine (Aza) has been proposed in the treatment of multiple sclerosis (MS) 
      since 1971 and continues to be used in MS Clinical Centres. Recent data, 
      suggesting its efficacy in reducing MRI lesion load and in refractory IFN-treated 
      MS patients, has renewed interest in this drug. Its therapeutic index over other 
      immunosuppressive agents is generally considered favourable, but concerns about a 
      possible risk of malignancy have limited its use. On the other hand, the 
      occurrence of unexpected adverse events (AEs) in clinical trials in recent years 
      has aroused the interest in the safety profile of the drugs. No systematic review 
      of AEs in patients affected by MS is available. The aim of this study is to 
      review the safety profile of the drug in patients affected by MS, in order to 
      support a correct management of these patients in the clinical practice. The 
      controlled and observational clinical studies published between 1971 and 2007 
      have been included. The AEs have been registered in ad hoc form and the frequency 
      has been calculated. The risk of cancer and toxicity on reproductive function has 
      been also considered. Gastrointestinal complaints and leukopenia are the most 
      frequent AEs of Aza therapy in MS, occurring in more than 10% of the patients, 
      while infections, allergy, anaemia, thrombocytopenia and pancytopenia are common 
      (>1%-<10%). Pancreatitis is not common (>0.1%-<1%). Most of them are easily 
      managed by dosage adjustment or therapy interruption. The cancer risk increases 
      with the treatment duration and cumulative dose. No data on reproductive toxicity 
      in MS treated with Aza are available. The safety profile of Aza is acceptable, if 
      strategies for management of expected AEs are adopted, following dosage and 
      treatment duration indications, and if long-term monitoring to evaluate the risk 
      of cancer is warranted.
FAU - La Mantia, L
AU  - La Mantia L
AD  - Dipartimento di Neuroscienze, Multiple Sclerosis Center Fondazione IRCCS Istituto 
      Neurologico C. Besta, Via Celoria 11, Milan, Italy. msgroup@istituto-besta.it
FAU - Mascoli, N
AU  - Mascoli N
FAU - Milanese, C
AU  - Milanese C
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
PL  - Italy
TA  - Neurol Sci
JT  - Neurological sciences : official journal of the Italian Neurological Society and 
      of the Italian Society of Clinical Neurophysiology
JID - 100959175
RN  - 0 (Immunosuppressive Agents)
RN  - MRK240IY2L (Azathioprine)
SB  - IM
MH  - Azathioprine/*therapeutic use
MH  - Databases, Factual/statistics & numerical data
MH  - *Drug Evaluation
MH  - Humans
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Longitudinal Studies
MH  - Magnetic Resonance Imaging/methods
MH  - Multiple Sclerosis/*drug therapy
MH  - Retrospective Studies
RF  - 42
EDAT- 2008/01/05 09:00
MHDA- 2008/06/13 09:00
CRDT- 2008/01/05 09:00
PHST- 2008/01/05 09:00 [pubmed]
PHST- 2008/06/13 09:00 [medline]
PHST- 2008/01/05 09:00 [entrez]
AID - 10.1007/s10072-007-0842-9 [doi]
PST - ppublish
SO  - Neurol Sci. 2007 Dec;28(6):299-303. doi: 10.1007/s10072-007-0842-9.