PMID- 26195525
OWN - NLM
STAT- MEDLINE
DCOM- 20160706
LR  - 20220321
IS  - 1098-6596 (Electronic)
IS  - 0066-4804 (Print)
IS  - 0066-4804 (Linking)
VI  - 59
IP  - 10
DP  - 2015 Oct
TI  - Toxic Profile of Benznidazole in Patients with Chronic Chagas Disease: Risk 
      Factors and Comparison of the Product from Two Different Manufacturers.
PG  - 6125-31
LID - 10.1128/AAC.04660-14 [doi]
AB  - Benznidazole is considered the first-line treatment option against Chagas 
      disease. The major drawback of benznidazole is its toxicity profile. The main 
      objectives of this study were to describe the adverse events (AEs) in patients 
      with chronic Chagas disease treated with benznidazole, determine the risk factors 
      involved and compare the toxic profiles of two different preparations of the drug 
      from ELEA and Roche. A total of 746 patients were diagnosed with Chagas disease 
      in a 5-year period, and of these 472 were treated with benznidazole. A high 
      proportion of patients (n = 360 [76%]) suffered AEs, the most frequent being 
      those related to hypersensitivity (52.9% of patients), headache (12.5%), and 
      epigastric pain (10.4%). In 72 (12.7%) cases, treatment was discontinued. 
      Overall, women had a higher incidence of AEs compared to men (81.3% versus 66%, P 
      = 0.001) and were subject to higher levels of hypersensitivity-related events. 
      Dermatological events, digestive tract manifestations, and general symptoms had a 
      greater likelihood to appear around day 10 and neurological AEs around day 40 
      after starting treatment. With respect to liver function and hematological tests, 
      the majority of patients did not suffer significant perturbation of liver enzymes 
      or altered blood cell counts. However, 14 patients suffered from neutropenia, and 
      14 patients had aminotransferase levels that were more than four times the upper 
      limit of the normal range. Patients treated with the ELEA benznidazole product 
      experienced more arthromyalgia, neutropenia, and neurological disorders (mainly 
      paresthesias) than those treated with the Roche product. Both drug products 
      resulted in approximately the same percentage of permanent withdrawals.
CI  - Copyright (c) 2015, American Society for Microbiology. All Rights Reserved.
FAU - Molina, I
AU  - Molina I
AD  - Infectious Disease Department, Vall d'Hebron Teaching Hospital, and International 
      Health Program of the Catalan Institute of Health (PROSICS) Barcelona, 
      Universitat Autonoma de Barcelona, Barcelona, Spain imolina@vhebron.net.
FAU - Salvador, F
AU  - Salvador F
AD  - Infectious Disease Department, Vall d'Hebron Teaching Hospital, and International 
      Health Program of the Catalan Institute of Health (PROSICS) Barcelona, 
      Universitat Autonoma de Barcelona, Barcelona, Spain.
FAU - Sanchez-Montalva, A
AU  - Sanchez-Montalva A
AD  - Infectious Disease Department, Vall d'Hebron Teaching Hospital, and International 
      Health Program of the Catalan Institute of Health (PROSICS) Barcelona, 
      Universitat Autonoma de Barcelona, Barcelona, Spain.
FAU - Trevino, B
AU  - Trevino B
AD  - Special Program for Infectious Diseases Vall d'Hebron-Drassanes, PROSICS 
      Barcelona, Universitat Autonoma de Barcelona, Barcelona, Spain.
FAU - Serre, N
AU  - Serre N
AD  - Special Program for Infectious Diseases Vall d'Hebron-Drassanes, PROSICS 
      Barcelona, Universitat Autonoma de Barcelona, Barcelona, Spain.
FAU - Sao Aviles, A
AU  - Sao Aviles A
AD  - Infectious Disease Department, Vall d'Hebron Teaching Hospital, and International 
      Health Program of the Catalan Institute of Health (PROSICS) Barcelona, 
      Universitat Autonoma de Barcelona, Barcelona, Spain.
FAU - Almirante, B
AU  - Almirante B
AD  - Infectious Disease Department, Vall d'Hebron Teaching Hospital, and International 
      Health Program of the Catalan Institute of Health (PROSICS) Barcelona, 
      Universitat Autonoma de Barcelona, Barcelona, Spain.
LA  - eng
PT  - Journal Article
DEP - 20150720
PL  - United States
TA  - Antimicrob Agents Chemother
JT  - Antimicrobial agents and chemotherapy
JID - 0315061
RN  - 0 (Nitroimidazoles)
RN  - YC42NRJ1ZD (benzonidazole)
SB  - IM
MH  - Adult
MH  - Chagas Disease/*drug therapy
MH  - Chronic Disease
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nitroimidazoles/*adverse effects/therapeutic use
MH  - Prospective Studies
MH  - Risk Factors
MH  - Treatment Outcome
PMC - PMC4576116
EDAT- 2015/07/22 06:00
MHDA- 2016/07/07 06:00
PMCR- 2016/04/01
CRDT- 2015/07/22 06:00
PHST- 2014/10/29 00:00 [received]
PHST- 2015/07/15 00:00 [accepted]
PHST- 2015/07/22 06:00 [entrez]
PHST- 2015/07/22 06:00 [pubmed]
PHST- 2016/07/07 06:00 [medline]
PHST- 2016/04/01 00:00 [pmc-release]
AID - AAC.04660-14 [pii]
AID - 04660-14 [pii]
AID - 10.1128/AAC.04660-14 [doi]
PST - ppublish
SO  - Antimicrob Agents Chemother. 2015 Oct;59(10):6125-31. doi: 10.1128/AAC.04660-14. 
      Epub 2015 Jul 20.