PMID- 27432838
OWN - NLM
STAT- MEDLINE
DCOM- 20171222
LR  - 20240323
IS  - 1537-6591 (Electronic)
IS  - 1058-4838 (Print)
IS  - 1058-4838 (Linking)
VI  - 63
IP  - 8
DP  - 2016 Oct 15
TI  - Safety Profile of Nifurtimox for Treatment of Chagas Disease in the United 
      States.
PG  - 1056-1062
LID - 10.1093/cid/ciw477 [doi]
AB  - BACKGROUND: Nifurtimox is 1 of only 2 medications available for treating Chagas 
      disease (CD) and currently the only drug available in the United States, but its 
      safety and tolerance have not been extensively studied. This is the first study 
      to evaluate tolerance of nifurtimox in US patients with CD. METHODS: This 
      investigation assessed side effects in a sample of 53 patients with CD, all Latin 
      American immigrants, who underwent treatment with nifurtimox (8-10 mg/kg in 3 
      daily doses for 12 weeks) from March 2008 to July 2012. The frequency and 
      severity of adverse events (AEs) was recorded. RESULTS: A total of 435 AEs were 
      recorded; 93.8% were mild, 3.0% moderate, and 3.2% severe. Patients experienced a 
      mean of 8.2 AEs; the most frequent were anorexia (79.2%), nausea (75.5%), 
      headache (60.4%), amnesia (58.5%), and >5% weight loss (52.8%). Eleven patients 
      (20.8%) were unable to complete treatment. Experiencing a moderate or severe AE 
      (odds ratio [OR], 3.82; P < .05) and Mexican nationality (OR, 2.29; P < .05) were 
      significant predictors of treatment discontinuation, but sex and cardiac 
      progression at baseline were not. Patients who did not complete treatment 
      experienced nearly 3 times more AEs per 30-day period (P = .05). CONCLUSIONS: 
      Nifurtimox produces frequent side effects, but the majority are mild and can be 
      managed with dose reduction and/or temporary suspension of medication. The high 
      frequency of gastrointestinal symptoms and weight loss mirrors results from prior 
      investigations. Special attention should be paid during the early stages of 
      treatment to potentially severe symptoms including depression, rash, and anxiety.
CI  - (c) The Author 2016. Published by Oxford University Press for the Infectious 
      Diseases Society of America.
FAU - Forsyth, Colin J
AU  - Forsyth CJ
AD  - Center of Excellence for Chagas Disease, Olive View-University of California, Los 
      Angeles Medical Center, Sylmar.
FAU - Hernandez, Salvador
AU  - Hernandez S
AD  - Center of Excellence for Chagas Disease, Olive View-University of California, Los 
      Angeles Medical Center, Sylmar.
FAU - Olmedo, Wilman
AU  - Olmedo W
AD  - Center of Excellence for Chagas Disease, Olive View-University of California, Los 
      Angeles Medical Center, Sylmar.
FAU - Abuhamidah, Adieb
AU  - Abuhamidah A
AD  - Center of Excellence for Chagas Disease, Olive View-University of California, Los 
      Angeles Medical Center, Sylmar.
FAU - Traina, Mahmoud I
AU  - Traina MI
AD  - Center of Excellence for Chagas Disease, Olive View-University of California, Los 
      Angeles Medical Center, Sylmar.
FAU - Sanchez, Daniel R
AU  - Sanchez DR
AD  - Center of Excellence for Chagas Disease, Olive View-University of California, Los 
      Angeles Medical Center, Sylmar.
FAU - Soverow, Jonathan
AU  - Soverow J
AD  - Center of Excellence for Chagas Disease, Olive View-University of California, Los 
      Angeles Medical Center, Sylmar.
FAU - Meymandi, Sheba K
AU  - Meymandi SK
AD  - Center of Excellence for Chagas Disease, Olive View-University of California, Los 
      Angeles Medical Center, Sylmar.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20160717
PL  - United States
TA  - Clin Infect Dis
JT  - Clinical infectious diseases : an official publication of the Infectious Diseases 
      Society of America
JID - 9203213
RN  - 0 (Trypanocidal Agents)
RN  - M84I3K7C2O (Nifurtimox)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Chagas Disease/*drug therapy/epidemiology/parasitology
MH  - Drug-Related Side Effects and Adverse Reactions/diagnosis/*epidemiology/*etiology
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Male
MH  - Middle Aged
MH  - Nifurtimox/*adverse effects/therapeutic use
MH  - Phenotype
MH  - Risk Factors
MH  - Severity of Illness Index
MH  - Symptom Assessment
MH  - Treatment Outcome
MH  - Trypanocidal Agents/*adverse effects/therapeutic use
MH  - Trypanosoma cruzi
MH  - United States/epidemiology
PMC - PMC5036918
OTO - NOTNLM
OT  - Chagas disease
OT  - Trypanosoma cruzi
OT  - benznidazole
OT  - nifurtimox
OT  - side effects
EDAT- 2016/07/20 06:00
MHDA- 2017/12/23 06:00
PMCR- 2016/07/17
CRDT- 2016/07/20 06:00
PHST- 2016/06/03 00:00 [received]
PHST- 2016/07/06 00:00 [accepted]
PHST- 2016/07/20 06:00 [entrez]
PHST- 2016/07/20 06:00 [pubmed]
PHST- 2017/12/23 06:00 [medline]
PHST- 2016/07/17 00:00 [pmc-release]
AID - ciw477 [pii]
AID - 10.1093/cid/ciw477 [doi]
PST - ppublish
SO  - Clin Infect Dis. 2016 Oct 15;63(8):1056-1062. doi: 10.1093/cid/ciw477. Epub 2016 
      Jul 17.