Safety profile of nifurtimox and treatment interruption for chronic Chagas disease in Colombian adults
Author(s)
Javier Olivera, Mario
Cucunuba, Zulma M
Arturo Alvarez, Carlos
Santiago Nicholls, Ruben
Type
Journal Article
Abstract
Nifurtimox (NFX) is one of the approved drugs used to treat Chagas disease. Safety profile studies and
models on risk factors for treatment interruption in adults are scarce in Latin America. This study evaluated retrospectively
the medical records of adult Chagas disease patients treated with NFX between 2007 and 2012 in Bogotá, Colombia.
An accelerated failure time model was used, and associations were expressed as time ratio (TR). In total, 76 adult patients
with NFX were included: 60 (79.0%) completed 60 days of treatment, 61 (80.3%) presented adverse drug reactions
(ADRs), and 16 (21.0%) required treatment interruption. The predominant symptoms were epigastric pain (23.7%),
nauseas (18.4%), sleep disturbances (18.4%), loss of appetite (17.1%), and temporary loss of memory (15.2%). ADRs
were classified as mild (64.5%), moderate (30.4%), and severe (5.1%). Time of treatment was significantly longer when
presenting ≤ 3 ADRs (TR: 1.78; 95% CI: 1.04–3.03), presence of non-severe ADRs (TR: 6.52; 95% CI: 3.24–13.1),
doses of NFX ≤ 8 mg/kg/day (TR: 1.78; 95% CI: 0.90–3.49), and age < 48 years (TR: 1.57; 95% CI: 0.90–2.74). Treatment
with NFX in adults caused a high frequency of ADRs, but most of the cases were mild and did not require treatment
interruption. Severity and number of ADRs were the main predictors for treatment interruption.
models on risk factors for treatment interruption in adults are scarce in Latin America. This study evaluated retrospectively
the medical records of adult Chagas disease patients treated with NFX between 2007 and 2012 in Bogotá, Colombia.
An accelerated failure time model was used, and associations were expressed as time ratio (TR). In total, 76 adult patients
with NFX were included: 60 (79.0%) completed 60 days of treatment, 61 (80.3%) presented adverse drug reactions
(ADRs), and 16 (21.0%) required treatment interruption. The predominant symptoms were epigastric pain (23.7%),
nauseas (18.4%), sleep disturbances (18.4%), loss of appetite (17.1%), and temporary loss of memory (15.2%). ADRs
were classified as mild (64.5%), moderate (30.4%), and severe (5.1%). Time of treatment was significantly longer when
presenting ≤ 3 ADRs (TR: 1.78; 95% CI: 1.04–3.03), presence of non-severe ADRs (TR: 6.52; 95% CI: 3.24–13.1),
doses of NFX ≤ 8 mg/kg/day (TR: 1.78; 95% CI: 0.90–3.49), and age < 48 years (TR: 1.57; 95% CI: 0.90–2.74). Treatment
with NFX in adults caused a high frequency of ADRs, but most of the cases were mild and did not require treatment
interruption. Severity and number of ADRs were the main predictors for treatment interruption.
Date Issued
2015-12-09
Date Acceptance
2015-07-27
Citation
American Journal of Tropical Medicine and Hygiene, 2015, 93 (6), pp.1224-1230
ISSN
0002-9637
Publisher
American Society of Tropical Medicine and Hygiene
Start Page
1224
End Page
1230
Journal / Book Title
American Journal of Tropical Medicine and Hygiene
Volume
93
Issue
6
Copyright Statement
© 2015 by The American Society of Tropical Medicine and Hygiene.
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000366540800019&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Public, Environmental & Occupational Health
Tropical Medicine
BENZNIDAZOLE
MANAGEMENT
TOLERANCE
MODEL
Publication Status
Published
Date Publish Online
2015-12-09