title: Safety Profile of Nifurtimox and Treatment Interruption for Chronic Chagas Disease in Colombian Adults.
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.
authors.forename: Mario Javier
authors.initials: MJ
authors.lastname: Olivera
authors.forename: Zulma M
authors.initials: ZM
authors.lastname: Cucunubá
authors.forename: Carlos Arturo
authors.initials: CA
authors.lastname: Álvarez
authors.forename: Rubén Santiago
authors.initials: RS
authors.lastname: Nicholls
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000981:Antiprotozoal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014355:Chagas Disease / Q000188:drug therapy*; D002908:Chronic Disease; D003105:Colombia; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009547:Nifurtimox / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D013997:Time Factors; D055815:Young Adult
chemical_list: D000981:Antiprotozoal Agents; D009547:Nifurtimox