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Safety Profile of Nifurtimox for Treatment of Chagas Disease in the United States

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ABSTRACT

We assessed the frequency and severity of adverse events (AEs) in 53 patients with Chagas disease treated with nifurtimox in a US clinic. There were 435 AEs, but 93.8% were mild. Moderate/severe AEs were associated with premature treatment cessation.

No MeSH data available.


Patient treatment outcomes. = Patients moving toward premature termination.  = Patients moving toward treatment completion.
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CIW477F1: Patient treatment outcomes. = Patients moving toward premature termination. = Patients moving toward treatment completion.

Mentions: Of the 42 patients who completed treatment, 2 required dose reductions, 8 underwent temporary suspension of treatment, and 6 had both (Figure 1). Five of the 14 interruptions in this group were due to AEs and 9 were from other factors such as running out of medication. Four patients required dose reduction (n = 1), temporary suspension of treatment (n = 1), or both (n = 2), but were still unable to complete the regimen. Although overall number of AEs was not associated with prematurely terminating treatment, experiencing moderate or severe AEs was a significant risk (OR, 3.82; P = .004; Table 4). In a survival analysis, the difference in completion between patients with and without moderate/severe AEs was significant in a log-rank (Mantel-Cox) test (P = .001). Mexican patients were more likely to stop treatment (OR, 2.29; P = .05), and 3 times as likely to experience moderate or severe AEs (Table 4), although the difference was only significant at P < .1.Table 4.


Safety Profile of Nifurtimox for Treatment of Chagas Disease in the United States
Patient treatment outcomes. = Patients moving toward premature termination.  = Patients moving toward treatment completion.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC5036918&req=5

CIW477F1: Patient treatment outcomes. = Patients moving toward premature termination. = Patients moving toward treatment completion.
Mentions: Of the 42 patients who completed treatment, 2 required dose reductions, 8 underwent temporary suspension of treatment, and 6 had both (Figure 1). Five of the 14 interruptions in this group were due to AEs and 9 were from other factors such as running out of medication. Four patients required dose reduction (n = 1), temporary suspension of treatment (n = 1), or both (n = 2), but were still unable to complete the regimen. Although overall number of AEs was not associated with prematurely terminating treatment, experiencing moderate or severe AEs was a significant risk (OR, 3.82; P = .004; Table 4). In a survival analysis, the difference in completion between patients with and without moderate/severe AEs was significant in a log-rank (Mantel-Cox) test (P = .001). Mexican patients were more likely to stop treatment (OR, 2.29; P = .05), and 3 times as likely to experience moderate or severe AEs (Table 4), although the difference was only significant at P < .1.Table 4.

View Article: PubMed Central - PubMed

ABSTRACT

We assessed the frequency and severity of adverse events (AEs) in 53 patients with Chagas disease treated with nifurtimox in a US clinic. There were 435 AEs, but 93.8% were mild. Moderate/severe AEs were associated with premature treatment cessation.

No MeSH data available.