02880nas a2200265   4500000000100000008004100001260001000042653002000052653001700072653003800089653003900127653001500166100001400181700001600195700001700211700001500228700001600243700001300259700001400272700001500286245022500301856006300526520200000589022002502589       2025                            d  bWiley10aChagas' disease10aBenznidazole10aSevere cutaneous adverse reaction10arandomized controlled trials (RCT)10aNifurtimox1 aVillar JC1 aSaavedra MF1 aBermúdez PA1 aHerrera EV1 aVásquez SM1 aArango H1 aCamacho A1 aOlivera MJ00aCutaneous reactions during treatment with Nifurtimox or Benznidazole among <i>Trypanosoma cruzi</i> seropositive adults without symptomatic cardiomyopathy: A safety sub analysis of a placebo‐controlled randomised trial  uhttps://onlinelibrary.wiley.com/doi/epdf/10.1111/tmi.141233 a<p><strong>Objectives: </strong>To determine, in a randomised placebo‐controlled trial, if cutaneous adverse reactions during treatment (CARDT) with Benznidazole occur as often as with Nifurtimox, and whether the dose and duration of treatment change that frequency.</p>

<p><strong>Methods:</strong> We conducted the EQUITY trial (NCT02369978), allocating Trypanosoma cruzi seropositive adults with no apparent clinical disease to a 120‐day, blinded treatment with Benznidazole, Nifurtimox, or Placebo (ratio 2:2:1). Active treatment groups included either 60‐day conventional‐dose (60CD) regimens (Benznidazole 300 mg/day or Nifurtimox 480 mg/day, followed or preceded by, 60 days of placebo) or 120‐day half‐dose (120HD) regimens (Benznidazole 150 mg/day or Nifurtimox 240 mg/day). CARDT had blinded adjudication as moderate to severe during the follow‐up visits.</p>

<p><strong>Results:</strong> Among 307 participants, 42 CARDT (17.1%, 95% confidence interval [CI] 12.6–22.4) occurred in 246 receiving active treatment, compared to two CARDT (3.3%, 95% CI 0.0–11.3) in 61 participants receiving placebo. In 122 patients treated with Benznidazole, there were 31 CARDT (25.4%, including eight severe), compared to 11 CARDT (8.9%, including four severe) in 124 individuals treated with Nifurtimox (p &lt; 0.001). Among the 125 participants assigned to the 120HD regimen, there were 26 CARDT (20.8%, including six severe), compared to 16 CARDT (13.2%, including six severe) among 121 in the 60CD group (p = 0.005). The agent‐regime interaction was not significant (p = 0.443). Eleven participants (25%) with CARDT did not complete their treatment.</p>

<p><strong>Conclusion</strong>: CARDT occurred more frequently with Benznidazole treatment, particularly with longer exposure despite the half‐dose regimen. Clinicians should consider these differences when discussing treatment options with patients receiving nitro derivative agents.</p>
  a1360-2276, 1365-3156