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A multicenter, retrospective study to evaluate the effectiveness, safety, and utilization patterns of super bioavailable itraconazole 50 mg in superficial dermatophytic infections

Vinod Khanna, Juzer Hussain, Shruti Patel, Dixit Patel, Alok Chaturvedi, Ankita Shah

Abstract:Background: Objectives of the study were to assess the clinical characteristics of patients with superficial dermatophytic infections, and to evaluate the safety and effectiveness of super bioavailable (SB) itraconazole 50 mg. Methods: In this cross-sectional observational study, data of patients with superficial dermatophytic infections treated as per physician’s discretion was collected retrospectively from 71 centers across India between April 2021 and March 2022. Patient’s demographics, prescribing patterns of SB-itraconazole, and clinician-rated effectiveness and safety were evaluated.Results: Of 432 analyzed patients, 72.22% (n=312) had new infections, 27.77% (n=120) had recalcitrant/recurrent infections. Majority of the patients were males (66%) and aged 21-40 years (72.45%). Tinea corporis (27.08%) was the most common fungal infection followed by Tinea cruris (20.60%). SB-itraconazole was most commonly prescribed with water (63.88%; n=276); majority (55.8%) of the patients received SB-itraconazole post-meals. Majority of the patients achieved clinical (naïve: 71.47%; recalcitrant: 79.17%) cures within 4 weeks. The efficacy was excellent/good in 71.95% of patients who received SB-itraconazole as the first choice over conventional itraconazole for overall benefits as per the clinician’s global assessment; and in 87.22% of patients who received concomitant acid-lowering drugs. Most (83.33%) patients reported excellent/good compliance with SB-itraconazole. The clinicians’ rated this newer formulation of itraconazole (SB-itraconazole) as excellent/good in efficacy (83.33%) and safety (79.17%) for most patients. Conclusions: SB-itraconazole was effective and safe in patients with superficial dermatophytic infections. The effectiveness of SB-itraconazole was similar with high response rates for naïve and recalcitrant cases. Further, the efficacy was excellent/good in most patients receiving SB-itraconazole as the first choice over conventional itraconazole, or who received concomitant acid-lowering drugs.
Keywords: safety / efficacy / strong / patients with superficial dermatophytic infections / conventional itraconazole / received concomitant

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