Comparative clinical effectiveness and safety of super bioavailable itraconazole and conventional itraconazole in management of dermatophytosis: a retrospective data analysis

Abstract

<p class="abstract"><strong>Background:</strong> A newer itraconazole formulation i.e., super bioavailable itraconazole has been launched recently in India which is claimed to overcome all the pharmacokinetic challenges faced with conventional itraconazole. The present retrospective data analysis was undertaken to evaluate the effectiveness and safety of super bioavailable itraconazole in comparison with conventional itraconazole in the treatment of dermatophytosis in Indian patients.</p><p class="abstract"><strong>Methods:</strong> The present multi-centric, retrospective data analysis was done at 12 dermatological centers across India from July 2020 to December 2020. Medical records of patients of dermatophytosis, who were prescribed with either super bioavailable itraconazole 50 mg twice daily for four weeks or conventional itraconazole 100 mg twice daily for four weeks were included in the study.<strong></strong></p><p class="abstract"><strong>Results:</strong> 56% patients (n=30) in super bioavailable itraconazole group achieved complete clearance of their symptoms (cured) compared to only 34% patients (n=17) in conventional itraconazole group and this difference was statistically significant (p=0.02). Significantly more patients achieved complete clearance of their lesions in super bioavailable itraconazole-37 patients (69%) compared to conventional itraconazole group-25 patients (49%) at the end of 4 week therapy (p=0.04). The difference in total symptom score (∆TSS) in super bioavailable itraconazole group was more (5.81) as compared to conventional itraconazole group (4.75) (p=0.09). Both the treatment were well tolerated.</p><p class="abstract"><strong>Conclusions:</strong> From the findings of the present study, super bioavailable itraconazole was more effective with similar safety profile as compared to conventional itraconazole in the treatment of dermatophytosis.</p>

An Open-Label, Randomized, Double-Arm Clinical Trial to Compare the Effectiveness and Safety of Super Bioavailable Itraconazole Capsules and Itraconazole Capsules in the Management of Dermatophytosis in India

“…In a retrospective study by Mahajan et al published in 2021, 56% of the patients achieved complete clearance of their symptoms in the SBITZ group, whereas 34% achieved the same in the CITZ group (p<0.05). 15 From their results, the authors concluded that SBITZ was more effective than CITZ, with a similar safety profile, in the treatment of dermatophytosis. In addition, a retrospective cohort study by Ghate et al on SBITZ concluded that patients treated with SBITZ showed greater improvement in the clearance of symptoms as well as lesions in just 4 weeks.…”

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

“…In our study, majority of the patients were males, similar to as reported in previous studies in patients with superficial dermatophytic infection. [20][21][22] The low incidence of dermatophytic infections in females could be attributed to the comparatively low reporting of female patients to hospitals due to the social stigma, especially in the rural areas of our country. 23 However, isolated reports have also shown contrasting results with female prepondrance as seen in a study by Das and colleagues in India.…”

“…13,20,[26][27][28] Several previous studies have reported a higher effectiveness with SB-itraconazole versus the conventional itraconazole for the treatment of superficial dermatophytic infections. 17,20,22,29 Shenoy et al compared the efficacy and safety of SB-itraconazole (n=26) versus conventional itraconazole (n=33) in an open-label, randomized, double-arm clinical trial. In patients receiving SB-itraconazole, a clinical cure was reported within 4 weeks in about 65.38% of the patients including the naïve as well as recalcitrant cases.…”

“…17 In a real world retrospective data analysis study by Ghate et al in 2743 patients, a complete clinical cure rate was reported at 51%, with 46% patients showing clinical improvements at 4 weeks with SB-itraconazole for superficial dermatophytic infections. 22 The widespread usage of antifungal agents have led to an increase in the recalcitrant/recurrent dermatophytosis. 3 In India, the increased cases of recalcitrant/recurrent dermatophytosis is alarming.…”

Efficacy of Super-Bioavailable Itraconazole and Conventional Itraconazole at Different Dosing Regimens in Glabrous Tinea Infection - A Randomized Clinical Trial

“…The desired sample size of 87 patients in each group was calculated considering 90% power to reject the null hypothesis of zero effect size, with a population effect size of 0.53, 15 the significance level (alpha) was 0.05, using a two-sided z-test with a dropout rate of 15%.…”