DOI: https://dx.doi.org/10.18203/issn.2455-4529.IntJResDermatol20222363
Published: 2022-09-17

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


SUBA, Super bioavailable itraconazole, Superficial dermatophytic infections

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References


Gupta C, Tripathi K, Tiwari S, Rathore Y, Nema S, Dhanvijay A. Current trends of clinicomycological profile of dermatophytosis in Central India. IOSR-JDMS. 2014;13:23-6.

Havlickova B, Czaika VA, Friedrich M. Epidemiological trends in skin mycoses worldwide. Mycoses. 2008;51(4):2-15.

Verma SB, Panda S, Nenoff P, Singal A, Rudramurthy SM, Uhrlass S, et al. The unprecedented epidemic-like scenario of dermatophytosis in India: I. Epidemiology, risk factors and clinical features. Indian J Dermatol Venereol Leprol. 2021;87.

Singh A, Masih A, Khurana A, Singh PK, Gupta M, Hagen F, et al. High terbinafine resistance in Trichophyton interdigitale isolates in Delhi, India harbouring mutations in the squalene epoxidase gene. Mycoses 2018;61:477-84.

Das S, De A, Saha R, Sharma N, Khemka M, Singh S, et al. The Current Indian Epidemic of Dermatophytosis: A Study on Causative Agents and Sensitivity Patterns. Indian J Dermatol. 2020;65:118-22.

Sahoo AK, Mahajan R. Management of tinea corporis, tinea cruris, and tinea pedis: A comprehensive review. Indian Dermatol Online J. 2016;7:77-86.

Jerajani H, Janaki C, Kumar S, Phiske M. Comparative assessment of the efficacy and safety of sertaconazole (2%) cream versus terbinafine cream (1%) versus luliconazole (1%) cream in patients with dermatophytoses: a pilot study. Indian J Dermatol. 2013;58:34.

Bishnoi A, Vinay K, Dogra S. Emergence of recalcitrant dermatophytosis in India. Lancet Infect Dis. 2018;18:250-1.

Rajagopalan M, Inamadar A, Mittal A, Miskeen AK, Srinivas CR, Sardana K, et al. Expert Consensus on The Management of Dermatophytosis in India (ECTODERM India). BMC Dermatol. 2018;18:6.

Potter M, Donnelly JP. The role of itraconazole in preventing and treating systemic fungal infections in immunocompromised patients. Acta Haematol. 2004;111:175-80.

Grant SM, Clissold SP. Itraconazole. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in superficial and systemic mycoses. Drugs. 1989;37:310-44.

Isoherranen N, Kunze KL, Allen KE, Nelson WL, Thummel KE. Role of itraconazole metabolites in CYP3A4 inhibition. Drug Metab Dispos. 2004;32:1121-31.

Sardana K, Mathachan SR. Super Bioavailable Itraconazole and Its Place and Relevance in Recalcitrant Dermatophytosis: Revisiting Skin Levels of Itraconazole and Minimum Inhibitory Concentration Data. Indian Dermatol Online J. 2021;12:1-5.

Jaruratanasirikul S, Kleepkaew A. Influence of an acidic beverage (Coca-Cola) on the absorption of itraconazole. Eur J Clin Pharmacol. 1997;52:235-7.

Lange D, Pavao JH, Wu J, Klausner M. Effect of a cola beverage on the bioavailability of itraconazole in the presence of H2 blockers. J Clin Pharmacol. 1997;37:535-40.

Van Peer A, Woestenborghs R, Heykants J, Gasparini R, Gauwenbergh G. The effects of food and dose on the oral systemic availability of itraconazole in healthy subjects. Eur J Clin Pharmacol. 1989;36:423-6.

Verma SB. Emergence of recalcitrant dermatophytosis in India. Lancet Infect Dis. 2018;18:718-9.

Verma SB, Zouboulis C. Indian irrational skin creams and steroid-modified dermatophytosis - an unholy nexus and alarming situation. J Eur Acad Dermatol Venereol. 2018;32:426-7.

Hu Y, Yang LJ, Wei L, Dai XY, Hua HK, Qi J, et al. Study on the compliance and safety of the oral antifungal agents for the treatment of onychomycosis. Zhonghua Liu Xing Bing Xue Za Zhi. 2005;26:988-91.

Bhatia VK, Sharma PC. Epidemiological studies on Dermatophytosis in human patients in Himachal Pradesh, India. SpringerPlus. 2014;3:134.

Verma S, Madhu R. The Great Indian Epidemic of Superficial Dermatophytosis: An Appraisal. Indian J Dermatol. 2017;62:227-36.

Mahajan H, Dhoot D, Deshmukh G, Barkate H. Comparative clinical effectiveness and safety of super bioavailable itraconazole and conventional itraconazole in management of dermatophytosis: a retrospective data analysis. Int J Res Dermatol. 2021;7:388-94.

Sharma M, Sharma R. Profile of dermatophytic and other fungal infections in jaipur. Indian J Microbiol. 2012;52:270-4.

Perea S, Ramos MJ, Garau M, Gonzalez A, Noriega AR, del Palacio A. Prevalence and risk factors of tinea unguium and tinea pedis in the general population in Spain. J Clin Microbiol. 2000;38:3226-30.

Haria M, Bryson HM, Goa KL. Itraconazole. A reappraisal of its pharmacological properties and therapeutic use in the management of superficial fungal infections. Drugs. 1996;51:585-620.

Abbotsford J, Foley DA, Goff Z, Bowen AC, Blyth CC, Yeoh DK. Clinical experience with SUBA-itraconazole at a tertiary paediatric hospital. J Antimicrob Chemother. 2021;76:249-52.

Abuhelwa AY, Foster DJ, Mudge S, Hayes D, Upton RN. Population pharmacokinetic modeling of itraconazole and hydroxyitraconazole for oral SUBA-itraconazole and sporanox capsule formulations in healthy subjects in fed and fasted states. Antimicrob Agents Chemother. 2015;59:5681-96.

Lindsay J, Mudge S, Thompson GR, 3rd. Effects of Food and Omeprazole on a Novel Formulation of Super Bioavailability Itraconazole in Healthy Subjects. Antimicrob Agents Chemother. 2018;62.

Shenoy M, Dhoot D, Mahajan H, Barkate H. 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. Clin Cosmet Investig Dermatol. 2021;14:1367-76.

Bishnoi A, Vinay K, Dogra S. Emergence of recalcitrant dermatophytosis in India. Lancet Infect Dis. 2018;18:250-1.

Verma S, Topical corticosteroid modified superficial dermatophytosis: morphological patterns, in A Treatise on Topical Corticosteroids in Dermatology. Springer. 2018;151-8.

Vishwanath V, Londhe P, Tare D, Deshmukh G, Dhoot D, Barkate H. Effectiveness and safety of combination of Itraconazole and Amorolfine in management of patients with recalcitrant multi-site dermatophytosis who failed previous combination antifungal therapy. IP Indian J Clin Exp Dermatol. 2020;6.

Sardana K, Gupta A, Sadhasivam S, Gautam RK, Khurana A, Saini S, et al. Checkerboard Analysis To Evaluate Synergistic Combinations of Existing Antifungal Drugs and Propylene Glycol Monocaprylate in Isolates from Recalcitrant Tinea Corporis and Cruris Patients Harboring Squalene Epoxidase Gene Mutation. Antimicrob Agents Chemother. 2021;65:e0032121.

Barone JA, Koh JG, Bierman RH, Colaizzi JL, Swanson KA, Gaffar MC, et al. Food interaction and steady-state pharmacokinetics of itraconazole capsules in healthy male volunteers. Antimicrob Agents Chemother. 1993;37:778-84.

Lindsay J, Mudge S, Thompson GR, 3rd. Effects of Food and Omeprazole on a Novel Formulation of Super Bioavailability Itraconazole in Healthy Subjects. Antimicrob Agents Chemotherap. 2018;62:e01723-18.