DOI: http://dx.doi.org/10.18203/issn.2455-4529.IntJResDermatol20211427

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

Harshal Mahajan, Dhiraj Dhoot, Gaurav Deshmukh, Hanmant Barkate

Abstract


Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.


Keywords


Super bioavailable itraconazole, Dermatophytosis, Effectiveness, Safety, Conventional itraconazole

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References


Sardana K, Khurana A, Singh A, Gautam RK. A pilot analysis of morphometric assessment of itraconazole brands using dermoscopy and its relevance in the current scenario. Indian Dermatol Online J. 2018;9(6):426-31.

Abuhelwa AY, Foster DJR, Mudge S, Hayes D, Upton RN. Population pharmacokinetic modeling of itraconazole and hydroxyl itraconazole for oral SUBA-itraconazole and Sporanox capsule formulations in healthy subjects in fed and fasted states. Antimicrob Agents Chemother. 2015;59(9):5681-96.

Australian Product Information. Lozanoc (itraconazole) capsules. Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2014-PI-01749-1&d=202009031016933. Accessed 15 March 2021.

Lindsay J, Mudge S, Thompson G. Effects of food and omeprazole on a novel formulation of super bioavailability itraconazole in healthy subjects. Antimicrob Agents Chemother. 2018;62(12):01723-18.

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):1-5.

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.

Kandhari S, Prabhat P, Rengarajan M, Dogra S, Nayak C, Banerjee D, et al. Consensus on Management of Dermatophytosis and Vulvovaginal Infections in Non- Pregnant and Pregnant Females. J Gynecol Obstetr. 2020;8(6):195-210.

Mahajan H, Dhoot D, Barkate H. Clinical assessment of itraconazole in dermatophytosis (CLEAR Study): a retrospective evaluation. Int J Sci Stud. 2020;8(2):1-5.

Prentice AG, Glasmacher A. Making sense of itraconazole pharmacokinetics. J Antimicrob Chemother. 2005;56(1):17-22.

NIH U.S. National Library of Medicine. Fact sheet: Study comparing SUBA™-Itraconazole with SPORANOX® (itraconazole) in the treatment of onychomycosis. Available at: https://clinicaltrials.gov/ct2/show/NCT00791219?term=suba+itraconazole&draw=2&rank=4. Accessed on 21 February 2021.

Brouwers J, Geboers S, Mols R, Tack J, Augustijns P. Gastrointestinal behavior of itraconazole in humans - Part 1: Supersaturation from a solid dispersion and a cyclodextrin-based solution. Int J Pharm. 2017;525(1):211-7.

Label. Fact sheet: Sporanox®(Itraconazole) capsules. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020083s048s049s050lbl.pdf. Accessed on 22 February 2021.

Abuhelwa AY, Mudge S, Hayes D, Upton RN, Foster DJR. Population in vitro-in vivo correlation model linking gastrointestinal transit time, ph, and pharmacokinetics: itraconazole as a model drug. Pharm Res. 2016;33(7):1782-94.

Cauwenbergh G, De Greef H, Heykants J, Woestenborghs R, Rooy PV, Haeverans K. Pharmacokinetic profile of orally itraconazole in human skin administered. J Am Acad Dermatol. 1988;18:263-8.

Verma S, Madhu R. The great Indian epidemic of superficial dermatophytosis: an appraisal. Indian J Dermatol. 2017;62(3):227-36.

Lindsay J, Sandaradura I, Wong K, Arthur C, Stevenson W, Kerridge I. Serum levels, safety and tolerability of new formulation SUBA-itraconazole prophylaxis in patients with haematological malignancy or undergoing allogeneic stem cell transplantation. J Antimicrob Chemother. 2017;72(12):3414-9.