Preprint Article Version 1 This version is not peer-reviewed

Real-World Evidence of the Effectiveness and Safety of Ciclopirox 8% HPCH Nail Lacquer Combined with Oral Antifungals for Onychomycosis Applying Artificial Intelligence to Electronic Health Records

Version 1 : Received: 24 July 2024 / Approved: 24 July 2024 / Online: 25 July 2024 (03:20:04 CEST)

How to cite: Roustan, G.; López Estébaranz, J. L.; De La Cueva, P.; Research Group, S.; Pajuelo, F.; Tamarit, M. L.; Valmaseda, A.; Galván, J. Real-World Evidence of the Effectiveness and Safety of Ciclopirox 8% HPCH Nail Lacquer Combined with Oral Antifungals for Onychomycosis Applying Artificial Intelligence to Electronic Health Records. Preprints 2024, 2024071944. https://doi.org/10.20944/preprints202407.1944.v1 Roustan, G.; López Estébaranz, J. L.; De La Cueva, P.; Research Group, S.; Pajuelo, F.; Tamarit, M. L.; Valmaseda, A.; Galván, J. Real-World Evidence of the Effectiveness and Safety of Ciclopirox 8% HPCH Nail Lacquer Combined with Oral Antifungals for Onychomycosis Applying Artificial Intelligence to Electronic Health Records. Preprints 2024, 2024071944. https://doi.org/10.20944/preprints202407.1944.v1

Abstract

A multicenter retrospective analysis of 408 patients diagnosed with onychomycosis and attended at three tertiary care Spanish hospitals was conducted to assess the effectiveness and safety of a combined treatment with ciclopirox 8% hydroxypropyl chitosan (CPX 8% HPCH) nail lacquer and oral antifungal agents (terbinafine, itraconazole, and fluconazole). Data were extracted and analyzed using the EHRead® technology based on natural language processing and machine learning and using SNOMED CT terminology. The median age was 51 years with a ratio male: female close to 1. Repeated nail trauma was the most common risk factor (7.1%). More than half of patients (56.6%) underwent fungal culture. Terbinafine was used in 67.7% of patients, itraconazole in 20.8%, and fluconazole in 11.5%. Treatment synchronicity distribution revealed that 59.1% of patients started concomitant treatment with CPX 8% HPCH and oral antifungals, 27.9% had initial oral antifungals, and 13% had initial nail lacquer. The response to treatment (positive response 15.7%, presumed positive 59.8%) was unrelated to treatment synchronicity or type of antifungal agent. Erythema (5.6%), diarrhea (4.9%) and fever (4.2%) were the most frequently registered potential adverse events. The present findings provide valuable insights for physicians paving the way for better management of patients with onychomycosis.

Keywords

onychomycosis; ciclopirox 8% HPCH; real-world data; machine learning; artificial intelligence; terbinafine; itraconazole; fluconazole

Subject

Medicine and Pharmacology, Pharmacology and Toxicology

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