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Prevalence of adverse events varies with the different oral isotretinoin brands in acne treatment: a retrospective observational study

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Abstract

Oral isotretinoin remains the most effective treatment for acne. The aim of this retrospective single-center cohort study was to estimate the prevalence of adverse events with the different oral isotretinoin brands used in acne treatment. The population consisted of all patients who consulted for acne between January 2015 and January 2020. The inclusion criterion was the initiation of treatment with oral isotretinoin. The exclusion criteria were the use of two or more brands during the same course of treatment and previous treatment with oral isotretinoin. Statistical analysis was carried out using Chi-square and Mann–Whitney tests. We analyzed 468 patients of whom 68.6% were female. The median age was 21 years. The median weight was 65 kg. The treatment was Roaccutane®, Curacné®, Acnotren®, Isosupra®, Contracné®, or Acnogen® in 44.2%, 28%, 14.5%, 10.5%, 1.7% and 0.4% of cases, respectively. Xerosis was the most frequently reported side effect regardless of the brand. The highest frequencies of hypercholesterolemia (25.6%) and eczema (13%) were noted with Roaccutane®; hypertriglyceridemia (16.8%), epistaxis (9.9%) and fatigue (3.1%) with Curacné®; excessive sweating (4.1%) and headache (4.1%) with Isosupra®; and abnormal liver function tests (11%) with Acnotren®. We found a significant correlation mainly between abnormal ASAT and Acnotren® (p = 0.009), hypercholesterolemia and Roaccutane® [OR = 1.652 (95% CI 1.056–2.585)], hypertriglyceridemia and higher body weight (p = 0.004). Factors related to the drug brand and to characteristics of acne patients could explain the variability in the prevalence of some adverse events.

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  1. Boutros Soutou and Joelle Sleiman have equally contributed to this work.

Authors and Affiliations

  1. Dermatology Department, Faculté de Médecine, Université Saint-Joseph, Beirut, Lebanon

    Boutros Soutou, Joelle Sleiman, Roland Tomb, Elio Kechichian & Josiane Helou

  2. Dermatology Department, Hôtel-Dieu de France University Hospital, Boulevard Alfred Naccache, Beirut, 16-6830, Lebanon

    Boutros Soutou, Joelle Sleiman, Roland Tomb, Elio Kechichian & Josiane Helou

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Contributions

BS and JS wrote the manuscript text and prepared the tables. BS and JH developed the concept and design. All authors contributed to data acquisition. BS and JS analyzed and interpreted the data with the remunerated assistance of a statistics specialist. All authors critically revised the manuscript for important intellectual content and had full access to all of the data in the study. They all take responsibility for the integrity of the data and the accuracy of the data analysis.

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Correspondence to Boutros Soutou.

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The study protocol was approved by the institution’s IRB committee (Reference Number: Tfem/2022/78).

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Soutou, B., Sleiman, J., Tomb, R. et al. Prevalence of adverse events varies with the different oral isotretinoin brands in acne treatment: a retrospective observational study. Arch Dermatol Res 315, 1533–1539 (2023). https://doi.org/10.1007/s00403-023-02532-6

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  • DOI: https://doi.org/10.1007/s00403-023-02532-6

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