The GENDER ATTENTION Observational Study: Gender and Hormonal Status Differences in the Incidence of Adverse Events During Cyclosporine Treatment in Psoriatic Patients

Maria Rita Bongiorno, Lucia Simoni, Gino Antonio Vena, Serafinella Patrizia Cannavò, Angelo Cattaneo, Enzo Berardesca, Emanuela Zagni, Gilberto Bellia, Alberico Motolese, Stefano Piaserico, Luca Stingeni, Anna Lanzoni, Alessandra Ori, Enrico Colombo, Salvatore Amato, Dario Donadio, Giuseppe Stinco, Giuseppe Lembo, Delia Colombo, Chiara LongagnaniConcetta Potenza, Patrizio Sedona, Alessandro Zullo, Francesca Trevisan, Andrea Locatelli, Saide Sala, Giovanna Magri, Rossella Ceschini, Piergiacomo Calzavara Pinton, Giovanni Gualberto Fiori, Christian Amici, Alessandro Zullo, Maurizio Germino, Stefano Donelli, Calcedonio Cannarozzo, Giovanni Borroni, Stefano Piaserico, Giancarlo Valenti, Francesca Trevisan, Sergio Chimenti, Saide Sala, Marco Marconi, Monica Pau, Enrico Colombo, Monica Pau, Patrizio Sedona, Leonardo Zichichi, Maurizio Congedo, Sergio Di Nuzzo, Cleto Veller Fornasa, Maria Laura Flori, Cristina Magnoni, Raffaele Filotico, Francesco Cusano, Alessandra Graziottin, Maria Rita Bongiorno, Giuseppe Ricotti, Nicoletta Cassano, Angelo Piccirillo, Ornella De Pità, Giuseppe Albertini, Monica Pau, Giampiero Girolomoni, Ferderico Bardazzi, Giuseppe Micali, Piergiacomo Calzavara Pinton, Stefano Calvieri, Ketty Peris, Franco Kokelj, Maria Grazia Bernengo, Fabio Ayala, Manuela Papini, Giuseppe Banfi, Clara De Simone, Aurora Parodi, Nicole Lanci, Andrea Locatelli

Risultato della ricerca: Articlepeer review

6 Citazioni (Scopus)

Abstract

Introduction: Female sex has been shown to be a risk factor for the development of adverse drug reactions; however, this has not been studied for cyclosporine (CsA). The aim of this study was to investigate, in Italian dermatological practice, the influence of gender and menopause and related hormones on the incidence of adverse events (AEs) during CsA treatment in psoriatic patients. Methods: Multicenter, prospective, observational study conducted from May 2011 to June 2013. Patients with plaque psoriasis, undergoing a new CsA administration course, or about to start it, were enrolled in the outpatient clinics of Italian dermatological centers. During the 2–6 months of study duration, patients had to note all AEs that occurred in a diary that was reviewed by the investigators at the follow-up visit. Sex hormone levels were measured within 7 days from the start date of a menstrual cycle. Results: A total of 969 adult psoriatic patients were enrolled in the study, divided into four cohorts: fertile women and corresponding age-matched men; postmenopausal women and corresponding age-matched men. A significant difference in the percentage of patients with AEs was observed between fertile and postmenopausal women, but not between women and age-matched men. AE incidence rate was about 37% higher in fertile women than in age-matched men and about 18% higher in postmenopausal women than in age-matched men, but differences were not statistically significant. Incidence rate ratio of fertile vs. postmenopausal women was 0.67, reaching statistical significance. AEs were mild or moderate in severity in the great majority of patients of all cohorts and postmenopausal women had significantly less grade 1–2 AEs compared to fertile women, but more grade 3–4 AEs. FSH levels were significantly higher in postmenopausal women reporting no AEs, and DHEA sulfate levels were about 10% higher in men with no AEs, compared to those reporting at least one AE. Cortisol levels were slightly though significantly higher in postmenopausal women with no AE. Conclusions: A better understanding of sex- and hormone-related influences on drug responses may help to improve drug safety and efficacy, by permitting one to tailor pharmacological treatments to individual subjects or defined patient cohorts. Funding: Novartis Farma S.p.A., Italy.
Lingua originaleEnglish
pagine (da-a)1349-1363
Numero di pagine15
RivistaAdvances in Therapy
Volume34
Stato di pubblicazionePublished - 2017

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

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