The GENDER ATTENTION Observational Study: Gender and Hormonal Status Differences in the Incidence of Adverse Events During Cyclosporine Treatment in Psoriatic Patients
نویسندگان
چکیده
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.
منابع مشابه
Medical adverse events during patient’s hospitalization at training Hospitals in Kerman
Introduction: Medical errors are one of important and noticeable challenges of health care, which threaten the health system of all countries. On the other hands this issue is a global, costly with serious complications for patients and society. Objective: The present study aimed to determine the rate of medical adverse events during patients' hospitalization. Methods...
متن کاملفراوانی عوارض جانبی ناشی از مصرف داروهای غیربیولوژیک در بیماران مبتلا به پسوریازیس مراجعهکننده به بخش پوست بیمارستانهای شهدای تجریش و لقمان حکیم تهران در سالهای 96-1395
Background and Aim: Psoriasis vulgaris is a chronic skin disease which is treated by many systemic or topical drugs. There is no cure for this disease and patients have to take medicaments for a long time, so having knowledge on adverse effects of current medicaments may prevent them and improve treatment process. The aim of this study was to evaluate the incidence of side effects of non biolog...
متن کاملEvaluation of delay in Primary PCI in golden time and its relationship with major adverse cardiac events
Background: In patients with ST-segment elevation myocardial infarction (STEMI), Primary percutaneous coronary intervention (PCI) is the preferred reperfusion therapy. Timely primary PCI is essential in improving the clinical outcomes of these patients. The aim of this study was to evaluate the factors affecting balloon delay in STEMI treated patients by primary PCI and its relationship with ma...
متن کاملAdverse reactions associated with intravenous immunoglobulin therapy in patients with dermatologic diseases: An 11-year retrospective study
Background: Intravenous immunoglobulin (IVIG) is used to treat many autoimmune and immunodeficiency disorders. The main indications of IVIG in dermatology include treatment for resistant autoimmune bullous diseases, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN). Although generally welltolerated, various adverse effects can occur.Methods: We designed a retrospective study ...
متن کاملPrevalence of acute and chronic viral seropositivity and characteristics of disease in patients with psoriatic arthritis treated with cyclosporine: a post hoc analysis from a sex point of view on the observational study of infectious events in psoriasis complicated by active psoriatic arthritis
BACKGROUND Sex medicine studies have shown that there are sex differences with regard to disease characteristics in immune-mediated inflammatory diseases, including psoriasis, in immune response and susceptibility to viral infections. We performed a post hoc analysis of the Observational Study of infectious events in psoriasis complicated by active psoriatic arthritis (SYNERGY) study in patient...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
دوره 34 شماره
صفحات -
تاریخ انتشار 2017