Safety and Tolerability of the Dual 5-Alpha Reductase Inhibitor Dutasteride in the Treatment of Androgenetic Alopecia

Abstract

BackgroundAfter the approval of dutastride for androgenic alopecia (AGA) in 2009, Korean authority required a post-marketing surveillance to obtain further data on its safety profile.ObjectiveThe objective was to monitor adverse events (AEs) of dutasteride 0.5 mg in Korean AGA male patients in a clinical practice environment.MethodsOpen label, multi-center, non-interventional observational study was done from July 2009 to July 2013. AGA subjects (18~41 years of age) with no experience of dutasteride were enrolled. Dosage regimen was recommended according to the prescribing information. The incidences of any AEs, serious adverse events (SAEs), and adverse drug reactions (ADRs) were evaluated. Multiple logistic regression method was used to identify risk factors related to ADRs. Effectiveness was generally evaluated by physicians.ResultsDuring study period, 712 subjects were enrolled. The subjects of 29.3±6.0 years old exposed to dutasteride for 204.7±161.5 days. One hundred and ten (15.4%) of subjects reported 138 AEs. Four subjects (0.6%) reported 5 SAEs (right radius fracture, 2 events of chronic follicular tonsillitis, influenza infection, and acute appendicitis). Sixty-six subjects (9.3%) reported 80 ADRs. Most frequent ADRs were libido decreased (9 subjects, 1.3%), dyspepsia (8 subjects, 1.1%), impotence (7 subjects, 1.0%), and fatigue (5 subjects, 0.7%). Other interested ADRs were sexual function abnormality (4 subjects, 0.6%), gynecomastia (2 subjects, 0.3%), and ejaculation disorder (1 subject, 0.1%). Most subjects (78.6%) showed overall improvement after treatment of dutasteride in the effectiveness.ConclusionDutasteride 0.5 mg is to be well-tolerated in 18 to 41 years old AGA patients in a clinical practice environment.

Guidelines for the diagnosis and treatment of male‐pattern and female‐pattern hair loss, 2017 version

“…With regard to the adverse reactions of dutasteride, in the aforementioned international clinical trial and a Korean post‐marketing surveillance study with 712 cases, the incidence of adverse events was 3.3%, 5.4% and 3.3%, and 1.3%, 1% and 0.1% for reduced libido, impotence and ejaculatory dysfunction, respectively. Meanwhile, in the aforementioned non‐RCT conducted in Japan (120 cases, 52 weeks), the incidence was relatively high at 8.3%, 11.7% and 5.0% for reduced libido, impotence and ejaculatory dysfunction, respectively .…”

Letter to the Editor: androgenetic alopecia; drug safety and therapeutic strategies

“…Furthermore, as treatment with 5ARIs had no significant effect on total or HDL cholesterol in this study, the authors suggested that androgens effects on lipoprotein metabolism are likely mediated by testosterone or its active metabolite rather than by DHT [8]. The Korean phase IV AGA study with dutasteride also reported very low rates (0.1%) of hypertriglyceridemia or weight increase and no reports of prostate cancer, breast cancer, or heart failure [5].…”

“…In comparison, in an open label, multicenter, noninterventional, regulatory requirement, post-marketing observational Phase IV study of dutasteride reported AEs in 712 Korean men with AGA (average treatment duration: 204.7 ± 161.5 days), treatment-related AEs were reported by 66 subjects (9.3%); the most frequent (>1%) were decreased libido (1.3%), dyspepsia (1.1%), and ED (1.0%) [5]. No deaths, treatment-related SAEs, AEs leading to treatment discontinuation or study withdrawal were reported.…”

Dermatology today and tomorrow: from symptom control to targeted therapy

“…Dutasteride is approved in the United States and Europe for BPH but is also used off‐label to treat male pattern baldness. As a newer drug, the long‐term effects of dutasteride have been studied less extensively than finasteride, although in parallel, single‐arm studies, only mild adverse events, particularly erectile dysfunction and decreased libido, were recorded over follow‐up periods up to 6 years . Well‐designed, randomized, double‐blind, long‐term follow‐up studies are needed to evaluate the true effectiveness and safety of dutasteride.…”