Ann Dermatol.  2016 Aug;28(4):444-450. 10.5021/ad.2016.28.4.444.

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

• Choi GS
• Kim JH
• Oh SY
• Park JM
• Hong JS
• Lee YS
• Lee WS

• KMID: 2344814
• DOI: http://doi.org/10.5021/ad.2016.28.4.444

Abstract

BACKGROUND
After 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.
OBJECTIVE
The objective was to monitor adverse events (AEs) of dutasteride 0.5 mg in Korean AGA male patients in a clinical practice environment.
METHODS
Open 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.
RESULTS
During 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.
CONCLUSION
Dutasteride 0.5 mg is to be well-tolerated in 18 to 41 years old AGA patients in a clinical practice environment.

Keyword

Alopecia; Drug-related side effects and adverse reactions; Dutasteride; Product surveillance; postmarketing; Safety; Treatment outcome

MeSH Terms

Alopecia*
Drug-Related Side Effects and Adverse Reactions
Dutasteride*
Dyspepsia
Ejaculation
Erectile Dysfunction
Fatigue
Gynecomastia
Humans
Incidence
Influenza, Human
Libido
Logistic Models
Male
Methods
Observational Study
Oxidoreductases*
Palatine Tonsil
Radius Fractures
Risk Factors
Tonsillitis
Treatment Outcome
Dutasteride
Oxidoreductases

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