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  • The efficacy and safety of 5α-reductase inhibitors in androgenetic alopecia: a network meta-analysis and benefit-risk assessment of finasteride and dutasteride.

The efficacy and safety of 5α-reductase inhibitors in androgenetic alopecia: a network meta-analysis and benefit-risk assessment of finasteride and dutasteride.

The Journal of dermatological treatment (2013-06-19)
Aditya K Gupta, Andrew Charrette
ABSTRACT

In the light of post-marketing reports of persistent sexual dysfunction with the use of finasteride, analysis of the extent of risk associated with 5α-reductase inhibitor treatment for androgenetic alopecia (AGA) is warranted. This study sought to evaluate the efficacy of 5α-reductase inhibitors using the outcomes hair count, global photographic assessment and patient self-assessment and evaluate the benefits of treatment versus the risk of global sexual dysfunction. A systematic review identified all relevant randomized controlled trials of finasteride 1 mg, 5 mg and dutasteride 0.5 mg. The efficacy outcome hair count was analyzed using pair-wise meta-analysis, while the efficacy outcomes global photographic assessment and patient self-assessment as well as the safety outcome global sexual dysfunction were analyzed through network meta-analyses. A benefit-risk assessment was also performed. The active interventions were not significantly different than each other in efficacy and were not significantly different from placebo in eliciting sexual dysfunction. Benefit-risk analysis resulted in an arbitrary ranking due to the lack of statistically significant difference between active treatments. Analysis results reiterate the efficacy and safety of 5α-reductase inhibitors for the treatment of AGA and may support the approval of dutasteride 0.5 mg as an additional treatment option, following further study.

MATERIALS
Product Number
Brand
Product Description

Finasteride for peak identification, European Pharmacopoeia (EP) Reference Standard
Finasteride, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Finasteride, ≥98% (HPLC), powder
Supelco
Finasteride, VETRANAL®, analytical standard