finasteride
Sources réglementaires consultées
Indications approuvées
- Premiers stades de l’alopécie androgénétique chez les hommes de 18 à 41 ans ; le traitement stabilise le processus. L’efficacité dans la récession bitemporale ou la perte avancée n’est pas établie.
Contre-indications
Absolues
- Femmes, en particulier pendant la grossesse ou si une grossesse est possible.
- Hypersensibilité au finastéride ou aux excipients.
Mises en garde cliniques
- Mise en garde majeure · Ne pas utiliser chez les moins de 18 ans. Le finastéride réduit le PSA ; interpréter les valeurs en tenant compte de cet effet. — CIMA/AEMPS, ficha técnica 76704
- Mise en garde majeure · Surveiller la dépression, les changements d’humeur et les idées suicidaires ; arrêter et demander un avis médical s’ils surviennent. Une dysfonction sexuelle peut persister après l’arrêt. — CIMA/AEMPS, ficha técnica 76704
- Mise en garde majeure · Les femmes enceintes ou susceptibles de l’être ne doivent pas manipuler de comprimés écrasés ou cassés en raison du risque pour un fœtus masculin. — CIMA/AEMPS, ficha técnica 76704
- Mise en garde majeure · Signaler rapidement toute masse, douleur, augmentation mammaire ou écoulement mamelonnaire ; un cancer du sein masculin a été signalé à une fréquence indéterminée. — CIMA/AEMPS, ficha técnica 76704
- Mise en garde majeure · Des déclarations spontanées d’infertilité ou d’altération de la qualité du sperme ont été reçues après commercialisation ; d’autres facteurs de risque étaient présents dans certains cas. Une amélioration ou une normalisation de la qualité du sperme a été rapportée après l’arrêt du finastéride, mais ces déclarations ne permettent pas d’établir un lien causal. — CIMA/AEMPS, ficha técnica 76704
Interactions médicamenteuses
- ModéréeInhibiteurs ou inducteurs du CYP3A4
Mécanisme: Ils peuvent modifier les concentrations plasmatiques du finastéride, bien qu’une importance clinique majeure soit jugée peu probable.
Recommandation: Évaluer le contexte clinique ; le RCP n’impose pas d’ajustement systématique.
CIMA/AEMPS, ficha técnica 76704https://cima.aemps.es/cima/dochtml/ft/76704/FT_76704.html
Grossesse et allaitement
Contre-indiqué chez les femmes enceintes ou susceptibles de l’être en raison du risque d’anomalies génitales chez le fœtus masculin. Il n’est pas indiqué chez la femme et son passage dans le lait est inconnu.
Bibliographie récente (PubMed)
Androgenetic alopecia (AGA) is the most common cause of hair loss, often challenging to treat. While oral finasteride (1 mg/d) is an FDA-approved treatment for male AGA, oral minoxidil and oral dutasteride are not approved yet. However, clinicians have been increasingly using these two drugs off-label for hair loss. Recently, Japan and South Korea have approved oral dutasteride (0.5 mg/d) for male AGA. A probable efficacy ranking, in decreasing order, is - dutasteride 0.5 mg/d, finasteride 5 mg/d, minoxidil 5 mg/d, finasteride 1 mg/d, followed by minoxidil 0.25 mg/d. Oral minoxidil predominantly causes hypertrichosis and cardiovascular system (CVS) symptoms/signs in a dose-dependent manner, whereas oral finasteride and dutasteride are associated with sexual dysfunction and neuropsychiatric side effects. The average plasma half-lives of minoxidil, finasteride, and dutasteride are ∼4 h, ∼4.5 h, and ∼5 weeks, respectively. Minoxidil acts through multiple pathways to promote hair growth. It has been shown as a vasodilator, an anti-inflammatory agent, a Wnt/β-catenin signaling inducer, and an antiandrogen. Finasteride inhibits 5α-reductase (5AR) type II isoenzyme, while dutasteride inhibits both type I and type II. Thus, dutasteride suppresses DHT levels more than finasteride in the serum and scalp.
Androgenetic alopecia (AGA), also known as male pattern hair loss (MPHL) or female pattern hair loss (FPHL), is the most common form of alopecia worldwide, and arises from an excessive response to androgens. AGA presents itself in a characteristic distribution unique to both sexes. Despite its prevalence, AGA can be quite challenging to treat. The condition is chronic in nature and stems from an interplay of genetic and environmental factors. There are only two US Food and Drug Administration (FDA)-approved drugs for the condition: topical minoxidil and oral finasteride. However, numerous non-FDA-approved treatments have been shown to be effective in treating AGA in various studies. Some of these treatments are relatively new and still to be explored, thus emphasizing the need for an updated review of the literature. In this comprehensive review, we discuss the evaluation of AGA and the mechanisms of action, costs, efficacies, and safety profiles of existing, alternative, and upcoming therapeutics for this widespread condition.
Oral finasteride is a well-established treatment for men with androgenetic alopecia (AGA), but long-term therapy is not always acceptable to patients. A topical finasteride formulation has been developed to minimize systemic exposure by acting specifically on hair follicles. To evaluate the efficacy and safety of topical finasteride compared with placebo, and to analyse systemic exposure and overall benefit compared with oral finasteride. This randomized, double-blind, double dummy, parallel-group, 24-week study was conducted in adult male outpatients with AGA at 45 sites in Europe. Efficacy and safety were evaluated. Finasteride, testosterone and dihydrotestosterone (DHT) concentrations were measured. Of 458 randomized patients, 323 completed the study and 446 were evaluated for safety. Change from baseline in target area hair count (TAHC) at week 24 (primary efficacy endpoint) was significantly greater with topical finasteride than placebo (adjusted mean change 20.2 vs. 6.7 hairs; P < 0.001), and numerically similar between topical and oral finasteride. Statistically significant differences favouring topical finasteride over placebo were observed for change from baseline in TAHC at week 12 and investigator-assessed change from baseline in patient hair growth/loss at week 24. Incidence and type of adverse events, and cause of discontinuation, did not differ meaningfully between topical finasteride and placebo. No serious adverse events were treatment related. As maximum plasma finasteride concentrations were >100 times lower, and reduction from baseline in mean serum DHT concentration was lower (34.5 vs. 55.6%), with topical vs. oral finasteride, there is less likelihood of systemic adverse reactions of a sexual nature related to a decrease in DHT with topical finasteride. Topical finasteride significantly improves hair count compared to placebo and is well tolerated. Its effect is similar to that of oral finasteride, but with markedly lower systemic exposure and l
Androgenetic alopecia (AGA) is the most common form of hair loss consisting of a characteristic receding frontal hairline in men and diffuse hair thinning in women, with frontal hairline retention, and can impact an individual's quality of life. The condition is primarily mediated by 5-alpha-reductase and dihydrotestosterone (DHT) which causes hair follicles to undergo miniaturization and shortening of successive anagen cycles. Although a variety of medical, surgical, light-based and nutraceutical treatment options are available to slow or reverse the progression of AGA, it can be challenging to select appropriate therapies for this chronic condition. To highlight treatment options for androgenetic alopecia taking into consideration the efficacy, side effect profiles, practicality of treatment (compliance), and costs to help clinicians offer ethically appropriate treatment regimens to their patients. A literature search was conducted using electronic databases (Medline, PubMed, Embase, CINAHL, EBSCO) and textbooks, in addition to the authors' and other practitioners' clinical experiences in treating androgenetic alopecia, and the findings are presented here. Although topical minoxidil, oral finasteride, and low-level light therapy are the only FDA-approved therapies to treat AGA, they are just a fraction of the treatment options available, including other oral and topical modalities, hormonal therapies, nutraceuticals, PRP and exosome treatments, and hair transplantation. Androgenetic alopecia therapy remains challenging as treatment selection involves ethical, evidence-based decision-making and consideration of each individual patient's needs, compliance, budget, extent of hair loss, and aesthetic goals, independent of potential financial benefits to the practitioners.
We aimed to determine the efficacy of the various available oral, topical, and procedural treatment options for hair loss in individuals with androgenic alopecia. Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, a systematic review of the National Library of Medicine was performed. Overall, 141 unique studies met our inclusion criteria. We demonstrate that many over the counter (e.g. topical minoxidil, supplements, low-level light treatment), prescription (e.g. oral minoxidil, finasteride, dutasteride), and procedural (e.g. platelet-rich plasma, fractionated lasers, hair transplantation) treatments successfully promote hair growth, highlighting the superiority of a multifaceted and individualized approach to management.