Clinical dose ranging studies with finasteride, a type 2 5α-reductase inhibitor, in men with male pattern hair loss

Roberts, Janet L.; Fiedler, Virginia C.; Imperato‐McGinley, Julianne; Whiting, David; Olsen, Elise A.; Shupack, Jerome L.; Stough, Dowling B.; DeVillez, Richard L.; Rietschel, Robert L.; Savin, Ronald C.; Bergfeld, Wilma F.; Swinehart, James M.; Funicella, Toni; Hordinsky, Maria; Lowe, Nicholas J.; Katz, Irving; Lucky, Anne W.; Drake, Lynn A.; Price, Vera H.; Weiss, Darryl; Whitmore, Elizabeth; Millikan, Larry E.; Muller, Sigfrid; Gencheff, Christopher; Carrington, Patrick R.; Binkowitz, Bruce; Kotey, Paul; He, Weili; Bruno, Karen; Jacobsen, Carol A.; Terranella, L.; Gormley, Glenn J.; Kaufman, Keith D.

doi:10.1016/s0190-9622(99)80052-8

Cited by 58 publications

(24 citation statements)

References 21 publications

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“…A similar study examining the use of finasteride in 326 men with predominantly frontal alopecia also found a significant improvement compared to placebo subjects [8]. Dose-finding studies were conducted to compare the efficacy of 5 mg versus 1, 0.2 and 0.01 mg finasteride to treat AGA in men, indicating that 1 mg finasteride daily can be regarded as a safe and efficient approach for treatment [9]. …”

Section: Discussionmentioning

confidence: 99%

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An Open, Randomized, Comparative Study of Oral Finasteride and 5% Topical Minoxidil in Male Androgenetic Alopecia

Arca¹,

Açıkgöz²,

Taştan³

et al. 2004

Dermatology

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Background and Aim: Androgenetic alopecia (AGA) is undoubtedly the most common form of hair loss in males. It is a condition which may cause cosmetic and psychosocial problems in androgen-dependent cases. In this open, randomized and comparative study we evaluated the efficacy of oral finasteride and 5% topical minoxidil treatment for 12 months in 65 male patients with mild to severe AGA. Methods: We randomly assigned 40 (61.53%) patients to receive 1 mg/day oral finasteride for 12 months, and 25 (38.47%) patients applied 5% topical minoxidil solution twice daily for 12 months. Results: There were no significant differences between the 2 groups considering age, age of onset of hair loss, family history and type of hair loss (p > 0.05). In the clinical evaluation at the endpoint of treatment, the clinical cure rates (i.e. increased intensity of hair) were 80% (32/40) for the oral finasteride group and 52% (13/25) for the 5% topical minoxidil group. Encountered side effects were all mild, and there was no need to stop the treatment. In the group given oral finasteride, side effects were noted in 7 patients: 6 patients suffered from loss of libido, and 1 patient had an increase in other body hairs; irritation of the scalp was seen in 1 patient in the group administered 5% minoxidil. These adverse events disappeared as soon as the treatment was stopped. The laboratory data on both drug groups did not show any statistically or clinically significant intragroup changes from baseline values to the endpoint (p > 0.05), except the level of serum total testosterone which was increased, and free testosterone and serum prostate-specific antigen in the finasteride group which were statistically decreased from baseline values to the endpoint (p < 0.05). Conclusion: In this comparative study of systemic finasteride and topical minoxidil, it was concluded that both drugs were effective and safe in the treatment of mild to severe AGA, although oral finasteride treatment was more effective (p < 0.05). Adverse events were not considered important either, and these side effects disappeared as soon as the treatment was stopped.

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Section: Discussionmentioning

confidence: 99%

“…It blocks the peripheral and systemic conversion of testosterone to DHT [5, 6]. After approval of finasteride in the USA for the treatment of men with male AGA by the Food and Drug Administration there are some reports that support the efficacy of finasteride in male AGA [7, 8, 9, 10, 11, 12, 13]. …”

Section: Introductionmentioning

confidence: 99%

An Open, Randomized, Comparative Study of Oral Finasteride and 5% Topical Minoxidil in Male Androgenetic Alopecia

Arca¹,

Açıkgöz²,

Taştan³

et al. 2004

Dermatology

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“…The chemical composition-of-matter patent for finasteride describes finasteride and related compounds as “antiandrogenic by virtue of their ability to inhibit testosterone-5α-reductase” ( Rasmusson & Reynolds, 1988 ). Exposure of men to finasteride mimics hereditary 5α-reductase deficiency by preferentially inhibiting 5α-R 2 ( Gormley et al, 1990 ), inducing a sex steroid profile “strikingly similar to that of pseudohermaphrodites” ( Imperato-McGinley et al, 1990 ), with a 70% reduction in serum 5α-DHT ( Drake et al, 1999 ; Grino, Griffin & Wilson, 1990 ; Marchetti & Barth, 2013 ; Roberts et al, 1999 ), corresponding to “circulating levels of 5α-DHT similar to those following castration” ( Stoner, 1990 ). Dutasteride inhibits both 5α-R 1 and 5α-R 2 , reducing serum 5α-DHT by 90% ( Rittmaster et al, 2008 ).…”

Section: Introductionmentioning

confidence: 99%

Persistent erectile dysfunction in men exposed to the 5α-reductase inhibitors, finasteride, or dutasteride

Kiguradze

Temps

Yarnold³

et al. 2017

PeerJ

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ImportanceCase reports describe persistent erectile dysfunction (PED) associated with exposure to 5α-reductase inhibitors (5α-RIs). Clinical trial reports and the manufacturers’ full prescribing information (FPI) for finasteride and dutasteride state that risk of sexual adverse effects is not increased by longer duration of 5α-RI exposure and that sexual adverse effects of 5α-RIs resolve in men who discontinue exposure.ObjectiveOur chief objective was to assess whether longer duration of 5α-RI exposure increases risk of PED, independent of age and other known risk factors. Men with shorter 5α-RI exposure served as a comparison control group for those with longer exposure.DesignWe used a single-group study design and classification tree analysis (CTA) to model PED (lasting ≥90 days after stopping 5α-RI). Covariates included subject attributes, diseases, and drug exposures associated with sexual dysfunction.SettingOur data source was the electronic medical record data repository for Northwestern Medicine.SubjectsThe analysis cohorts comprised all men exposed to finasteride or dutasteride or combination products containing one of these drugs, and the subgroup of men 16–42 years old and exposed to finasteride ≤1.25 mg/day.Main outcome and measuresOur main outcome measure was diagnosis of PED beginning after first 5α-RI exposure, continuing for at least 90 days after stopping 5α-RI, and with contemporaneous treatment with a phosphodiesterase-5 inhibitor (PDE5I). Other outcome measures were erectile dysfunction (ED) and low libido. PED was determined by manual review of medical narratives for all subjects with ED. Risk of an adverse effect was expressed as number needed to harm (NNH).ResultsAmong men with 5α-RI exposure, 167 of 11,909 (1.4%) developed PED (persistence median 1,348 days after stopping 5α-RI, interquartile range (IQR) 631.5–2320.5 days); the multivariable model predicting PED had four variables: prostate disease, duration of 5α-RI exposure, age, and nonsteroidal anti-inflammatory drug (NSAID) use. Of 530 men with new ED, 167 (31.5%) had new PED. Men without prostate disease who combined NSAID use with >208.5 days of 5α-RI exposure had 4.8-fold higher risk of PED than men with shorter exposure (NNH 59.8, all p < 0.002). Among men 16–42 years old and exposed to finasteride ≤1.25 mg/day, 34 of 4,284 (0.8%) developed PED (persistence median 1,534 days, IQR 651–2,351 days); the multivariable model predicting PED had one variable: duration of 5α-RI exposure. Of 103 young men with new ED, 34 (33%) had new PED. Young men with >205 days of finasteride exposure had 4.9-fold higher risk of PED (NNH 108.2, p < 0.004) than men with shorter exposure.Conclusion and relevanceRisk of PED was higher in men with longer exposure to 5α-RIs. Among young men, longer exposure to finasteride posed a greater risk of PED than all other assessed risk factors.

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“…Finasteride, approved by the U.S. Food and Drug Administration (FDA) in 1997, is an androgen modifier that specifically inhibits type II 5areductase, which primarily localizes in the innermost layer of the outer root sheath, inner root sheath, and infundibular region of the hair follicle (5). Additionally, dose-ranging studies suggested that finasteride at 1mg/day is the optimal dose for the treatment of MAGA (6).…”

Section: Introductionmentioning

confidence: 99%

Combined treatment with oral finasteride and topical minoxidil in male androgenetic alopecia: a randomized and comparative study in Chinese patients

Sheng

et al. 2015

Dermatologic Therapy

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Finasteride at 1 mg/day and 5% topical minoxidil are effective in male androgenetic alopecia (MAGA). However, studies describing their effects in Chinese individuals are scarce. 450 Chinese MAGA patients were randomly assigned to receive finasteride (n = 160), minoxidil (n = 130) and combined medication (n = 160) for 12 months. The patients returned to the clinic every 3 months for efficacy evaluation. And efficacy was evaluated in 428 men at treatment end, including 154, 122, and 152 in the finasteride, 5% minoxidil, and combination groups, respectively. All groups showed similar baseline characteristics, including age at enrollment, and duration and severity of alopecia (p > 0.05). At 12 months, 80.5, 59, and 94.1% men treated with finasteride, 5% minoxidil and the combination therapy showed improvement, respectively. Adverse reactions were rare (finasteride, 1.8%; minoxidil, 6.1%), and disappeared right after drug withdrawal. In conclusion, finasteride is superior to 5% minoxidil, while the combined medication showed the best efficacy.

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Clinical dose ranging studies with finasteride, a type 2 5α-reductase inhibitor, in men with male pattern hair loss

Cited by 58 publications

References 21 publications

An Open, Randomized, Comparative Study of Oral Finasteride and 5% Topical Minoxidil in Male Androgenetic Alopecia

An Open, Randomized, Comparative Study of Oral Finasteride and 5% Topical Minoxidil in Male Androgenetic Alopecia

Persistent erectile dysfunction in men exposed to the 5α-reductase inhibitors, finasteride, or dutasteride

Combined treatment with oral finasteride and topical minoxidil in male androgenetic alopecia: a randomized and comparative study in Chinese patients

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