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Drug Treatment for Androgenetic Alopecia: First Italian Questionnaire Survey on What Dermatologists Think about Finasteride

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Abstract

Introduction: Treatment with finasteride 1 mg/day represents the therapy of choice for androgenetic alopecia (AGA). We investigated how Italian dermatologists approach use of finasteride for treatment of AGA and common side effects reported by patients. Methods: A tablet-based survey was conducted from February 2017 to January 2018 in Italy to investigating use of 1 mg/day finasteride in the treatment of AGA. Approximately 1153 Italian dermatologists were surveyed about prescription frequency, therapy duration, treatment practices, and side effects eventually reported. Results: Dermatologists considered treatment with 1 mg/day finasteride to be the most efficacious treatment for AGA, as reflecting by its long-term (5 years) prescription. Data on sexual side effects from our survey are in line with previous scientific evidence, especially regarding loss of libido, erectile dysfunction, and problems with ejaculation, but also in the psychological sphere and regarding physical impairments such as myalgia and loss of muscle tone. Conclusions: This is the first preliminary observational study on how Italian dermatologists approach use of finasteride to treat AGA. Although side effects have been reported, especially in the sexual sphere, lack of alternative treatments with the same efficacy leads dermatologists to prescribe 1 mg/day finasteride with a tendency to prolong therapy in the long term. Funding: Giuliani S.p.A.
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... It is considered as the most effective oral therapy for AGA based on extensive clinical data. 31 Finasteride at the dose of 1 mg per day is considered as the optimal dose and long-term use results in sustained improvement. 32 Sexual side effects of finasteride were reported to occur at the rate of 2.1%-3.8%, ...
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p class="abstract">The diagnosis and management of hair loss needs an organized and systematic approach for recognizing pattern of hair loss and identification of hair loss etiology. Early and specific diagnosis is essential to initiate appropriate treatment in the early phases of hair loss. Topical minoxidil and oral finasteride are the only approved drugs for androgenetic alopecia (AGA). Various other treatment options are widely used but have limited clinical evidence. Similarly, there are no specific treatments recommended for telogen effluvium (TE). However, the treatment may become challenging with increasing availability of new formulations and drugs with no substantial evidence to support them. Multiple focused group discussions were conducted among Indian dermatologists to gain expert opinion on appropriate management of AGA and TE in the current scenario. This article summarizes the consensus clinical viewpoints for topical and oral medications, role of nutritional supplements, and other adjunctive therapies in managing AGA and TE. The panel highlighted that the choice of treatment for AGA and TE depends on the individual hair loss pattern and response to medications. A brief discussion on the use of shampoos and procedures has also been highlighted. </p
... It is generally accepted that dihydrotestosterone (DHT) is the primary androgen associated with the development and progression of AGA in men [2], and finasteride, an inhibitor of 5α-reductase, is commonly used for the treatment of AGA [3]. The majority of dermatologists prescribed finasteride (1 mg/day) for more than one year to improve alopecia, and it slows hair loss and increases hair growth in men with AGA [4]. However, the beneficial effects of finasteride on AGA disappear within 12 months after the withdrawal of therapy [5], indicating that the continued use of finasteride is required to maintain the beneficial effects. ...
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Objectives: Plant extracts possessing specific constituents with anti-inflammatory, antimicrobial, antioxidant, or 5α-reductase inhibitory properties are known to provide benefits against androgenetic alopecia (AGA) in men. A solid shampoo was formulated, and it contained a mixture of six different plant extracts that possess these beneficial properties against AGA. The improvement in AGA and changes in steroid concentrations were assessed after 4 months of formulated shampoo use. Methods: This study was conducted based on a randomized, placebo-controlled, and single-blind design. Hair-related variables and hair and saliva samples were collected bi-monthly in the treatment (n=48) and placebo (n=52) groups and at a single time point in the hairy controls (n=50). Results: The formulated shampoo was more effective on AGA than the placebo based on the hair shaft thickness and hair density in the receding hairline. The baseline hair cortisol and dihydrotestosterone (DHT) concentrations were significantly higher in the treatment and placebo groups than in the hairy controls. After 4 months, the hair steroid concentrations in the treatment group were reduced to those observed in the hairy controls, although the main effect of time on hair steroid concentrations was negligible in the placebo group. Salivary cortisol and DHT levels during the post-awakening period were comparable among the groups or assessment time points. Conclusion: The constituents of plant extracts included in the formulated shampoo would prevent hair loss, increase hair growth effects, and reduce hair cortisol and DHT concentrations without changes in the post-awakening salivary steroid levels in men with AGA.
... In nonscarring alopecia, the progenitor cells are destructed, while the hair follicle stem cells (HFSCs) are preserved, which is why this kind of alopecia can be reversible (Mohammadi et al., 2016;Owczarczyk-Saczonek et al., 2018). Androgenetic alopecia (AGA) accounts for the majority of the nonscarring alopecia cases, affecting up to 80% of Caucasian men by the age of 80 and nearly 40% of Caucasian women by the age of 70 (Al-Refu, 2012;Gentile et al., 2017a;Sorbellini et al., 2018). ...
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Alopecia is resulted from various factors that can decrease the regeneration capability of hair follicles and affect hair cycles. This process can be devastating physically and psychologically. Nevertheless, the available treatment strategies are limited, and the therapeutic outcomes are not satisfactory. According to the possible pathogenesis of nonscarring alopecia, especially androgenetic alopecia, recovering or replenishing the signals responsible for hair follicle stem cells activation is a promising strategy for hair regeneration. Recently, stem cell-based therapies, especially those based on the stem cell-derived conditioned medium (CM), which is secreted by stem cells and is rich in paracrine factors, have been widely explored as the hair regenerative medicine. Several studies have focused on altering the composition and up-regulating the amount of secretome of the stem cells, thereby enhancing its therapeutic effects. Besides, stem cell-derived exosomes, which are present in the CM as message entities, are also promising for hair regrowth. In this review, the up-to-date progress of research efforts focused on stem cell-based therapies for hair regeneration will be discussed, including their therapeutic potentials with respective merits and demerits, as well as the possible mechanisms.
... These results are consistent with the published data on the ability of finasteride to potentiate the antinociceptive effect of morphine, which is presumably mediated by inhibition of 5α-reductase by finasteride [12]. On the other hand, the analgesic effect of finasteride can be related to modulation of the muscle tone [11]. ...
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It was shown that finasteride, a 5α-reductase inhibitor (50 mg/kg, intraperitoneally) produced analgesic and antiexudative effects in experimental peritonitis induced by intraperitoneal injection of 1% acetic acid. These results agree with published data on its anti-inflammatory properties and ability to potentiate the analgesic effect of morphine in rodents. New pyrazolo[C] pyridine derivative GIZh-72 (4,6-dimethyl-2-(4-chlorphenyl)-2,3-dihydro-1H-pyrazolo[4,3-C]pyridine-3-on, chloral hydrate) injected intraperitoneally in doses of 20-80 mg/kg produced dose-dependent antiexudative effects, but exhibited no analgesic properties.
... Findings from these studies were used by clinicians to argue against the existence of persistent sexual adverse side effects and in turn dismissed any claims that PFS is a real syndrome. Table 3 summarizes the findings from systematic reviews and meta-analyses and pharmacovigilance studies and general reviews (60,83,85,86,102,(161)(162)(163)(164)(165)(166)(167)(168)(169)(170)(171)(172)(173)(174)(175)(176). While some of these studies attempted to dismiss the mere existence of persistent sexual and psychiatric adverse events, the overwhelming conclusions of majority of these studies acknowledged the evidence for the persistent sexual and neurological adverse side effects and highlighted the need for better understanding of this syndrome in order to offer treatment for afflicted individuals. ...
Article
Post-finasteride syndrome (PFS) is a constellation of serious adverse side effects manifested in clinical symptoms that develop and persist in patients during and/or after discontinuing finasteride treatment in men with pattern hair loss (androgenetic alopecia) or benign prostatic hyperplasia. These serious adverse side effects include persistent or irreversible sexual, neurological, physical and mental side effects. To date, there are no evidence-based effective treatments for PFS. Although increasing number of men report persistent side effects, the medical community has yet to recognize this syndrome nor are there any specific measures to address this serious and debilitating symptoms. Here we evaluate the scientific and clinical evidence in the contemporary medical literature to address the very fundamental question: Is PFS a real clinical condition caused by finasteride use or are the reported symptoms only incidentally associated with but not caused by finasteride use? One key indisputable clinical evidence noted in all reported studies with finasteride and dutasteride was that use of these drugs is associated with development of sexual dysfunction, which may persist in a subset of men, irrespective of age, drug dose or duration of study. Also, increased depression, anxiety and suicidal ideation in a subset of men treated with these drugs were commonly reported in a number of studies. It is important to note that many clinical studies suffer from incomplete or inadequate assessment of adverse events and often limited or inaccurate data reporting regarding harm. Based on the existing body of evidence in the contemporary clinical literature, the author believes that finasteride and dutasteride induce a constellation of persistent sexual, neurological and physical adverse side effects, in a subset of men. These constellations of symptoms constitute the basis for PFS in individuals predisposed to epigenetic susceptibility. Indeed, delineating the pathophysiological mechanisms underlying PFS will be of paramount importance to the understanding of this syndrome and to development of potential novel therapeutic modalities.
... Several studies using questionnaires on AGA administered to patients and doctors have been reported [26][27][28]. We evaluated the questionnaires administered to patients with AGA who were treated with finasteride for 10 years. ...
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Our research objective is to understand more, through subjective, self-reports on discussion boards/forums, persons' experiences associated with the use of drugs that alter androgen metabolism, such as finasteride. Finasteride is an orally active, specific inhibitor of 5α-reductase, which is localized to many androgen-dependent tissues. Finasteride inhibits the conversion of testosterone (T) to dihydrotestosterone (DHT), and is commonly used to treat benign prostatic hypertrophy (BPH) and male pattern baldness (MPB), both disorders associated with elevated DHT levels and 5α-reductase activity in the prostate and hair follicles, respectively. It is now acknowledged that long-term use and discontinuation of finasteride has adverse effects (AEs); however, these claims have not been well documented. In this study, discussion board posts (forums) were analyzed as self-reports of what finasteride users indicate is problematic for them. Reports were categorized by the age of subjects as well as the types of AEs described: antiandrogenic, estrogenic, central, and nonspecific/severe. A total of 244 cases were recorded and analyzed on the discussion forum on propeciahelp.com . Among these, 74 (32%) cases reported antiandrogenic affects, 43 (19%) reported estrogenic effects, 70 (30%) reported central effects, 11 (5%) reported nonspecific/severe AEs, and 31 (14%) reported AEs in all categories. The categorization of AEs may prompt further investigation into the pathophysiology of post-finasteride syndrome (PFS). Also, subjective reports may engender greater understanding of the perceived lasting AEs of finasteride.
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Finasteride, a 5α-reductase inhibitor, is marketed in a low dose (1 mg) as a popular therapy for androgenic alopecia in young men. As case reports and small surveys have suggested a link between persistent sexual dysfunction (SD) and suicidal ideation (SI) with low-dose finasteride, the aim of this study was to detect signals of SD and SI secondary to low-dose finasteride use in young men. Retrospective pharmacovigilance disproportionality analysis. United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Low-dose finasteride-related adverse event reports for men aged 18-45 years that were submitted to the FAERS between 1998 and 2013 were retrieved. Multi-item Gamma Poisson Shrinker disproportionality analysis was applied to calculate the empirical Bayes geometric mean (EBGM) and corresponding 95% confidence interval (CI) as an association metric between low-dose finasteride and the events of interest. Signals were defined as associations with thresholds of a CI lower limit of 2.0 or greater. Medical Dictionary for Regulatory Activities Preferred Terms denoting to SD and SI were identified to reflect the outcome of interest. In total, of 4910 reports, 577 persistent SD and 39 SI adverse event reports (11.8% and 7.9%, respectively) were identified for young men using low-dose finasteride; 34 (87.2%) of the 39 men with SI also experienced SD. The majority of these events were serious (e.g., contributed to the patient's death, hospitalization, or disability). Low-dose finasteride was associated with more than expected reporting of SD in young men compared with reporting of these events with all other drugs within the database (EBGM 28.0, 95% CI 26.1-30.0). Disproportional reporting in SI events was noted, although it did not reach signal threshold (EBGM 1.72; 95% CI 1.31-2.23). Among serious SD events, 43% led to disability; 28% required medical intervention, including hospitalization; and 5% were life-threatening. Six fatal SD reports were identified. Persistent SD might be a potential risk of low-dose finasteride for androgenic alopecia therapy in young men, and this risk might contribute to SI. Our findings provide a strong hypothesis for pharmacoepidemiologic studies to further examine this association. © 2015 Pharmacotherapy Publications, Inc.
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The immunobullous diseases comprise a number of clinically heterogeneous disorders caused by the production of antibodies directed against different proteins present in the skin and/or mucous membranes. Multiple therapies, both topical and systemic, make up the armamentarium for these varied conditions. In terms of the systemic therapies that are available, the appropriate medication in each individual patient must take into account the specific diagnosis, severity of the disease, comorbidities of the patient, potential interactions with other medications, and short and long-term goals of therapy. In this chapter, we review the oral systemic agents that can be used for the different immunobullous diseases and review their efficacy, side effects, and recommendations for patient monitoring for long-term therapy.
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Introduction: 5α-Reductase inhibitors (5ARIs) are widely used for the treatment of benign prostatic hyperplasia (BPH) and androgenetic alopecia (AGA). Aim: To review all the available data on the effect of 5ARIs on sexual function and assess whether 5ARIs increase the risk of sexual dysfunction. Methods: A systematic search of the literature was conducted using the Medline, Embase, and Cochrane databases. The search was limited to articles published in English and up to October 2015. Article selection proceeded according to the search strategy based on Preferred Reporting Items for Systematic Reviews and Meta-analyses criteria. Data were analyzed using Stata 12.0. A fixed- or a random-effects model was used to calculate the overall combined risk estimates. Publication bias was assessed using Begg and Egger tests. Main outcome measures: Sexual dysfunction, erectile dysfunction, and decreased libido. Results: After screening 493 articles, 17 randomized controlled trials with 17,494 patients were included. Nine studies evaluated the efficacy of 5ARIs in men with BPH. The other eight reported using 5ARIs in the treatment of men with AGA. The mean age of participants was 60.10 years across all studies. We included 10 trials (6,779 patients) on the efficacy and safety of finasteride, 4 trials (6,222 patients) on the safety and tolerability of dutasteride, and 3 trials (4,493 patients) using finasteride and dutasteride for AGA. The pooled relative risks for sexual dysfunction were 2.56 (95% CI = 1.48-4.42) in men with BPH and 1.21 (95% CI = 0.85-1.72) in men with AGA; those for erectile dysfunction were 1.55 (95% CI = 1.14-2.12) in men with BPH and 0.66 (95% CI = 0.20-2.25) in men with AGA; and those for decreased libido were 1.69 (95% CI = 1.03-2.79) in men with BPH and 1.16 (95% CI = 0.50-2.72) in men with AGA. Estimates of the total effects were generally consistent with the sensitivity analysis. No evidence of publication bias was observed. Conclusion: Evidence from the randomized controlled trials suggested that 5ARIs were associated with increased adverse effects on sexual function in men with BPH compared with placebo. However, the association was not statistically significant in men with AGA. Well-designed randomized controlled trials are indicated to study further the mechanism and effects of 5ARIs on sexual function.
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Concern regarding adverse effects of finasteride is increasing. We aimed to determine the type and frequency of symptoms in men having long-term sexual and non-sexual side effects after finasteride treatment (a condition recently called post-finasteride syndrome, PFS) against androgenetic alopecia (AGA). Subjects were recruited at the Urology Unit of the Trieste University-Hospital, and from a dedicated website. Out of 79 participants, 34% were white Italians, mean age was 33.4 ± 7.60 years, mean duration of finasteride use was 27.3 ± 33.21 months; mean time from finasteride discontinuation was 44.1 ± 34.20 months. Symptoms were investigated by an ad hoc 100 questions' questionnaire, and by validated Arizona Sexual Experience Scale (ASEX) and Aging Male Symptom Scale (AMS) questionnaires. By ASEX questionnaire, 40.5% of participants declared getting and keeping erection very difficult, and 3.8% never achieved; reaching orgasm was declared very difficult by 16.5%, and never achieved by 2.5%. By the ad hoc questionnaire, the most frequent sexual symptoms referred were loss of penis sensitivity (87.3%), decreased ejaculatory force (82.3%), and low penile temperature (78.5%). The most frequent non-sexual symptoms were reduced feeling of life pleasure or emotions (anhedonia) (75.9%); lack of mental concentration (72.2%), and loss of muscle tone/mass (51.9%). We contributed to inform about symptoms of PFS patients; unexpectedly loss of penis sensitivity was more frequent than severe erectile dysfunction and loss of muscle tone/mass was affecting half of the subjects. Further studies are necessary to investigate the pathophysiological and biochemical pathways leading to the post-finasteride syndrome.
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Background. Finasteride 1 mg (Propecia®) is indicated for the treatment of men with androgenetic alopecia (male pattern hair loss, MPHL). However, the long-term (> 2 years) efficacy and safety of finasteride in this population has not been previously reported. Objectives. To assess the efficacy and safety of finasteride in men with MPHL compared to treatment with placebo over five years. Methods. In two 1-year, Phase III trials, 1,553 men with MPHL were randomized to receive finasteride 1 mg/day or placebo, and 1,215 men continued in up to four 1-year, placebo-controlled extension studies. Efficacy was evaluated by hair counts, patient and investigator assessments, and panel review of clinical photographs. Results. Treatment with finasteride led to durable improvements in scalp hair over five years (p ≤ 0.001 versus placebo, all endpoints), while treatment with placebo led to progressive hair loss. Finasteride was generally well tolerated and no new safety concerns were identified during long-term use. Conclusions. In men with MPHL, long-term treatment with finasteride 1 mg/day over five years was well tolerated, led to durable improvements in scalp hair growth, and slowed the further progression of hair loss that occurred without treatment.
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To examine the clinical and basic studies regarding persistent adverse effects associated with 5α reductase inhibitor treatment for androgenetic alopecia. Recent postmarketing reports and a US Food and Drug Administration analysis have documented uncommon persistent sexual and nonsexual side-effects in a subset of younger men who have taken finasteride 1 mg for androgenic alopecia. While the mechanisms of the sexual side-effects in humans is incompletely understood, one study found lower cerebrospinal fluid concentrations of dihydrotestosterone, progesterone, dihydroprogesterone and allopregnanolone, and higher levels of testosterone, 5α-androstane-3α,17β-diol and pregnenolone. Another study found up-regulation of the androgen receptor in the human foreskin with a mean of 5 years after finasteride discontinuation. Studies of erectile dysfunction in finasteride-treated rats showed fewer autophagosomes in smooth muscle on transmission electron microscopy, increased apoptosis, decreased smooth muscle, increased collagen deposition and decreased endothelial nitric oxide synthase. Finally, 5α reductase inhibitors have also been found to alter semen parameters in healthy men. Multiple animal studies provide a biological basis for many of the persistent effects seen in humans such as erectile dysfunction, depression and decreased alcohol consumption. Prescribers of 5α reductase inhibitors should discuss the potential risks with their patients seeking treatment for androgenetic alopecia.