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Michael S Irwig - One of the best experts on this subject based on the ideXlab platform.
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Finasteride and Suicide: A Postmarketing Case Series.
Dermatology (Basel Switzerland), 2020Co-Authors: Michael S IrwigAbstract:Background: In 2011, depression was added to the product labeling of Finasteride in the USA. The US Food and Drug Administration’s Adverse Event Reporting System database contains at least 36 death cases for Finasteride. The aim of this study is to characterize the clinical histories and symptoms reported by a series of 6 suicide victims who took Finasteride for treatment of androgenic alopecia. Methods: Medical records and autopsy reports were provided by family members of the cases. Relevant information was extracted according to guidelines for submitting adverse event reports. Results: An important pattern of symptoms was common among all cases who committed suicide in the setting of Finasteride use – insomnia and persistent sexual dysfunction after medication discontinuation. Insomnia and fatigue/tiredness were some of the most debilitating symptoms. Apart from 1 case who had hyperlipidemia, there was no documentation of concomitant medication use with Finasteride or any baseline medical or psychiatric diagnoses prior to starting Finasteride. The findings of this postmarketing series may not be generalizable to the population of men who committed suicide in the setting of Finasteride use due to small sample size and bias. Associations between medication use and symptoms cannot prove causality. Conclusion: Men under the age of 40 who use Finasteride for alopecia are at risk for suicide if they develop persistent sexual adverse effects and insomnia. Further research is needed to establish whether Finasteride has a causal relationship to suicide.
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depressive symptoms and suicidal thoughts among former users of Finasteride with persistent sexual side effects
The Journal of Clinical Psychiatry, 2012Co-Authors: Michael S IrwigAbstract:OBJECTIVE Finasteride, a commonly prescribed medication for male pattern hair loss, has recently been associated with persistent sexual side effects. In addition, depression has recently been added to the product labeling of Propecia (Finasteride 1 mg). Finasteride reduces the levels of several neuroactive steroids linked to sexual function and depression. This study assesses depressive symptoms and suicidal thoughts in former users of Finasteride who developed persistent sexual side effects despite the discontinuation of Finasteride. METHOD In 2010-2011, former users of Finasteride (n = 61) with persistent sexual side effects for ≥ 3 months were administered standardized interviews that gathered demographic information, medical and psychiatric histories, and information on medication use, sexual function, and alcohol consumption. All former users were otherwise healthy men with no baseline sexual dysfunction, chronic medical conditions, current or past psychiatric conditions, or use of oral prescription medications before or during Finasteride use. A control group of men (n = 29), recruited from the community, had male pattern hair loss but had never used Finasteride and denied any history of psychiatric conditions or use of psychiatric medications. The primary outcomes were the prevalence of depressive symptoms and the prevalence of suicidal thoughts as determined by the Beck depression inventory II (BDI-II); all subjects self-administered this questionnaire at the time of the interview or up to 10 months later. RESULTS Rates of depressive symptoms (BDI-II score ≥ 14) were significantly higher in the former Finasteride users (75%; 46/61) as compared to the controls (10%; 3/29) (P < .0001). Moderate or severe depressive symptoms (BDI-II score ≥ 20) were present in 64% (39/61) of the Finasteride group and 0% of the controls. Suicidal thoughts were present in 44% (27/61) of the former Finasteride users and in 3% (1/29) of the controls (P < .0001). CONCLUSIONS Clinicians and potential users of Finasteride should be aware of the potential risk of depressive symptoms and suicidal thoughts. The preliminary findings of this study warrant further research with controlled studies.
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persistent sexual side effects of Finasteride for male pattern hair loss
The Journal of Sexual Medicine, 2011Co-Authors: Michael S Irwig, Swapna KolukulaAbstract:ABSTRACT Introduction Finasteride has been associated with reversible adverse sexual side effects in multiple randomized, controlled trials for the treatment of male pattern hair loss (MPHL). The Medicines and Healthcare Products Regulatory Agency of the United Kingdom and the Swedish Medical Products Agency have both updated their patient information leaflets to include a statement that “persistence of erectile dysfunction after discontinuation of treatment with Propecia has been reported in post-marketing use.” Aim We sought to characterize the types and duration of persistent sexual side effects in otherwise healthy men who took Finasteride for MPHL. Methods We conducted standardized interviews with 71 otherwise healthy men aged 21–46 years who reported the new onset of sexual side effects associated with the temporal use of Finasteride, in which the symptoms persisted for at least 3 months despite the discontinuation of Finasteride. Main Outcome Measures The types and duration of sexual dysfunction and the changes in perceived sexual frequency and sexual dysfunction score between pre- and post-Finasteride use. Results Subjects reported new-onset persistent sexual dysfunction associated with the use of Finasteride: 94% developed low libido, 92% developed erectile dysfunction, 92% developed decreased arousal, and 69% developed problems with orgasm. The mean number of sexual episodes per month dropped and the total sexual dysfunction score increased for before and after Finasteride use according to the Arizona Sexual Experience Scale ( P Conclusion Physicians treating MPHL should discuss the potential risk of persistent sexual side effects associated with Finasteride. Irwig MS and Kolukula S. Persistent sexual side effects of Finasteride for male pattern hair loss.
Claus G Roehrborn - One of the best experts on this subject based on the ideXlab platform.
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treatment satisfaction and clinically meaningful symptom improvement in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia secondary results from a 6 month randomized double blind study comparing
International Journal of Urology, 2015Co-Authors: Claus G Roehrborn, Sidney Glina, Adolfo Casabe, Sebastian Sorsaburu, Carsten Henneges, Lars ViktrupAbstract:Objectives To report the secondary analyses of treatment satisfaction and clinically meaningful improvements in a randomized study comparing coadministration of tadalafil 5 mg with Finasteride 5 mg versus Finasteride alone in men with prostatic enlargement secondary to benign prostatic hyperplasia. Methods An international, randomized, double-blind, parallel study was carried out in men aged ≥45 years who were 5-alpha reductase inhibitor naive, and had an International Prostate Symptom Score ≥13 and prostate volume ≥30 mL; 350 men received placebo/Finasteride and 345 received tadalafil/Finasteride over 26 weeks. Treatment satisfaction was assessed per protocol using the Treatment Satisfaction Scale-Benign Prostatic Hyperplasia. Responder cut-offs, analyzed post-hoc were total International Prostate Symptom Score improvement ≥3 points or ≥25% from randomization. Results Baseline patient characteristics were generally comparable between responders and non-responders. The proportion of patients with an International Prostate Symptom Score improvement ≥3 points with tadalafil/Finasteride and placebo/Finasteride, respectively, at week 4 was 57.0% and 47.9% (OR 1.45, 95% confidence interval 1.07–1.97), at week 12 was 68.8% and 60.7% (OR 1.48, 95% confidence interval 1.07–2.05) and at week 26 was 71.4% and 70.2% (OR 1.14, 95% confidence interval 0.81–1.61); for IPSS change ≥25%, the corresponding proportions were 44.8% and 32.9% (OR 1.66, 95% confidence interval 1.21–2.28), 55.5% and 51.9% (OR 1.18, 95% confidence interval 0.87–1.62), and 62.0% and 58.3% (OR 1.23, 95% confidence interval 0.89–1.70). Treatment satisfaction at week 26 was significantly greater with tadalafil/Finasteride versus placebo/Finasteride for total treatment satisfaction scale score (P=0.031) and satisfaction with efficacy subscore (P = 0.025); scores were not significantly different between treatments for satisfaction with dosing or side-effects (both P ≥ 0.371). Conclusions Tadalafil/Finasteride results in significantly more patients achieving early clinical meaningful improvements in symptoms, and in greater treatment satisfaction versus placebo/Finasteride.
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Efficacy and tolerability of doxazosin and Finasteride, alone or in combination, in treatment of symptomatic benign prostatic hyperplasia: The prospective european doxazosin and combination therapy (predict) trial
Urology, 2003Co-Authors: Roger Kirby, Georg Bartsch, Alain Jardin, Margaret M Cary, Michael O Sweeney, Peter Boyle, Claus G Roehrborn, Eric Ben GrossmanAbstract:Objectives To evaluate the efficacy and tolerability of the selective alpha1-adrenergic antagonist doxazosin and the 5-alpha-reductase inhibitor Finasteride, alone and in combination, for the symptomatic treatment of benign prostatic hyperplasia. Methods In a prospective, double-blind, placebo-controlled trial, 1095 men aged 50 to 80 years were randomized to treatment for 52 weeks with doxazosin, Finasteride, the combination of doxazosin and Finasteride, or placebo. The dose of Finasteride (or its matched placebo) was 5 mg/day. Doxazosin (or its matched placebo) was initiated at 1 mg/day, and titrated up to a maximum of 8 mg/day over approximately 10 weeks according to the response of the maximal urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS). The IPSS and Qmax were assessed at baseline and at weeks 10, 14, 26, 39, and 52 or at the endpoint. Results An intent-to-treat analysis of 1007 men showed doxazosin and doxazosin plus Finasteride combination therapy produced statistically significant improvements in total IPSS and Qmax compared with placebo and Finasteride alone (P
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efficacy and tolerability of doxazosin and Finasteride alone or in combination in treatment of symptomatic benign prostatic hyperplasia the prospective european doxazosin and combination therapy predict trial
Urology, 2003Co-Authors: R S Kirby, Georg Bartsch, Alain Jardin, Margaret M Cary, Michael O Sweeney, Peter Boyle, Claus G Roehrborn, Eric Ben GrossmanAbstract:Objectives To evaluate the efficacy and tolerability of the selective alpha1-adrenergic antagonist doxazosin and the 5-alpha-reductase inhibitor Finasteride, alone and in combination, for the symptomatic treatment of benign prostatic hyperplasia. Methods In a prospective, double-blind, placebo-controlled trial, 1095 men aged 50 to 80 years were randomized to treatment for 52 weeks with doxazosin, Finasteride, the combination of doxazosin and Finasteride, or placebo. The dose of Finasteride (or its matched placebo) was 5 mg/day. Doxazosin (or its matched placebo) was initiated at 1 mg/day, and titrated up to a maximum of 8 mg/day over approximately 10 weeks according to the response of the maximal urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS). The IPSS and Qmax were assessed at baseline and at weeks 10, 14, 26, 39, and 52 or at the endpoint. Results An intent-to-treat analysis of 1007 men showed doxazosin and doxazosin plus Finasteride combination therapy produced statistically significant improvements in total IPSS and Qmax compared with placebo and Finasteride alone (P <0.05). Finasteride alone was not significantly different statistically from placebo with respect to total IPSS and Qmax. All treatments were generally well tolerated. Conclusions Doxazosin was effective in improving urinary symptoms and urinary flow rate in men with benign prostatic hyperplasia, and was more effective than Finasteride alone or placebo. The addition of Finasteride did not provide further benefit to that achieved with doxazosin alone.
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the effect of Finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia
The New England Journal of Medicine, 1998Co-Authors: John D Mcconnell, Claus G Roehrborn, Reginald C Bruskewitz, Patrick C Walsh, Gerald L Andriole, Michael M Lieber, Logan H Holtgrewe, Peter C Albertsen, Curtis J Nickel, Daniel Z WangAbstract:Background Finasteride is known to improve urinary symptoms in men with benign prostatic hyperplasia, but the extent to which the benefit is sustained and whether Finasteride reduces the incidence of related events, including the need for surgery and the development of acute urinary retention, are not known. Methods In this double-blind, randomized, placebo-controlled trial, we studied 3040 men with moderate-to-severe urinary symptoms and enlarged prostate glands who were treated daily with 5 mg of Finasteride or placebo for four years. Symptom scores (on a scale of 1 to 34), urinary flow rates, and the occurrence of outcome events were assessed every four months in 3016 men. Prostate volume was measured in a subgroup of the men. Complete data on outcomes were available for 2760 men. Results During the four-year study period, 152 of the 1503 men in the placebo group (10 percent) and 69 of the 1513 men in the Finasteride group (5 percent) underwent surgery for benign prostatic hyperplasia (reduction in risk with Finasteride, 55 percent; 95 percent confidence interval, 41 to 65 percent). Acute urinary retention developed in 99 men (7 percent) in the placebo group and 42 men (3 percent) in the Finasteride group (reduction in risk with Finasteride, 57 percent; 95 percent confidence interval, 40 to 69 percent). Among the men who completed the study, the mean decreases in the symptom score were 3.3 in the Finasteride group and 1.3 in the placebo group (P<0.001). Treatment with Finasteride also significantly improved urinary flow rates and reduced prostate volume (P<0.001). Conclusions Among men with symptoms of urinary obstruction and prostatic enlargement, treatment with Finasteride for four years reduces symptoms and prostate volume, increases the urinary flow rate, and reduces the probability of surgery and acute urinary retention.
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Meta-Analysis of Randomized Clinical Trials of Finasteride
Urology, 1998Co-Authors: Claus G RoehrbornAbstract:A meta-analysis was recently published based on six randomized clinical trials of at least one year duration involving Finasteride 5 mg and placebo in the treatment of men with clinical benign prostatic hyperplasia (BPH). In a pooled analysis, mean improvement in symptoms and urinary flow rate with Finasteride were found to increase with increasing prostate size. This article reviews the previous publication of this meta-analysis, which indicated prostate volume is a key predictor of outcomes with Finasteride treatment and suggested that Finasteride is most effective in men with large prostates.
D A Whiting - One of the best experts on this subject based on the ideXlab platform.
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lack of efficacy of Finasteride in postmenopausal women with androgenetic alopecia
Journal of The American Academy of Dermatology, 2000Co-Authors: Vera H Price, J L Roberts, M Hordinsky, E A Olsen, A Lucky, D A Whiting, Ronald C Savin, Wilma F Bergfeld, Virginia C Fiedler, F PappasAbstract:Abstract Background: Finasteride, an inhibitor of type 2 5α-reductase, decreases serum and scalp dihydrotestosterone (DHT) by inhibiting conversion of testosterone to DHT and has been shown to be effective in men with androgenetic alopecia (AGA). The effects of Finasteride in women with AGA have not been evaluated. Objective: The purpose of this study was to evaluate the efficacy of Finasteride in postmenopausal women with AGA. Methods: In this 1-year, double-blind, placebo-controlled, randomized, multicenter trial, 137 postmenopausal women (41-60 years of age) with AGA received Finasteride 1 mg/day or placebo. Efficacy was evaluated by scalp hair counts, patient and investigator assessments, assessment of global photographs by a blinded expert panel, and histologic analysis of scalp biopsy specimens. Results: After 1 year of therapy, there was no significant difference in the change in hair count between the Finasteride and placebo groups. Both treatment groups had significant decreases in hair count in the frontal/parietal (anterior/mid) scalp during the 1-year study period. Similarly, patient, investigator, and photographic assessments as well as scalp biopsy analysis did not demonstrate any improvement in slowing hair thinning, increasing hair growth, or improving the appearance of the hair in Finasteride-treated subjects compared with the placebo group. Finasteride was generally well tolerated. Conclusion: In postmenopausal women with AGA, Finasteride 1 mg/day taken for 12 months did not not increase hair growth or slow the progression of hair thinning. (J Am Acad Dermatol 2000;43:768-76.)
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Lack of efficacy of Finasteride in postmenopausal women with androgenetic alopecia.
Journal of the American Academy of Dermatology, 2000Co-Authors: V H Price, J L Roberts, M Hordinsky, E A Olsen, R Savin, W Bergfeld, V Fiedler, A Lucky, D A Whiting, F PappasAbstract:Finasteride, an inhibitor of type 2 5alpha-reductase, decreases serum and scalp dihydrotestosterone (DHT) by inhibiting conversion of testosterone to DHT and has been shown to be effective in men with androgenetic alopecia (AGA). The effects of Finasteride in women with AGA have not been evaluated. The purpose of this study was to evaluate the efficacy of Finasteride in postmenopausal women with AGA. In this 1-year, double-blind, placebo-controlled, randomized, multicenter trial, 137 postmenopausal women (41-60 years of age) with AGA received Finasteride 1 mg/day or placebo. Efficacy was evaluated by scalp hair counts, patient and investigator assessments, assessment of global photographs by a blinded expert panel, and histologic analysis of scalp biopsy specimens. After 1 year of therapy, there was no significant difference in the change in hair count between the Finasteride and placebo groups. Both treatment groups had significant decreases in hair count in the frontal/parietal (anterior/mid) scalp during the 1-year study period. Similarly, patient, investigator, and photographic assessments as well as scalp biopsy analysis did not demonstrate any improvement in slowing hair thinning, increasing hair growth, or improving the appearance of the hair in Finasteride-treated subjects compared with the placebo group. Finasteride was generally well tolerated. In postmenopausal women with AGA, Finasteride 1 mg/day taken for 12 months did not not increase hair growth or slow the progression of hair thinning.
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Finasteride increases anagen hair in men with androgenetic alopecia
The British journal of dermatology, 2000Co-Authors: D Van Neste, J L Roberts, D A Whiting, V Fuh, P Sanchez-pedreno, E Lopez-bran, Helmut H. Wolff, Daisy Kopera, J. J. Stene, Stefano CalvieriAbstract:BACKGROUND The growth of scalp hair is a cyclical process of successive phases of growth (anagen) and rest (telogen). In previous clinical trials in men with androgenetic alopecia, treatment with Finasteride increased scalp hair counts in a defined area (i.e. increased hair density). OBJECTIVES The current study used a phototrichogram methodology to assess the effect of Finasteride on the phases of the hair growth cycle. PATIENTS/METHODS Two hundred and twelve men, age 18-40 years, with androgenetic alopecia were randomized to receive Finasteride 1 mg daily or placebo for 48 weeks. At baseline and at 24 and 48 weeks, macrophotographs were taken to measure total and anagen hair count in a 1-cm(2) target area of the scalp. RESULTS At baseline, mean total and anagen hair counts in the Finasteride group were 200 and 124 hairs, respectively (% anagen = 62%) and the anagen to telogen ratio was 1.74 (geometric mean). In the placebo group, the respective values were 196 and 119 hairs (% anagen = 60%) and 1.57. At week 48, the Finasteride group had a net improvement (mean +/- SE) compared with placebo in total and anagen hair counts of 17.3 +/- 2.5 hairs (8.3% +/- 1.4%) and 27.0 +/- 2.9 hairs (26% +/- 3.1%), respectively (P < 0.001). Furthermore, treatment with Finasteride resulted in a net improvement in the anagen to telogen ratio of 47% (P < 0.001). In this study, treatment with Finasteride 1 mg day(-1) for 48 weeks increased both total and anagen hair counts, and improved the anagen to telogen ratio. CONCLUSIONS These data provide direct evidence that Finasteride 1 mg daily promotes the conversion of hairs into the anagen phase. These data support that Finasteride treatment results in favourable effects on hair quality that contribute to the visible improvements in hair growth observed in treated patients.
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the effects of Finasteride on scalp skin and serum androgen levels in men with androgenetic alopecia
Journal of The American Academy of Dermatology, 1999Co-Authors: Lynn A Drake, M Hordinsky, Virginia C Fiedler, James M Swinehart, Walter P Unger, Paul C Cotterill, Diane Thiboutot, Nicholas J Lowe, Coleman Jacobson, D A WhitingAbstract:Background: Data suggest that androgenetic alopecia is a process dependent on dihydrotestosterone (DHT) and type 2 5α-reductase. Finasteride is a type 2 5α-reductase inhibitor that has been shown to slow further hair loss and improve hair growth in men with androgenetic alopecia. Objective: We attempted to determine the effect of Finasteride on scalp skin and serum androgens. Methods: Men with androgenetic alopecia (N=249) underwent scalp biopsies before and after receiving 0.01, 0.05, 0.2, 1, or 5 mg daily of Finasteride or placebo for 42 days. Results: Scalp skin DHT levels declined significantly by 13.0% with placebo and by 14.9%, 61.6%, 56.5%, 64.1%, and 69.4% with 0.01, 0.05, 0.2, 1, and 5 mg doses of Finasteride, respectively. Serum DHT levels declinied significantly ( P Conclusion: In this study, doses of Finasteride as low as 0.2 mg per day maximally decreased both scalp skin and serum DHT levels. These data support the rationale used to conduct clinical trials in men with male pattern hair loss at doses of Finasteride between 0.2 and 5 mg.
Hans Lennernas - One of the best experts on this subject based on the ideXlab platform.
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the effect of st john s wort on the pharmacokinetics metabolism and biliary excretion of Finasteride and its metabolites in healthy men
European Journal of Pharmaceutical Sciences, 2009Co-Authors: Anna Lundahl, Mikael Hedeland, Ulf Bondesson, Lars Knutson, Hans LennernasAbstract:Abstract The aim of this study was to investigate what the consequences of induced drug metabolism, caused by St. John's wort (SJW, Hypericum perforatum ) treatment, would have on the plasma, biliary and urinary pharmacokinetics of Finasteride and its two previously identified phase I metabolites (hydroxy-Finasteride and carboxy-Finasteride). Twelve healthy men were administered 5 mg Finasteride directly to the intestine via a catheter with a multi-channel tubing system, Loc-I-Gut, before and after 14 days SJW (300 mg b.i.d, hyperforin 4%) treatment. Bile samples were withdrawn via the Loc-I-Gut device from the proximal jejunum. LC–ESI-MS/MS was used to analyze Finasteride and its metabolites in plasma, bile and urine. HPLC-UV was used to analyze hyperforin in plasma. The herbal treatment significantly reduced the peak plasma concentration ( C max ), the area under the plasma concentration–time curve (AUC 0–24h ) and the elimination half-life ( t 1/2 ) of Finasteride. The geometric mean ratios (90% CI) were 0.42 (0.36–0.49), 0.66 (0.56–0.79) and 0.54 (0.48–0.61), respectively. Finasteride was excreted unchanged to a minor extent into bile and urine. Hydroxy-Finasteride was not detected in plasma, bile or urine. Carboxy-Finasteride was quantified in all three compartments and its plasma pharmacokinetics was significantly affected by SJW treatment. Hyperforin concentration in plasma was 21 ± 7 ng/ml approximately 12 h after the last dose of the 14 days SJW treatment. In conclusion, SJW treatment for 2 weeks induced the metabolism of Finasteride and caused a reduced plasma exposure of the drug. New knowledge was gained about the biliary and urinary excretion or the drug and its metabolites.
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The effect of St John’s Wort treatment on Finasteride metabolism and identification of new Finasteride metabolites in humans
2008Co-Authors: Anna Lundahl, Mikael Hedeland, Ulf Bondesson, Lars Knutson, Hans LennernasAbstract:The effect of St John’s Wort treatment on Finasteride metabolism and identification of new Finasteride metabolites in humans
Swapna Kolukula - One of the best experts on this subject based on the ideXlab platform.
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persistent sexual side effects of Finasteride for male pattern hair loss
The Journal of Sexual Medicine, 2011Co-Authors: Michael S Irwig, Swapna KolukulaAbstract:ABSTRACT Introduction Finasteride has been associated with reversible adverse sexual side effects in multiple randomized, controlled trials for the treatment of male pattern hair loss (MPHL). The Medicines and Healthcare Products Regulatory Agency of the United Kingdom and the Swedish Medical Products Agency have both updated their patient information leaflets to include a statement that “persistence of erectile dysfunction after discontinuation of treatment with Propecia has been reported in post-marketing use.” Aim We sought to characterize the types and duration of persistent sexual side effects in otherwise healthy men who took Finasteride for MPHL. Methods We conducted standardized interviews with 71 otherwise healthy men aged 21–46 years who reported the new onset of sexual side effects associated with the temporal use of Finasteride, in which the symptoms persisted for at least 3 months despite the discontinuation of Finasteride. Main Outcome Measures The types and duration of sexual dysfunction and the changes in perceived sexual frequency and sexual dysfunction score between pre- and post-Finasteride use. Results Subjects reported new-onset persistent sexual dysfunction associated with the use of Finasteride: 94% developed low libido, 92% developed erectile dysfunction, 92% developed decreased arousal, and 69% developed problems with orgasm. The mean number of sexual episodes per month dropped and the total sexual dysfunction score increased for before and after Finasteride use according to the Arizona Sexual Experience Scale ( P Conclusion Physicians treating MPHL should discuss the potential risk of persistent sexual side effects associated with Finasteride. Irwig MS and Kolukula S. Persistent sexual side effects of Finasteride for male pattern hair loss.