National Institutes of Health. Adverse events of 5-alpha-reductase inhibitors. Available at: https://rarediseases.info.nih.gov/diseases/12407/post-finasteride-syndrome. Last accessed January 29, 2020.
National Institutes of Health. Adverse events of 5-alpha-reductase inhibitors. Available at: https://rarediseases.info.nih.gov/diseases/12407/post-finasteride-syndrome. Last accessed January 29, 2020.
- Garreton A.S.
- Valzacchi G.R.
- Layus O.
- Matusevich L.
- Gueglio G.
Clinical Studies Reporting Sexual Adverse side effects
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|Author, year (reference)||Nature of the study||Authors’ interpretations||Safety evaluations methods|
|Nickel JC et al., 1996 (|
Efficacy and safety of finasteride therapy for benign prostatic hyperplasia: results of a 2-year randomized controlled trial (the PROSPECTstudy). PROscar Safety Plus Efficacy Canadian Two-year Study.
CMAJ. 1996; 155: 1251-1259
|Double-blind, parallel-group, placebo-controlled, multicenter, prospective randomized study. A total of 613 men were entered into the study; 472 completed the 2 years of treatment.||The incidence of adverse events related to sexual dysfunction were significantly higher in the finasteride group than in the placebo group (ejaculation disorder 7.7% vs. 1.7% and impotence 15.8% vs. 6.3%; P <.01 for both parameters).||Investigators assessed patient well-being, incidence of adverse events and treatment compliance during an open-ended interview at each visit.|
|McConnell et al., 1998 (|
|Double-blind, randomized, placebo-controlled trial of 3,040 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. Complete data on outcomes were available for 2,760 men.||The only drug-related adverse effects that occurred in 1% or more of the men for which the rates differed significantly between the groups were symptoms of sexual dysfunction, breast enlargement or tenderness, and rashes.||Investigators assessed patient well-being, incidence of adverse events and treatment compliance during an open-ended interview at each visit.|
|Moinpour et al., 2007 (|
|Longitudinal analysis of sexual function reported by men in the Prostate Cancer Prevention Trial. Sexual dysfunction was assessed in 17,313 PCPT participants during a 7-year period.||Finasteride increased sexual dysfunction only slightly and its impact diminished over time. The effect of finasteride on sexual functioning is minimal for most men and should not impact the decision to prescribe or take finasteride.||A battery of questionnaires was used to assess sexual dysfunction|
|Hudson et al., 1999 (|
|A Phase III North American BPH clinical trial originally enrolled 895 men, 297 of whom were randomized to receive finasteride 5 mg.||Finasteride was well tolerated, with no significant increase in the prevalence of sexual adverse events over time.||Safety was assessed throughout the study by physical examination and laboratory tests and by monitoring all clinical and laboratory adverse events at least every 6 months|
|Thompson et al 2003 (|
|Randomized clinical trial, 18,882 men 55 years age or older randomly assigned to treatment with finasteride (5 mg per day) or placebo for seven years.||Reduced volume of ejaculate, erectile dysfunction, loss of libido, and gynecomastia was more common in the finasteride group than in the placebo group (P<.001 for all comparisons).||Adverse events and side effects were reported by the men during directed interviews over the course of their treatment.|
|Andriole et al 2010 (|
|Randomized clinical trial, of 6,729 men who underwent a biopsy or prostate surgery 3,305 men were treated with dutasteride and 3,424 men in the placebo group||A drug-related decrease and or loss of libido was reported by the men in the dutasteride group, as compared with the men in the placebo group (P<.001 and P =.03, respectively). A drug related decrease in or loss of erectile function was reported in men in the dutasteride group as compared to the placebo group (P<.001).||Adverse events were reported by the investigators of the study. No details on how such events were fully assessed.|
|Wessells et al., 2003 (|
|A 4-year, randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of finasteride 5 mg in 3,040 men, aged 45 to 78 years.||15% of finasteride-treated patients and 7% of placebo-treated patients had sexual AEs that were considered drug related by the investigator (P <.001) during year 1 of the study. In men who discontinued with a sexual AE, 50% and 41% experienced resolution of their sexual AE after discontinuing finasteride or placebo therapy, respectively.||During the treatment period, spontaneously self-reported sexual adverse events were recorded. Physicians were asked to classify the intensity of sexual AEs as mild, moderate or severe.|
|Debruyne et al., 2004 (|
|A total of 4,325 patients were randomized to dutasteride or placebo in the double-blind portion of the Phase III studies. Patients were eligible for a 2-year open-label extension, where all patients received dutasteride 0.5 mg daily (dutasteride/dutasteride (D/D) group and placebo/dutasteride (P/D group)).||The most common drug-related adverse events were sexual events (impotence, decreased libido, and ejaculation disorders) and gynecomastia. The onset of most new drug-related sexual AEs occurred within the first 6 months of therapy.||Safety was assessed through AE reporting, clinical laboratory assessments, and yearly physical examinations, which included focused gynecomastia evaluations.|
|Brenner &Matz 1999 (|
|Twenty-eight men with AGA, aged 53–76 years (mean, 65 years), were selected to, participate in this trial from a double blind, placebo controlled, multicenter study of subjects with moderate symptoms of BPH.||No adverse event reporting.||No assessments of adverse events were made.|
|Gormley et al., 1992 (|
|Double-blinded study of 1 and 5 mg of finasteride vs placebo in 895 men with BPH.||The proportion of men reporting decreased libido and decrease ejaculate volume was significantly higher (P <.05) in both finasteride treated groups than in the placebo group. The proportion of men reporting impotence with 1 mg finasteride were higher than in the placebo group (P<.05). Two men died. One died of cardiac arrest and one committed suicide.||Investigators assessed patient well-being, incidence of adverse events and treatment compliance during an open-ended interview at each visit.|
|Marberger et al., 1998 (|
|A double-blinded placebo controlled multicenter trial assessing long term effects of finasteride on men with BPH. Of the 3,270 men enrolled, 3,168 contributed data to the safety analysis, and 2,902 to the efficacy evaluation.||Only decreased libido, ejaculation disorders, and impotence were considered by the investigators to be drug related. A total of 273 patients reported a sexual adverse event (change in libido, ejaculation disorder, impotence, or orgasm dysfunction) during the treatment period, 165 (10%) in the finasteride group and 108 (7%) in the placebo group (P ≤.001).|
|Roehrborn et al., 2002 (|
|A total of 4,325 men (2,951 completed) with clinical BPH were enrolled into three identical clinical trials and randomized to 0.5 mg dutasteride daily or placebo. After a 1-month, single-blind, placebo lead-in, patients were followed up for 24 months in a double-blind trial with multiple interval assessments.||Drug-related AEs were seen in 14% and 19% of placebo-treated and dutasteride-treated patients, respectively, with sexually related AEs the most common in both groups. Impotence, reduced libido, ejaculation disorders, and gynecomastia occurred more frequently in dutasteride-treated patients. .|
|Vaughan et al., 2002 (|
|A total of 190 men with BPH entered one of two Phase II double-blind 3 to 6-month studies and 156 patients continued to take finasteride in an open label study and more than 70 patients completed 7 to 8 years of treatment.||The most common drug-related adverse events were impotence, ejaculation disorder, and decreased libido. The incidence of new occurrences of drug-related sexual adverse events was highest during the first year of the open extension and decreased to much lower levels throughout the extension.||No information was provided on how assessment of adverse events was made.|
|Andriole et al., 2003 (|
|The safety and tolerability data from four large, randomized, double-blind clinical trials (n =5,655) with the novel, dual 5α-reductase inhibitor, dutasteride.||Sexual adverse events were the most commonly reported class of drug-related adverse event.||Safety was assessed at each visit by asking the patient about any adverse events that had been experienced.|
|Tsukamoto et al., 2009 (|
|This was a randomized, double-blind, placebo-controlled, parallel-group study of 378 subjects with clinical BPH were randomized to receive placebo or dutasteride once daily for 52 weeks.||The percentages of subjects with drug-related adverse events were 5% and 6% in the placebo and dutasteride groups, respectively. The most common drug-related adverse events (≥1% in any treatment group) included erectile dysfunction, stomach discomfort, libido decreased, and dizziness.|
|Fwu et al., 2014 (|
|The Medical Therapy of Prostatic Symptoms study was a multicenter, randomized, double-blind, placebo controlled clinical trial with a primary outcome of time to benign prostatic hyperplasia progression.||Men assigned to finasteride and combined therapy experienced overall statistically significant but slight worsening of ejaculatory function compared with men on placebo. Men assigned to combined therapy also experienced significant worsening in erectile function and sexual problem assessment.||Change in sexual function was a secondary outcome. We analyzed the records of 2,783 men enrolled in the study who completed the inventory at baseline and at least once during follow-up.|
|Kaplan et a., 2012 (|
A 5-year retrospective analysis of 5α-reductase inhibitors in men with benign prostatic hyperplasia: finasteride has comparable urinary symptom efficacy and prostate volume reduction, but less sexual side effects and breast complications than dutasteride.
Int J Clin Pract. 2012; 66: 1052-1055
|A retrospective analysis of 378 consecutive men treated with 5α-reductase inhibitor monotherapy (197 on finasteride and 211 on dutasteride) in a single clinic was performed.||The incidence of erectile dysfunction, ejaculatory dysfunction and decreased libido resulting in discontinuation from therapy was significantly (P <.01) higher in the dutasteride (5.1%, 2.4%, and 2.7% respectively) compared with the finasteride group (2.1%, 1.8%, 1.4% and respectively).||Safety assessments included International Index of Erectile Function and adverse events. Patients were evaluated at 3 months, 1 year and yearly thereafter.|
|Author, year (reference)||Nature of the study as described by authors||Study authors assessment of adverse events||Safety assessments as described by the study investigators|
|Ganzer and Jacobs, 2016 (|
|This is a retrospective observational study using self-administered questionnaire in which participants in this online survey completed the BDI, the BAI, and Ten-Item Personality Inventory.||An important finding in this study was that almost 57% (n = 97) of men reported a psychiatric diagnosis and 28% (n = 27) had a first-degree relative with a mental health disorder, of this group 17 only had a family history. Nearly 50% of the men surveyed reported clinically significant depression as evidenced by BDI score and 34% experienced anxiety on the BAI.||Psychological sequelae were assessed using two self-report scales, the BDI and the BAI. The BAI, selected to evaluate anxiety, is a 21-item self-report questionnaire that distinguishes anxious diagnostic groups (e.g., panic disorder) from non-anxious diagnostic groups (e.g., major depressive disorder).|
|Melcangi et al., 2017 (|
|A multicentric, prospective, longitudinal, case-control clinical trial. PFS patients were recruited through the Italian network finasteride side effects. Only subjects who had discontinued finasteride at least 3 months earlier, did not use drugs known to potentially interfere with neuroactive steroid levels and did not report depression or sexual dysfunction before finasteride use were included.||Objective evidence in PFS patients of peripheral neuropathy of the pudendal nerve which is critical for normal neurogenic control of erection. Pelvic nerve somatosensory evoked potential abnormalities were found in 25% of PFS patients, despite normal neurological examination and no prior history of neurological disease. PFS patients show altered levels of important physiological regulators of brain function, such as neuroactive steroids.||A questionnaire was used to evaluate the absence of PFS signs and symptoms before the finasteride treatment, as well as the presence of this accompanying signs and symptoms during and after the drug treatment. Patients were assessed for the presence of any neurological impairment through careful personal and family history assessment and physical examination performed by a certified neurologist.|
|Kiguradze et al., 2017 (|
|A single-group study design and CTA to model PED lasting greater than 90 days after stopping finasteride or dutasteride. The data source was the electronic medical record data repository for Northwestern Medicine.||Among men with finasteride or dutasteride exposure, 167 of 11,909 (1.4%) developed PED. Of 530 men with new ED, 167 (31.5%) had new PED. Men without prostate disease who combined nonsteroidal anti-inflammatory drug 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 <.002). Young men with >205 days of finasteride exposure had 4.9-fold higher risk of PED (NNH 108.2, P <.004) than men with shorter exposure.||Main outcome measure was diagnosis of PED beginning after first 5a-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 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 NNH.|
|Basaria, et al., 2016 (|
|A clinical study utilizing biochemical and imaging techniques to assess sexual function, mood, affect, cognition, hormone levels, body-composition, fMRI response to sexually and affectively-balanced stimuli were assessed in finasteride users, who reported persistent sexual symptoms after discontinuing finasteride||Symptomatic finasteride-users had impaired sexual function, higher depression scores, a more negative affectivity balance, and more cognitive complaints than men in groups 2 and 3 but had normal objectively-assessed cognitive function. These men also exhibited depressed mood; and moderate to severe depression. Symptomatic finasteride-users revealed depressed mood and fMRI findings consistent with those observed in depression.||Sexual function was assessed using the IIEF and the Male Sexual Health Questionnaire for more precise assessment of sexual desire and ejaculatory function than is provided by IIEF. Sexual activity was ascertained using sexual encounter profile diaries for a period of 7 days. Mood/depression was assessed using Patient Health Questionnaire-9 depression|
scale, BDI, and Hamilton Depression Scale 17, and affect using the Positive and Negative Affect Scale.
|Chiriaco et al., 2016 (|
|An observational retrospective evaluation of 79 young men with long-term adverse effects after use of finasteride against androgenetic alopecia. The type and frequency of symptoms in men having long-term sexual and non-sexual side effects after finasteride treatment (a condition recently called PFS against AGA were assessed.||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%). 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%).||Symptoms were investigated by an ad hoc 100 questions’ questionnaire, and by validated ASEX and Aging Male Symptom Scale questionnaires.|
|Guo et al., 2016 (|
|A retrospective cohort study using the Intercontinental Medical Statistics U.S. health claims database. From an original cohort of 6,110,723 patients, 1,390 men were identified who had stopped using finasteride 1mg and 20,000 randomly selected age- and calendar time-matched users of omeprazole.||The median time to first PSD event after discontinuation of finasteride 1mg prescription was 339 days. The rate of PSD for finasteride users and omeprazole users was 37.9 and 15 per 1,000-person-years, respectively.||In the primary analysis, we followed the cohorts to the first incidence of one of the following sexual dysfunction codes: erectile dysfunction, inhibited sex excitement, psychosexual dysfunction, premature ejaculation, hypoactive sexual desire disorder, decreased libido, or unspecified psychosexual disorder.|
|Choi et al., 2016 (|
|Open label, multi-center, non-interventional observational study. 712 subjects with AGA (18 to 41 years of age) with no experience of dutasteride were enrolled.||Most frequent AEs were libido decreased, dyspepsia, impotence and fatigue. Other interested AEs were sexual function abnormality, gynecomastia, and ejaculation disorder. Dutasteride 0.5 mg is well-tolerated in AGA patients in a clinical practice environment.||Physicians were guided to record any treatment-emergent adverse events during the follow up. At the last treatment visit, the effectiveness was additionally evaluated as “improved,” “no change,” “worsened,” and “not assessed.” The overall effectiveness assessment will depend on the physician’s medical judgement|
|Caruso et al., 2015 (|
|A case control study of 19 post-finasteride syndrome patients to assess changes in neuroactive steroid levels.||Overall all the subjects had a complex and constant neuropsychiatric pattern. The present observations show that altered levels of neuroactive steroids, associated with depression symptoms, are present in AGA patients even after discontinuation of the finasteride treatment.||Symptoms reported by the patients were collected using standardized questionnaire. In order to limit selection and recall bias, it was filled in by the patients only once before they were made aware of the possibility to undergo neuroactive steroid assessment.|
|Ali et al., 2015 (|
|Using the United States FAERS Database to retrieve adverse drug events that were voluntarily submitted to the FAERS between 1998 and 2013. The database was restricted to reports of male patients between 18 and 45 years of age to investigate the risk in young men and to minimize exposure misclassification.||In total, of 4,910 reports, 577 exhibited 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. Most 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.||A real-world adverse event reporting database to detect SD and SI signals in men aged 18–45 years who were treated with low-dose finasteride for treatment of men with AGA.|
|Ganzer et al., 2015 (|
|A web-based survey was constructed after conducting an extensive literature search of MEDLINE (restricted to the years 1995-2013) using the key words finasteride, sexual dysfunction, 5-α reductase, male pattern hair loss, Propecia, and side effects. A total of 149 surveys were retrieved with 18 excluded because they were less than 70% complete.||Persistent sexual side effects were prevalent. A large majority of respondents reported an overall decrease in sexual drive, intermittent erectile dysfunction, or a loss of spontaneous morning erections—or all three—and many reported physical and sensory changes to the penis and scrotum included penile and scrotal shrinkage and diminished semen volume and force.||Questions were asked about symptom onset after starting and stopping therapy. Symptom onset was characterized as beginning immediately after initiating finasteride, 3 to 6 months or 6 to 12 months into the therapy, or never while taking finasteride.|
|Di Loreto , et al., 2014 (|
|A retrospective case-control study of healthy, AGA positive, with no history of finasteride or any other drug capable of impairing androgens action use and no use of hormonal treatments ever were enrolled.||In all subjects, adverse side effects persisted for over 6 months after finasteride discontinuation and were still affecting the patients at the time of the visit day for study enrolment. All of the 8 finasteride treated patients had loss of penis sensitivity and loss of pleasurable response to touch, 7 out of 8 cases had loss of scrotum and/or testicles sensitivity, hardened tissue and/or rubbery texture, flaccidity, wrinkledness and retraction into the scrotum, and erectile dysfunction. All cases except 2 reported reduced penis dimension and declared pain in penis and/or scroto or testis.||Two different structured questionnaires were administered to the former finasteride users (cases) to evaluate the development and severity of persistent side effects. Additionally, formers finasteride users filled the ASEX questionnaire.|
|Harcha, et al., 2014 (|
A randomized, active- and placebo-controlled study of the efficacy and safety of different doses of dutasteride versus placebo and finasteride in the treatment of male subjects with androgenetic alopecia.
J Am Acad Dermatol. 2014; 70: 489-498
|A randomized, active- and placebo-controlled study of the efficacy and safety of different doses of dutasteride versus placebo and finasteride in the treatment of male subjects with AGA. Men aged 20 to 50 years (n = 917) with AGA were randomized to receive dutasteride (0.02, 0.1, or 0.5 mg/d), finasteride (1 mg/d), or placebo for 24 weeks.||The incidence of adverse events of special interest related to sexual functioning and breast disorders was greater in the treatment groups and lower with placebo, with the composite adverse events ‘‘altered libido’’ being the main cause for the difference between placebo and active treatments.||AEs, vital signs, clinical laboratory tests, breast examinations, and prostates specific antigen levels were monitored during the study.|
|Irwig 2014 (|
|Healthy young men (n = 24) who developed persistent sexual adverse effects associated with finasteride use (≤1.00-1.25 mg/d) for AGA were administered standardized interviews that included the use of a validated instrument to assess sexual function.||Low serum androgen levels at the time of the study cannot explain the persistent sexual adverse effects because mean levels were like those in other studies.||Participants were administered standardized interviews that included the use of a validated instrument to assess sexual function.|
|Motofei et al., 2013 (|
|In total, 33 sexually healthy Romanian men participated in this study. Patients prospectively provided information regarding their sexual functioning (over 4 weeks), as measured by the IIEF prior to and after commencing treatment with 1 mg finasteride for male pattern baldness.||In the current study, because patients were advised about possible inhibitory or stimulatory effects on sexual function, a higher level was reported, but the direction of these effects appeared to be related to the patients’ handedness.||For 4 weeks prior to treatment, patients prospectively noted their sexual functioning, which was then assessed using the IIEF. At the end of this 6-week period of treatment, sexual functioning was then again assessed using the IIEF, using the prior 4 weeks as the reference period.|
|Irwig 2012 (|
|Standardized interviews of 61 former finasteride users with persistent sexual dysfunction used to gather demographic, information, medical and psychiatric histories and information on medication use, sexual dysfunction, chronic medical conditions, current or past psychiatric conditions or use of oral prescription medication before or during finasteride use.||Rates of depressive symptoms were significantly higher in the former finasteride users (75%) compared with 10% in the control group. Also, suicidal thoughts were present in almost half of all former finasteride users and only 3% in the control group.||AE assessment was based on structured interviews.|
|Olsen et al., 2012 (|
|A multicenter, double-blind randomized study of patients with vertex hair loss to finasteride (1 mg/d) or placebo. Men (N = 1553) were randomized to daily finasteride (1 mg) or placebo in a 1:1 ratio for 1 year. Men who completed the original 1-year studies were enrolled in 1-year, double-blind, placebo-controlled extension studies.||A higher incidence of drug-related sexual adverse experiences including decreased libido, ejaculation disorder, primarily decreased ejaculate volume, and erectile dysfunction were reported in the finasteride group than in the placebo group, irrespective of age. In addition, there were higher rates of discontinuation in the younger men (18-41 years), as a result of drug-related sexual adverse experiences in men treated with finasteride compared with placebo||Investigators evaluated potential risk of persistent sexual side effects associated with finasteride. Safety assessments included clinical and laboratory evaluations and reports of adverse experiences.|
|Sato et al., 2012 (|
|The efficacy and safety of finasteride (1 mg) was evaluated in Japanese men with AGA in a long-term study. The study enrolled 3,177 men.||No specific safety problems associated with long-term use were observed. Many patients did not receive follow-up examination. Adverse reactions occurred in 0.7% of the entire study population (23 of 3,177) during the entire period of the study. Decreased libido (n = 8), hepatic functional disorder (n = 3) and unilateral mammary hypertrophy (n = 2).||Safety data were assessed by interviews and laboratory tests in all men enrolled in the study.|
|Rossi et al., 2011 (|
|One hundred eighteen men, aged between 20 and 61 years, in good physical and mental health, with mild to moderate AGA were enrolled.||Five patients of 118 abandoned the study during the years because of adverse reactions. Side effects were observed in 5.9% (7) patients. Libido and ejaculated semen reduction plus erection problems were reported only by one patient, which interrupted the treatment just at the beginning of the treatment. The most frequent side effect was the libido reduction (5.1%) of the ejaculated semen amount, leading to therapy discontinuation in 67% of cases (13–15). Gynecomastia and depression were not reported at all.||Patients were evaluated for loss of libido or ejaculated semen reduction, erection problems.|
|Yamazaki et al., 2011(|
|A case control study of twenty-seven male AGA patients aged 19-76 years (average, 33.8) answered the Visual Analog Scale, Dermatology Life Quality Index, WHO/QOL-26 and State-Trait Anxiety Inventory questionnaires before and after the administration of finasteride (1mg/day) for 6 months.||No assessment of adverse events.||No assessment of adverse events.|
|Irwig and Kolukula, 2011 (|
|A retrospective study utilizing interviews with 71 healthy men aged 21–46 years who reported new onset of sexual side effects associated with the temporal use of finasteride, in which the symptoms persisted for at least 3 months after discontinuation of finasteride.||Approximately 94% of all subjects developed low libido, 92% developed erectile dysfunction, 92% developed decreased arousal, and 69% developed problems with orgasm. The mean duration of finasteride use was 28 months and the mean duration of persistent sexual side effects was 40 months from the time of finasteride cessation to the interview date.||Investigators evaluated potential risk of persistent sexual side effects associated with finasteride.|
|Camacho et al., 2008 (|
|A 12-month study of 270 men was conducted to determine the hormonal influences of finasteride 1 mg daily on hair growth in men aged 14–58 years with AGA were treated with finasteride 1 mg daily.||No assessment of adverse events was provided.||No reported method of assessment.|
|Kaufman et al., 2008 (|
|Data from two Phase III trials in which 1,553 men with AGA with mean age of 33 years who received finasteride 1 mg/day or placebo for up to 5 years.||No assessment of adverse events was provided.||No reported method of assessment.|
|D’Amico et al., 2007 (|
|A randomized controlled trial of 355 men aged 40–60 years with male-pattern hair loss who were stratified by age decade (40–49 years and 50–60 years) and randomized in a ratio of four to one to 1 mg/day finasteride or placebo.||Adverse events were not fully assessed. The authors state that 30 men discontinued treatment 12 because of clinical adverse Events. In the placebo 7 discontinued treatment 2 because of clinical adverse events.||No reported method of assessment.|
|Olsen et al., 2006 (|
Dutasteride Alopecia Research Team. The importance of dual 5alpha-reductase inhibition in the treatment of male pattern hair loss: results of a randomized placebo-controlled study of dutasteride versus finasteride.
J Am Acad Dermatol. 2006; 55: 1014-1023
|Four hundred sixteen men, 21 to 45 years old, were randomized to receive dutasteride 0.05, 0.1, 0.5, or 2.5 mg, finasteride 5 mg, or placebo daily for 24 weeks. In total, 11 subjects withdrew because of adverse events.||There were no significant differences in total adverse events, serious adverse events, or withdrawals due to adverse events among any of the treatment groups, including placebo. Some subjects had more than one adverse event. Decreased libido was noted in 2 subjects in the placebo group, 2 subjects in each of the 0.05-mg and 0.1-mg dutasteride groups, 1 subject in the 0.5-mg dutasteride group, 9 subjects in the 2.5 mg dutasteride group, and 3 subjects in the finasteride group.||Safety assessments included were based on the investigator’s evaluations.|
|Ryu et al., 2006 (|
|Twenty-one healthy men between the ages of 23 and 52 years (mean 31-36) with moderate male-pattern hair loss were enrolled. Patients were then given finasteride 1 mg once daily. The patients with male pattern bolding, aged 23-52 years, were treated with finasteride 1 mg daily for 5 months.||No reported adverse effects||No assessment of adverse events was made.|
|Price et al., 2006 (|
|Sixty-six men with mild to moderate AGA who were between 22 and 40 years of age and in good physical and mental health were enrolled in this study. Men were randomized to receive finasteride (1 mg/d) or placebo for 192 weeks.||Finasteride was generally well tolerated. No patients were discontinued from the study because of an adverse event. No other drug-related clinical or laboratory adverse events were reported during either the second or the third study extensions.||Percentage of patients with a given clinical or laboratory adverse event was estimated.|
|Rahimi-Ardabili et al., 2006 (|
|A prospective observational study of 128 men with AGA, who were prescribed finasteride (1 mg/day) were enrolled in this study. Information on depressed mood and anxiety was obtained by BDI, and HADS. Participants completed BDI and HADS questionnaires before beginning the treatment and two months after.||Finasteride treatment increased both BDI (P <.001) and HADS depression scores significantly (P =.005). HADS anxiety scores were increased, but the difference was not significant (P =.061).||Information on depressed mood was acquired using translated and validated Persian versions of BDI and HADS|
|Leavitt et al., 2005 (|
|In this randomized, double-blind, placebo-controlled Study, 79 men with AGA (20–45 years of age) were assigned to treatment with finasteride 1 mg (n = 40) or placebo (n = 39) once daily from 4 weeks before until 48 weeks after hair transplant.||The authors stated that finasteride treatment was generally well tolerated, however, no detailed information on the assessment of adverse events or the accuracy of reporting of such events.||Vital signs were recorded at screening and on the day of hair transplant. Adverse events were documented at each clinic visit during treatment with study medication.|
|Arca et al., 2004 (|
|An open, randomized, comparative study of oral finasteride and 5% topical minoxidil in male androgenetic alopecia in which 40 (61.53%) patients were randomly assigned 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.||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. Adverse events were not considered important either, and these side effects disappeared as soon as the treatment was stopped.||Safety assessments included were based on the investigator’s evaluations.|
|Tostie et al., 2004 (|
|A total of 186 patients with androgenetic alopecia were evaluated before and 4 to 6 months after the initiation of finasteride therapy (1 mg).||Our results support the clinical impression that sexual side effects are much less common than reported in clinical trials. The sexual function of all patients remained stable during treatment with 1mg of finasteride.||Patients (N =186) with androgenetic alopecia were asked to complete the IIEF-5 regarding the domain of erectile function before (at baseline) and 4 to 6 months after beginning finasteride treatment. The test was self-administered.|
|Kawashima, et al., 2004 (|
|In this double- blind randomized study, 414 Japanese men with male pattern hair loss received finasteride 1 mg (n = 139), finasteride 0.2 mg (n = 137), or placebo (n = 38) once daily for 48 weeks.||Finasteride treatment was generally well tolerated.||Safety assessments included were based on the investigator’s evaluations.|
|Whiting et al., 2003 (|
|A 24-month double-blind, randomized, placebo-controlled, parallel-group, multicenter study of 424 men was conducted to determine the efficacy and tolerability of finasteride 1 mg on hair growth/loss in men aged 41 to 60 years with mild-to-moderate, predominantly vertex male pattern hair loss.||Treatment with finasteride 1 mg was generally well tolerated.||Safety analyses included assessment of clinical and laboratory adverse experiences, including sexual adverse experiences.|
|Altomare, Capella, 2002 (|
|A retrospective case series in which 23 patients were treated and followed up for AGA. Nineteen of them developed a mood disturbance. Mean age 28.16 years ± 7.68 standard deviation||19 patients (14 males, 5 females) developed a mood disturbance (moderate to severe depression) during treatment with finasteride, 1 mg/day orally, for AGA.||Safety assessments included were based on the investigator’s evaluations.|
|Kaufman et al., 2002 (|
|Two 1-year, Phase III trials, 1,553 men with male pattern hair loss 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.||Finasteride was generally well tolerated, and no new safety concerns were identified during long-term use.||Safety assessments included were based on the investigator’s evaluations.|
|Lin et al., 2002 (|
|An open-label study assessed the efficacy and safety of finasteride for the treatment of Taiwanese men with AGA. Thirty-four men (aged 18-40 years) with AGA were enrolled.||Adverse effects, including abnormal liver function (5/34), were minimal, and the causal relationship with finasteride could not be established.||Safety assessments included were based on the investigator’s evaluations.|
|Khandpur et al., 2002 (|
|One hundred male patients with AGA were enrolled in an open, randomized, parallel-group study, designed to evaluate and compare the efficacy of oral finasteride (1 mg per day), topical 2% minoxidil solution and topical 2% ketoconazole shampoo alone and in combination.||No significant adverse events occurred during the follow-up period of one year. One patient (1.32%) complained of loss of libido after 3 months of finasteride administration but continued to take the drug without any further decrease in sexual function.||Any medical event occurring during the course of the study was recorded with special emphasis on the vital signs, i.e., pulse rate, blood pressure, weight, ECG changes, local reactions on the scalp secondary to topical applications, or sexual dysfunction including loss of libido, ejaculation disorder or impotence.|
|Price et al., 2002 (|
|Sixty-six men with AGA received finasteride, 1 mg/d, or placebo in a 48-week study, and 49 men continued in a 48-week extension. One hundred and seventy-seven patients completed the 48-week study.||Treatment with finasteride was generally well tolerated, and no subject discontinued the study because of an adverse effect of treatment. One subject receiving finasteride reported decreased libido during the initial 48-week study but did not withdraw from the trial.||No data or discussion of the adverse events or how they were assessed. Conflict of interest may have introduced a large bias in this study.|
|Tostie et al., 2001 (|
|236 subjects, aged 18–47 years, who were followed as outpatients for hair disorders during finasteride 1 mg treatment for androgenetic alopecia.||The sexual and erectile function of subjects taking finasteride does not significantly differ from that of age-matched controls. This is consistent with the experience of many dermatologists who do not see sexual or erectile dysfunction in patients taking Propecia.||The IIEF, a brief, reliable questionnaire, was self-administered to 236 patients taking Propecia and 236 age-matched males|
|Van Neste et al., 2000 (|
|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.||In this study, drug-related sexual adverse events occurred in two patients in the finasteride group and in one patient in the placebo group. Of the two finasteride patients, one reported resolution of the adverse event while on therapy, whereas the other reported resolution of the adverse event 2 weeks after completion of therapy. Treatment with finasteride was generally well tolerated.||Safety measurements included clinical and laboratory evaluations, and adverse event reports.|
|Overstreet et al., 1999 (|
|In this double-blind, placebo controlled multicenter study 181 men 19 to 41 years old were randomized to receive 1 mg. finasteride or placebo for 48 weeks followed by a 60-week off-drug period. Of the 181 men 79 were included in a subset for the collection and analysis of sequential semen samples.||During the treatment period 4 (4.4%) finasteride and 3 (3.3%) placebo treated subjects spontaneously reported sexual adverse experiences considered by the investigator to be related to the study drug. These reports included ejaculation disorders, erectile dysfunction or changes in libido. The sexual adverse experiences were mild, and in 3 of the 4 men on finasteride they resolved with continued treatment.||Adverse events assessments were based on investigator clinical evaluation|
|Drake et al., 1999 (|
|Men with AGA (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.||Of the 249 patients who entered the study, only 2 drug-related adverse experiences were reported in more than 1 patient in any treatment group: headache (placebo 3%, 1 mg 2.7%, none on 5, 0.2, 0.05, or 0.01 mg) and decreased libido (placebo 4.5%, 0.01 mg 2.7%, 0.05 mg 2.9%, 0.2 mg 8.3%, 1 mg 0%, and 5 mg 2.6%).||Adverse events assessments were based on investigator clinical evaluation.|
|Roberts et al., 1999 (|
|One clinical study conducted in 13 centers in the United States, randomized 227 men into a 12-month, double-blind, placebo-controlled study to evaluate the effects of finasteride 5 mg/day on male pattern hair loss. The second clinical trial (dose range study), conducted in 23 centers in the United States, randomized 466 men into a 6-month, double-blind, placebo-controlled study to evaluate the effects of low doses (1, 0.2, and 0.01 mg/day) of finasteride.||The incidence of these side effects with finasteride therapy was generally comparable to that observed with treatment with placebo, and there was no evidence of dose dependency or increased incidence with longer therapy out to 12 months. In addition, these side effects ceased in some patients while they continued to receive finasteride. No significant safety issues were identified in the trials.||Safety was assessed by clinical and laboratory measurements and by analysis of adverse experiences. A physical examination was performed at baseline and at months 6 and 12. All adverse events that were considered by the investigator to be possibly, probably, or drug-related and that occurred in at least 1% of patients in any treatment group during the placebo-controlled portion of the pilot and dose range studies were reported.|
|Leyden et al., 1999 (|
|This was a multicenter, double-blind, placebo-controlled study conducted at 15 investigational sites in the United States. Of 326 patients with mean age of 33 years, 166 received finasteride 1 mg dose for 52 weeks.||Over the course of the study, finasteride was generally well tolerated. The only drug-related adverse experiences were sexual adverse effects and were reported in approximately 2% of men in both treatment groups.||Adverse events were assessed by the Investigators clinical judgments.|
|Kaufman et al., 1998 (|
|In two 1-year trials, 1,553 men (18 to 41 years of age) with male pattern hair loss received oral finasteride 1 mg/d or placebo, and 1,215 men continued in blinded extension studies for a second year.||Adverse effects occurred in a higher proportion in the finasteride-treated arm than placebo treated patients (sexual function 4.2% vs 2.2%, P <.05). Eleven men (1.4%) in the finasteride group and 8 (1.0%) in the placebo group discontinued the study because of sexual adverse events, which resolved after discontinuation, however no data was provided to document this resolution of adverse events.||Safety measurements included clinical and laboratory evaluations, adverse event reports, and patient body hair assessment via a self-administered questionnaire.|
|Dallob et al., 1994 (|
|In a double-blind study, 17 male patients undergoing hair transplantation with mean age of 30-55 years were treated with oral finasteride (n = 8, 5 mg/day) or placebo for 28 days.||Inadequate adverse event reporting and unknown quality of blindness coupled with conflict of interest.||No adverse effects assessments were reported.|
|Author, year (reference)||Systematic reviews and/or meta-analyses studies||Study authors’ summary and interpretations||Study authors’ conclusions|
|Zakhem et al., 2019 (|
|A systematic review was conducted of all articles in the PubMed database published from the time of inception to May 2018 to identify studies evaluating the use of systemic dermatologic medications in men with evidence of sexual adverse effects. Sexual dysfunction was measured using any existing validated instrument and self-reported adverse events.||Among men taking 1 mg finasteride for androgenic alopecia, the evidence for sexual adverse effects is less conclusive. Five studies t did not support the increased rates of sexual dysfunction in men taking 1 mg finasteride for AGA. However, 10 studies demonstrated sexual adverse effects, including ED and decreased libido, in patients taking 1 mg finasteride and we find the evidence describing increased rates of sexual dysfunction is more compelling.||The information in this review may serve as a reference of adverse effects when deciding on a therapeutic agent and a guide to help identify patients to screen for sexual dysfunction.|
|Zhou et al., 2019 (|
|The efficacy and safety of Dutasteride compared with finasteride in treating men with androgenetic alopecia: a systematic review and meta-analysis. Randomized controlled trials of dutasteride and finasteride for treating AGA were searched using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register.||With regard to the assessment of safety, altered libido (P=.54), erectile dysfunction (P=.07), and ejaculation disorders (P=.58), dutasteride did not show a significant difference compared with finasteride. According to the current analysis of the safety of the two drugs, the application of two drugs should be carefully considered for young middle-aged men, especially for patients who are sexually active.||Dutasteride seems to provide a better efficacy compared with finasteride in treating AGA. The two drugs appear to show similar rates of adverse reactions, especially in sexual dysfunction.|
|Lee et al., 2019 (|
|A systematic review and meta-analysis were performed following the principles of the PRISMA.||The authors reported that 9 of 11 studies on finasteride 1 mg/day, and all of 5 studies on dutasteride 0.5 mg/day, provided individual incidence of erectile dysfunction, decreased libido, and difficulty in ejaculation. One hundred thirty two of 2,257 subjects treated with 5α-RIs (5.85%) (vs. placebo: 80 of 2,122 [3.77%]) had at least one adverse sexual effect. For each regimen,100 of 1,882 subjects treated with finasteride 1 mg/day (5.31%) (vs. placebo: 57 of 1,869 [3.05%]) had adverse sexual effects, whereas 32 of 375 subjects treated with dutasteride 0.5 mg/day (8.27%) (vs. placebo: 23 of 369 [6.23%]) had adverse sexual effects.||Use of 5α-RIs carried a 1.57-fold risk of sexual dysfunction (95% confidence interval (95% CI 1.19–2.08). The relative risk was 1.66 (95% CI 1.20– 2.30) for finasteride and 1.37 (95% CI 0.81–2.32) for dutasteride. Both drugs were associated with an increased risk, although the increase was not statistically significant for dutasteride.|
|Shin et al., 2019 (|
|The authors reviewed most recent studies of finasteride treatment for BPH and male AGA and the incidence of ED.||Evidence from clinical studies suggested that finasteride was associated with increased adverse effects on ED in men with BPH. The authors, however believe that such association was not statistically significant in men with AGA.||Although there is not enough evidence to prove the relationship between finasteride and ED, most studies in this review found that finasteride for BPH was correlated with ED. However, most studies included in this review revealed that finasteride for MAA was not correlated with ED. On the other hand, some studies reported side effects of finasteride associated with sexual dysfunction, including ED, male infertility, ejaculation problem, and loss of libido, even in MAA patients.|
|Healy et al., 2018 (|
|Data from RxISK.org, a global adverse event reporting website, have been used to establish the clinical features, demographic details and clinical trajectories of syndromes of persistent sexual difficulties following three superficially different treatment modalities.||The symptom profile and frequency for finasteride were reported. ED 216 (88.2%); loss of libido 193 (78.8%); Pleasureless or weak orgasm 80 (32.7%); difficulties achieving orgasm 61 (24.9%); emotional blunting 46 (18.8%); loss of nocturnal erections 36 (14.7%); reduced seminal volume 33 (13.5%); penile or testicular pain 20 ( 8.2%); reduce penile size 20 (8.2%);||These data point to a legacy syndrome or syndromes comprising a range of disturbances to sexual function.|
|Lee et al., 2018 (|
|A Systematic Review of Topical Finasteride in the Treatment of Androgenetic Alopecia in Men and Women. Clinically relevant case reports, RCTs, and prospective studies were included.||No assessment of adverse events was reported.||Preliminary results on the use of topical finasteride are limited but safe and promising.|
|Bass et al., 2018 (|
|FAERS dataset for 5 alpha reductase inhibitors from April 2011 to October 2014 was obtained. Each FAERS report had 16 categories for completion, but not every report was fully completed. Statistical analysis compared variables of interest between the two doses of finasteride (1mg vs 5 mg).||Finasteride use was reported with many sexual AEs including diminished libido, erectile dysfunction, and ejaculatory complaints. Other common AEs included dermatologic, metabolic, and psychological and/or neurologic complaints. There were more AE reports with the 1mg dose than the 5mg dose. Data suggests that finasteride exposure is reported with a diverse collection of symptoms, particularly in younger men on 1 mg dosage compared to older men on 5mg.||FAERS data suggests that finasteride exposure is reported with a diverse collection of symptoms, particularly in younger men on 1 mg dosage compared to older men on 5 mg. Many of these complaints fall well out of the realm of previously established adverse events from long-term controlled studies.|
|Sorbellini et al., 2018 (|
|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 1,153 Italian dermatologists were surveyed about prescription frequency, therapy duration, treatment practices, and side effects eventually reported||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.||Italian dermatologists are rather confident regarding use of finasteride, as reflected in its prescription. Even if side effects, especially in the sexual sphere, are reported, due to a lack of alternative treatments with the same efficacy, this does not significantly impact on dermatologists’ decisions to prescribe finasteride, with a tendency to prolong therapy in the long term, unless symptoms became incompatible with patient quality of life.|
|Adil et al., 2017 (|
|A systematic review of randomized controlled trials was conducted. PubMed, EMBASE, and Cochrane were searched up to December 2016, with no lower limit on the year. We included only randomized controlled trials of good or fair quality based on the U.S. Preventive Services Task Force quality assessment process.||No assessments of adverse events were reported.||No assessments of adverse events were reported.|
|Corona et al., 2017 (|
|This meta-analysis was performed in line with the PRISMA reporting guideline. An extensive Medline, EMBASE and Cochrane search was performed. The search, which accrued data from January 1, 1969 up to May 1st, 2016, was restricted to placebo-controlled RCTs and humans.||Use of finasteride or dutasteride in men with BPH is associated with an increased risk of ED and HSD, when compared with placebo. No difference between finasteride and dutasteride was observed.||In conclusion, present data show that the use of 5α-RI significantly increases the risk of erectile dysfunction and hypoactive sexual desire in subjects with benign prostatic hyperplasia. Patients should be adequately informed before 5α-RIs are prescribed.|
|Fertig et al., 2017 (|
|A PubMed search identified documented cases of finasteride and dutasteride sexual side effects in the literature. Clinical trials, review articles, case series, and case reports that mentioned finasteride and dutasteride sexual side effects were included.||Sexual side effects in men who have taken finasteride (1mg, 5mg) and dutasteride (0.5mg) are well documented and include decreased libido, erectile dysfunction, and ejaculatory dysfunction. Randomized clinical trials have demonstrated increased incidences of these sexual side effects||Persistent sexual and psychiatric side effects after 5α-RIs are not documented by high-quality studies, and prospective studies to establish true incidence and frequency of the problem are really needed.|
|Hirshburg et al., 2017 (|
|A systematic review: a search of Medline, Ovid, and Google scholar database and search engines for relevant articles on human subjects, published from 1990 to November 2015 was conducted. The list of references generated was searched by hand to identify additional studies of interest.||Finasteride and dutasteride are well-tolerated. Currently, there is no direct link between finasteride and dutasteride use and depression; however, several small studies have led depression to be listed as a side effect on the medication packaging. Sexual adverse effects, such as decreased libido, erectile dysfunction, and decreased ejaculate, have been reported in as many as 3.4 to 15.8 percent of men.||Currently, there is no direct link between 5α-RI inhibitor use and depression; however, several small studies have led to depression being listed as a side effect on the medication packaging. Sexual effects including erectile dysfunction and decreased libido and ejaculate were reported in as many as 3.4 to 15.8 percent of men.|
|Jun et al., 2017 (|
|A systematic review and meta-analysis of RCT, quasi-randomized trials, and systematic reviews comparing finasteride with dutasteride, either as monotherapy or in combination with a-blockers, for treatment of men with BPH were included.||No assessment of adverse events was reported.||No assessment of adverse events was reported.|
|Liu et al., 2016 (|
|A systematic review and meta-analyses||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.||Evidence from the randomized controlled trials suggested that 5α-RIs 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.|
|Belknap et al., 2015 (|
|AE reporting in clinical trials of finasteride for androgenic alopecia: a meta-analysis.||Of 34 clinical trials, none had adequate safety reporting, 19 were partially adequate, 12 were inadequate, and 3 reported no adverse events. Funnel plots were asymmetric with a bias toward lower odds ratio for sexual adverse effects, suggesting systematic under detection. No reports assessed adequacy of blinding, 18 (53%) disclosed conflicts of interest, and 19 (56%) received funding from the manufacturer. Duration of drug safety evaluation was 1 year or less for 26 of 34 trials (76%). Of 5704 men in the clinical data repository who were treated for AGA with finasteride, 1.25mg/d or less, for AGA, only 31% met inclusion criteria for the pivotal trials referenced in the manufacturer’s full prescribing information and 33%took finasteride for more than 1 year.||Available toxicity information from clinical trials of finasteride in men with AGA is very limited, is of poor quality, and seems to be systematically biased. In a cohort of men prescribed finasteride for routine treatment of AGA, most would have been excluded from the pivotal studies that supported US Food and Drug Administration approval for AGA. Published reports of clinical trials provide insufficient information to establish the safety profile for finasteride in the treatment of AGA.|
|Mella JM et al., 2010 (|
|A systematic review and meta-analysis.||Finasteride therapy increased the risk of erectile dysfunction: RR, 2.22 (95% CI 1.03- 4.78). Finasteride therapy did not decrease libido: RR, 1.08 (95% CI 0.67-1.76); We considered the quality of evidence as moderate because of imprecision.||Moderate-quality evidence suggests that daily use of oral finasteride increases hair count and improves patient and investigator assessment of hair appearance, while increasing the risk of sexual dysfunction.|
|Hagberg et al., 2016 (|
|A population-based study using the Clinical Practice Research Datalink. Cohort studies with nested case-control analyses||The authors suggested that 5-α reductase inhibitors do not increase the risk of clinically meaningful incident erectile dysfunction and sexual dysfunction in men who are free of sexual dysfunction prior to treatment.||5-α reductase inhibitors do not seem to significantly increase the risk of incident erectile dysfunction, regardless of indication for use. Risk of erectile dysfunction increased with longer duration of benign prostatic hyperplasia.|
|Gacci et al., 2014 (|
|Impact of medical treatments for male lower urinary tract symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review and meta-analysis||EjD was significantly more common with 5α-RI s as compared with placebo (OR 2.73; P <.0001). Both finasteride (OR 2.70; P <.0001) and dutasteride (OR 2.81; P =.0002) were associated with significantly higher risk of EjD than placebo. EjD was significantly more common with combination therapy as compared with ABs alone (OR 3.75; P <.0001), or with 5α-RIs alone (OR 2.76; P =.02).||ABs and 5α-RI were both associated with significantly higher risk of EjD than placebo. More the AB is effective over time, greater is the incidence of EjD. Finasteride has the same risk of Dutasteride to cause EjD. Combination therapy with ABs and 5α-RIs resulted in a 3-fold increased risk of EjD as compared with ABs or 5α-RIs alone. These data can be relevant both for drug selection and patients counseling|
|Edwards and Moore, 2002 (|
|Finasteride in the treatment of clinical benign prostatic hyperplasia: a systematic review of randomized trials.||The most commonly reported adverse effects were impotence, decreased libido and ejaculation disorder. Definitions of these adverse effects were generally not provided in the trials. Since cumulative adverse effect information was not available after year one in some studies, analyses were conducted for different time points up to one year for most adverse effects. Significantly more men reported any sexual dysfunction, decreased libido, impotence, or ejaculation disorder with finasteride than with placebo at 12 months of treatment.||No specific conclusion about adverse side effects.|
|Park and Choi, 2014 (|
|Efficacy and safety of dutasteride for the treatment of symptomatic BPH: a systematic review and meta-analysis.||Pooled data indicated adverse events and drug-related adverse events were more significantly common in patients treated with dutasteride compared with placebo (RR 1.04, 95 % CI 1.00–1.07 and RR 1.35, 95 % CI 1.19–1.54, respectively). They also more frequently reported sexual adverse events, including erectile dysfunction, decreased libido, and gynecomastia (RR 1.83, 95 % CI 1.42–2.36, RR 2.00, 95 % CI 1.42–2.83, and RR 3.11, 95 % CI 1.79–5.40, respectively).||Dutasteride can be used to improve urinary symptoms (IPSS and Qmax ) and reduce TPV but with awareness of its potential adverse events.|
- Irwig M.S.