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

التفاصيل البيبلوغرافية
العنوان: Persistent erectile dysfunction in men exposed to the 5α-reductase inhibitors, finasteride, or dutasteride
المؤلفون: John Cashy, Paul R. Yarnold, Beatrice Nardone, Dennis P. West, Steven M. Belknap, Giuseppe Micali, William H. Temps, Robert E. Brannigan, Tina Kiguradze
المصدر: PeerJ
PeerJ, Vol 5, p e3020 (2017)
بيانات النشر: PeerJ Inc., 2017.
سنة النشر: 2017
مصطلحات موضوعية: Genetics and Molecular Biology (all), medicine.medical_specialty, Epidemiology, Urology, 030232 urology & nephrology, lcsh:Medicine, Dermatology, Finasteide, Biochemistry, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Prescribing information, Internal Medicine, Medicine, Adverse effect, Drug safety, Pharmacology, Dutasteride, Impotence, Low libido, Persistent sexual dysfunction, Pharmacoepidemiology, Neuroscience (all), Medicine (all), Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), business.industry, General Neuroscience, lcsh:R, General Medicine, medicine.disease, 3. Good health, 5α reductase, Clinical trial, Erectile dysfunction, chemistry, 030220 oncology & carcinogenesis, Finasteride, General Agricultural and Biological Sciences, business
الوصف: ImportanceCase reports describe persistent erectile dysfunction (PED) associated with exposure to 5α-reductase inhibitors (5α-RIs). Clinical trial reports and the manufacturers’ full prescribing information (FPI) for finasteride and dutasteride state that risk of sexual adverse effects is not increased by longer duration of 5α-RI exposure and that sexual adverse effects of 5α-RIs resolve in men who discontinue exposure.ObjectiveOur chief objective was to assess whether longer duration of 5α-RI exposure increases risk of PED, independent of age and other known risk factors. Men with shorter 5α-RI exposure served as a comparison control group for those with longer exposure.DesignWe used a single-group study design and classification tree analysis (CTA) to model PED (lasting ≥90 days after stopping 5α-RI). Covariates included subject attributes, diseases, and drug exposures associated with sexual dysfunction.SettingOur data source was the electronic medical record data repository for Northwestern Medicine.SubjectsThe analysis cohorts comprised all men exposed to finasteride or dutasteride or combination products containing one of these drugs, and the subgroup of men 16–42 years old and exposed to finasteride ≤1.25 mg/day.Main outcome and measuresOur main outcome measure was diagnosis of PED beginning after first 5α-RI exposure, continuing for at least 90 days after stopping 5α-RI, and with contemporaneous treatment with a phosphodiesterase-5 inhibitor (PDE5I). Other outcome measures were erectile dysfunction (ED) and low libido. PED was determined by manual review of medical narratives for all subjects with ED. Risk of an adverse effect was expressed as number needed to harm (NNH).ResultsAmong men with 5α-RI exposure, 167 of 11,909 (1.4%) developed PED (persistence median 1,348 days after stopping 5α-RI, interquartile range (IQR) 631.5–2320.5 days); the multivariable model predicting PED had four variables: prostate disease, duration of 5α-RI exposure, age, and nonsteroidal anti-inflammatory drug (NSAID) use. Of 530 men with new ED, 167 (31.5%) had new PED. Men without prostate disease who combined NSAID use with >208.5 days of 5α-RI exposure had 4.8-fold higher risk of PED than men with shorter exposure (NNH 59.8, allp< 0.002). Among men 16–42 years old and exposed to finasteride ≤1.25 mg/day, 34 of 4,284 (0.8%) developed PED (persistence median 1,534 days, IQR 651–2,351 days); the multivariable model predicting PED had one variable: duration of 5α-RI exposure. Of 103 young men with new ED, 34 (33%) had new PED. Young men with >205 days of finasteride exposure had 4.9-fold higher risk of PED (NNH 108.2,p< 0.004) than men with shorter exposure.Conclusion and relevanceRisk of PED was higher in men with longer exposure to 5α-RIs. Among young men, longer exposure to finasteride posed a greater risk of PED than all other assessed risk factors.
اللغة: English
تدمد: 2167-8359
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6313cae7a25fa278207173655428e46fTest
http://europepmc.org/articles/PMC5346286Test
حقوق: OPEN
رقم الانضمام: edsair.doi.dedup.....6313cae7a25fa278207173655428e46f
قاعدة البيانات: OpenAIRE