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Autor: clive |
Sehr geehrte Damen und Herren, meine Frage bzw. Anmerkung bezieht sich auf die Frage des users Ambro und die Antwort von Herrns PD Dr. Kunte. 1.) Natürlich gibt es in der Fachliteratur Berichte zu irreversiblen Nebenwirkungen zu Finasterid, als aktuelle Arbeit, sei die von Irwig, 2012 genannt. 2.) Wurde diese UAW bereits in die Fachinfo von Procepia übernommen (Stand 2011) Es wäre dem offenen Dialog also dienlich, wenn sie diese Fakten nicht negieren würde, sonden konkret dazu Stellung nehmen. Beste Grüße, Clive |
Priv. Doz. Dr. Christian Kunte Experte Beiträge:628 | 2012-07-17 |
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Sehr geehrter Clive, so einfach kann man es sich auch nicht machen! Es gibt Studien (unter anderen die großen Zulassungsstudien >1500 Männer) die zeigen, dass die sexuellen Nebenwirkungen dann auftreten, wenn man danach fragt und nach Absetzen auch wieder verschwinden. In der unten angefügte Studie zeigt zum Beispiel auch, dass die Nebenwirkungen vor allem dann auftreten, wenn man über sie spricht - Nocebo Effekt! J Sex Med. 2007 Nov;4(6):1708-12. Epub 2007 Jul 26. Finasteride 5 mg and sexual side effects: how many of these are related to a nocebo phenomenon? Mondaini N, Gontero P, Giubilei G, Lombardi G, Cai T, Gavazzi A, Bartoletti R. Source UO Urology, S Maria Annunziata Hospital, University of Florence, Florence, Italy. nicola.mondaini@unifi.it Abstract INTRODUCTION: Sexual adverse experiences such as erectile dysfunction (ED), loss of libido, and ejaculation disorders have been consistent side effects of finasteride in a maximum percentage of 15% after 1 year of therapy. Such data could be seen as far from reality, if compared to a higher percentage that may be found in any common clinical practice. AIM: This study aims to explain the dichotomy between literature's data and clinical practice data. METHODS: One hundred twenty patients with a clinical diagnosis of benign prostatic hyperplasia (BPH), sexually active and with an International Index of Erectile Function-erectile function (IIEF-EF) domain >/=25 were randomized to receive finasteride 5 mg concealed as an "X compound of proven efficacy for the treatment of BPH" for 1 year with (group 2) or without (group 1) counseling on the drug sexual side effect. The phrase used to inform group 2 patients was ". . . it may cause erectile dysfunction, decreased libido, problems of ejaculation but these are uncommon". MAIN OUTCOME MEASURES: The estimation of side effect was conducted at 6 and 12 months using the male sexual function-4 (MSF-4 item) questionnaire and a self-administered questionnaire. RESULTS: One hundred seven patients completed the study. Group 2 patients (N = 55) reported a significant higher proportion of one or more sexual side effects as compared to group 1 (N = 52) (43.6% vs. 15.3%) (P = 0.03). The incidence of ED, decreased libido, and ejaculation disorders were 9.6, 7.7, and 5.7% for group 1, and 30.9, 23.6, and 16.3% for group 2, respectively (P = 0.02, P = 0.04, and P = 0.06). CONCLUSION: In the current study, blinded administration of finasteride was associated with a significantly higher proportion of sexual dysfunction in patients informed on sexual side effects (group 2) as compared to those in which the same information was omitted (group 1) (P = 0.03). A scenario similar to group 2 of the current study is likely to occur in clinical practice, where the patient is counseled by the physician and has access to the drug information sheet. The burden of this nocebo effect (an adverse side effect that is not a direct result of the specific pharmacological action of the drug) has to be taken into account when managing finasteride sexual side effects. Natürlich gibt es die von Ihnen beschriebene Irwig Studie von 2011: J Sex Med. 2011 Jun;8(6):1747-53. doi: 10.1111/j.1743-6109.2011.02255.x. Epub 2011 Mar 18. Persistent sexual side effects of finasteride for male pattern hair loss. Irwig MS, Kolukula S. Source Center for Andrology and Division of Endocrinology, The George Washington University, Washington, DC 20037, USA. mirwig@mfa.gwu.edu 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<0.0001 for both). 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. Study limitations include a post hoc approach, selection bias, recall bias for before finasteride data, and no serum hormone levels. CONCLUSION: Physicians treating MPHL should discuss the potential risk of persistent sexual side effects associated with finasteride. Meiner Meinung nach weist diese Studie extreme Schwächen im Design auf, an erster Stelle natürlich schon eine Negativselektion -alles Patienten die schon entsprechende Nebenwirkungen aufweisen. So eine Studie muß begonnen werden, bevor man eine Therapie beginnt und bevor Patienten diese Nebenwirkungen angeben! Fachinformation aktuell: erektile Dysfunktion, Ejakulationsstörung (einschl. vermindertes Ejakulatvolumen). Keine Erwähnung irreversibler Probleme, da aktuell nicht nachgewiesen bzw. die Hinweise hierfür nicht stark genug! Prof. H. Wolff: Für die Potenz sollte eigentlich nur Testosteron (T) und nicht DHT zuständig sein. Da T durch Finasterid nicht erniedrigt wird, kommt es in der Regel auch zu keinen Potenzstörungen. Warum 1% der Anwender Potenzstörungen bekommen, kann ich nicht genau erklären. Mit freundlichen Grüßen PD Dr. Kunte | |
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