Zusammenfassung
Ziel und Methode
In der prospektiven, multizentrischen, nicht interventionellen AVANTI-Studie wurden die Selektionskriterien für den PDE-5-Hemmer Avanafil evaluiert und seine Akzeptanz in der Behandlung von Patienten mit erektiler Dysfunktion untersucht. Zur Auswertung kamen die Daten von 1.804 Probanden mit einem Durchschnittsalter von 58,0 Jahren.
Ergebnisse
Als Grund für die Entscheidung zur Therapie mit Avanafil nannten Ärzte und Patienten am häufigsten den schnellen Wirkeintritt (70,6% bzw. 78,6%). Ein günstiges Nebenwirkungsprofil stand mehr im Fokus, wenn der Patient mitentscheiden konnte (62,7%), als wenn nur der Arzt auswählte (48,4%). 41,2% der Ärzte legten besonderen Wert auf die Wirkstärke, für 56,7% der Patienten war ausschlaggebend, dass sie ein modernes Medikament erhielten. Ärzte und Patienten beurteilten das Medikament als gut wirksam und gut verträglich.
Abstract
Objective and method
In the prospective, multicentric, non-interventional AVANTI study, the selection criteria for the PDE-5 inhibitor Avanafil were evaluated and it's acceptance in the treatment of patients with erectile dysfunction was investigated. Data from 1,804 probands with an average age of 58.0 years were analyzed.
Results
Doctors and patients most commonly referred to Avanafil as a fast-acting substance (70.6% and 78.6%, respectively). A favorable side-effect profile was more focused when the patient co-decided (62.7%) than if the doctor selected (48.4%). 41.2% of the physicians emphasized the potency, 56.7% of the patients preferred to receive a modern medicine. Doctors and patients assessed the drug as effective and well tolerated.
Literatur
Hatzimouratidis K, Eardley I, Giuliano F, et al (Hrsg). Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. European Association of Urology, Aarnheim/The Nederlands 2015. Abrufbar unter: http://uroweb.org/wp-content/uploads/14-Male-Sexual-Dysfunction_LR1.pdf (aufgerufen am 4.10.2016).
Eardley I. The incidence, prevalence, and natural history of erectile dysfunction. Sex Med Rev 2013; 1: 3–16.
Braun M, Wassmer G, Klotz T, et al. Epidemiology of erectile dysfunction: results of the ‘Cologne Male Survey’. Int J Impot Res. 2000; 12(6): 305–311.
Capogrosso P, Colicchia M, Ventimiglia E, et al. One patient out of four with newly diagnosed erectile dysfunction is a young man — worrisome picture from the everyday clinical practice. J Sex Med 2013; 10(7): 1833–1841.
Capogrosso P, Montorsi F, Salonia A. Erectile dysfunction in young patients is a proxy of overall men’s health status. Curr Opin Urol 2016; 26(2): 140–145.
Rosen RC, Fisher WA, Eardley I, et al. The multinational Men’s Attitudes to Life Events and Sexuality (MALES) study: I. Prevalence of erectile dysfunction and related health concerns in the general population. Curr Med Res Opin 2004; 20(5): 607–617.
Montague DK, Jarow JP, Broderick GA, et al. Chapter 1: The management of erectile dysfunction: an AUA update. J Urol 2005; 174(1): 230–239.
Porst H, Burnett A, Brock G, et al. SOP conservative (medical and mechanical) treatment of erectile dysfunction. J Sex Med 2013; 10(1): 130–171.
Mcmahon CN, Smith CJ, Shabsigh R. Treating erectile dysfunction when PDE5 inhibitors fail. BMJ 2006; 332(7541): 589–592.
Carvalheira AA, Pereira NM, Maroco J, et al. Dropout in the treatment of erectile dysfunction with PDE5: a study on predictors and a qualitative analysis of reasons for discontinuation. J Med Sex 2012; 9(9): 2361–2369.
Jiann BP, Yu CC, Su CC, et al. Compliance of sildenafil treatment for erectile dysfunction and factors affecting it. Int J Impot Res 2006; 18(2): 146–149.
Bruzziches R, Francomano D, Gareri P, et al. An update on pharmacological treatment of erectile dysfunction with phosphodiesterase type 5 inhibitors. Expert Opin Pharmacother 2013; 14(10): 1333–1344.
Fachinformation Viagra 25 mg Pfizer [Internet]. Stand: Juni 2016 [zitiert am 4.10.2016]. PFIZER Limited, Kent, Vereinigtes Königreich. Zulassungsnummer: EU/1/98/077/002-004, EU/1/98/077/013. URL: https://www.pfizer.de/fileadmin/produktdatenbank/pdf/003927_freigabe.pdf.
Fachinformation Cialis Lilly 5 mg [Internet]. Stand: Juli 2016 [zitiert am 4.10.2016]. Eli Lilly Nederland B.V, Utrecht, Belgien. Zulassungsnummer: EU/1/02/237/007. URL: https://www.lilly-pharma.de/de/pdf/fachinfor-mation/fachinformation_cialis.pdf.
Fachinformation Levitra Bayer 10 mg [Internet]. Stand: Dezember 2015 [zitiert am 4.10.2016]. Bayer Pharma AG, Berlin. Zulassungsnummer: EU/1/03/248/001-004, EU/1/03/248/001-021. URL: https://www.gelbe-liste.de/produkte/levitra-10-mg-filmtabletten_366355/fachinformation.
Cui YS, Li N, Zong HT, et al. Avanafil for male erectile dysfunction: a systematic review and meta-analysis. Asian J Androl 2014; 16(3): 472–477.
Wang R, Burnett AL, Heller WH, et al. Selectivity of avanafil, a PDE5 inhibitor for the treatment of erectile dysfunction: implications for clinical safety and improved tolerability. J Sex Med 2012; 9(8): 2122–2129.
Katz EG, Tan RB, Rittenberg D, et al. Avanafil for erectile dysfunction in elderly and younger adults: differential pharmacology and clinical utility. Ther Clin Risk Manag 2014; 10: 701–711.
Kedia GT, Uckert S, Assadi-Pour F, et al. Avanafil for the treatment of erectile dysfunction: initial data and clinical key properties. Ther Adv Urol 2013; 5(1): 35–41.
Goldstein I, Jones LA, Belkoff LH, et al. Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus. Mayo Clin Proc 2012; 87(9): 843–852.
Goldstein I, Mccullough AR, Jones LA, et al. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction. J Sex Med 2012; 9(4): 1122–1133.
Mulhall JP, Burnett AL, Wang R, et al. A phase 3, placebo controlled study of the safety and efficacy of avanafil for the treatment of erectile dysfunction after nerve sparing radical prostatectomy. J Urol 2013; 189(6): 2229–2236.
Sadovsky R. The role of the primary care clinician in the management of erectile dysfunction. Rev Urol 2002; 4(Suppl 3): S54–63.
Bedell SE, Duperval M, Goldberg R. Cardiologists' discussions about sexuality with patients with chronic coronary artery disease. Am Heart J 2002; 144(2): 239–242.
Bedell SE, Graboys TB, Duperval M, et al. Sildenafil in the cardiologist's office: patients' attitudes and physicians' practices toward discussions about sexual functioning. Cardiology 2002; 97(2): 79–82.
Mirone V, Gentile V, Zizzo G, et al. Did men with erectile dysfunction discuss their condition with partner and physicians? A survey of men attending a free call information service. Int J Impot Res 2002; 14(4): 256–258.
Steinke EE, Jaarsma T, Barnason SA, et al; on behalf of the Council on Cardiovascular and Stroke Nursing of the American Heart Association and the ESC Council on Cardiovascular Nursing and Allied Professions (CCNAP). Sexual counseling for individuals with cardiovascular disease and their partners: a consensus document from the American Heart Association and the ESC Council on Cardiovascular Nursing and Allied Professions (CCNAP). Circulation 2013; 128(18): 2075–2096.
Burri A, Porst H. Results from an online survey investigating ED patients’ insights and treatment expectations. Int J Impot Res 2015; 27(5): 191–196.
Schedlowski M, Enck P, Rief W, et al. Neuro-bio-behavioral mechanisms of placebo and nocebo responses: implications for clinical trials and clinical practice. Pharmacol Rev 2015; 67(3): 697–730.
Bingel U, Colloca L, Vase L. Mechanisms and clinical implications of the placebo effect: is there a potential for the elderly? A mini-review. Gerontolog 2011; 57(4): 354–363.
Zolnierek KB, Dimatteo MR. Physician communication and patient adherence to treatment: a meta-analysis. Med Care 2009; 47(8): 826–834.
Zhao C, Kim SW, Yang DY, et al. Efficacy and safety of avanafil for treating erectile dysfunction: results of a multicentre, randomized, double-blind, placebo-controlled trial. BJU Int 2012; 110(11): 1801–1806.
Yuan J, Zhang R, Yang Z, et al. Comparative effectiveness and safety of oral phosphodiesterase type 5 inhibitors for erectile dysfunction: a systematic review and network meta-analysis. Eur Urol 2013; 63(5): 902–912.
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Medical Writing und finanzielle Unterstützung
Die Studie wurde finanziell durch die Berlin-Chemie AG unterstützt.
Die Autoren haben die Inhalte des Manuskriptes festgelegt, das Manuskript kritisch gegengelesen und die finale Version freigegeben.
Interessenkonflikt
Dr. med. Richard Berges († 2017) war niedergelassener Urologe an der PAN-Klinik, Köln. Er hat Vortrags- und Beratungshonorare von Berlin-Chemie AG erhalten. Dr. Berges war der Studienleiter der AVANTI-Studie und hat im Auftrag der Berlin-Chemie AG die Konzeption und die Manuskripterstellung zu der AVANTI-Studie übernommen.
Dr. Dieter Schremmer ist Leiter der Abteilung Biostatistik bei der GKM Gesellschaft für Therapieforschung mbH, München. Die GKM wurde als Auftragsforschungsinstitut von der Berlin-Chemie AG mit der Auswertung der AVANTI Studie beauftragt.
Dr. med. Roger Limberg ist Mitarbeiter bei der Berlin-Chemie AG.
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Berges, R., Schremmer, D. & Limberg, R. Avanafil zur Therapie der erektilen Dysfunktion in der Praxis. MMW - Fortschritte der Medizin 159 (Suppl 5), 16–21 (2017). https://doi.org/10.1007/s15006-017-9804-1
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DOI: https://doi.org/10.1007/s15006-017-9804-1