The ‘effectiveness’ scale—therapeutic outcome of pharmacologic therapies for ED: an international consensus panel report

Abstract

Despite availability of outcome measures and scales for assessing erectile dysfunction (ED) treatment efficacy, guidelines are not available for assessing broader therapeutic outcomes or defining treatment failure in ED. An International Consensus Advisory Panel was convened to develop guidelines, definitions and a new algorithm for evaluating treatment effectiveness in ED. These new guidelines are recommended for use in both research and clinical practice. A multidisciplinary, international panel, consisting of 11 senior researchers and clinicians, was convened to address pertinent issues concerning therapeutic outcome assessment for ED. The panel utilized a modified Delphi method of consensus development and proposed a new model for outcomes assessment. This model is inherently testable, using existing instruments and current methods of assessment. Following a comprehensive literature review and discussion, the Panel recommended adoption of a new treatment effectiveness conceptual framework or theoretical model for assessing therapeutic outcomes in ED. Treatment effectiveness is presumed to be a combined function of two other factors, treatment response and treatment satisfaction. Treatment response is based on the combined assessment of efficacy and tolerability, and treatment satisfaction on the combined assessment of patient and partner satisfaction. Taken together, these two domains define an overall domain of treatment effectiveness. This therapeutic index would be derived by independently assessing treatment efficacy and satisfaction by means of event logs, questionnaires or the more typical patient interview methods. In conclusion, the Ad Hoc Advisory Consensus Panel recommends adoption of a new framework or conceptual model for conducting ED outcome trials or clinical research. The concept of 'treatment effectiveness' is proposed as a new 'umbrella concept' or distal outcome to be evaluated.

Phosphodiesterase type 5 inhibitors’ extended duration of response as a variable in the treatment of erectile dysfunction

“…34 It has been shown that 65% of prescriptions written in the United States for PDE5 inhibitors are from primary care clinicians. 35 Ideally, these clinicians will provide early encouragement to help couples select ED treatments to enhance emotional and physical intimacy and to identify those couples who may benefit most from a long-acting PDE5 inhibitor.…”

Phosphodiesterase Type 5 Inhibitors: Unmet Needs

“…Main reasons for nonresponse included inappropriate timing of sexual intercourse, single dose trial, and lack of titration to the highest recommended dose. Such data emphasize the need for regular follow-up and exploration of the self-reports of non-response; a patient should be considered as truly non-responder only after '4 sexual attempts with administration of the highest tolerated drug dose, in accordance with manufacturer's guidelines with respect to timing relative to meals, alcohol ingestion, use of concomitant medications, and adequate sexual stimulation/arousal' [73]. Furthermore, recent study clearly demonstrated that counseling may also convert "non-responders" to responders [74].…”

Tadalafil for the treatment of erectile dysfunction

“…Although the effectiveness of PDE5 inhibitors on such intermediate objective outcomes as penile rigidity through penile plethysmography with the RigiScan device (Dacomed Corporation, Minneapolis, MN, USA) has been studied, measuring the therapeutic effectiveness of tadalafi l is more accurately defi ned through an integration of the patient's reported treatment response and tolerability with the reported satisfaction of both the patient and his partner (Carson et al 2004b). Despite their intrinsically subjective nature, validated questionnaires are the preferred major outcome measure of treatment effectiveness of tadalafi l and other PDE5 inhibitors.…”