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Outcomes






Harms. All trials but one114 reported some information on the absence and/or occurrence of adverse events: any adverse events, 117, 159, 248, 250, 251 serious adverse events (including death), 117, 159, 248, 250, 251 withdrawals due to adverse events, 117, 120, 159, 248, 249, 253 and frequently reported (≥ 5 percent) specific adverse events.120, 148, 159, 248253

Efficacy. The efficacy outcomes measured in the 11 trials varied to some degree. The most commonly measured and reported outcome across the trials was the percentage of successful intercourse attempts.114, 117, 120, 148, 159, 248, 252, 253 In four trials, the percentage of attempts resulting in erections firm enough for intercourse was also measured 148, 252, 253. Similarly, in one trial, 251 the proportions of successful vaginal penetration and vaginal intercourse leading to orgasm were estimated. The above-mentioned outcomes were calculated based on the patients' and/or their partners' responses to pre-specified questions provided in home-use diaries.

In five trials, the mean IIEF score (domains of “erectile function, ” “orgasmic function, ” “sexual desire, ” “intercourse satisfaction, ” “overall satisfaction”) was used to assess the relative efficacy of apomorphine.117, 148, 159, 249, 253 For example, in one trial117 the primary endpoint was the mean difference in IIEF score for the “erectile function” domain, whereas secondary endpoints were mean difference IIEF scores for other domains (e.g. “orgasmic function, ” “sexual desire, ” “intercourse satisfaction, ” and “overall satisfaction”). In another trial, 253 the authors provided differences between treatment-arm specific mean IIEF scores for the “erectile function, ” “intercourse satisfaction, ” and “overall satisfaction” domains as secondary efficacy endpoints. In this trial, 249 primary efficacy endpoint was a response rate defined as the proportion of patients who answered “yes” to a Global Efficacy Question (GEQ) (i.e., “ Has the treatment you have been taking over the past two or four weeks improved your erections? ”) combined with an improvement of ≥ 5 points in the “erectile function” domain of the IIEF.

Global Assessment Questions (GAQs) were evaluated and reported in three trials, 117, 159, 251 as a secondary response endpoint. In one trial117 the endpoint was defined as the proportion of patients who answered “yes” to two GAQ questions, and in the other trial251 the corresponding endpoint was treated as a continuous variable whereby responses to one GAQ were given on an ordinal scale (1 = very satisfied, 5 = very dissatisfied).

The treatment preference/satisfaction was measured and reported in three trials.117, 120, 251 In one trial the treatment satisfaction was measured as a proportion of patients satisfied with one drug only, alternative drug only, both drugs, or none of the drugs.120 In two trials, 117, 159 the treatment-arm specific differences in IIEF “Overall Satisfaction” domain and the Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire-based mean scores were used to evaluate the patient's satisfaction with treatment regimens. In their trial, Lammers et al., 251 employed the Visual Analogue Scale (VAS; range 0–100) to assess patients' treatment satisfaction. The endpoint was the post-treatment mean VAS satisfaction score calculated for patients in each treatment arm.

The authors of one trial251 measured and reported the mean Sexual Encounter Profile (SEP) questionnaire-based overall score.

Penile rigidity was reported in two trials.250, 251 In one trial, 251 it was measured on VAS as the mean VAS rigidity (range 0–100), and in the other trial, 250 it was measured using a RigiScan and expressed as the percentage rigidity (i.e., percent of linear displacement of the loops due to the constant force). A post-treatment rigidity of at least 40 percent was considered a positive treatment response.


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