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Can we predict patients’ compliance to PDE5 inhibitors at baseline assessment?

Capogrosso, P1Ventimiglia, E1; Boeri, L2; Cazzaniga, W1; Pederzoli, F1; Chierigo, F1; Frego, N1; Abbate, C1; Deho', F1; Gaboardi, F1; Montanari, E2; Mirone, V3; Montorsi, F1; Salonia, A1

1: San Raffaele Hospital - University Vita-Salute San Raffaele, Italy; 2: Fondazione Ca’ Granda – Maggiore Hospital, University of Milan, Italy; 3: University of Naples Federico II, Italy

Objective: Currently, no user-friendly parameters allow to predict patients’ compliance to PDE5 inhibitors (PDE5is) at the time of their first clinical assessment. We looked at potential predictors of PDE5is discontinuation over time in a cohort of patients seeking medical help at a single center, as a surrogate of therapy compliance.

Materials and Methods: Complete data from 386 men with ED as a primary compliant and naïve for PDE5Is were analyzed. Patients were included if they were prescribed with a PDE5i therapy for ED (any type) at the first office visit. Every patient completed a baseline International Index of Erectile Function-Erectile Function domain (IIEF-EF) questionnaire. Patients were re-assessed every 6 months and were asked about their compliance with the prescribed therapy; the time at therapy discontinuation was recorded. Patients who did not discontinue their therapy were censored at the date of last follow-up. Kaplan Meier analyses estimated the probability of therapy discontinuation over time. Cox-regression analysis tested the association between baseline patients’ characteristics and the risk of discontinuing from therapy.

Results: Median (IQR) age at first assessment for ED was 53 (43-62) years. The median baseline IIEF-EF score was 16.5 (7-24). Overall, 102 (26%) patients had a Charlson Comorbidity Index (CCI) score >=1; of all, 216 (56%), 106 (27%), 46 (12%) and 18 (4.7%) patients received a prescription for tadalafil, vardenafil, sildenafil and avanafil, respectively. Median (IQR) length of follow-up was 6 (3-15) months. The probabilities of therapy discontinuation were 10% (95%CI: 8-14), 25% (95%CI: 20-30) and 41% (95%, 35-47%) at 3, 6 and 12 months after the first prescription, respectively. At Cox-regression analysis no significant associations among user-friendly clinical predictors (patients-age, CCI score, body mass index, baseline IIEF-EF score, educational status and relationship status) and the risk of therapy discontinuation were observed (all p>0.05).

Conclusions: Patients’ compliance to PDE5is decreases over time after first prescription ever in men seeking first medical help for ED, with more than half of patients still on therapy after 12 months in a real-life setting. Patients’ discontinuation from PDE5is cannot be reliably predicted according to baseline patients’ characteristics.


Work supported by industry: no.

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