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Consecutive enrollment was planned to be stopped as soon as either 3,000 patients were enrolled overall, or 600 patients were enrolled in the tadalafil OaD cohort. All patients prescribed tadalafil OaD treatment at baseline were included in the analysis.

The distribution of time to discontinuation of tadalafil OaD was estimated using the Kaplan-Meier product-limit method.

• In rare cases, tadalafil can cause vision changes.
• Allergic reactions may include rash, swelling, or difficulty breathing.
• Seek medical advice if side effects are severe or persistent.

The Kaplan-Meier proportions and associated 95 % confidence intervals (CIs) of patients on tadalafil OaD at Months 2, 4, and 6 were reported for the tadalafil OaD cohort (primary analysis) as well as subgroups stratified by age (18–65 years and >65 years), pretreatment with PDE5 inhibitors, ED severity (mild, moderate, severe), and presence or absence of BPH, diabetes, CVD, hypertension, and dyslipidemia (prespecified subgroup analyses, reported in this manuscript).

An additional, prespecified exploratory analysis was performed to investigate the association between time to discontinuation of tadalafil OaD and selected baseline factors using a Cox proportional hazards model; hazard ratios (HRs) and the corresponding 95 %CIs were reported. The final model included factors associated with treatment discontinuation identified by backward selection (removing those with p > 0.1). These included presence of relevant comorbidities, type of physician who initially diagnosed the ED, country, duration of living arrangement, age, ED etiology, ED severity, and work status [20]. All patients prescribed tadalafil OaD at baseline were included in the longitudinal analyses. Least-square (LS) mean effects in IIEF domain scores and EDITS total score from baseline to Month 6 were assessed using a mixed model for repeated measures (MMRM), including the following prespecified variables as fixed effects: visit, age (18–65 vs >65 years), pretreatment with PDE5 inhibitors (yes vs no), etiology of ED, ED severity, BPH (yes vs no), diabetes (yes vs no), CVD (yes vs no), hypertension (yes vs no), and dyslipidemia (yes vs no).

• Some people may experience nasal congestion or dizziness.
• Use caution when combining with other erectile dysfunction drugs.
• Always keep medication out of reach of children.

p-values <0.05 were considered statistically significant and 95 % CIs were produced. Data were analyzed using the SAS 9.2 software (SAS Institute Inc., Cary, NC, USA). Overall, 778 patients received prescriptions for initiating or switching to tadalafil OaD at baseline. The majority of patients were aged 18 to 65 years (76.9 %), had suffered from ED for at least 1 year (63.1 %), and presented with mild to moderate disease at baseline (73.7 %) (Table 1). Most patients (65.6 %) were naïve to PDE5 inhibitor treatment. Baseline IIEF domain scores were similar in PDE5 inhibitor-naïve and pretreated patients (Additional file 2).

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However, treatment satisfaction remained predominantly unaffected by any comorbid condition or baseline characteristic except for age, with patients aged 18–65 years reporting significantly higher satisfaction scores vs those aged >65 years. In our study, younger patients (18–65 years) had higher chances of continuing tadalafil OaD vs older patients. This finding resonates with that from the DETECT observational study in which age less than 60 years was one of the factors associated with continuation of tadalafil on-demand treatment at 12 months [23]. Similarly, an observational study in Latin America found that persistence and adherence rates for PDE5 inhibitor treatment at 6 months were generally higher in younger men with ED (mean age, 52.3 years vs 54.9 years for non-persistent patients and 52.1 years vs 55.5 years for non-adherent patients) [24]. In a Korean study, the most common reason for discontinuing PDE5 inhibitor treatment given by older men (>70 years) with ED was concerns about the side effects, possibly due to higher prevalence of comorbidities in this subgroup [25].

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We observed significant improvement from baseline in all the IIEF domain scores and EDITS total score at the second (1–3 months) and third (4–6 months) visits in the overall tadalafil OaD cohort. In particular, the LS mean IIEF-EF domain score increased by 7.1 points from baseline to 4 to 6 months after initiation of tadalafil OaD, exceeding the minimal clinically important difference (MCID) of 4 points [26]; this observation aligns with the 9.4-point increase observed with tadalafil OaD in a previous randomised controlled trial [27]. We found that PDE5 inhibitor pretreatment had a significant impact on IIEF scores, i.e. pretreated patients showed less improvement during tadalafil OaD treatment compared with treatment-naïve patients, in the domains of EF, orgasmic function, intercourse satisfaction, and overall satisfaction. In the EDATE cohort, 36.7 % of patients switched to tadalafil OaD due to lack of efficacy of previous PDE5 inhibitor treatment [20].

Additional file 2: (download PDF )

Thus, we believe that some of the patients in the tadalafil OaD cohort who were pretreated with PDE5 inhibitors may have been insufficient responders to any PDE5 inhibitor treatment, leading to a negative effect on their IIEF domain scores. Over half of the patients (58.4 %) reported having at least 1 comorbid condition.

The most commonly reported comorbidities included CVD (34.5 %), hypertension (33.4 %), dyslipidemia (18.5 %), and diabetes (15.9 %).

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Over half of the patients (58.4 %) reported having at least 1 comorbid condition. The most commonly reported comorbidities included CVD (34.5 %), hypertension (33.4 %), dyslipidemia (18.5 %), and diabetes (15.9 %). A small proportion of patients reported BPH (6.3 %) and hypogonadism (1.5 %). Approximately 57.1 % of the patients were on at least 1 concomitant medication (Table 1). At Month 2, Kaplan-Meier estimation revealed that more than 90 % of patients were still on tadalafil OaD, except those aged >65 years (86.7 %) and men with severe ED (89.0 %) (Table 2).

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More than 80 % of patients in all subgroups, except those aged >65 years (75.0 %) continued tadalafil OaD at Month 6 (Table 2; Additional file 3). Reasons for discontinuation did not differ notably between the older (>65 years) and younger age group (Table 3). As the majority of patients remained on tadalafil OaD at Month 6, the median time to discontinuation could not be estimated in any of the subgroups. Patients with severe ED had lower treatment continuation rates than those with mild ED or moderate ED, but these were still >80 % at all time points (Additional file 4). The Kaplan-Meier analysis did not suggest any influence of individual comorbidities on treatment continuation rates (Table 2).

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These findings were consistent with those from the Cox proportional hazard model evaluating factors associated with time to discontinuation of tadalafil OaD. The risk of discontinuation was significantly decreased among younger vs older patients (HR [95 % CI]: 18–65 vs >65 years: 0.54 [0.30, 0.96], p = 0.038). There was no significant effect of disease severity (mild vs moderate ED: 1.26 [0.68, 2.32], p = 0.462; severe vs moderate ED: 1.51 [0.95, 2.39], p = 0.077), or the presence of relevant comorbidities (presence vs absence of relevant comorbidities, namely, BPH, diabetes, CVD, hypertension, dyslipidemia: 1.27 [0.82, 1.94], p = 0.287) in this model. Overall, treatment with tadalafil OaD for 6 months was associated with significant improvement at Visit 2 (1–3 months) and Visit 3 (4–6 months) in all IIEF domain scores, including the IIEF-erectile function (EF) domain (p < 0.001 for both visits), as well as the EDITS total score (p = 0.035 and p = 0.028 for Visits 2 and 3, respectively) (Table 4). Improvements in the mean (standard deviation [SD]) IIEF domain scores and EDITS total score are given in Additional file 5. A small proportion of patients reported BPH (6.3 %) and hypogonadism (1.5 %). Approximately 57.1 % of the patients were on at least 1 concomitant medication (Table 1). At Month 2, Kaplan-Meier estimation revealed that more than 90 % of patients were still on tadalafil OaD, except those aged >65 years (86.7 %) and men with severe ED (89.0 %) (Table 2). More than 80 % of patients in all subgroups, except those aged >65 years (75.0 %) continued tadalafil OaD at Month 6 (Table 2; Additional file 3). Reasons for discontinuation did not differ notably between the older (>65 years) and younger age group (Table 3). As the majority of patients remained on tadalafil OaD at Month 6, the median time to discontinuation could not be estimated in any of the subgroups. Patients with severe ED had lower treatment continuation rates than those with mild ED or moderate ED, but these were still >80 % at all time points (Additional file 4). The Kaplan-Meier analysis did not suggest any influence of individual comorbidities on treatment continuation rates (Table 2). These findings were consistent with those from the Cox proportional hazard model evaluating factors associated with time to discontinuation of tadalafil OaD.

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The risk of discontinuation was significantly decreased among younger vs older patients (HR [95 % CI]: 18–65 vs >65 years: 0.54 [0.30, 0.96], p = 0.038). There was no significant effect of disease severity (mild vs moderate ED: 1.26 [0.68, 2.32], p = 0.462; severe vs moderate ED: 1.51 [0.95, 2.39], p = 0.077), or the presence of relevant comorbidities (presence vs absence of relevant comorbidities, namely, BPH, diabetes, CVD, hypertension, dyslipidemia: 1.27 [0.82, 1.94], p = 0.287) in this model. Overall, treatment with tadalafil OaD for 6 months was associated with significant improvement at Visit 2 (1–3 months) and Visit 3 (4–6 months) in all IIEF domain scores, including the IIEF-erectile function (EF) domain (p < 0.001 for both visits), as well as the EDITS total score (p = 0.035 and p = 0.028 for Visits 2 and 3, respectively) (Table 4). Improvements in the mean (standard deviation [SD]) IIEF domain scores and EDITS total score are given in Additional file 5. MMRM analysis showed that PDE5 pretreatment had a significantly smaller LS mean effect on IIEF-EF (p < 0.001), orgasmic function (p = 0.003), intercourse satisfaction (p = 0.003), and overall satisfaction (p = 0.001) domain scores vs no previous PDE5 inhibitor treatment. Mild ED had a significantly smaller LS mean effect on IIEF-EF (p = 0.011), sexual desire (p = 0.029), and overall satisfaction (p < 0.001) domain scores, while severe ED had a significantly increased LS mean effect on the IIEF orgasmic function (p < 0.001) domain score relative to moderate ED. The negative effect of BPH on change in IIEF-EF (p = 0.014), orgasmic function (p tadalafil over the counter uk = 0.044), and sexual desire (p = 0.017) domain scores was statistically significant.

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MMRM analysis showed that PDE5 pretreatment had a significantly smaller LS mean effect on IIEF-EF (p < 0.001), orgasmic function (p = 0.003), intercourse satisfaction (p = 0.003), and overall satisfaction (p = 0.001) domain scores vs no previous PDE5 inhibitor treatment. Mild ED had a significantly smaller LS mean effect on IIEF-EF (p = 0.011), sexual desire (p = 0.029), and overall satisfaction (p < 0.001) domain scores, while severe ED had a significantly increased LS mean effect on the IIEF orgasmic function (p < 0.001) domain score relative to moderate ED. The negative effect of BPH on change in IIEF-EF (p = 0.014), orgasmic function (p tadalafil over the counter uk = 0.044), and sexual desire (p = 0.017) domain scores was statistically significant. Furthermore, diabetes showed a significant positive effect on changes in IIEF-EF (p = 0.007), orgasmic function (p = 0.013), intercourse satisfaction (p = 0.030), and overall satisfaction (p = 0.009) domain scores (Table 4). There were no significant effects for age, ED etiology, CVD, hypertension, or dyslipidemia (p > 0.05 for all comparisons) on IIEF domain scores over 6 months of tadalafil OaD treatment.

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LS mean effects in EDITS total score were not affected by any comorbidity or baseline characteristic except age (p = 0.008) (Table 4). No treatment-related serious adverse events were reported during the study. The most frequently reported adverse events included headache (1.3 %), dyspepsia (0.5 %), and a new diagnosis of BPH (0.5 %); no new or unexpected safety signals were observed [20]. Currently, there are few observational studies in patients with ED that assess the impact of baseline characteristics and presence of comorbid conditions on PDE5 inhibitor treatment continuation rates. In particular, few existing studies assess treatment satisfaction and effectiveness beyond the IIEF-EF domain.

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The primary analysis of the EDATE observational study demonstrated high treatment continuation rates (86.3 %) over a period of 6 months in 778 patients with ED who initiated or switched to PDE5 inhibitor treatment with tadalafil OaD at baseline (Additional file 6) [20]. Here in this cohort with high frequency of comorbidities and use of concomitant medications, we found that continuation rates over 6 months of treatment with tadalafil OaD were comparable across subgroups. Furthermore, continuation rates were over 80 % regardless of the presence of comorbidities, pretreatment with PDE5 inhibitors, or ED severity. Even in the subgroup of older patients (>65 years), the continuation rate was 75 % at Month 6. IIEF was affected by some baseline characteristics including ED severity, pretreatment with PDE5 inhibitors, and the presence or absence of diabetes and BPH. Furthermore, diabetes showed a significant positive effect on changes in IIEF-EF (p = 0.007), orgasmic function (p = 0.013), intercourse satisfaction (p = 0.030), and overall satisfaction (p = 0.009) domain scores (Table 4). There were no significant effects for age, ED etiology, CVD, hypertension, or dyslipidemia (p > 0.05 for all comparisons) on IIEF domain scores over 6 months of tadalafil OaD treatment. LS mean effects in EDITS total score were not affected by any comorbidity or baseline characteristic except age (p = 0.008) (Table 4). No treatment-related serious adverse events were reported during the study. The most frequently reported adverse events included headache (1.3 %), dyspepsia (0.5 %), and a new diagnosis of BPH (0.5 %); no new or unexpected safety signals were observed [20].

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Consecutive enrollment was planned to be stopped as soon as either 3,000 patients were enrolled overall, or 600 patients were enrolled in the tadalafil OaD cohort. All patients prescribed tadalafil OaD treatment at baseline were included in the analysis. The distribution of time to discontinuation of tadalafil OaD was estimated using the Kaplan-Meier product-limit method. The Kaplan-Meier proportions and associated 95 % confidence intervals (CIs) of patients on tadalafil OaD at Months 2, 4, and 6 were reported for the tadalafil OaD cohort (primary analysis) as well as subgroups stratified by age (18–65 years and >65 years), pretreatment with PDE5 inhibitors, ED severity (mild, moderate, severe), and presence or absence of BPH, diabetes, CVD, hypertension, and dyslipidemia (prespecified subgroup analyses, reported in this manuscript). An additional, prespecified exploratory analysis was performed to investigate the association between time to discontinuation of tadalafil OaD and selected baseline factors using a Cox proportional hazards model; hazard ratios (HRs) and the corresponding 95 %CIs were reported.

Drug Interactions

The final model included factors associated with treatment discontinuation identified by backward selection (removing those with p > 0.1). These included presence of relevant comorbidities, type of physician who initially diagnosed the ED, country, duration of living arrangement, age, ED etiology, ED severity, and work status [20]. All patients prescribed tadalafil OaD at baseline were included in the longitudinal analyses. Least-square (LS) mean effects in IIEF domain scores and EDITS total score from baseline to Month 6 were assessed using a mixed model for repeated measures (MMRM), including the following prespecified variables as fixed effects: visit, age (18–65 vs >65 years), pretreatment with PDE5 inhibitors (yes vs no), etiology of ED, ED severity, BPH (yes vs no), diabetes (yes vs no), CVD (yes vs no), hypertension (yes vs no), and dyslipidemia (yes vs no). p-values <0.05 were considered statistically significant and 95 % CIs were produced.

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Data were analyzed using the SAS 9.2 software (SAS Institute Inc., Cary, NC, USA). Overall, 778 patients received prescriptions for initiating or switching to tadalafil OaD at baseline. The majority of patients were aged 18 to 65 years (76.9 %), had suffered from ED for at least 1 year (63.1 %), and presented with mild to moderate disease at baseline (73.7 %) (Table 1). Most patients (65.6 %) were naïve to PDE5 inhibitor treatment. Baseline IIEF domain scores were similar in PDE5 inhibitor-naïve and pretreated patients (Additional file 2). Currently, there are few observational studies in patients with ED that assess the impact of baseline characteristics and presence of comorbid conditions on PDE5 inhibitor treatment continuation rates. In particular, few existing studies assess treatment satisfaction and effectiveness beyond the IIEF-EF domain. The primary analysis of the EDATE observational study demonstrated high treatment continuation rates (86.3 %) over a period of 6 months in 778 patients with ED who initiated or switched to PDE5 inhibitor treatment with tadalafil OaD at baseline (Additional file 6) [20].

• The drug is available by prescription only.
• It is essential to discuss health history with your doctor.
• Not suitable for individuals with certain eye or heart conditions.

Here in this cohort with high frequency of comorbidities and use of concomitant medications, we found that continuation rates over 6 months of treatment with tadalafil OaD were comparable across subgroups. Furthermore, continuation rates were over 80 % regardless of the presence of comorbidities, pretreatment with PDE5 inhibitors, or ED severity. Even in the subgroup of older patients (>65 years), the continuation rate was 75 % at Month 6. IIEF was affected by some baseline characteristics including ED severity, pretreatment with PDE5 inhibitors, and the presence or absence of diabetes and BPH. However, treatment satisfaction remained predominantly unaffected by any comorbid condition or baseline characteristic except for age, with patients aged 18–65 years reporting significantly higher satisfaction scores vs those aged >65 years. In our study, younger patients (18–65 years) had higher chances of continuing tadalafil OaD vs older patients. This finding resonates with that from the DETECT observational study in which age less than 60 years was one of the factors associated with continuation of tadalafil on-demand treatment at 12 months [23]. Similarly, an observational study in Latin America found that persistence and adherence rates for PDE5 inhibitor treatment at 6 months were generally higher in younger men with ED (mean age, 52.3 years vs 54.9 years for non-persistent patients and 52.1 years vs 55.5 years for non-adherent patients) [24]. In a Korean study, the most common reason for discontinuing PDE5 inhibitor treatment given by older men (>70 years) with ED was concerns about the side effects, possibly due to higher prevalence of comorbidities in this subgroup [25]. We observed significant improvement from baseline in all the IIEF domain scores and EDITS total score at the second (1–3 months) and third (4–6 months) visits in the overall tadalafil OaD cohort. In particular, the LS mean IIEF-EF domain score increased by 7.1 points from baseline to 4 to 6 months after initiation of tadalafil OaD, exceeding the minimal clinically important difference (MCID) of 4 points [26]; this observation aligns with the 9.4-point increase observed with tadalafil OaD in a previous randomised controlled trial [27]. We found that PDE5 inhibitor pretreatment had a significant impact on IIEF scores, i.e.

• Tadalafil 5mg is primarily used to treat erectile dysfunction.
• It works by relaxing blood vessels in the penis.
• Typically taken once daily for ongoing management.

pretreated patients showed less improvement during tadalafil OaD treatment compared with treatment-naïve patients, in the domains of EF, orgasmic function, intercourse satisfaction, and overall satisfaction. In the EDATE cohort, 36.7 % of patients switched to tadalafil OaD due to lack of efficacy of previous PDE5 inhibitor treatment [20]. Thus, we believe that some of the patients in the tadalafil OaD cohort who were pretreated with PDE5 inhibitors may have been insufficient responders to any PDE5 inhibitor treatment, leading to a negative effect on their IIEF domain scores.