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The LSmean effect on change in IIEF-EF was significantly positive for diabetes (2.28 [0.64,3.92], p = 0.007), most likely because those with diabetes had more severe ED at baseline. For all other parameters, no statistically significant LSmean effects in IIEF-EF changes were observed.
- 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.
No comorbidity or baseline-characteristic except age (18 − 65 years vs >65 years: 11.25 [2.96,19.54], p = 0.008) affected changes in EDITS. Under routine clinical conditions, treatment continuation rate or satisfaction does not seem to be significantly affected by the presence of comorbidities in men who choose ED-treatment with TAD-OaD.
Can erectile dysfunction be treated with prescription medicines?
The LSmean effect on change in IIEF-EF was significantly positive for diabetes (2.28 [0.64,3.92], p = 0.007), most likely because those with diabetes had more severe ED at baseline. For all other parameters, no statistically significant LSmean effects in IIEF-EF changes were observed. No comorbidity or baseline-characteristic except age (18 − 65 years vs >65 years: 11.25 [2.96,19.54], p = 0.008) affected changes in EDITS. Under routine clinical conditions, treatment continuation rate or satisfaction does not seem to be significantly affected by the presence of comorbidities in men who choose ED-treatment with TAD-OaD. The magnitude of treatment effectiveness was affected by certain baseline characteristics and comorbid conditions.
Enregistrement de l’Essai
The study (H6D-EW-LVIU) is registered in the German VfA Registry of Non-Interventional Studies (Verband Forschender Arzneimittelhersteller) since 06 December 2011; available at: Men with erectile dysfunction (ED) have several comorbid conditions such as cardiovascular disease (CVD) and associated risk factors including diabetes, hypertension, dyslipidemia, smoking, obesity, sedentary lifestyle, and others such as depression, premature ejaculation, lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), and overactive bladder [1–4]. In the Men’s Attitudes to Life Events and Sexuality (MALES) study, 64 % of the men reported having at least 1 comorbid condition including hypertension (36 %), dyslipidemia (29 %), depression (25 %), CVD (17 %), and diabetes (14 %) [1]. Given these prevalence rates of comorbidities in men with ED, it is important to choose an appropriate treatment that maintains its efficacy and tolerability in the presence of the comorbidities [5]. Oral phosphodiesterase type 5 (PDE5) inhibitors including avanafil, sildenafil, tadalafil, and vardenafil are proven to be safe and effective for managing ED [6–14]. Furthermore, these drugs have demonstrated efficacy in men with ED who have comorbid cardiovascular risk factors including hypertension, dyslipidemia, and/or diabetes [5], and tadalafil once daily (OaD) has shown efficacy in the treatment of BPH/LUTS [15–17]. The magnitude of treatment effectiveness was affected by certain baseline characteristics and comorbid conditions.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 20mg | 10 Pills | 31.49€ 29.99€ | |
| Cialis Generic | 40mg | 20 Pills | 59.47€ 56.64€ | |
| Tadalista Super Active | 20mg | 60 + 8 Pills | 230.32€ 219.35€ | |
| Cialis Generic | 5mg | 30 + 4 Pills | 53.56€ 51.01€ | |
| Cialis Generic | 2.5mg | 10 Pills | 28.51€ 27.15€ | |
| Cialis Generic | 60mg | 180 + 10 Pills | 313.11€ 298.20€ | |
| Cialis Generic | 5mg | 60 + 4 Pills | 86.02€ 81.92€ | |
| Cialis Generic | 2.5mg | 180 + 10 Pills | 154.86€ 147.49€ | |
| Cialis Generic | 10mg | 90 + 6 Pills | 146.17€ 139.21€ | |
| Cialis Generic | 20mg | 270 + 10 Pills | 335.21€ 319.25€ | |
| Cialis Generic | 60mg | 30 + 2 Pills | 85.33€ 81.27€ | |
| Cialis Generic | 40mg | 360 + 10 Pills | 477.87€ 455.11€ | |
| Cialis Generic | 40mg | 10 Pills | 37.79€ 35.99€ | |
| Tadalista Super Active | 20mg | 90 + 10 Pills | 314.14€ 299.18€ | |
| Cialis Generic | 10mg | 270 + 10 Pills | 308.71€ 294.01€ |
The study (H6D-EW-LVIU) is registered in the German VfA Registry of Non-Interventional Studies (Verband Forschender Arzneimittelhersteller) since 06 December 2011; available at: Men with erectile dysfunction (ED) have several comorbid conditions such as cardiovascular disease (CVD) and associated risk factors including diabetes, hypertension, dyslipidemia, smoking, obesity, sedentary lifestyle, and others such as depression, premature ejaculation, lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH), and overactive bladder [1–4].
In case of emergency/overdose
In the Men’s Attitudes to Life Events and Sexuality (MALES) study, 64 % of the men reported having at least 1 comorbid condition including hypertension (36 %), dyslipidemia (29 %), depression (25 %), CVD (17 %), and diabetes (14 %) [1]. Given these prevalence rates of comorbidities in men with ED, it is important to choose an appropriate treatment that maintains its efficacy and tolerability in the presence of the comorbidities [5]. Oral phosphodiesterase type 5 (PDE5) inhibitors including avanafil, sildenafil, tadalafil, and vardenafil are proven to be safe and effective for managing ED [6–14]. Furthermore, these drugs have demonstrated efficacy in men with ED who have comorbid cardiovascular risk factors including hypertension, dyslipidemia, and/or diabetes [5], and tadalafil once daily (OaD) has shown efficacy in the treatment of BPH/LUTS [15–17]. It has been suggested that appropriate treatment of concomitant ED may help in improving the adherence and management of associated comorbidities, which may eventually decrease healthcare costs and improve the overall health of the affected men [18]. However, some pharmacological drugs used for treating these comorbid conditions have sexual side effects. This further underscores the significance of choosing an efficacious medication for treating ED in these subpopulations, if required. The study highlighted that more than 85 % of men who choose to be treated with tadalafil OaD maintained the treatment in the next 6 months [20].
Before Using
It has been suggested that appropriate treatment of concomitant ED may help in improving the adherence and management of associated comorbidities, which may eventually decrease healthcare costs and improve the overall health of the affected men [18]. However, some pharmacological drugs used for treating these comorbid conditions have sexual side effects. This further underscores the significance of choosing an efficacious medication for treating ED in these subpopulations, if required. The study highlighted that more than 85 % of men who choose to be treated with tadalafil OaD maintained the treatment in the next 6 months [20]. In this article, we present results of secondary analyses for the impact of patient characteristics and relevant comorbidities on treatment continuation rates as well as treatment effectiveness and satisfaction in patients with ED who had started with or switched to tadalafil OaD and were followed for a period of 6 months.
Consent for publication
EDATE was a prospective, longitudinal, observational study conducted in 59 centres across Germany, France, Italy, and Greece, enrolling patients from November 2011 through June 2012 [20]. Adult male patients who met the investigator’s criteria for ED and presented within the normal course of care were eligible to participate if they had decided, in consultation with their physician, to either initiate PDE5 inhibitor treatment for the first time (treatment-naïve) or switch from any previous PDE5 inhibitor taken on-demand. Patients with previous experience with tadalafil OaD were excluded. The study was approved by the Comité de protection des personnes “Nord-Ouest IV”, centre hospitalier universitaire, faculté de médecine, pôle recherche, 59045 Lille Cedex, and additional ethical review boards as per individual study site and country requirements (full list provided as Additional file 1). Patients provided written informed consent for data collection, storage, and release of anonymised data. In this article, we present results of secondary analyses for the impact of patient characteristics and relevant comorbidities on treatment continuation rates as well as treatment effectiveness and satisfaction in patients with ED who had started with or switched to tadalafil OaD and were followed for a period of 6 months. EDATE was a prospective, longitudinal, observational study conducted in 59 centres across Germany, France, Italy, and Greece, enrolling patients from November 2011 through June 2012 [20]. Adult male patients who met the investigator’s criteria for ED and presented within the normal course of care were eligible to participate if they had decided, in consultation with their physician, to either initiate PDE5 inhibitor treatment for the first time (treatment-naïve) or switch from any previous PDE5 inhibitor taken on-demand. Patients with previous experience with tadalafil OaD were excluded. The study was approved by the Comité de protection des personnes “Nord-Ouest IV”, centre hospitalier universitaire, faculté de médecine, pôle recherche, 59045 Lille Cedex, and additional ethical review boards as per individual study site and country requirements (full list provided as Additional file 1).
8.1 Pregnancy
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). 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 %).
US Brand Name
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). Patients provided written informed consent for data collection, storage, and release of anonymised data. Assessment and treatment of patients were performed as per routine investigator practice for managing ED. In this article, data from patients who initiated or switched to treatment with tadalafil OaD at baseline (Visit 1) and were followed up longitudinally for up to 6 months (tadalafil OaD cohort) are reported. Post-baseline data were collected at routine visits (Visit 2, Visit 3) within 1 to 3 months and 4 to 6 months after initiation of therapy. Patients who switched or discontinued tadalafil OaD treatment during the observation were followed until the end of the 6-month observation period. A follow-up phone call was made to patients who did not visit within 4 to 6 months after baseline. The primary results on the time to treatment discontinuation of tadalafil OaD in men who had initiated or switched to tadalafil OaD at baseline have already been published [20]. The current article includes secondary outcome results on the impact of patients characteristics and comorbidities on time to treatment discontinuation, and on mean changes from baseline to end of observation in the International Index of Erectile Function (IIEF) domain scores [21], and Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) total score [22]. A sample size of 250 patients initiating or switching to tadalafil OaD at baseline was planned, based on the primary outcome (continuation rate on tadalafil OaD, estimated to be 50 − 80 % after 6 months of treatment) [20]. 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).
What happens if the prescriber decides treatment is not suitable?
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. 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).
If you take more than the recommended amount of tadalafil
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. 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 20mg tadalafil price 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). 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).
- Tadalafil 5mg has a duration of action up to 36 hours.
- It can improve spontaneous sexual activity.
- Dosage adjustments may be necessary for certain health conditions.
Most patients (65.6 %) were naïve to PDE5 inhibitor treatment.
| Side Effect | Frequency | Severity | Additional Comments |
|---|---|---|---|
| Headache | Common | Mild | Usually resolves spontaneously |
| Indigestion | Common | Mild | May be reduced with food |
| Back Pain | Less common | Mild | Usually occurs with higher doses |
| Flushing | Common | Mild | Redness of face and neck |
| Dizziness | Less common | Moderate | Avoid driving if affected |
Baseline IIEF domain scores were similar in PDE5 inhibitor-naïve and pretreated patients (Additional file 2). 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).
Author information
Assessment and treatment of patients were performed as per routine investigator practice for managing ED. In this article, data from patients who initiated or switched to treatment with tadalafil OaD at baseline (Visit 1) and were followed up longitudinally for up to 6 months (tadalafil OaD cohort) are reported. Post-baseline data were collected at routine visits (Visit 2, Visit 3) within 1 to 3 months and 4 to 6 months after initiation of therapy. Patients who switched or discontinued tadalafil OaD treatment during the observation were followed until the end of the 6-month observation period. A follow-up phone call was made to patients who did not visit within 4 to 6 months after baseline.
Other Medical Problems
The primary results on the time to treatment discontinuation of tadalafil OaD in men who had initiated or switched to tadalafil OaD at baseline have already been published [20]. The current article includes secondary outcome results on the impact of patients characteristics and comorbidities on time to treatment discontinuation, and on mean changes from baseline to end of observation in the International Index of Erectile Function (IIEF) domain scores [21], and Erectile Dysfunction Inventory for Treatment Satisfaction (EDITS) total score [22]. A sample size of 250 patients initiating or switching to tadalafil OaD at baseline was planned, based on the primary outcome (continuation rate on tadalafil OaD, estimated to be 50 − 80 % after 6 months of treatment) [20]. 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. 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).
| Aspect | Details |
|---|---|
| Recommended Dose | 5 mg once daily |
| Timing of Dose | With or without food, same time daily |
| Missed Dose | Take as soon as remembered, do not double dose |
| Duration of Use | As prescribed, typically long-term |
| Overdose | Seek medical attention; symptoms may include headache, dizziness |
The Kaplan-Meier analysis did not suggest any influence of individual comorbidities on treatment continuation rates (Table 2).
Warnings & Precautions
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 20mg tadalafil price 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].
Cite this article
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. 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. 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.
- 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.