From the Guidelines
Erectile dysfunction (ED) should be treated with oral medications like sildenafil, tadalafil, vardenafil, or avanafil as the first-line treatment, taken 30-60 minutes before sexual activity, as recommended by the American College of Physicians 1. The treatment of ED typically involves a stepwise approach, starting with the least invasive and least risky options.
- The choice of a specific PDE-5 inhibitor should be based on the individual preferences of men with erectile dysfunction, including ease of use, cost of medication, and adverse effects profile 1.
- Addressing underlying causes is essential, such as managing diabetes, hypertension, high cholesterol, obesity, and stopping smoking, which can improve erectile function.
- Psychological factors like stress, anxiety, and depression often contribute to ED, so counseling may be beneficial.
- Regular exercise, maintaining a healthy weight, limiting alcohol consumption, and avoiding recreational drugs can also help improve erectile function by promoting better vascular health and hormone balance 1.
- For those who don't respond to oral medications, alternatives include vacuum erection devices, penile injections (alprostadil), urethral suppositories, or surgical penile implants, as recommended by the American Urological Association 1. The patient and, when possible, his partner should be informed of the relevant treatment options and their associated risks and benefits, and the choice of treatment should be made jointly by the physician, patient, and partner, when possible, taking into consideration patient preferences and expectations and the experience and judgment of the physician 1.
From the FDA Drug Label
The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients. Tadalafil, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED) Tadalafil was studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-weeks duration. Results in ED Population in US Trials — The 2 primary US efficacy and safety trials included a total of 402 men with erectile dysfunction, with a mean age of 59 years (range 27 to 87 years) The treatment effect of tadalafil did not diminish over time Table 11: Mean Endpoint and Change from Baseline for the Primary Efficacy Variables in the Two Primary US Trials Study A Study B Placebo Tadalafil 20 mg Placebo Tadalafil 20 mg (N=49) (N=146) p-value (N=48) (N=159) p-value EF Domain Score Endpoint 13.5 19.5 13.6 22.5 Change from baseline -0.2 6.9 <.001 0.3 9.3 <.001 Insertion of Penis (SEP2) Endpoint 39% 62% 43% 77% Change from baseline 2% 26% <. 001 2% 32% <.001 Maintenance of Erection (SEP3) Endpoint 25% 50% 23% 64% Change from baseline 5% 34% <.001 4% 44% <.001
Tadalafil is effective in treating erectile dysfunction (ED).
- The drug has been evaluated in 22 clinical trials with over 4000 patients.
- Tadalafil improved erectile function in men with ED, with significant improvements in EF domain score, insertion of penis, and maintenance of erection.
- The treatment effect of tadalafil did not diminish over time 2. Key considerations for treatment:
- Tadalafil should not be used in men for whom sexual activity is inadvisable due to underlying cardiovascular status 2.
- Patients with certain cardiovascular conditions, such as myocardial infarction within the last 90 days or unstable angina, should not take tadalafil 2.
From the Research
Definition and Prevalence of Erectile Dysfunction
- Erectile dysfunction (ED) is a common medical condition that has a negative impact on men and their partners 3.
- It is a common male sexual dysfunction associated with a reduced quality of life for patients and their partners 4.
- The prevalence of ED is increasing worldwide, and it is associated with increasing age, depression, obesity, lack of exercise, diabetes mellitus, hypertension, dyslipidaemia, cardiovascular disease, and lower urinary tract symptoms related to benign prostatic hyperplasia 4.
Treatment Options for Erectile Dysfunction
- The most commonly prescribed therapies for ED are oral phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil, tadalafil, and vardenafil 3, 5.
- PDE5 inhibitors are recognized as efficacious and well-tolerated, and are the first-line treatment for ED 5.
- Other treatment options include patient-administered intracorporal injection therapy using vasodilator drugs, surgical treatment with multicomponent inflatable penile implants, penile arterial revascularisation, and venous ligation surgery 4.
Lifestyle Modifications and Erectile Dysfunction
- Lifestyle modifications such as smoking cessation, weight reduction, dietary modification, physical activity, and psychological stress reduction have been increasingly recognized as foundational to the prevention and treatment of ED 6, 7.
- Modifiable risk factors for ED include smoking, lack of physical activity, wrong diets, overweight or obesity, metabolic syndrome, and excessive alcohol consumption 7.
- Lifestyle and nutrition have been recognized as central factors influencing both vascular NO production, testosterone levels, and erectile function 7.
Patient Preference and Adherence to Treatment
- The existence of multiple PDE5 inhibitors has resulted in an increase in their marketing, and the question of which PDE-5 inhibitor to use has become relevant for clinicians, patients, and their partners 3.
- There are no significant differences in the safety and efficacy of PDE5 inhibitors, and patient preference and adherence to treatment are important factors to consider 3, 5.
- Strategies to improve compliance and satisfaction with treatment include individualized treatment plans, consideration of clinical, demographic, and relational factors, and patient education 3, 5.