What is the treatment for amyloidosis (Amyloidosis) associated erectile dysfunction (Erectile Dysfunction)?

From the Guidelines

Treatment for erectile dysfunction (ED) in patients with transthyretin (ATTR) amyloidosis should prioritize phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, tadalafil, or vardenafil, as first-line therapy, considering the most recent evidence from 2024 1.

Key Considerations

• The choice of PDE5 inhibitor and dosage should be individualized, taking into account the patient's specific needs and potential contraindications.
• If PDE5 inhibitors are ineffective or contraindicated, second-line options include vacuum erection devices or intracavernosal injections with medications like alprostadil.
• Addressing the underlying ATTR amyloidosis with disease-modifying treatments like tafamidis, patisiran, or inotersen is crucial to prevent further progression of autonomic neuropathy that contributes to ED.
• Managing cardiovascular risk factors, avoiding medications that may worsen ED, and psychological counseling are also important components of treatment.

Treatment Approach

• First-line treatment: PDE5 inhibitors (sildenafil, tadalafil, or vardenafil)
• Second-line treatment: vacuum erection devices or intracavernosal injections with medications like alprostadil
• Third-line treatment: penile prosthesis implantation for patients who do not respond to other treatments

Underlying Disease Management

• Disease-modifying treatments for ATTR amyloidosis, such as tafamidis, patisiran, or inotersen, should be considered to prevent further progression of autonomic neuropathy.
• Managing cardiovascular risk factors and avoiding medications that may worsen ED are also essential.

Additional Considerations

• Psychological counseling can be beneficial in addressing the emotional and psychological aspects of ED in patients with ATTR amyloidosis.
• A multidisciplinary approach, involving cardiologists, neurologists, and urologists, may be necessary to manage the complex needs of these patients, as highlighted in recent guidelines 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)

The treatment for erectile dysfunction (including cases associated with amyloidosis) is tadalafil.

• The recommended starting dose of tadalafil for use as needed is 10 mg, taken prior to anticipated sexual activity.
• The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability.
• The maximum recommended dosing frequency is once per day in most patients 2.
• Tadalafil tablets for once daily use is not recommended for patients with severe renal impairment or on hemodialysis 2.
• Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention 2.

From the Research

Treatment for ATTR Amyloidosis Erectile Dysfunction

• The treatment for erectile dysfunction (ED) in patients with ATTR amyloidosis is similar to that for ED in the general population, with phosphodiesterase type 5 inhibitors (PDE5Is) being a common first-line therapy 3, 4.
• PDE5Is, such as sildenafil, tadalafil, vardenafil, and avanafil, have been shown to be effective in treating ED in patients with various underlying conditions, including diabetes, hypertension, and cardiovascular disease 5, 4.
• However, some patients may not respond to PDE5Is, and alternative treatments such as alprostadil injections or combination therapy with PDE5Is and alprostadil may be considered 6, 3.
• Lifestyle modifications, such as exercise and weight loss, may also be beneficial in improving ED symptoms 3.
• It is essential to note that urinary and sexual dysfunction are common in patients with ATTR amyloidosis, and a comprehensive assessment and multidisciplinary management approach are necessary to address these issues 7.

Efficacy and Safety of PDE5Is

• PDE5Is have been shown to be effective in treating ED, with response rates of 60-65% in patients with various underlying conditions 3, 4.
• The safety profile of PDE5Is is generally good, with common adverse events including headache, flushing, and dyspepsia 5.
• However, PDE5Is may be associated with a small increased risk of non-arteritic ischemic optic neuropathy and melanoma, although the evidence is limited and controversial 5.

Alternative Treatments

• Alprostadil injections are an effective treatment for ED, particularly in patients who do not respond to PDE5Is 6, 3.
• Combination therapy with PDE5Is and alprostadil may be considered in patients who do not respond to PDE5Is alone 6.
• Surgical treatment options, such as penile implants, may be considered in patients with severe ED who do not respond to medical therapy 3.