What is the recommended treatment approach for a 50-year-old patient with diabetes (Diabetes Mellitus) and hypertension (High Blood Pressure) who has erectile dysfunction?

From the Guidelines

For a 50-year-old patient with diabetes, hypertension, and erectile dysfunction (ED), first-line therapy typically includes phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra) 50mg, tadalafil (Cialis) 10mg, or vardenafil (Levitra) 10mg taken as needed before sexual activity, as recommended by the American College of Physicians 1.

Indications for Further Evaluation

Before initiating treatment with PDE5 inhibitors, it is essential to evaluate the patient's cardiovascular risk factors, as ED and cardiovascular disease often share a common etiology 1. The Princeton Consensus Panel guidelines recommend assigning patients to one of three risk levels (high, intermediate, and low) based on their cardiovascular risk factors 1.

• High-risk patients are defined as those with unstable or refractory angina; uncontrolled hypertension; left ventricular dysfunction/congestive heart failure (CHF; New York Heart Association class II); MI or a cardiovascular accident within the previous 2 weeks; high-risk arrhythmias; hypertrophic obstructive and other cardiomyopathies; or moderate-to-severe valvular disease.
• Patients at low risk may be considered for all first-line therapies.
• Patients whose risk is indeterminate should undergo further evaluation by a cardiologist before receiving therapies for sexual dysfunction.

Treatment Approach

The American College of Physicians recommends that clinicians initiate therapy with a PDE-5 inhibitor in men who seek treatment for erectile dysfunction and who do not have a contraindication to PDE-5 inhibitor use (Grade: strong recommendation; high-quality evidence) 1.

• Tadalafil 5mg daily is also an option for continuous therapy.
• Before starting these medications, it's essential to optimize management of the underlying conditions, as both diabetes and hypertension contribute significantly to ED through vascular damage and neuropathy.
• Blood pressure should be controlled to target levels below 130/80 mmHg, and diabetes management should aim for HbA1c below 7%.
• Certain antihypertensive medications like thiazide diuretics and beta-blockers may worsen ED, so considering ACE inhibitors, ARBs, or calcium channel blockers might be beneficial.
• Lifestyle modifications are crucial and include regular exercise (150 minutes weekly), weight reduction if overweight, smoking cessation, limiting alcohol consumption, and following a Mediterranean-style diet.
• If PDE5 inhibitors are ineffective or contraindicated due to nitrate use, second-line options include vacuum erection devices, intracavernosal injections (alprostadil), or urethral suppositories.

Additional Considerations

The management of ED should always be considered secondary to maintaining cardiovascular function, and treatment for ED should not negatively affect cardiovascular health 1.

• Potential effects on erectile function of agents used to treat cardiovascular risk factors should be considered.
• For example, the β-blocker nebivolol, which has direct vasodilating properties, is less likely to cause ED than are other β-blockers.
• Angiotensin receptor blockers are also less likely to cause ED than are other antihypertensive agents (eg, diuretics).

From the FDA Drug Label

Tadalafil for once daily use was shown to be effective in treating ED in patients with diabetes mellitus. Patients with diabetes were included in both studies in the general ED population (N=79) A third randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design trial included only ED patients with type 1 or type 2 diabetes (N=298). In this third trial, tadalafil demonstrated clinically meaningful and statistically significant improvement in erectile function, as measured by the EF domain of the IIEF questionnaire and Questions 2 and 3 of the SEP diary

The patient's diabetes and hypertension do not appear to be contraindications for treatment with a phosphodiesterase inhibitor like tadalafil.

• Indications for treatment: The patient has erectile dysfunction, and tadalafil has been shown to be effective in treating ED in patients with diabetes mellitus.
• Further evaluation may be necessary to assess the patient's overall health and to determine the best course of treatment, but the presence of diabetes and hypertension alone does not require further evaluation before starting treatment with tadalafil 2.

From the Research

Evaluation and Treatment Approach

The evaluation of a 50-year-old patient with diabetes and hypertension who has erectile dysfunction involves:

• A complete medical history, including a review of medical risk factors such as hypertension, diabetes, cardiovascular disease, renal failure, and medications, as well as lifestyle risk factors such as obesity and tobacco, alcohol, and illicit drug use 3
• A detailed sexual history, including assessment of duration of ED, loss of libido, and overall sexual satisfaction 3
• A physical examination 3
• A psychosocial assessment, with particular attention to depressive symptoms 3
• Appropriate laboratory tests, including fasting glucose levels, a fasting lipid profile, and in select cases, a total testosterone level and a prostate-specific antigen test 4

Indications for Further Evaluation

Further evaluation is indicated in patients with:

• Complex medical histories, such as cardiovascular disease, renal failure, or other comorbidities 4
• Psychosocial issues, such as depression or anxiety 3
• Uncertain or unclear diagnoses 4

Treatment with Phosphodiesterase Inhibitors

Treatment with phosphodiesterase inhibitors, such as sildenafil, tadalafil, or vardenafil, is indicated in patients with:

• Mild to moderate erectile dysfunction 4
• No contraindications to phosphodiesterase inhibitor use, such as nitrates or alpha-blockers 4
• A willingness to try oral therapy 4
• Between 60% and 65% of men with ED, including those with hypertension, diabetes mellitus, spinal cord injury, and other comorbid medical conditions, can successfully complete intercourse in response to phosphodiesterase type 5 inhibitors (PDE5i) 4

Alternative Treatment Options

Alternative treatment options, such as:

• Intracavernosal injections 4, 5
• Intraurethral prostaglandin 5
• Vacuum erection devices 5
• Penile prosthetic surgery 4, 5
• Combination therapy of phosphodiesterase type 5 inhibitors and other oral treatments such as arginine or l-carnitine 5
• Novel therapies such as low-intensity shockwave therapy and stem-cell therapy 5 may be considered in patients who:
• Have not responded to phosphodiesterase inhibitor therapy 5
• Have complex medical histories or comorbidities 4, 5
• Prefer alternative treatment options 4, 5