Is a 5mg dose of tadalafil (Cialis) sufficient for a 60-year-old man?

From the Guidelines

Tadalafil 5mg daily is the recommended starting dose for a 60-year-old man with erectile dysfunction, as it provides a good balance of efficacy and minimal side effects, according to the most recent and highest quality study 1.

Key Considerations

• The 5mg daily dosing regimen allows for spontaneous sexual activity without needing to time medication intake before intercourse.
• Individual factors such as kidney function, liver health, other medications (particularly nitrates which are absolutely contraindicated), and overall cardiovascular status should be considered.
• Common side effects may include headache, indigestion, back pain, muscle aches, flushing, and nasal congestion.

Dosing and Administration

• If the 5mg dose is insufficient after several attempts, discussing with a healthcare provider about increasing to 10mg or 20mg as needed dosing might be appropriate.
• The clinician should work with the man and his partner to find the dose that meets treatment expectations without resulting in unacceptable levels of adverse effects, as suggested by the American Urological Association guideline 1.

Important Precautions

• Men with mild to moderate hepatic or renal impairment or men with spinal cord injury should use PDE5i with caution at least initially at lower doses given the potential for delayed metabolism.
• In men with severe renal or liver disease, use of PDE5i is generally not recommended, as stated in the guideline 1.

Evidence-Based Recommendation

• The improvement in erectile function was related to higher dose for sildenafil and vardenafil but not tadalafil, as indicated in the study 1.
• High-quality evidence indicated that all 5 agents (sildenafil, vardenafil, tadalafil, mirodenafil, and udenafil) improved erections compared with placebo, as reported in the study 1.

From the FDA Drug Label

The efficacy and safety of tadalafil for once daily use in the treatment of erectile dysfunction has been evaluated in 2 clinical trials of 12-weeks duration and 1 clinical trial of 24-weeks duration, involving a total of 853 patients Tadalafil, when taken once daily, was shown to be effective in improving erectile function in men with erectile dysfunction (ED). Results in General ED Population — The primary US efficacy and safety trial included a total of 287 patients, with a mean age of 59 years (range 25 to 82 years) In each of these trials, conducted without regard to the timing of dose and sexual intercourse, 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

Tadalafil 5mg is enough for a 60-year-old man.

• The primary efficacy and safety trial included patients with a mean age of 59 years, which is close to the age of the man in question.
• Tadalafil 5mg was shown to be effective in improving erectile function in men with erectile dysfunction (ED) in the clinical trials.
• The drug label does not provide information that would suggest a dose of 5mg is insufficient for a 60-year-old man 2.

From the Research

Tadalafil Tablets 5mg for a 60-Year-Old Man

• The efficacy and safety of tadalafil, a phosphodiesterase-5 (PDE5) inhibitor, have been established in various studies 3, 4, 5, 6, 7.
• Tadalafil is effective in improving erectile function in men with erectile dysfunction, including those with underlying medical conditions such as diabetes, cardiovascular disease, and prostate cancer 3, 6.
• The recommended dose of tadalafil is 5mg, which is sufficient for a 60-year-old man, as it allows for the relaxation of penile smooth muscle and improves erectile function 3.
• Tadalafil has a longer duration of action compared to other PDE5 inhibitors, with a duration of action of approximately 36 hours 3, 5.
• Common side effects of tadalafil include headache, facial flushing, nasal congestion, and dyspepsia, but these are generally mild and transient 3, 7.
• Tadalafil can interact with other medications, such as nitrates, alpha-blockers, and certain antihypertensive agents, which can lead to hypotension or other adverse effects 4, 5, 6.
• However, studies have shown that tadalafil is safe and effective in most patient populations, including men with ischemic cardiovascular disease or those receiving anti-hypertensive agents 6.