What are the recommendations for a 57-year-old male with Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) who is currently taking Cialis (Tadalafil) 5 mg daily, which helps with BPH and nocturia, but not with ED?

From the Guidelines

For a 57-year-old male with BPH and ED who is not experiencing ED relief from daily Cialis 5 mg, I recommend increasing to Cialis 20 mg taken 1-2 hours before sexual activity, as this dose has been shown to be effective for ED treatment with a favorable safety profile 1. The patient's current dose of Cialis 5 mg may be sufficient for BPH symptoms but inadequate for ED, as the mechanisms, though related to PDE5 inhibition, may require different dosing thresholds.

• Increasing the dose to 20 mg may help improve ED symptoms while maintaining the benefits for BPH.
• Alternatively, the patient could try sildenafil (Viagra) 50-100 mg taken 30-60 minutes before sexual activity, as it has been shown to be effective for ED treatment 1.
• If these options don't provide adequate results, combination therapy with his current Cialis 5 mg plus a vacuum erection device or adding a PDE5 inhibitor with different pharmacokinetics might help.
• For more severe ED, alprostadil (available as urethral suppositories or injections) could be considered. A urological evaluation would be beneficial to rule out other contributing factors and to discuss potential surgical options if medication adjustments are unsuccessful.
• Additionally, lifestyle modifications such as smoking cessation, weight loss, and increasing physical activity may also help improve ED symptoms 1.
• It is also important to note that if the patient's total morning testosterone is <300 ng/dL, hypogonadism may be diagnosed, and testosterone therapy may relieve symptoms of ED, problems with ejaculation, or problems with orgasm 1.

From the FDA Drug Label

The efficacy and safety of tadalafil for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either tadalafil 2.5 mg, 5 mg, for once daily use or placebo. Tadalafil 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. The recommended dose of tadalafil tablets for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

The patient is already taking tadalafil 5 mg daily, which is the recommended dose for treating both ED and BPH. However, the patient is not experiencing improvement in ED.

• The patient may be considered for tadalafil 5 mg to be taken as needed for ED, with a maximum recommended dosing frequency of once per day.
• Alternatively, the patient could be considered for a different treatment for ED, such as other phosphodiesterase type 5 (PDE5) inhibitors or other treatments for ED.
• It is also important to consider the patient's overall health and any potential interactions with other medications they may be taking 2.

From the Research

Treatment Options for BPH and ED

The patient is currently taking Cialis 5 mg daily, which is helping with BPH and nocturia, but not with ED. Based on the studies, here are some potential recommendations:

• Tadalafil 5 mg once daily has been shown to be effective in treating both BPH and ED in men with both conditions 3, 4, 5.
• The patient may benefit from continuing to take tadalafil 5 mg once daily, as it has been shown to improve both IPSS and IIEF-EF Domain scores 4.
• Alternatively, the patient could consider taking a different phosphodiesterase type 5 inhibitor, such as another PDE5-I combination, but tadalafil monotherapy has been shown to have higher treatment satisfaction scores and greater reported ease of treatment planning and convenience 6.

Efficacy and Safety of Tadalafil

The studies suggest that:

• Tadalafil 5 mg once daily is a safe and effective treatment option for both LUTS/BPH and ED 3, 4, 5, 7.
• Tadalafil improves significantly the total International Prostate Symptom Score (IPSS), the voiding and storage subscores, the IPSS Quality of Life (QoL) and the BPH Impact Index (BII) 7.
• The efficacy of tadalafil is irrelevant to the erectile function status of the patients, and it can treat both ED and LUTS at the same time 7.

Considerations for Treatment

When considering treatment options, it's important to note that:

• Tadalafil monotherapy patients had higher treatment satisfaction scores and greater reported ease of treatment planning and convenience than PDE5-I combination patients 6.
• The safety profile of tadalafil is well established, and no new or unexpected adverse events other than those reported in ED studies have been recorded 7.