What is the recommended treatment for pulmonary arterial hypertension (PAH) with Tadalafil (generic name: Tadalafil)?

From the Guidelines

Tadalafil is recommended for the treatment of pulmonary arterial hypertension (PAH) at a dose of 40 mg once daily. This recommendation is based on the most recent and highest quality study available, which suggests that tadalafil improves exercise capacity, symptoms, and hemodynamics in patients with PAH 1. The medication works as a phosphodiesterase type 5 (PDE5) inhibitor, helping to relax the pulmonary blood vessels and reduce pulmonary vascular resistance.

Key Considerations for Treatment

• Treatment should begin with a dose of 40 mg once daily unless there are contraindications or concerns about tolerability, in which case a lower starting dose may be considered.
• Patients should not take nitrates (such as nitroglycerin) while on tadalafil due to the risk of severe hypotension.
• Common side effects include headache, muscle pain, flushing, and nasal congestion.
• Patients with severe renal or hepatic impairment may require dose adjustments.

Monitoring and Follow-Up

• Regular follow-up appointments are necessary to monitor treatment effectiveness, typically including assessments of:
  • Exercise capacity
  • Functional class
  • Echocardiography to evaluate right heart function
• Tadalafil should be part of a comprehensive PAH management plan that may include other medications depending on disease severity, as suggested by recent guidelines 1.

Evidence Summary

The most recent guideline update suggests the addition of tadalafil to background therapy with ambrisentan for stable or symptomatic PAH patients to improve 6-minute walk distance (6MWD) 1. Earlier studies also support the use of tadalafil at a dose of 40 mg once daily for improving exercise capacity and reducing clinical worsening in PAH patients 1. However, the 2019 update provides the most current recommendation based on the latest evidence.

From the FDA Drug Label

Tadalafil tablets are also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take both tadalafil tablets and ADCIRCA. Do not take sildenafil citrate (Revatio®) with tadalafil tablets. • have pulmonary hypertension medicines called guanylate cyclase stimulators, such as riociguat (Adempas®), used to treat pulmonary hypertension

The recommended treatment for pulmonary arterial hypertension (PAH) with Tadalafil is to take it as prescribed by the healthcare provider, and it is also marketed as ADCIRCA for this condition. Tadalafil should not be taken with other medications such as riociguat (Adempas®) or sildenafil citrate (Revatio®). 2 2

From the Research

Tadalafil for Pulmonary Arterial Hypertension (PAH)

Tadalafil is a phosphodiesterase-5 (PDE-5) inhibitor that has been approved for the treatment of PAH. The recommended treatment for PAH with Tadalafil is as follows:

• The dosage of Tadalafil for PAH is 40 mg once daily 3, 4.
• Tadalafil has been shown to improve exercise capacity and reduce clinical worsening in patients with PAH 3, 4, 5.
• The treatment is generally safe and well tolerated, with common adverse events including headache, myalgia, and flushing 3, 4.

Clinical Efficacy

The clinical efficacy of Tadalafil in PAH has been demonstrated in several studies:

• A controlled clinical study found that patients receiving Tadalafil 40 mg once daily had significant improvements in 6-minute walk distance and time to clinical worsening compared to those receiving placebo 3.
• Another study found that Tadalafil 40 mg improved exercise capacity, quality of life, and reduced clinical worsening in patients with PAH 4.
• A review of the evidence found that Tadalafil is effective and well tolerated in patients with PAH, with improvements in exercise capacity and quality of life 5.

Pediatric Patients

There is limited data on the use of Tadalafil in pediatric patients with PAH:

• A population pharmacokinetic study found that Tadalafil plasma concentrations in pediatric patients were similar to those in adults at similar doses 6.
• The study suggested that dosing of 40 mg once daily in pediatric patients with a body weight ≥ 40 kg, and a dose of 20 mg once daily in patients with a body weight < 40 kg and aged ≥ 2 years may be suitable for phase III evaluation 6.

Comparison with Other Treatments

There is limited evidence comparing Tadalafil with other treatments for PAH:

• A study found that Tadalafil had adverse effects similar to placebo, with headache being the most commonly reported 3.
• Another study found that Tadalafil was effective and well tolerated when used to treat patients with PAH, with improvements in exercise capacity and quality of life 4.
• A review of the evidence found that Tadalafil is a suitable alternative to sildenafil and may be beneficial when used in combination with other treatments for PAH 5.