Why the study?
Clinical researchers have begun investigating whether tadalafil's cardiovascular benefits extend to other cardiovascular diseases, especially heart failure, where clinical trial evidence remains limited.
Does tadalafil improve cardiovascular outcomes in patients with heart failure or other cardiovascular diseases?
Does tadalafil improve cardiovascular outcomes in patients with heart failure or other cardiovascular diseases?
Current evidence for tadalafil in heart failure is mixed, with promising preclinical and observational data but a lack of benefit in a recent HFpEF/PAH trial, highlighting the need for further clinical trials.
Tadalafil should not yet inform HFpEF/PAH practice; leaves open dedicated RCTs to test observational signals in broader populations.
Tadalafil is a phosphodiesterase inhibitor currently approved for use in erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (PAH). While tadalafil's benefits in ED and BPH have been well-established for years, its benefits in PAH were identified only recently in major clinical trials, resulting in the recent approval of a single-tablet, combination therapy of tadalafil with an endothelin receptor antagonist for PAH. With Tadalafil's cardiovascular benefits in ED, BPH, and PAH, clinical researchers have begun investigating whether tadalafil's use extends to other cardiovascular diseases, especially heart failure (HF), an emerging epidemic in medicine. Recent research in animal models has demonstrated a potential benefit of tadalafil use in ischemic cardiomyopathy and HF, as numerous studies in mice and sheep demonstrated improved left ventricular function and contractility, with reduced adverse remodeling and hypertrophy. A retrospective cohort study identified that tadalafil use in patients with ED and coronary artery disease was associated with a significant decrease in the incidence of HF, acute myocardial infarction, and mortality compared with sildenafil or no treatment. However, a randomized controlled trial in patients with comorbid PAH and HF with preserved ejection fraction demonstrated no significant benefit with the use of tadalafil. Unfortunately, there is limited evidence from clinical trials investigating the impact of tadalafil in patients with HF with reduced or preserved ejection fraction without comorbid PAH. Further studies are needed on this topic to better identify whether tadalafil has a role in the prevention or treatment of HF.
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Kallash et al. (2025) studied this question.
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