The association of tadalafil exposure with lower rates of major adverse cardiovascular events and mortality in a general population of men with erectile dysfunction

Abstract

Background

Tadalafil is a long‐acting phosphodiesterase‐5 inhibitor (PDE‐5i) indicated for erectile dysfunction (ED).

Hypothesis

Our hypothesis was that tadalafil will reduce the risk of major adverse cardiovascular events (MACE: composite of cardiovascular death, myocardial infarction, coronary revascularization, unstable angina, heart failure, stroke) and all‐cause death in men with ED.

Methods

A retrospective observational cohort study was conducted in a large US commercial insurance claims database in men with a diagnosis of ED without prior MACE within 1 year. The exposed group ( n = 8156) had ≥1 claim for tadalafil; the unexposed group ( n = 21 012) had no claims for any PDE‐5i.

Results

Primary outcome was MACE; secondary outcome was all‐cause death. Groups were matched for cardiovascular risk factors, including preventive therapy. Over a mean follow‐up of 37 months for the exposed group and 29 months for the unexposed group, adjusted rates of MACE were 19% lower in men exposed to tadalafil versus those unexposed to any PDE‐5i (hazard ratio [HR] = 0.81; 95% confidence intervals [CI] = 0.70−0.94; p = .007). Tadalafil exposure was associated with lower adjusted rates of coronary revascularization (HR = 0.69; 95% CI = 0.52−0.90; p = .006); unstable angina (HR = 0.55; 95% CI = 0.37−0.81; p = .003); and cardiovascular‐related mortality (HR = 0.45; CI = 0.22−0.93; p = .032). Overall mortality rate was 44% lower in men exposed to tadalafil (HR = 0.56; CI = 0.43−0.74; p < .001). Men in the highest quartile of tadalafil exposure had the lowest rates of MACE (HR: 0.40; 95% CI: 0.28−0.58; p < .001) compared to lowest exposure quartile.

Conclusion

In men with ED, exposure to tadalafil was associated with significant and clinically meaningful lower rates of MACE and overall mortality.

Abstract

Forest plot demonstrating that men with erectile dysfunction (ED) who were exposed to tadalafil ( N = 8156), had significantly lower adjusted rates of major adverse cardiovascular events (hazard ratio [HR]: 0.81), coronary revascularization (HR: 0.69), unstable angina (HR: 0.55), cardiovascular related deaths (HR: 0.45), and all cause death (HR: 0.56), compared to closely matched men with ED not exposed to tadalafil or other PDE‐5 inhibitors ( N = 21 012). Py, patient‐years.