Tadalafil for Stroke Prevention
Tadalafil is not indicated for stroke prevention in labeled indications or major stroke-prevention guidance. [1], [2]
Approved Indications for Tadalafil
Tadalafil is FDA-labeled for erectile dysfunction and benign prostatic hyperplasia (and the combination of both). [1] Tadalafil is also marketed under a different brand for pulmonary arterial hypertension (not for stroke prevention). [1]
Stroke-Prevention Recommendations
Major stroke-prevention guidelines recommend risk-factor and disease-specific therapies such as antiplatelet therapy, lipid lowering, and blood-pressure management. [2] Tadalafil is not among the recommended pharmacologic classes for routine stroke secondary prevention. [2]
Evidence Base for Cerebrovascular Outcomes
A randomized clinical trial (ETLAS-2) has evaluated tadalafil in cerebral small-vessel disease populations, indicating that the evidence base remains investigational rather than guideline-directed stroke prevention. [3] A recent systematic review and meta-analysis of PDE5 inhibitors for cerebral small vessel disease-related ischemic stroke and cognitive decline reported worse overall symptom outcomes with PDE5 inhibitors (primarily sildenafil and tadalafil) versus placebo. [4]
Clinical Implication
Tadalafil should not be used for stroke prevention unless a separate, standard indication exists (for example, erectile dysfunction, benign prostatic hyperplasia, or pulmonary arterial hypertension). [1] Stroke prevention should be managed with guideline-recommended antithrombotic and vascular risk therapies. [2]