Can cilostazol be given to patients with heart failure?

Cilostazol is Contraindicated in Patients with Heart Failure of Any Severity

Cilostazol should not be administered to patients with heart failure of any severity due to increased mortality risk associated with phosphodiesterase III inhibitors in this population. 1, 2

Mechanism and Contraindication Rationale

• Cilostazol is a phosphodiesterase type III inhibitor that increases cyclic adenosine monophosphate, providing vasodilator and antiplatelet effects 1
• Other phosphodiesterase inhibitors (such as milrinone and vesnarinone) have demonstrated increased mortality in patients with heart failure with reduced ejection fraction 1
• The FDA has mandated a black box warning that cilostazol should not be used in patients with heart failure of any severity due to concerns about a potential class effect 1, 2
• The contraindication applies to heart failure of any severity, including both reduced and preserved ejection fraction 2

Evidence Supporting Contraindication

• The 2024 ACC/AHA guideline for peripheral artery disease explicitly states that cilostazol should not be administered in patients with PAD and congestive heart failure of any severity 1
• The FDA drug label clearly states: "Cilostazol tablets are contraindicated in patients with congestive heart failure of any severity" 2
• This contraindication is based on the observation that drugs with similar pharmacologic effects have caused decreased survival compared to placebo in patients with class III-IV congestive heart failure 2

Clinical Considerations

• When evaluating patients for cilostazol therapy, clinicians must:
  • Screen for any history or symptoms of heart failure before prescribing 3
  • Consider alternative therapies for patients with both PAD and heart failure 1
• For patients with peripheral artery disease and heart failure who need treatment for claudication:
  • Supervised exercise therapy remains the first-line non-pharmacological treatment 3
  • Consider alternative pharmacological approaches that don't carry heart failure risks 1

Safety Concerns

• A pharmacovigilance study using the FDA Adverse Event Reporting System found that cardiac disorders ranked highest among adverse events associated with cilostazol, with cardiac failure being the most frequently reported adverse event 4
• Despite the black box warning, some clinicians have prescribed cilostazol to patients with heart failure 5, which is contrary to current guidelines and FDA recommendations 1, 2
• Serious cardiac adverse events, including ventricular tachycardia, have been reported with cilostazol use even in patients without pre-existing heart failure 6

Conclusion

The evidence is clear and consistent across multiple guidelines and the FDA drug label that cilostazol is contraindicated in patients with heart failure of any severity. The potential risk of increased mortality outweighs any potential benefit for claudication symptoms in this population.