What is the recommended dose of Cilostazol (Pletal) for Peripheral Arterial Occlusive Disease (PAOD)?

From the Guidelines

The standard dose of cilostazol for peripheral arterial occlusive disease (PAOD) is 100 mg taken orally twice daily, at least 30 minutes before or 2 hours after breakfast and dinner. This medication should be taken consistently to achieve optimal therapeutic effects, which typically begin within 2-4 weeks but may take up to 12 weeks for maximum benefit. Cilostazol works by inhibiting phosphodiesterase type 3, which increases cyclic adenosine monophosphate (cAMP) levels, resulting in vasodilation and inhibition of platelet aggregation. This dual action improves blood flow in the peripheral arteries and reduces claudication symptoms.

Key Considerations

• Patients should be advised that cilostazol is contraindicated in heart failure of any severity due to its potential to worsen cardiac function, as noted in the 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS guideline 1.
• Common side effects include headache, diarrhea, palpitations, and dizziness.
• The dose should be reduced to 50 mg twice daily if the patient is taking medications that inhibit CYP3A4 or CYP2C19 enzymes, such as erythromycin, diltiazem, or omeprazole, as these can increase cilostazol blood levels.

Clinical Evidence

• The recommended dose is supported by the 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS guideline, which suggests that cilostazol improves symptoms and increases walking distance in patients with lower extremity PAD and intermittent claudication 1.
• A therapeutic trial of cilostazol should be considered in all patients with lifestyle-limiting claudication, as stated in the 2006 ACC/AHA guidelines for the management of patients with peripheral arterial disease 1.
• Cilostazol has been shown to improve maximal walking distance by 40% to 60% after 12 to 24 weeks of therapy, and it also improves walking ability and health-related quality of life, as reported in the 2006 ACC/AHA guidelines 1.

From the FDA Drug Label

CLINICAL STUDIES: The ability of cilostazol to improve walking distance in patients with stable intermittent claudication was studied in eight large, randomized, placebo-controlled, double-blind trials of 12 to 24 weeks’ duration using dosages of 50 mg b.i.d. (n=303), 100 mg b.i. d. (n=998), and placebo (n=973). The recommended dose of Cilostazol (Pletal) for Peripheral Arterial Occlusive Disease (PAOD) is 100 mg b.i.d. or 50 mg b.i.d., as these dosages were used in the clinical trials to improve walking distance in patients with stable intermittent claudication 2.

• The 100 mg b.i.d. dose was the most commonly used dosage in the trials, with 998 patients receiving this dose.
• The 50 mg b.i.d. dose was also effective in improving walking distance, with 303 patients receiving this dose.

From the Research

Recommended Dose of Cilostazol for Peripheral Arterial Occlusive Disease (PAOD)

• The recommended dose of Cilostazol for PAOD is 100 mg twice daily 3, 4, 5.
• The dose can be reduced to 50 mg twice daily if patients experience adverse events that may be related to the medication 3.
• Cilostazol is indicated for the treatment of intermittent claudication and increasing walking distance in patients with peripheral arterial disease (PAD) 3, 5.
• The medication has been shown to improve walking distance and quality of life in patients with PAOD, with a continuous prolongation of walking distance up to 12 months after initiation of treatment 6.

Administration and Efficacy

• Cilostazol is administered orally, twice daily 3, 4, 5.
• The medication has been shown to improve pain-free and maximum walking distance in patients with intermittent claudication 5, 7.
• Cilostazol has also been shown to improve quality of life in patients with PAOD, although the evidence is limited 7, 6.

Side Effects and Safety

• Common side effects of Cilostazol include headache, diarrhea, and abdominal pain 3, 4, 7.
• The medication has been shown to be safe and tolerable in patients with PAOD, with no significant increase in serious bleeding events or cardiovascular events 3, 7.
• However, the evidence is limited, and further studies are needed to fully assess the safety and efficacy of Cilostazol in patients with PAOD 7.