From the Guidelines
The recommended dosing for cilostazol (Pletal) in the treatment of intermittent claudication is 100 mg taken orally twice daily. This dosing schedule is important because food, particularly high-fat meals, increases cilostazol absorption and can lead to higher blood levels of the medication. For patients who are taking strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, erythromycin) or CYP2C19 inhibitors (such as omeprazole), the dose should be reduced to 50 mg twice daily due to potential drug interactions that can increase cilostazol levels 1.
Key Considerations
- Patients should be advised that clinical improvement may take 2-12 weeks to become apparent, so adherence to the medication regimen is important even if benefits aren't immediately noticeable.
- Cilostazol works by inhibiting phosphodiesterase type 3, which leads to vasodilation and inhibition of platelet aggregation, thereby improving blood flow to the legs and reducing claudication symptoms.
- The medication is contraindicated in patients with heart failure of any severity due to its potential to decrease survival in this population 1.
- Recent data have suggested potential benefit of cilostazol in prevention of in-stent restenosis in patients who have undergone stenting of the femoropopliteal segment 1.
Important Side Effects and Interactions
- Adverse effects include headache, diarrhea, dizziness, and palpitations 1.
- It may be valuable to assess patient tolerance of cilostazol at 2 to 4 weeks and to evaluate benefit within 3 to 6 months to determine whether long-term therapy will be beneficial 1.
From the FDA Drug Label
CLINICAL STUDIES: ... using dosages of 50 mg b.i.d. (n=303), 100 mg b.i. d. (n=998), and placebo (n=973). The recommended dosing for cilostazol (Pletal) in the treatment of intermittent claudication is 100 mg b.i.d. or 50 mg b.i.d. 2.
- The 100 mg b.i.d. dose has been shown to improve walking distances in patients with stable intermittent claudication.
- The 50 mg b.i.d. dose has also been studied and shown to be effective in improving walking distances.
From the Research
Cilostazol Dosing for Intermittent Claudication
- The recommended dose of cilostazol for the treatment of intermittent claudication is 100 mg twice daily, taken 30 minutes before or 2 hours after breakfast and dinner 3.
- This dosing regimen has been shown to be effective in improving walking distances and quality of life in patients with intermittent claudication, with significant improvements in pain-free and maximal walking distances compared to placebo 4, 5.
- Cilostazol has also been compared to pentoxifylline, with studies showing that cilostazol 100 mg twice daily is more effective than pentoxifylline 400 mg three times daily in improving walking distances and quality of life 6, 5.
- The efficacy and safety of cilostazol have been evaluated in several clinical trials, with results showing that it is generally well tolerated, with common adverse events including headache, diarrhea, abnormal stools, and dizziness 6, 4, 5.
- A systematic review of 15 double-blind, randomized controlled trials found that cilostazol improved initial and absolute claudication distances, with a significant increase in walking distance compared to placebo 7.