A dose-effect study of beraprost sodium in intermittent claudication

Area of Science:

• Vascular Medicine
• Pharmacology
• Clinical Trials

Background:

• Intermittent claudication (Fontaine's stage II) significantly impacts quality of life.
• Epoprostenol analogues, like beraprost sodium, offer potential therapeutic benefits due to vasodilating and antiplatelet properties.

Purpose of the Study:

• To evaluate the efficacy and safety of three oral doses of beraprost sodium compared to placebo.
• To determine the optimal dosage of beraprost sodium for treating intermittent claudication.

Main Methods:

• A double-blind, randomized trial involving 164 patients with intermittent claudication.
• Patients received placebo, 20, 40, or 60 micrograms of beraprost sodium orally three times daily for 12 weeks.
• Treadmill exercise tests were used to measure pain-free walking distance at baseline, week 10, and week 12.

Main Results:

• All beraprost sodium groups showed increased pain-free walking distance by week 10 and 12.
• The greatest improvements in pain-free walking distance were observed in the 60 (BPS60) and 120 (BPS120) microgram daily dose groups (p=0.055 at week 10, p=0.023 at week 12).
• Gastrointestinal disorders, headaches, skin disorders, and flushes were the most common adverse events.

Conclusions:

• Oral beraprost sodium at daily doses of 60 and 120 micrograms is effective in increasing short-term pain-free walking distance in patients with intermittent claudication.
• The highest dose tested (180 micrograms daily) showed lower efficacy, suggesting a need for further dose-ranging studies.
• Beraprost sodium is a promising therapeutic option for intermittent claudication, offering both vasodilating and antiplatelet effects.