Randomized controlled trial of antioxidants in intermittent claudication

Area of Science:

• Cardiovascular Research
• Nutritional Science
• Clinical Trials

Background:

• Epidemiological studies suggest antioxidants may prevent atherosclerosis.
• Peripheral atherosclerosis, characterized by intermittent claudication, impacts lower limb function.
• Limited data exists on antioxidant therapy's efficacy in this patient population.

Purpose of the Study:

• To evaluate the effectiveness of antioxidant therapy in patients with lower limb atherosclerosis.
• To assess the impact of antioxidants on cardiovascular events, lower limb function, and safety markers.

Main Methods:

• A randomized, placebo-controlled trial involving 120 patients with intermittent claudication and ABPI < or = 0.9.
• Intention-to-treat analysis over a 2-year follow-up period.
• Measurements included plasma lipids, hemostatic and rheological factors, ankle-brachial pressure index (ABPI), walking distance, cardiovascular events, and adverse events.

Main Results:

• Low-density lipoprotein cholesterol was significantly lower in the antioxidant group at 6 months.
• No significant differences were observed in ABPI or walking distance between groups.
• Cardiovascular event and death rates were nonsignificantly lower in the antioxidant group.
• Serious adverse events were significantly fewer in the antioxidant group compared to placebo.

Conclusions:

• Antioxidant therapy may offer a protective effect against cardiovascular events in peripheral atherosclerosis.
• Antioxidants did not demonstrate improvement in lower limb function for patients with intermittent claudication.
• Further research is warranted to confirm the cardiovascular benefits and optimal use of antioxidants in peripheral atherosclerosis.