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Limbs International Medical Buflomedil Trial

LIMB. Limbs International Medical Buflomedil Trial. Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. Alain Leizorovicz. LIMB.

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Limbs International Medical Buflomedil Trial

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  1. LIMB Limbs International Medical Buflomedil Trial Presented at American College of Cardiology Scientific Sessions 2005 Presented by Dr. Alain Leizorovicz

  2. LIMB 2,078 patients, age ≥ 40 years, with objectively confirmed peripheral arterial occlusive disease (PAOD), ankle brachial index (ABI) of 0.3-0.8, and Fontaine stage II Placebo controlled. Randomized. Blinded. Mean age 61 years. 18% female. Placebo n=1035 Buflomedil 300 mg BID or 140 BID if serum creatinine clearance < 40 ml/min n=1043 • Endpoints (median follow-up 2.75 years): • Primary: Composite of clinical deterioration of symptoms, fatal or non-fatal cardiovascular events, lower limb arterial surgery or angioplasty and amputation • Secondary: individual components of primary composite Presented at ACC Scientific Sessions 2005

  3. LIMB Primary Composite Endpoint: Clinical deterioration of symptoms, fatal or non-fatal cardiovascular events, lower limb arterial surgery or angioplasty and amputation Hazard Ratio [HR] 0.91 p=0.019 • Baseline clinical characteristics were similar between the treatment groups, with a median ABI of 0.64 and median initial claudication distance of 250 m • The primary composite endpoint occurred less frequently in the buflomedil compared with the placebo (9.1% vs 12.4%) Presented at ACC Scientific Sessions 2005

  4. LIMB Secondary Endpoints: Individual components of primary composite Symptomatic deterioration of PAOD p=0.09 Cardiovascular death p=0.21 • Secondary endpoints favored buflomedil but did not reach statistical significance Amputation of lower limb p=0.24 Presented at ACC Scientific Sessions 2005

  5. LIMB Fatal or Non-Fatal Cardiovascular Events p=0.44 • There was no difference in total death, MI, or stroke among the two treatment groups p=0.75 p=0.40 Presented at ACC Scientific Sessions 2005

  6. LIMB Median increase in ABI, from baseline to last visit Median increase in initial claudication distance, from baseline to last visit • Median initial claudication distance increased 42.9% from baseline to last visit in the buflomedil group and 0% in the placebo group • Median ABI increased 9.2% from baseline in the buflomedil group and decreased 3.6% in the placebo group Presented at ACC Scientific Sessions 2005

  7. LIMB • Among patients with peripheral arterial occlusive disease, long-term treatment with the vasoactive drug buflomedil was associated with a reduction in the primary endpoint of fatal or non-fatal cardiovascular events, lower limb arterial surgery or angioplasty and amputation compared with placebo. Presented at ACC Scientific Sessions 2005

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