Fibroblast Growth Factor Improves Severe Claudication

June 14, 2002 —

Recombinant fibroblast growth factor-2 (rFGF-2) may enhance angiogenesis and improve severe claudication in patients at high risk for amputation or in whom bypass is not feasible, according to results of the TRAFFIC study reported in the June 15 issue of The Lancet. “Angiogenesis is an extremely exciting area with a great deal of potential.

 This study provides the strongest and most convincing data to date that an angiogenic agent can have a positive effect in humans,” senior author Brian Annex, MD, from Duke University Medical Center in Durham, N.C., said in a news release. “It is also one that has been in need of positive randomized, placebo-controlled data to accelerate further research. This study is an important step in that direction, [because it is] the first to show a positive result in its primary endpoint.”

The Therapeutic Angiogenesis with FGF for Intermittent Claudication (TRAFFIC) study was a multicenter, phase II, double-blinded, controlled trial enrolling 190 patients with intermittent claudication of the calf muscle caused by atherosclerosis.

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