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WEDNESDAY, June 1 (HealthDay News) -- Treatment with non-viral 1 fibroblast growth factor (NV1FGF) does not reduce the risk of amputation or death in patients with critical limb ischemia, according to a study published online May 31 in The Lancet.
Jill Belch, M.D., from the Ninewells Hospital and Medical School in Dundee, U.K., and colleagues on behalf of the TAMARIS Committees and Investigators, evaluated whether NV1FGF would improve amputation-free survival in 525 patients with critical limb ischemia unsuitable for revascularization. The participants (average age 70 years) had either ischemic leg ulcers or minor skin gangrene, and met the hemodynamic criteria of less than 70 mm Hg ankle pressure, 50 mm Hg toe pressure, or both; or had transcutaneous oxygen pressure less than 30 mm Hg on the treated leg. They were randomly assigned to receive eight intramuscular injections of either 0.2 mg/mL of NV1FGF (259 participants) or visually identical placebo (266 participants) in the index leg on days one, 15, 29, and 43. Time to major amputation or death at one year analyzed by intention to treat was the primary end point.
The investigators found that there was no difference in the primary end point or components of the primary end point in the treatment groups. There were 86 major amputations or deaths (33 percent) in the placebo group and 96 (36 percent) in the active group. There were no significant safety issues.
"TAMARIS provided no evidence that NV1FGF is effective in reduction of amputation or death in patients with critical limb ischemia," the authors write.
All of the study authors disclosed financial relationships with Sanofi-Aventis, which funded the study. All the authors are members of the steering committee of the TAMARIS trial.
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