1. Therapy with GM-CSF did not lead to increases in walking time at 3 months compared to placebo.
2. Patients on GM-CSF therapy did show increases circulating progenitor cells as well as improvements in distance measures in the walking impairment questionnaires and physical function tests compared to the placebo group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Patients with peripheral artery disease have impairments in walking secondary to claudication. Increasing progenitor cells that promote neoangiogenesis is an emerging therapy for peripheral arterial disease (PAD). In animal models, stimulation with GM-CSF has been successful in promoting arteriogenesis and increased neovascularization in a hind-limb ischemia model. In this study, GM-CSF was administered to patients with symptomatic PAD to examine if it could improve treadmill walking performance compared to placebo. At 3 months, the difference in peak walking time was not significantly different in those receiving GM-CSF compared to those receiving placebo. The patients on GM-CSF therapy did however show improvements in other outcome measures, including walking impairment and physical function compared those on placebo. The study was well designed with no significant difference in baseline characteristics between the two groups. However, the study did not have the power to comment on the serious adverse event rates between the two groups and may not have had to power to account for the variability in peak treadmill walking time. Overall, this study does imply that there may be benefit to this therapy if measured by other outcome measures, providing a rationale for further investigation.
In-Depth [randomized controlled trial]: This study examined the effects of GM-CSF subcutaneous injection on peak walking time in patients with symptomatic peripheral artery disease. 159 patients were randomized with 73 in the GM-CSF treatment group and 76 in the placebo group. Peak treadmill times were recorded at three months and six months with no difference seen between the two treatment groups. Circulating progenitor cells (PCs) were examined every week for the first 4 weeks with another measure at three months and six months with an increase found in the GM-CSF group found compared to the placebo group (p < 0.001). In addition, at three months, other measurements of physical function were also improved in the GM-CSF groups. There was an increase in distance scores significant to 0.047 and an improvement in physical functioning with a change of 11.4 compared to 8.1 (p = 0.03).
By Camellia Banerjee and Brittany Hasty
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