מתוך medicontext.co.il
NEW YORK (Reuters Health) – Results of a new randomized trial indicate that recombinant fibroblast growth factor-2 (rFGF2) does not improve exercise tolerance or myocardial perfusion in patients with CAD, as had been previously found in a phase I trial.
Writing in the February 19th issue of Circulation: Journal of the American Heart Association, Dr. Michael Simons, from Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, and colleagues report the results of the FGF Initiating RevaScularization Trial (FIRST).
Three hundred thirty-seven CAD patients were randomly selected to receive a single intracoronary bolus of rFGF2 or placebo. Patients received rFGF2 doses of 0.3 µg/kg, 3 µg/kg or 30 µg/kg. At 90 and 180 days, the researcher assessed the efficacy of rFGF2 using exercise tolerance and myocardial nuclear perfusion imaging. Patients also were evaluated using the Seattle Angina Questionnaire and the Short Form 36 (SF-36) questionnaire.
At 90 days, exercise tolerance increased in both the rFGF2 and placebo groups, with no significant difference between patients receiving rFGF2 or placebo, the FIRST group reports.
Compared with patients receiving placebo, angina symptoms in patients receiving rFGF2 were reduced, as measured by the angina frequency score of the Seattle Angina Questionnaire and by the physical component summary scale of the SF-36. These differences were seen to a greater extent among the most symptomatic patients.
However, at 180 days none of these differences were significant, "because of continued improvement in the placebo group," Dr. Simons' team notes. While adverse effects were similar in all patient groups, patients who received 30 µg/kg of rFGF2 had an increased frequency of hypotension.
Nuclear perfusion scans at 90 and 180 days showed no significant changes in rest or stress perfusion among patients receiving any dose of rFGF2 or placebo, the researchers add.
Dr. Simons and colleagues conclude that a "single intracoronary rFGF2 infusion seems to result in short-term symptomatic improvement that is most pronounced in the more symptomatic patient subgroups; however, this did not translate into improved exercise tolerance."
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