Table 1.
Summary of clinical trials of basic fibroblast growth factor*
| Reference | N | Study design | Control group | Formulation | Route | Dose | Primary end point | Secondary end point | Toxicity | Results |
|---|---|---|---|---|---|---|---|---|---|---|
| Trials of peripheral artery disease | ||||||||||
| Lazarous et al. (2000) | 19 | Phase I | Yes | FGF-2 protein | Intra-arterial | 0/10/30 μg kg−1 | Calf blood flow | Calf blood flow | None | ↑Blood flow |
| Lederman et al. (2002) | 190 | RCT, Phase II | Yes | FGF-2 protein | Intra-arterial | 0/30 μg kg−1 | WIQ, SF-36, ETT | ABI | Brief; ↓BP proteinuria | ↑PWT at 90 days; ↑ABI |
| Trials of coronary artery disease | ||||||||||
| Unger et al. (2000) | 25 | Phase I | Yes | FGF-2 protein | Intracoronary | 0/3/10/30/ 100 μg kg−1 | ETT, ECG | ↓BP; ↓HR proteinuria; ↓platelets | Null | |
| Laham et al. (2000)/Udelson et al. (2000) | 52/59 | Open-label, Phase I | No | FGF-2 protein | Intracoronary and intravenous | 0.33–48 μg kg−1 | SAQ | SPECT, MRI, ETT | ↓BP if >36 μg kg−1 | ↓Stress-induced ischemia and resting perfusion; ↑ETT time; ↑perfusion/function; ↓angina |
| Simons et al. (2002) | 337 | RCT, Phase I, II | Yes | FGF-2 protein | Intracoronary | 0/0.3/3/30 μg kg−1 | CCS, SAQ, ETT, SF-36 | SPECT | ↓BP (30 μg kg−1) | Null post hoc analysis; ↓angina |
| Laham et al. (1999b)/(Ruel et al. (2002) | 24 | RCT, Phase I, II | Yes | FGF-2, sustained- release heparin- alginate capsules | Intramuscular, surgical | 0/10/100 μg kg−1 | Death, MI, angina, revasc. | SPECT, MRI | None | ↑Perfusion; ↓angina |
*
Studies are presented in hierarchal order according to the reliability of results based on the robustness of study design. FGF-2 = recombinant fibroblast growth factor 2; ETT = exercise treadmill test; ABI = ankle-brachial index; WIQ = walking impairment questionnaire; SF-36 = short form 36; BP = blood pressure; PWT = peak walking time; CCS = Canadian Cardiovascular Society (angina class); SAQ = Seattle Angina Questionnaire; SPECT = single-photon emission computed tomography; MRI = magnetic resonance imaging; revasc = revascularization; MI = myocardial infarction.