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Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia

(2008) MOLECULAR THERAPY. 16(5). p.972-978
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Abstract
This study evaluated the efficacy and safety of intramuscular administration of NV1FGF, a plasmid-based angiogenic gene delivery system for local expression of fibroblast growth factor 1 (FGF-1), versus placebo, in patients with critical limb ischemia (CLI). In a double-blind, randomized, placebo-controlled, European, multinational study, 125 patients in whom revascularization was not considered to be a suitable option, presenting with nonhealing ulcer(s), were randomized to receive eight intramuscular injections of placebo or 2.5 ml of NV1FGF at 0.2 mg/ml on days 1, 15, 30, and 45 (total 16 mg: 4 x 4 mg). The primary end point was occurrence of complete healing of at least one ulcer in the treated limb at week 25. Secondary end points included ankle brachial index (ABI), amputation, and death. There were 107 patients eligible for evaluation. Improvements in ulcer healing were similar for use of NV1FGF (19.6%) and placebo (14.3%; P = 0.514). However, the use of NV1FGF significantly reduced (by twofold) the risk of all amputations [hazard ratio (HR) 0.498; P = 0.015] and major amputations (HR 0.371; P = 0.015). Furthermore, there was a trend for reduced risk of death with the use of NV1FGF (HR 0.460; P = 0.105). The adverse event incidence was high, and similar between the groups. In patients with CLI, plasmid-based NV1FGF gene transfer was well tolerated, and resulted in a significantly reduced risk of major amputation when compared with placebo.
Keywords
PREDICTORS, PHVEGF(165), INTERMITTENT CLAUDICATION, AUTOLOGOUS TRANSPLANTATION, PHASE-I TRIAL, CRITICAL LEG ISCHEMIA, GENE-TRANSFER PROMOTES, COLLATERAL VESSELS, FIBROBLAST-GROWTH-FACTOR, PERIPHERAL ARTERIAL-DISEASE

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MLA
Nikol, Sigrid, et al. “Therapeutic Angiogenesis with Intramuscular NV1FGF Improves Amputation-Free Survival in Patients with Critical Limb Ischemia.” MOLECULAR THERAPY, vol. 16, no. 5, 2008, pp. 972–78, doi:10.1038/mt.2008.33.
APA
Nikol, S., Baumgartner, I., Van Belle, E., Diehm, C., Visona, A., Capogrossi, M. C., … Meyer, F. (2008). Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia. MOLECULAR THERAPY, 16(5), 972–978. https://doi.org/10.1038/mt.2008.33
Chicago author-date
Nikol, Sigrid, Iris Baumgartner, Eric Van Belle, Curt Diehm, Adriana Visona, Maurizio C. Capogrossi, Nicole Ferreira-Maldent, et al. 2008. “Therapeutic Angiogenesis with Intramuscular NV1FGF Improves Amputation-Free Survival in Patients with Critical Limb Ischemia.” MOLECULAR THERAPY 16 (5): 972–78. https://doi.org/10.1038/mt.2008.33.
Chicago author-date (all authors)
Nikol, Sigrid, Iris Baumgartner, Eric Van Belle, Curt Diehm, Adriana Visona, Maurizio C. Capogrossi, Nicole Ferreira-Maldent, Augusto Gallino, Michael Graham Wyatt, Lasantha Dinesh Wijesinghe, Melissa Fusari, Dominique Stephan, Joseph Emmerich, Giulio Pompilio, Frank Vermassen, Emmanuel Pham, Vincent Grek, Michael Coleman, and Francois Meyer. 2008. “Therapeutic Angiogenesis with Intramuscular NV1FGF Improves Amputation-Free Survival in Patients with Critical Limb Ischemia.” MOLECULAR THERAPY 16 (5): 972–978. doi:10.1038/mt.2008.33.
Vancouver
1.
Nikol S, Baumgartner I, Van Belle E, Diehm C, Visona A, Capogrossi MC, et al. Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia. MOLECULAR THERAPY. 2008;16(5):972–8.
IEEE
[1]
S. Nikol et al., “Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia,” MOLECULAR THERAPY, vol. 16, no. 5, pp. 972–978, 2008.
@article{745571,
  abstract     = {{This study evaluated the efficacy and safety of intramuscular administration of NV1FGF, a plasmid-based angiogenic gene delivery system for local expression of fibroblast growth factor 1 (FGF-1), versus placebo, in patients with critical limb ischemia (CLI). In a double-blind, randomized, placebo-controlled, European, multinational study, 125 patients in whom revascularization was not considered to be a suitable option, presenting with nonhealing ulcer(s), were randomized to receive eight intramuscular injections of placebo or 2.5 ml of NV1FGF at 0.2 mg/ml on days 1, 15, 30, and 45 (total 16 mg: 4 x 4 mg). The primary end point was occurrence of complete healing of at least one ulcer in the treated limb at week 25. Secondary end points included ankle brachial index (ABI), amputation, and death. There were 107 patients eligible for evaluation. Improvements in ulcer healing were similar for use of NV1FGF (19.6%) and placebo (14.3%; P = 0.514). However, the use of NV1FGF significantly reduced (by twofold) the risk of all amputations [hazard ratio (HR) 0.498; P = 0.015] and major amputations (HR 0.371; P = 0.015). Furthermore, there was a trend for reduced risk of death with the use of NV1FGF (HR 0.460; P = 0.105). The adverse event incidence was high, and similar between the groups. In patients with CLI, plasmid-based NV1FGF gene transfer was well tolerated, and resulted in a significantly reduced risk of major amputation when compared with placebo.}},
  author       = {{Nikol, Sigrid and Baumgartner, Iris and Van Belle, Eric and Diehm, Curt and Visona, Adriana and Capogrossi, Maurizio C. and Ferreira-Maldent, Nicole and Gallino, Augusto and Wyatt, Michael Graham and Wijesinghe, Lasantha Dinesh and Fusari, Melissa and Stephan, Dominique and Emmerich, Joseph and Pompilio, Giulio and Vermassen, Frank and Pham, Emmanuel and Grek, Vincent and Coleman, Michael and Meyer, Francois}},
  issn         = {{1525-0016}},
  journal      = {{MOLECULAR THERAPY}},
  keywords     = {{PREDICTORS,PHVEGF(165),INTERMITTENT CLAUDICATION,AUTOLOGOUS TRANSPLANTATION,PHASE-I TRIAL,CRITICAL LEG ISCHEMIA,GENE-TRANSFER PROMOTES,COLLATERAL VESSELS,FIBROBLAST-GROWTH-FACTOR,PERIPHERAL ARTERIAL-DISEASE}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{972--978}},
  title        = {{Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia}},
  url          = {{http://doi.org/10.1038/mt.2008.33}},
  volume       = {{16}},
  year         = {{2008}},
}

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