التفاصيل البيبلوغرافية
| العنوان: |
Integrating the results of phase IV (postmarketing) clinical trial with four previous trials reinforces the position that Regranex (Becaplermin) Gel 0.01% is an effective adjunct to the treatment of diabetic foot ulcers. |
| المؤلفون: |
Robson MC, Payne WG, Garner WL, Biundo J, Giacalone VF, Cooper DM, Ouyang P |
| المصدر: |
Journal of Applied Research; Spring2005, Vol. 5 Issue 1, p35-45, 11p |
| مستخلص: |
Background: Platelet-derived growth factor (PDGF) has been demonstrated in pre-clinical studies to promote granulation tissue and stimulate cutaneous ulcer healing. Becaplermin gel 100 microg/g is the commercial preparation of the PDGF-BB homodimer and has been Materials and Methods:A Phase IV (Postmarketing) investigator-blinded, randomized, parallel group, multicenter trial was performed comparing once daily application of Regranex Gel 0.01% plus standardized wound therapy to standardized therapy alone. Metaanalyses were performed on the results of the Phase IV trial integrated into the pooled results of 4 previous trials using becaplermin gel evaluating incidence of complete healing, time to healing, and relative ulcer size at endpoint. Results: In the Phase IV trial, 42% of the Regranex Gel treatment group healed versus 35% for the standardized therapy alone (P = 0.316). Of the subjects who achieved complete healing, there was evidence for preferential healing of ulcers with baseline areas less than 1.46 cm2 for Regranex Gel treatment (P = 0.0286).The integrated analysis showed that becaplermin 100 µg/g was superior to vehicle gel (P = 0.015) and standardized care (P = 0.002) in achieving complete healing. In the ulcers less than or equal to 10 cm2 in area, the becaplermin gel 100 µg/g was also superior to vehicle gel (P = 0.011) and standardized care (P = 0.006). Significant differences were seen among treatment groups (P = 0.010; Cox's Proportional Hazards Analysis).The Kaplan-Meier estimate of the 35th percentile for the time to complete healing was 99 days for becaplermin gel 100 microg/g versus 141 days for the vehicle. Conclusion: The results of the pooled integrated analyses are consistent with those reported from the 4 preapproval studies showing that Regranex Gel 0.01% significantly increases the incidence of complete healing and reduces the time to complete closure of diabetic neuropathic ulcers. These results reinforce the position that Regranex Gel 0.01% is a useful adjunct for the treatment of diabetic foot ulcers. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
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