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At least 19 recordsLinked to original sources

PubMed1998

Clinical safety of becaplermin (rhPDGF-BB) gel. Becaplermin Studies Group.

This overview of the safety of becaplermin gel is based on six well-controlled clinical studies that included patients with lower extremity diabetic neuropathic ulcers. Patients receiving becaplermin gel (n = 538), placebo gel (n = 278), or good ulcer care alone (n = 190) had a similar incidence of ulcer-related adverse events, such as infection, cellulitis, or osteomyelitis. Erythematous rash occurred in 2% of patients with suspected wound infections treated with becaplermin gel and 1% of patients treated with placebo gel. No rashes were observed in patients treated with good ulcer care alone. The incidence of cardiovascular, respiratory, musculoskeletal, and central and peripheral nervous system disorders were similar across all treatment groups. Mortality rates were also similar across all treatment groups. Patients treated with becaplermin gel did not develop neutralizing antibodies against becaplermin. Therefore, becaplermin gel appears to be a safe therapy for the treatment of lower extremity diabetic ulcers.

Absorption↗

PubMed1998

Effects of chronic wound fluid on the structure and biological activity of becaplermin (rhPDGF-BB) and becaplermin gel.

In this study, the effects of chronic wound fluid on the structure and biological activity of becaplermin (recombinant human platelet-derived growth factor-BB [rhPDGF-BB]) were evaluated. Wound fluid was collected from 12 subjects with diabetic ulcers or pressure ulcers. Wound fluid +/- becaplermin was added to cell cultures before- and after incubation for 12 hours at 37 degrees C or after 12 hours' topical treatment. Biological activity, concentration, and immunogenicity were determined by [3H]thymidine incorporation into quiescent human foreskin fibroblasts, enzyme-linked immunosorbent assay (ELISA), and Western blot analysis, respectively. No PDGF-BB or mitogenic activity was detected in chronic wound fluid alone. Mitogenic activity was present in post-treatment samples from becaplermin-treated subjects but not placebo-treated subjects. Exposure to chronic wound fluid for 12 hours did not alter the amount, banding pattern, or mitogenic activity of becaplermin. Biologically active becaplermin remains in wound fluid 12 hours after topical application of becaplermin gel.

Adult↗

PubMed1998

Clinical efficacy of becaplermin (rhPDGF-BB) gel. Becaplermin Gel Studies Group.

The results of four multicenter, randomized, placebo-controlled, parallel group studies of the efficacy of becaplermin gel are reviewed here. The four studies included a total of 922 patients, all of whom received a standardized regimen of good ulcer care. Patients were randomized to receive placebo gel, 30 or 100 microg/g becaplermin gel, or good ulcer care alone. In Studies 1 and 2, the incidence of complete healing was significantly higher in patients receiving becaplermin gel (30 microg/g, Study 1; 100 microg/g, Study 2) compared with that in patients receiving placebo gel. In Study 3, which was not powered for statistical analysis, the incidence of complete healing in patients treated with 100 microg/g becaplermin gel was approximately twice that of patients treated with good ulcer care alone. In Study 4, there was no significant difference in the incidence of complete healing in patients treated with becaplermin gel versus good ulcer care alone.

Administration, Topical↗

PubMedDate not supplied

Becaplermin gel in the treatment of pressure ulcers: a phase II randomized, double-blind, placebo-controlled study.

Pressure ulcers are associated with significant rates of morbidity and mortality, particularly in the geriatric and spinal cord-injured populations. Newer pharmacologically active therapies include the use of topically applied recombinant human platelet-derived growth factor-BB (becaplermin), the active ingredient in REGRANEX) (becaplermin) Gel 0.01%, which has been approved in the United States for treatment of lower extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue or beyond and have an adequate blood supply. In this study, the efficacy of becaplermin gel in the treatment of chronic full thickness pressure ulcers was compared with that of placebo gel. A total of 124 adults (>/= 18 years of age) with pressure ulcers were assigned randomly to receive topical treatment with becaplermin gel 100 microg/g (n = 31) or 300 microg/g (n = 32) once daily alternated with placebo gel every 12 hours, becaplermin gel 100 microg/g twice daily (n = 30), or placebo (sodium carboxymethylcellulose) gel (n = 31) twice daily until complete healing was achieved or for 16 weeks. All treatment groups received a standardized regimen of good wound care throughout the study period. Study endpoints were the incidence of complete healing, the incidence of >/= 90% healing, and the relative ulcer volume at endpoint (endpoint/baseline). Once-daily treatment of chronic pressure ulcers with becaplermin gel 100 microg/g or 300 microg/g significantly increased the incidences of complete and >/= 90% healing and significantly reduced the median relative ulcer volume at endpoint compared with that of placebo gel (p < 0.025 for all comparisons). Becaplermin gel 300 microg/g did not result in a significantly greater incidence of healing than that observed with 100 microg/g. Treatment with becaplermin gel was generally well tolerated and the incidence of adverse events was similar among treatment groups. In conclusion, once-daily application of becaplermin gel is efficacious in the treatment of chronic full thickness pressure ulcers.

Administration, Cutaneous↗

PubMedDate not supplied

Efficacy and safety of becaplermin (recombinant human platelet-derived growth factor-BB) in patients with nonhealing, lower extremity diabetic ulcers: a combined analysis of four randomized studies.

The results of a combined analysis and separate analyses of four multicenter, randomized, parallel group studies that evaluated the effects of once-daily topical administration of becaplermin gel for the treatment of chronic, full thickness, lower extremity diabetic ulcers are presented. The four studies included a total of 922 patients with nonhealing lower extremity diabetic ulcers of at least 8 weeks' duration. Following initial complete sharp debridement of the ulcer, patients were randomized to receive a standardized regimen of good ulcer care alone, good ulcer care plus placebo gel, or good ulcer care plus becaplermin gel-30 microg/g, or good ulcer care plus becaplermin gel-100 microg/g, with various combinations of regimens used in the four studies. Safety was assessed by monitoring adverse events and by clinical laboratory evaluations. Meta-analytic statistical techniques were used in the combined analysis to establish homogeneity of treatment comparisons across studies. Based on an analysis of patients with baseline ulcer area common to all trials (</= 10 cm2), representing 95% of all patients, becaplermin gel-100 microg/g significantly increased (p = 0.007) the probability of complete healing compared with placebo gel. It was determined that for the median ulcer area of these patients, which was 1.5 cm2, the becaplermin gel-100 microg/g treatment group showed a 39% increase in complete healing compared with that of the placebo gel treatment group (50% vs. 36%, respectively, p = 0.007). Becaplermin gel-100 microg/g significantly decreased (p = 0.01) the time to complete healing compared with placebo gel, with the 35th percentile of time to complete healing being reduced by 30% (14.1 weeks vs. 20. 1 weeks, respectively). In patients with ulcers </= 5 cm2 at baseline (a more homogeneous group), becaplermin gel-100 microg/g also significantly increased the incidence of complete healing with a similar decrease in the time to healing. Adverse events reported during treatment or during a 3-month follow-up period were not unexpected for this patient population and were similar in nature and incidence across all treatment groups. We therefore conclude that treatment with becaplermin gel at a dose of 100 microg/g once daily, in conjunction with good ulcer care, is effective and well tolerated in patients with full thickness lower extremity diabetic ulcers.

Administration, Topical↗

PubMed2001

Cost effectiveness of Becaplermin in the treatment of diabetic foot ulcers in four European countries.

OBJECTIVE: The primary objective of this study was to estimate the cost effectiveness of treating diabetic foot ulcers with becaplermin (Regranex) plus good wound care (GWC) compared with GWC alone in a variety of European healthcare settings. A secondary objective was to analyse the effect of different treatment practices on the economics of caring for diabetic foot ulcers. DESIGN AND SETTING: Markov-based simulation study from the perspective of a national health system. METHODS: A 12-month Markov computer simulation model was used to assess the cost effectiveness in 4 European countries of treating diabetic foot ulcers with becaplermin plus GWC versus GWC alone. Transition probabilities were taken from a prospective study of 183 patients and becaplermin efficacy was based on 20-week healing rates in a recent meta-analysis of clinical trials involving 449 patients. Country-specific treatment cost data were collected in collaboration with local economic consultations and combined with the disease model to estimate the incremental cost per ulcer-free month gained. The model was then run using hypothetical low- and high-intensity resource usage profiles to investigate the economics of caring for diabetic foot ulcers. RESULTS: Over the course of 1 year, individuals who received becaplermin plus GWC were, on average, predicted to spend an additional 0.81 months (24% longer) free of ulcers and to experience a 9% lower risk of undergoing a lower extremity amputation than individuals who received GWC alone. Consequently, becaplermin plus GWC was estimated to be net cost saving in Sweden, Switzerland and the UK. In France, the addition of becaplermin was estimated to add $US19 (1999 values) for each additional ulcer-free month gained. There were substantial intercountry differences in treatment practices and the costs of treating diabetic foot ulcers. CONCLUSIONS: Becaplermin may be a cost-effective treatment for neuropathic diabetic foot ulcers in a wide range of European settings. In Sweden, Switzerland and the UK, becaplermin may even be cost saving. Substantial intercountry differences in resource patterns appear, at least partly, to be the logical outcome of differences in unit costs.

Becaplermin↗

PubMed1998

Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study.

OBJECTIVE: To compare the efficacy and safety of topically applied recombinant human platelet-derived growth factor-BB (rhPDGF-BB) (becaplermin) with placebo gel in patients with chronic diabetic neuropathic ulcers of the lower extremities. RESEARCH DESIGN AND METHODS: This multicenter double-blind placebo-controlled phase III trial included 382 patients with type 1 or type 2 diabetes and chronic ulcers of at least 8 weeks' duration. After sharp debridement of the ulcer, patients were randomized to receive becaplermin gel 30 micrograms/g, becaplermin gel 100 micrograms/g, or placebo gel, in conjunction with a standardized regimen of good wound care until complete wound closure was achieved or for a maximum of 20 weeks. Moist saline-soaked gauze dressings were changed twice daily with study medication applied by patients or caregivers at the evening dressing change. Safety was assessed by monitoring adverse events (AEs) and by clinical laboratory evaluations. RESULTS: Compared with placebo gel, becaplermin gel 100 micrograms/g significantly increased the incidence of complete wound closure by 43% (50 vs. 35%, P = 0.007) and decreased the time to achieve complete wound closure by 32% (86 vs. 127 days; estimated 35th percentile, P = 0.013). AEs reported during treatment or during a 3-month follow-up period were similar in nature and incidence across all treatment groups. CONCLUSIONS: Becaplermin gel 100 micrograms/g, in conjunction with good wound care, significantly increased the incidence of complete wound closure and significantly reduced the time to complete closure of chronic diabetic neuropathic ulcers. The safety profile of becaplermin gel was similar to that of placebo gel.

Administration, Topical↗

PubMed1998

A review of nonclinical toxicology studies of becaplermin (rhPDGF-BB).

Becaplermin (recombinant human platelet-derived growth factor-BB [BB homodimer, rhPDGF-BB]) has demonstrated a favorable safety profile in a series of nonclinical studies designed to assess its systemic toxicity, sensitization, local irritation, and genotoxic potential. No significant local or systemic toxicity directly attributable to becaplermin was observed following single and multiple intravenous or subcutaneous administration at doses up to 3 mg/kg in monkeys. Administration of single large intravenous doses (up to 100 mg/kg) and repeated dosing at 1 or 3 mg/kg in mice resulted in rapidly reversible vasodilation and central nervous system depression. In a bone-toxicity study, becaplermin produced histomorphologic changes suggestive of accelerated bone remodeling, which were judged to be potentially reversible. Similar findings have not been observed in humans. Although becaplermin was not considered a dermal or ocular irritant, some skin-sensitizing effects were observed in animals; this finding was not unexpected for a recombinant human-derived protein. Becaplermin was not genotoxic in a variety of in vitro assays and in one in vivo assay.

Animals↗

PubMed2002

Becaplermin: recombinant platelet derived growth factor, a new treatment for healing diabetic foot ulcers.

Chronic or non-healing lower extremity ulcerations in diabetics are a significant cause of morbidity and mortality, and account for a large proportion of the financial burden related to the care of diabetics. Lower extremity ulcerations develop primarily as a consequence of neuropathy and the goal in addressing any wound is to re-establish tissue integrity as soon as possible. The healing of wounds is a complex procedure involving multiple growth factors, some of which have multiple effects on different cell types, in particular, platelet derived growth factor (PDGF) is a prominent agent, active in all stages of the healing process. Becaplermin (0.01% Regranex gel) is a homodimeric protein produced by recombinant DNA technology through the insertion of the gene for the B chain PDGF into the yeast Saccharomyces cerevisiae. The biological activity of becaplermin is similar to that of indigenous PDGF-BB, specifically, the promotion of chemotactic recruitment and the proliferation of cells involved in wound repair. Becaplermin has undergone extensive animal and human studies, demonstrating that it is highly effective as an adjunctive measure for the healing of ulcerations in the feet of diabetics when used in conjunction with standard wound healing practices. Specifically these practices include the provision of a moist environment free of debris and necrotic tissue, control of infection and optimal weight displacement from the affected area. Becaplermin is safe and easy to use, being applied once-daily and at present, becaplermin is the only growth factor licensed for use in wound healing.

Animals↗

PubMed2002

Adenosine A2A receptor agonists promote more rapid wound healing than recombinant human platelet-derived growth factor (Becaplermin gel).

Animal studies of the topical application of adenosine A2A receptor agonists show that it promotes wound closure. To further confirm the efficacy of adenosine A2A receptor agonists as promoters of wound healing, we compared the effect of MRE0094, a novel selective adenosine A2A receptor agonist, to CGS-21680, a reference selective adenosine A2A receptor agonist, as well as to recombinant human platelet-derived growth factor (0.01% Becaplermin gel), an agent currently used to promote healing of diabetic ulcers, on wound closure in healthy BALB/C mice. Wounds (approximately 12 mm diameter) were created on the dorsum of mice (two per mouse) and then treated daily with vehicle, 0.01% Becaplermin gel, or different doses of the adenosine A2A receptor agonists. The wound margins were traced onto plastic sheets, and the wound areas were digitized, quantitated, and compared. We found that application of MRE0094 (1 microg/wound and 10 microg/wound) and CGS-21680 (1 microg/wound and 5 microg/wound) achieved 50% wound closure significantly more rapidly than control application (day 1.9, 1.9, 3.5, 3.2, respectively, versus control day 4, p < 0.05 ANOVA). Surprisingly, neither higher nor lower concentrations of CGS-21680 affected the rate of wound closure, as compared to control. In contrast, Becaplermin gel did not increase the rate at which wounds closed (50% closure by day 7.2, p = NS versus control). These data confirm our prior observations that adenosine A2A receptor agonists promote wound closure, and they suggest that these agents may be as effective if not more effective than Becaplermin gel for the treatment of poorly healing wounds.

Adenosine↗

PubMedDate not supplied

The nitric oxide connection: hyperbaric oxygen therapy, becaplermin, and diabetic ulcer management.

Clinical experience with adjunctive hyperbaric oxygen therapy in the treatment of diabetic ulcers has shown that wound hyperoxia increases wound granulation tissue formation and accelerates wound contraction and secondary closure. In addition to wound hyperoxia, increased wound nitric oxide production caused by hyperbaric oxygen therapy also appears to be important for successful diabetic wound repair. The results of a preliminary retrospective study suggest that nitric oxide production is reduced in the nonhealing diabetic wound, and that topical becaplermin therapy is effective only when wound nitric oxide production deficiency is corrected. In addition, the data suggest that below a critical level of endogenous nitric oxide production, diabetic ulcer repair may not be achieved. Under this hypothesis, diabetic patients with chronic, nonhealing ulcers that respond to becaplermin should have substantially increased endogenous nitric oxide production compared with those ulcers that do not respond to becaplermin. The results of a preliminary clinical study support the use of combined therapy using topical becaplermin and hyperbaric oxygen therapy as a means of successfully treating the chronic diabetic ulcer patient with deficient nitric oxide production and local wound hypoxia.

Administration, Cutaneous↗

PubMedDate not supplied

Treatment of chronic ulcers in the lower extremities with topical becaplermin gel .01%: a multicenter open-label study.

This prospective, multicenter, open-label study assessed the efficacy and tolerability of recombinant human platelet-derived growth factor BB (becaplermin) in the treatment of chronic ulcers of the lower extremities in 73 patients with and without type 2 diabetes mellitus. Becaplermin gel .01% was applied once daily for 12 weeks. Efficacy was assessed in terms of progression to healing (100% epithelialization); the secondary efficacy endpoint was time to complete healing. Safety was assessed in terms of incidence of adverse events. Ninety-five percent of all ulcers were completely healed at week 9; only 5% remained incompletely healed at week 12 and were considered treatment failures. Healing time did not differ between diabetic and nondiabetic patients. The major adverse events were pain, burning sensation, and pruritus at the ulcer site, with an overall incidence of 10%. No patients dropped out because of adverse events. Becaplermin gel .01% was safe and well tolerated. Further studies are necessary to assess the durability of healing with this treatment.

Adult↗

PubMedDate not supplied

Recombinant human platelet-derived growth factor-BB (becaplermin) for healing chronic lower extremity diabetic ulcers: an open-label clinical evaluation of efficacy.

Topically applied recombinant human platelet-derived growth factor-BB (becaplermin) is a new pharmacologically active therapy for chronic, neuropathic, lower extremity diabetic ulcers. In previous studies, becaplermin gel was administered once daily but dressings were changed twice daily. In the present study of 134 patients with diabetes mellitus and full thickness lower extremity ulcers, dressings were changed only once per day, simplifying the treatment regimen. Efficacy criteria included the percentage of patients achieving complete healing within the 20-week treatment period, the time to achieve complete healing, the rate of ulcer recurrence during the 6-month period following healing, and treatment compliance. Complete healing of ulcers was achieved in 57. 5% of patients, with a mean time to closure of 63 days and a recurrence rate of 21% at 6 months. Of the potential factors affecting ulcer healing, only drug compliance (p < 0.001), dressing compliance (p < 0.01), the presence of infection (p < 0.01), baseline ulcer area (p < 0.05), and baseline total wound evaluation score (p < 0.05) were significantly associated with healing. Results of this study further confirm the efficacy and safety of becaplermin gel for the treatment of lower extremity diabetic ulcers.

Becaplermin↗

PubMed2001

Topical becaplermin: new preparation. A slight short-term help for some diabetic patients.

(1) The reference curative treatment for chronic ulcers in diabetic patients is to avoid pressure on the lesions, and to give appropriate local care. (2) A topical gel containing 0.01% becaplermin, a cell growth factor, is now marketed in Europe for the treatment of chronic neuropathic ulcers measuring less than 5 cm2 in diabetic patients. (3) The clinical file mainly comprises four trials, two of which were double-blind, testing two concentrations. In the largest trial, which gave the most favourable results, the lesions healed completely after 20 weeks in 50% of patients, compared with 35% of patients who used the excipient gel and received local care. (4) The optimal concentration of becaplermin gel is not known. Neither is its effect on lesions larger than 5 cm2 or its ability to prevent the need for amputation. (5) None of the clinical trials revealed any severe adverse effects (particularly tumour growth), but pharmacovigilance data are limited. (6) In practice, the very expensive topical becaplermin gel can help some patients, in whom it slightly accelerates ulcer healing.

Anticoagulants↗

PubMed1998

Preclinical promise of becaplermin (rhPDGF-BB) in wound healing.

Advances in molecular biology have made possible the production of highly purified recombinant human proteins, and recombinant human growth factors have emerged as potential therapeutic wound healing agents. Becaplermin (recombinant human platelet-derived growth factor-BB [rhPDGF-BB]) quickly emerged as one of the leading candidates for clinical trials. Before the expected therapeutic potential of rhPDGF-BB and other growth factors could be realized, a number of concerns had to be addressed (eg, would growth factors show effects in normal animals, what parameters of wound healing would be affected, and would quality of healed wounds be normal?). In animal models, rhPDGF-BB demonstrated wound healing activity, predominantly by enhancing the formation of granulation tissue, but it was not known whether this effect on granulation tissue would translate into enhanced healing of chronic skin ulcers in humans. The objective of this article is to review how the study of rhPDGF-BB in animal wound healing models has assisted in addressing the potential clinical utility of rhPDGF-BB. Results of animal studies are summarized, and the advantages and limitations of the animal models are discussed.

Animals↗

PubMedDate not supplied

Use of topical recombinant human platelet-derived growth factor-BB (becaplermin) in healing of chronic mixed arteriovenous lower extremity diabetic ulcers.

Lower extremity ulcers cause significant morbidity and mortality in patients with diabetes. The primary factors that contribute to the development of this type of ulcer are peripheral neuropathy and peripheral vascular disease, which are often accompanied by infection. Lower extremity diabetic ulcers are chronic and difficult to treat, in part due to underlying pathologic conditions in individuals with diabetes that can contribute to impaired wound healing. This article reports the author's experience with treatment of chronic lower extremity ulcers of mixed etiologies with recombinant human platelet-derived growth factor--BB [rhPDGF-BB, REGRANEX (becaplermin) Gel 0.01%] in a patient with multiple risk factors including long-standing insulin-dependent type 2 diabetes.

Administration, Topical↗

PubMed2000

Becaplermin gel (PDGF-BB) as topical wound therapy. Plastic Surgery Educational Foundation DATA Committee.

Becaplermin gel is the first topical growth factor to demonstrate therapeutic efficacy in the healing of diabetic wounds. For diabetic patients who have poorly healing ulcers despite good perfusion and a reasonable trial of wound care, this product may be of considerable benefit. It should be tried for a 2-week time period and the results objectively assessed before continuation of therapy.

Administration, Topical↗

PubMed1999

Treatment of stingray injury with topical becaplermin gel.

Stingray injuries are most commonly characterized by localized pain, ulceration, and edema; however, potentially serious sequelae may result, including tissue necrosis and life-threatening infection. This case report describes a stingray injury that had progressed to ulceration and was treated with topical application of recombinant human platelet-derived growth factor-BB (becaplermin gel 0.01%) and a standardized regimen of wound care.

Animals↗