New Drug Reviews
Becaplermin (Regranex) for Diabetic Foot Ulcers
Am Fam Physician. 2008 Jul 15;78(2):255-256.
Becaplermin (Regranex) topical gel is labeled for adjunctive treatment of stage III and IV diabetic neuropathic ulcers of the lower extremities. Becaplermin is a recombinant human platelet-derived growth factor; therefore, it promotes wound healing by enhancing the formation of granulation tissue.1
|Name||Dose||Dose form||Approximate cost*|
Becaplermin (Regranex) 0.01% gel
Apply once daily until complete healing has occurred.
15-g tube containing 100 mcg of becaplermin per g
$586 per 15-g tube
Calculate length of gel needed as follows:
Multiply length (cm) and width (cm) of ulcer, then divide by 4.
Recalculate amount needed weekly or biweekly
*— Average wholesale cost, based on Red Book, Montvale, N.J.: Medical Economics Data, 2007.
Adverse reactions are rare with becaplermin.1 Although it is a human-derived protein, becaplermin is not systemically absorbed, and neutralizing antibodies do not develop. Growth factors may contribute to the pathogenesis of atherosclerosis, but research has not demonstrated a higher likelihood of cardiovascular events with becaplermin than with placebo.2 In June 2008, the U.S. Food and Drug Administration (FDA) required the addition of a boxed warning to the labeling of becaplermin regarding cancer risk. Becaplermin use has not been associated with an increase in cancer; however, mortality from cancer is higher in patients who have used at least three tubes.3 Rash, infection, cellulitis, and osteomyelitis were no more common with becaplermin than with placebo.2 Becaplermin is FDA pregnancy category C.1
Becaplermin is well tolerated. An erythematous rash developed in 2 percent of patients.1
Studies evaluated becaplermin in combination with good wound care (e.g., initial and as-needed sharp debridement, nonweight-bearing regimen, infection control, moist saline dressings). Compared with placebo, treatment with becaplermin will result in complete ulcer closure in more patients with nonhealing neuropathic ulcers of the lower extremities. One additional patient will experience complete ulcer closure for every seven patients treated with becaplermin (number needed to treat = 6.7; 95% confidence interval, 3.8 to 36.9), and time to complete ulcer closure is accelerated by six weeks with becaplermin (P = .013).4 However, one study showed only a small difference in rates of complete ulcer closure with becaplermin versus good wound care alone (36 and 32 percent, respectively).5 Becaplermin does not seem to prevent recurrence; recurrence rates are approximately 30 percent at three months, regardless of treatment strategy.4
The effect of becaplermin on amputation rates has not been evaluated in controlled studies, nor has becaplermin been directly compared with any other products, including other growth factors (e.g., granulocyte colony-stimulating factor). It has been evaluated for the treatment of other ulcer types in patients without diabetes (e.g., pressure ulcers, venous stasis ulcers), but with mixed results.1,6
The cost of becaplermin is substantial at $586 per 15-g tube, which will provide treatment for a 2 cm2 ulcer for approximately four weeks. Treatment generally will take at least 10 weeks, necessitating two to three tubes per treatment course.
A thin layer is applied to the entire ulcer area, covered by a saline-moistened dressing, and left in place for 12 hours. Daily application should continue until the ulcer is completely healed, or for up to 20 weeks.1 It should be used with a comprehensive regimen of good wound care.1 Becaplermin should be stored in the refrigerator.1
Although patients treated with becaplermin are more likely to experience complete and faster ulcer healing than patients continuing good wound care alone, the increased risk of cancer mortality and significant cost outweigh the possible benefits in most patients.
1. Regranex (becaplermin) gel 0.01% [prescribing information]. Raritan, N.J.: Ortho-McNeil Pharmaceutical, Inc.; 2005. http://www.regranex.com/content/backgrounders/www.regranex.com/www.regranex.com/PI_Full_Version.pdf. Accessed May 14, 2008.
2. Smiell JM. Clinical safety of becaplermin (rhPDGF-BB) gel. Becaplermin Studies Group. Am J Surg. 1998;176(2A suppl):68S–73S.
3. FDA announces new labeling changes for Regranex [news release]. Rockville, Md.: U.S. Food and Drug Administration; June 6, 2008. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01845.html. Accessed June 10, 2008.
4. Wieman TJ, SuY Smiell JM. 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. Diabetes Care. 1998;21(5):822–827.
5. Steed DL. Clinical evaluation of recombinant human platelet-derived growth factor for the treatment of lower extremity diabetic ulcers. Diabetic Ulcer Study Group. J Vasc Surg. 1995;21(1):71–81.
6. Rees RS, Robson MC, Smiell JM, Perry BH. Becaplermin gel in the treatment of pressure ulcers: a phase II randomized, double-blind, placebo-controlled study. Wound Repair Regen. 1999;7(3):141–147.
STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.
The series coordinator for AFP is Allen F. Shaughnessy, PharmD, Tufts University Family Medicine Residency Program at Cambridge Health Alliance, Malden, Mass.
Copyright © 2008 by the American Academy of Family Physicians.
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