STEPS

New Drug Reviews

Becaplermin (Regranex) for Diabetic Foot Ulcers



FREE PREVIEW Log in or buy this issue to read the full article. AAFP members and paid subscribers get free access to all articles. Subscribe now.


FREE PREVIEW Subscribe or buy this issue. AAFP members and paid subscribers get free access to all articles.

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.

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.

SAFETY

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

TOLERABILITY

Becaplermin is well tolerated. An erythematous rash developed in 2 percent of patients.1

EFFECTIVENESS

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

PRICE

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.

SIMPLICITY

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

Bottom Line

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.

Address correspondence to Courtney I. Jarvis, PharmD, at Courtney. Jarvis@mcphs.edu. Reprints are not available from the author.

Author disclosure: Nothing to disclose.

REFERENCES

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.
This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. Contact afpserv@aafp.org for copyright questions and/or permission requests.

Want to use this article elsewhere? Get Permissions


Article Tools

  • Print page
  • Share this page
  • AFP CME Quiz

Information From Industry

Navigate this Article