February 2013

Pages: 12 - 14

Phase III Studies Examine New Topical For Onychomycosis

By Brian McCurdy, Senior Editor
Two phase III studies, recently published in the Journal of the American Academy of Dermatology, say a new topical triazole antifungal may be a viable alternative to oral treatments for onychomycosis.

   Researchers conducted two identical, multicenter, randomized, double-blind studies on a total of 1,655 patients with distal lateral subungual onychomycosis. Patients received either a vehicle or efinaconazole 10% (Valeant Pharmaceuticals), which they applied once a day for 48 weeks with four weeks of follow-up. The study authors note that mycological cure rates were “significantly higher” for patients treated with the topical agent. Treatment success rates in the first study ranged from 21.3 to 44.8 percent for efinaconazole patients in comparison to 5.6 to 16.8 percent for vehicle patients, according to the study. Researchers noted that treatment success rates in the second study ranged from 17.9 to 40.2 percent for efinaconazole patients in comparison to 7 to 15.4 percent for vehicle patients.

   “I don’t think the future for antifungals is in the oral market. I think it is topicals,” says study co-author Richard Pollak, DPM.

   Warren Joseph, DPM, believes efinaconazole holds promise as a new topical treatment for onychomycosis. As he notes, to date, the Food and Drug Administration (FDA) has only approved one topical, ciclopirox lacquer (Penlac, Sanofi-Aventis), for onychomycosis and “most people were disappointed with its efficacy.” He elaborates that the FDA approved “complete cure” (defined as negative mycology and 0 percent residual involvement) rates for that drug were in the 5 to 8 percent range.

   Dr. Pollak says efinaconazole is more effective than other topical treatments. He also notes that while efinaconazole is more effective than ciclopirox and is nearly as effective or comparable to oral itraconazole (Sporanox, Janssen Pharmaceuticals), it is not as effective as the “gold standard” oral terbinafine (Lamisil, Novartis).

   Dr. Joseph opines that there is still room for more drugs and studies in topical therapy of onychomycosis. He points out that at least two more drugs are currently in or recently completed Phase III trials.

   “We will be seeing a major upstart in interest in this disease state in the very near future,” says Dr. Joseph, a Fellow of the Infectious Diseases Society of America and a consultant to Valeant Pharmaceuticals.

   However, there is still work to be done and Dr. Joseph says research needs to focus on proving the efficacy of the over-the-counter products podiatrists are selling to patients out of their offices. He says research must also determine the optimum dosing time, noting that shorter durations for topicals would improve patient adherence.

   Dr. Pollak cites the rise of generic terbinafine as why it may not be worthwhile to market a new oral for onychomycosis. When terbinafine was a brand name, he says there was a barrier to treatment since not all insurance companies covered it. However, now patients can buy a one-month supply of terbinafine in retail stores for $4.

   “The cost of treatment of fungal toenails systemically is not a barrier to anybody,” says Dr. Pollak, who is in private practice in San Antonio, Texas.

   Editor’s note: For a related article, see the Online Case Study “Could Efinaconazole 10% Have An Impact For Onychomycosis?” at http://tinyurl.com/artray3 .

Study Takes A Closer Look At Arthroscopic Versus Open Ankle Arthrodesis

By Danielle Chicano, Editorial Associate

When it comes to ankle arthrodesis, can a less invasive approach be more effective? A recent study in the Journal of Bone and Joint Surgery concludes that arthroscopic ankle arthrodesis is a more viable alternative to open ankle arthrodesis in patients with end-stage ankle arthritis.

   In this comparative case series, researchers assessed the improvements of 30 patients who received open ankle arthrodesis and 30 patients who had arthroscopic ankle arthrodesis. According to study authors, both groups of patients showed substantial improvements in both the Ankle Osteoarthritis Scale score and the Short Form-36 physical component score after one and two years. However, patients in the arthroscopic group had significantly greater improvements in the Ankle Osteoarthritis Scale score and also experienced shorter hospital stays.

   Patrick DeHeer, DPM, FACFAS, is skeptical on the study’s advantageous outcomes with arthroscopic ankle arthrodesis. He agrees that a less invasive approach would provide less soft tissue damage but notes that once bone healing occurs, the approach used is insignificant. Dr. DeHeer says he generally uses a mini-arthrotomy approach, a combination of the two procedures as described by Myerson.

   “I find arthroscopic ankle arthrodesis to be a bit tedious and only use an open approach when there is a deformity that would make the mini-arthrotomy approach not viable,” explains Dr. DeHeer, who is in private practice in Indianapolis.

   Dr. DeHeer maintains that one must keep in mind certain anatomical deformities when choosing the best procedure. Specifically, he notes that severe degenerative changes with joint space narrowing would make arthroscopic arthrodesis difficult. In addition, any type of angular deformity, such as ankle varus or valgus, requires an open approach, according to Dr. DeHeer.

   He doubts that this study will have a great impact overall for podiatric surgeons treating patients with ankle osteoarthritis.

   “I do think the significant improvement in Ankle Osteoarthritis Scale score could be a factor for surgical approval from an insurance standpoint,” adds Dr. DeHeer.

Which Fixation Method Is Strongest For Tailor’s Bunion Osteotomies?

By Brian McCurdy, Senior Editor

A recent study in the Journal of Foot and Ankle Surgery compares fixation methods for tailor’s bunions and finds the Chevron osteotomy is superior in strength.

   Researchers tested osteotomies to failure with a sample size of 10 for each construct. They tested the distal reverse Chevron (Kirschner wire fixation), the long plantar reverse Chevron osteotomy (two screws), a mid-diaphyseal sagittal plane osteotomy (two screws), the mid-diaphyseal sagittal plane osteotomy (two screws), and an additional cerclage wire and a transverse closing wedge osteotomy (box wire fixation technique). The authors note the Chevron was statistically the strongest construct at 130 N with the second strongest being the long plantar osteotomy at 78 N.

   Study co-author Todd Haddon, DPM, feels the Chevron is the easiest osteotomy to perform but is still challenging to fixate. The fact that the Chevron typically offers only one point of fixation is the primary reason he switched to the long plantar arm osteotomy, which allows two screws from dorsal to plantar. Dr. Haddon adds that if a surgeon has difficulty with the cuts becoming too long, he or she can make a small plantar exit to the osteotomy with a back cut of the plantar arm, making it into a small scarf osteotomy.

   Although he notes that the Chevron has worked well for patients in the long term, Dr. Haddon cites a primary issue of a limited amount of bone in the typical fifth metatarsal head. He also prefers the long plantar arm procedure since it allows the capital fragment to be rotated medially, reducing complete reliance on translocation for correction.

   “It becomes very challenging to try to shift adequately such a small piece of bone and fixate it with a single pin or screw,” says Dr. Haddon, who is in private practice in Mesa, Ariz.

   Study co-author Stephan J. LaPointe, DPM, PhD, prefers two-screw fixation for fifth metatarsal osteotomies. He cites the Acutrak cannulated screw (Acumed), saying its guide pins function as temporary fixation and the guide for the screws.

   “I use two screws because I am concerned mostly with rotation since there is little bone to bone contact at the osteotomy site due to the size of the bone,” says Dr. LaPointe, who is in private practice in Rome, Ga.

   Dr. LaPointe says the Chevron itself is fairly stable and he adds to that stability by applying two screws. He allows full weightbearing but has patients use a modified controlled ankle motion walker to offload the osteotomy site for at least four weeks. Following that, Dr. LaPointe may remove the felt insert or transition the patient into normal shoe gear depending on the quality of bone and X-rays. He cautions his patients that erythema, edema and pain are signs that they should spend less time on their feet. Dr. LaPointe says he has yet to require complete non-weightbearing for a patient.

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