APR 2013

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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36 EW CORNEA April 2013 Education fuels medication success by Maxine Lipner EyeWorld Senior Contributing Writer Persistence pays off A dry eye patient who has been on Restasis (cyclosporine, Allergan, Irvine, Calif.) without success arrives in the office. What do you do—move on to another approach? Not so fast, according to Francis Mah, MD, director of corneal and external disease, and co-director of refractive surgery, Scripps Clinic, La Jolla, Calif. Results of a recent study e-published in the November 2012 issue of Clinical Ophthalmology show that 80% of patients deemed Restasis failures can succeed on a second attempt when armed with the proper education. Dr. Mah, who led the study, recalled how the idea for this emerged from the mutual frustration of several practitioners. They all had patients referred to them who claimed they had tried and failed on Restasis, but who, in reality, hadn't given the medication a fair shake. "I was getting a lot of patients who were failures at Restasis therapy and it turned out so were Mark Milner [MD], Sammy Yiu [MD], and Eric Donnenfeld [MD]," he said. "But when I talked to the patients, it turned out that their complaints should have been addressed either before or during the treatments." Premature failures One of the most common reasons given by patients for discontinuing the medication at around the twoto four-week mark was that they didn't feel that it was working. "They would say, 'I didn't feel like anything was changing,'" Dr. Mah said. "But the clinical trials showed that it took four to six months in those patients with pretty severe dry eyes to get a response." Dr. Donnenfeld, clinical professor of ophthalmology at New York University medical center, N.Y., concurs. "I find that with aqueous deficiency dry eye about 90% of patients benefit from the use of Restasis," he said. "However the patients who don't benefit from the treatment overwhelmingly do not use the medication the right way or do not use it for a sufficient amount of time." Moxifloxacin treatment found similar to combination therapy in corneal ulcer cases F or the treatment of moderate bacterial corneal ulcers, 0.5% moxifloxacin monotherapy was equivalent to combination therapy of fortified cefazolin and tobramycin for corneal healing, a study found. The study, a randomized, controlled, equivalence clinical trial, looked at 224 patients with bacterial keratitis. Patients were randomized into two groups: group A, with 114 patients and group B, with 110 patients. Group A received combination therapy of fortified cefazolin sodium 5% and tobramycin sulfate, and group B received monotherapy of moxifloxacin 0.5%. The primary outcome variable in the study was the percentage of ulcers healed at three months. "A complete resolution of keratitis and healing of ulcers occurred in 90 patients (81.8%) in group A and 88 patients (81.4%) in group B at 3 months," said study authors. "The observed percentage of healing at 3 months was less than the equivalence margin of 20%. Worsening of ulcer was seen in 18.2% cases in group A and in 18.5% cases in group B. Mean time to epithelialization was similar, and there was no significant difference in the 2 groups (P=0.065). No serious events attributable to therapy were reported." The study was published in the Feb. 2013 edition of Ophthalmology. EW Editors' note: The study authors had no financial interests related to this article. Dry eye patients who have "tried Restasis before" can potentially benefit from a second go-round with emphasis on education. Source: Eric D. Donnenfeld, MD This runs contrary to Dr. Donnenfeld's usual assumptions. "My normal kneejerk reaction is to assume that the patient tried the medication as prescribed and did not receive the optimal effect," he said. "The reality was that the patients who failed on Restasis did not use the medication in the correct manner, so they hadn't been given a true trial of the medication." In the multicenter, retrospective trial, results of 35 patients indicated that prior discontinuation of Restasis at less than 12 weeks was usually linked to burning and stinging. For 10 patients a second trial of cyclosporine was initiated and lasted for a mean of 10 months. In 97.1% of cases, physician education of patients on the medication was stressed in this second trial. Road to success Dr. Mah emphasized the importance of taking time to educate patients about Restasis. "I always like to counsel patients from the outset that this is not like an antibiotic," he said. "You're not going to get a response in a weekend or over two days." He explains to patients that the clinical trial showed that it might take as long as four to six months before a real difference can be seen. Likewise, Dr. Donnenfeld stressed how important patient education is with Restasis given how so many don't give the medication a real trial. "It made me think again how important compliance and patient education is and how important it is that we as clinicians take the time to explain the patients' condition so that they can understand their disease," Dr. Donnenfeld said. This, he finds, enables patients to use their therapy in a proper manner to achieve the desired results. "In some patients, particularly baby boomers, we have to realize that they don't listen to doctors in many cases as willingly as other patients do—they have to understand the reason," Dr. Donnenfeld said. "Once they are educated and understand their disease, they are much more compliant and are more likely to achieve a therapeutic result." When it comes to dealing with burning and stinging resulting from Restasis, Dr. Mah addresses this possibility from the start. "I'm very proactive about that, but a lot of patients come in and say, 'I didn't like the burning sensation,'" he said. "When you talk to these people, they were never told about the sensation." As long as they understand that this is normal, they are usually willing to continue, he finds. Likewise, Dr. Donnenfeld stresses to patients how commonplace burning and stinging can be. "Burning and stinging are normal in about 17% of patients who take

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