Researchers test treatments for painful mouth ulcers

The drug pentoxifylline offers only limited benefit for treating one form of mouth ulcers, while a cream commonly used to treat eczema appears effective in treating another kind, according to two studies published in the April issue of the journal Archives of Dermatology.

In the first study, British researchers at the University of Sheffield found that pentoxifylline provided limited benefit to patients with mouth ulcers due to recurrent aphthous stomatitis, which is characterized by recurring mouth ulcers in otherwise healthy people. The condition affects about 20 percent of the population.

The 60-day study included 26 people, average age 33, who took either one 400-milligram tablet of pentoxifylline three times a day or three placebo pills per day.

"Patients taking pentoxifylline had less pain and reported smaller and fewer ulcers compared with baseline," the study authors wrote. "Patients taking placebo reported no improvement in these variables. Patients taking pentoxifylline also reported more ulcer-free days than those taking placebo. However, the differences were small and, with the exception of median ulcer size, did not reach statistical significance."

Sixty days after they stopped taking the drug, all patients reported ulcers similar to those they had before the start of the trial. Dizziness, headaches, stomach upset, and increased heart rate were among the side effects reported by those who took the drug.

"Pentoxifylline did not prevent the ulcer episodes from occurring or result in a long-term cure. Thus, given the potential for significant adverse effects and the small benefits of the drug demonstrated in this clinical trial, we cannot recommend pentoxifylline as the drug of first choice for treatment of recurrent aphthous stomatitis, although it may have a second-line role in the management of patients unresponsive to other treatments or as an adjunct to other treatments," the researchers concluded.

The second study found that one percent pimecrolimus cream was effective against oral erosive lichen planus, a severe inflammatory condition that causes painful mouth ulcers. People with the condition, which affects about one percent of the population, may even lose weight because of the mouth pain they experience when eating.

The study, by French researchers at the University of Nice, included six patients who applied pimecrolimus cream on mouth sores twice a day for four weeks and six patients who applied a placebo cream without any active ingredient.

The patients were assessed at the start of the study and again at 14 and 28 days. After 28 days, the average clinical score in the pimecrolimus group decreased from 6.83 to 3.33 and from 4.67 to 3.33 in the placebo group. There were few side effects in either group.

"In the pimecrolimus group, all the patients but one reported a moderate to important improvement of their symptoms and were satisfied by the treatment. This improvement was observed from the first week of treatment, usually within the first two days, and most notably, patients reported less pain when eating," the study authors wrote.

However, all the patients who improved during the study had a relapse within a month after treatment.

Larger studies are needed to better evaluate the safety and efficacy of pimecrolimus cream compared to other treatments, the authors wrote.

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Drug shows promise in spinal cord injury treatment

A drug called Cethrin shows promise in treating people with spinal cord injury (SCI), according to a study by American and Canadian researchers.

Cethrin inhibits Rho, a signaling master switch that, when activated, triggers cell death and increases damage after SCI. Tests in animals with SCI have found that Cethrin inhibits cell death and promotes neural regeneration.

This one-year study looked at the use of Cethrin (a recombinant protein) formulated with a fibrin sealant in 37 patients who had just suffered an SCI that left them with no sensory or motor function below the area of the injury.

All the patients had an "A" grade injury as ranked by the American Spinal Injury Association (ASIA). Grades of injury go from A through E. An "A" is the most serious while "E" is normal.
After the patients had surgical decompression/reconstruction, the researchers started treatment with Cethrin, an average of 53 hours after the injury occurred. The patients received increasing doses of the drug (0.3, 1.0, 3.0 and 6 milligrams) administered extradurally to the injured spinal cord. The patients were assessed at various points over a year.

The study found that at six weeks, 30.6 percent of the patients improved by one or ASIA grades of injury. At six months, 28 percent of patients improved by one or more ASIA grades. Five patients improved to "C" and two improved to "D." One patient died from acute respiratory distress syndrome.

The study, which was funded by BioAxone Therapeutique of Montreal and Boston Life Sciences Inc., was presented Monday at the annual meeting of the American Association of Neurological Surgeons, in Washington, D.C. The findings from this Phase I/II study warrant moving on to a prospective randomized trial of Cethrin, the researchers said.

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Rheumatoid arthritis drug may help treat type 2 diabetes

A drug designed to treat juvenile rheumatoid arthritis may also be helpful for managing type 2 diabetes, new research suggests.

The study found that daily injections of anakinra led to a drop in long-term levels of glucose in the blood, while they increased in people given a placebo.

"We (showed) that a 13-week treatment with anakinra improves glucose regulation and insulin production in people with type 2 diabetes," said one of the study's authors, Dr. Marc Donath, an attending physician and a professor of endocrinology and diabetes at University Hospital Zurich in Switzerland.

The study is published in the April 12 issue of the New England Journal of Medicine.
Almost 21 million Americans -- or about 7 percent of the U.S. population -- have diabetes, according to the American Diabetes Association. Type 2 diabetes is the most common form of the disease, and those most at risk for developing type 2 diabetes include people who are overweight, the elderly, and people from certain races, such as blacks or Native Americans, according to the diabetes group.

Type 2 diabetes occurs when the body doesn't produce enough insulin, or it doesn't use insulin effectively. Insulin, a hormone, is needed to transport sugar from the blood to cells, where it is used for energy.

Sometimes, beta cells -- insulin-producing cells -- in the pancreas are destroyed in type 2 diabetes as they are in type 1 diabetes. Through previous research, Donath and his colleagues learned that a substance called interleukin-1 beta was a factor in the demise of these cells in people with type 2 diabetes.

The drug anakinra is an interleukin-1-receptor antagonist, which means it can block the action of interleukin-1 beta.

To assess whether or not this could have an effect on people with type 2 diabetes, the researchers randomly assigned 36 people to receive a once-daily placebo injection and 34 people to receive once-daily injections of 100 milligrams of anakinra for 13 weeks.

After 13 weeks, the glycated hemoglobin levels were 0.46 percent lower in the group that received anakinra. Glycated hemoglobin, also referred to as glycosylated hemoglobin or A1C, is a test that measures the average amount of glucose in the blood for about three months. People without diabetes generally have levels around 5 percent. The higher the level, the greater the risk of diabetes complications, which can include heart disease, nerve damage, kidney failure and loss of vision.

"Our study is proof of concept for a mechanism underlying the disease and (may possibly) block its progression," said Donath, who added, "Interleukin-1 beta may be involved in other complications of the disease, such as arteriosclerosis. Therefore, this therapy may also prevent cardiovascular events. However, this remains to be shown."

Anakinra was well tolerated by the study participants, and Donath and his colleagues plan on conducting larger, follow-up studies of the medication.

"This study points to inflammation as definitely having a role in the (diabetes) story," said Dr. Stuart Weiss, an endocrinologist at New York University Medical Center, and a clinical assistant professor of medicine at the New York University School of Medicine.

But, Weiss said that while this avenue of research is "worth pursuing, I wouldn't get my hopes up for a clinical application, especially since the drug appears to lose its effectiveness over time."
Additionally, Weiss pointed out that it appeared the drug was more effective in thinner people.

"The authors don't really discuss this, but it's an interesting finding -- it's not what we'd expect."

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Ibuprofen risky for heart patients?

The common painkiller ibuprofen may boost heart attack risk by blocking the lifesaving effects of aspirin, a new study shows.

“The public health impact of this is monstrous," Michael Farkouh, director of clinical trials at Mount Sinai Heart, a premier New York cardiovascular centre has said. “Ibuprofen is relatively safe except when we give it with aspirin to people at high risk of heart attack," Farkouh says.

"But when given with aspirin, we do we see an excess of heart attacks." This is a controversial conclusion. The study itself had not been designed to look at ibuprofen safety, nor has it proved that ibuprofen is harmful to people at high risk of heart disease. But it does provide a clear warning sign that ibuprofen is risky for people who need the blood-clot-reducing effect of daily low-dose aspirin.

Those taking aspirin in the ibuprofen arm of the study had a ninefold excess of heart attacks. But another expert Steve Nissen, chairman of cardiovascular medicine at The Cleveland Clinic and past president of the American College of Cardiology, urges caution. He notes that the findings are based on only eight heart attacks among thousands of high-risk patients taking ibuprofen and aspirin. Still Dr.Farkouh says the numbers may be small but the potential risks are great. And it would not be the first time that relatively small numbers of heart attacks caused a major change in how doctors look at pain drugs.

“The whole Vioxx thing was based on 64 heart events among 21,000 patients studied," Farkouh recalls. "Here we are talking about potentially a higher magnitude of impact. The interaction of ibuprofen with aspirin is a bigger public health concern than Vioxx was."

Rofecoxib, a nonsteroidal anti-inflammatory drug, was marketed under the brand name Vioxx by Merck for treatment of osteoarthritis, and related acute pain conditions. Worldwide, over 80 million people were prescribed rofecoxib at some time.

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Antibiotic combinations could fight resistant germs

Using two competing antibiotics against a bacterium -- even when the bug is resistant to one of them -- appears to help conquer the germ and suppress the resistance, new research shows.
The finding is a bit counterintuitive, since for years, doctors have been warning of the overuse of antibiotics, because it encourages germ resistance.

But the new study suggests that sometimes, "antibiotics can be used in suppressive combinations" to limit resistant bacteria, said senior researcher Roy Kishony, an assistant professor in the department of systems biology at Harvard Medical School.

The finding, published in the April 5 issue of the journal Nature, is preliminary and does not have immediate implications for the way doctors use antibiotics. However, the researchers said the study does offer tantalizing new avenues for research.

The advent of antibiotics remains one of the great achievements of modern medicine, credited with saving millions of lives. But the emergence of strains of bacteria that are resistant to nearly all antibiotics has health officials worried.

For example, in 2006, experts warned that methicillin-resistant Staphylococcus aureus (MRSA) had moved from hospital wards to the general community, threatening to become a global epidemic.

And "the issue is broader than MRSA," Dr. Edward Chapnick, director of infectious diseases at Maimonides Medical Center in New York City, told HealthDay at the time. "The issue is antibiotic resistance as a whole. That's not the only resistant organism. It's a big problem, but it's not the only one."

Alarmed by the threat, medical groups and doctors have warned against overusing antibiotics in both humans and animals.

But the Harvard study suggests that combining these drugs in a surprising new way could curb the problem.

In their laboratory experiments, Kishony and Harvard graduate student Remy Chait focused on two strains of the E. coli bacterium -- one that was resistant to doxycycline, a widely used antibiotic, and one that was not.

They exposed the two bacteria to both doxycycline and ciprofloxacin (Cipro), a drug from a different class of antibiotics. Experts call this combination of antibiotics "hyper-antagonistic," because under normal circumstances, doxycycline works to suppress Cipro's germ-killing effects.

Typically, when using antibiotics in combination, any resistant strain should flourish at the expense of strains that had not developed resistance, Kishony explained.

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Parkinson's drug pergolide withdrawn over heart concerns

The Parkinson's disease drug pergolide has been removed from the market because it has been linked to heart valve damage in patients.

The drug, which goes by the brand name Permax, has had a troubled history. It was voluntarily withdrawn Thursday by its maker, Valeant Pharmaceuticals, at the request of the U.S. Food and Drug Administration.

Two generic versions are manufactured by Par Pharmaceuticals and Teva Pharmaceutical Industries.

"The reason for the withdrawal is because of the high rate of damage to the heart valves in users of pergolide," Dr. Robert Temple, director of the Office of Medical Policy at the FDA's Center for Drug Evaluation and Research, said during a teleconference Thursday afternoon. "The damage causes the valve to become leaky. The drug is called a dopamine agonist and is used as starting therapy for Parkinson's patients."

The drug has been available since 1988, and the first reports of heart valve damage surfaced in 2002, Temple said. In 2003, the drug's label was changed to reflect these problems. In 2006, further studies prompted the FDA to mandate a "black box warning" on the drug's label.
The last straw was the publication of two studies in January in the New England Journal of Medicine that showed a fivefold increased risk of valve damage from taking the drug. One of the studies also revealed that about 23 percent of people on the drug developed heart valve problems, Temple said. "That what led to our new action," he said.

In addition, reports showed that other dopamine agonists did not cause heart valve problems, Temple noted. "Pergolide has no advantage over any of the other therapies for Parkinson's," he said. "Almost all patients can be converted to another drug. We concluded that this drug really didn't have a place in therapy anymore."

Currently, about 12,000 to 25,000 patients are taking pergolide in the United States, and its use has been declining, Temple said.

Temple said there are some patients who only do well on pergolide. "We hope to make some arrangement for those people so they can get the drug, providing they understand the risk," he said.

"We are telling these patients not to stop the drug abruptly," he added. "If the patients, with their physicians, conclude they need a dopamine agonist, there are ways to switch."
The voluntary withdrawal will not take place immediately. This will allow time for health-care providers and patients to make appropriate treatment decisions, Temple said.

According to the U.S. National Institutes of Health, Parkinson's is a disease of the nervous system. The four main symptoms are tremors, stiffness of the limbs and trunk, slowness of movement, and impaired balance. These symptoms usually begin gradually and worsen with time. As they become more pronounced, patients may have difficulty walking, talking or completing other simple tasks.

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