Pasadena, U.S.A. – People who have had an episode of herpes zoster, also known as shingles, face a relatively low short-term risk of developing shingles again, according to a Kaiser Permanente Southern California study published online in the Journal of Infectious Diseases. These findings suggest that among people with immune systems that have not been compromised, the risk of a second shingles episode is low.

Researchers reviewed electronic health records and monitored recurrence of shingles for more than 6,000 individuals. They found fewer than 30 cases of recurrent shingles in an average of two years of follow-up and little difference in the rate of recurrence between the vaccinated and unvaccinated population.

“This study’s findings are important because we found that the risk of having a recurrent shingles episode is not as high as previous research indicates,” said Hung Fu Tseng, PhD, MPH, study lead author with the Kaiser Permanente Southern California Department of Research & Evaluation in Pasadena, California. “We now have empirical data that show the risk of recurrence is low among an elderly population who did not have compromised immune systems, regardless of their vaccination status.”

More than 1 million people develop shingles every year in the United States. Shingles is a painful contagious rash caused by the dormant chickenpox virus, which can reactivate and replicate, damaging the nerve system. The elderly are especially vulnerable because immunity against the virus that causes shingles declines with age.

When the Food and Drug Administration approved the shingles vaccine in 2006, the agency said that having an episode of shingles boosts immunity and suggested it was unlikely that people would experience a recurrence. It further stated that the effectiveness of the vaccine in preventing repeat episodes had not been proven in clinical trials because trials have not been conducted.

By contrast, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended the herpes zoster vaccine for people ages 60 and older, including those who reported a previous episode.

“While this latest study adds to the growing evidence base of emerging knowledge about the shingles vaccine, more research is needed. Our findings need to be replicated by studies with larger populations. Kaiser Permanente Southern California researchers will continue to follow this population of vaccinated people in order to determine the long term preventative efficacy,” said Dr. Tseng.

Researchers studied electronic health records for 1,036 vaccinated and 5,180 unvaccinated Kaiser Permanente members aged 60 and older. The vaccinated population included members who received vaccines between 2007 and 2010. The zoster vaccine is not recommended for patients with immune systems that have been compromised as a result of cancer or other medical conditions, so they were excluded from this study.

Based on the clinically confirmed cases, researchers found the risk of the recurrence of shingles after a recent episode is fairly low, regardless of vaccination status. Each year, on average, 19 persons per 10,000 in the vaccinated cohort experienced a recurrence of shingles. The rate was only slightly higher for the unvaccinated population, at approximately 24 persons per 10,000 per year.

This is the latest in a series of published Kaiser Permanente studies conducted to better understand vaccine effectiveness and safety. In 2011, Dr. Tseng was a lead researcher in a Vaccine Safety Datalink study published in the Journal of Internal Medicine that found the herpes zoster vaccine to be safe. Also last year, Dr. Tseng published a study in the journalVaccine that found that administering the pneumococcal and the herpes zoster vaccines at the same time is as beneficial as if they were administered separately. In addition to that study, Dr. Tseng published a study in 2011 in the Journal of the American Medical Association that found the shingles vaccine is associated with a fifty-five percent reduced risk of developing the disease. In 2010, another study by Dr. Tseng in JAMA found the pneumococcal pneumonia vaccination is not associated with a reduced risk of heart attacks or strokes in men.

Two Kaiser Permanente studies found that the combination vaccine for measles, mumps, rubella and chickenpox is associated with double the risk of febrile seizures for 1- to 2-year-old children, compared to same-day administration of the separate vaccine for MMR (measles, mumps, rubella) and the varicella vaccine for chickenpox. Other Kaiser Permanente studies found that children of parents who refuse vaccines are nine times more likely to get chickenpox and 23 times more likely to get pertussis (commonly known as whooping cough), compared to fully immunized children. Another study found that herpes zoster is very rare among children who have been vaccinated against chickenpox.

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The U.S. Food and Drug Administration has approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

CF is a serious genetic disorder affecting the lungs and other organs that ultimately leads to an early death. It is caused by mutations (defects) in a gene that encodes for a protein called CFTR that regulates ion (such as chloride) and water transport in the body. The defect in chloride and water transport results in the formation of thick mucus that builds up in the lungs, digestive tract and other parts of the body leading to severe respiratory and digestive problems, as well as other complications such as infections and diabetes.

CF, which affects about 30,000 people in the United States, is the most common fatal genetic disease in the Caucasian population. About 4 percent of those with CF, or roughly 1,200 people, are believed to have the G551D mutation.

“Kalydeco is an excellent example of the promise of personalized medicine – targeted drugs that treat patients with a specific genetic makeup,” said FDA Commissioner Margaret A. Hamburg, M.D. “The unique and mutually beneficial partnership that led to the approval of Kalydeco serves as a great model for what companies and patient groups can achieve if they collaborate on drug development.”

The FDA reviewed and approved Kalydeco in approximately three months under the agency’s priority review program that is designed to expedite the review of drugs. The priority review program uses a six-month review, instead of the standard 10 months, for drugs that may offer significant advances in treatment over available therapy.

Kalydeco was approved ahead of the drug’s April 18, 2012, prescription user fee goal date and is designated as an orphan drug, which identifies the disease as affecting fewer than 200,000 people in the United States.

In patients with the G551D mutation, Kalydeco, a pill taken two times a day with fat-containing food, helps the protein made by the CFTR gene function better and as a result, improves lung function and other aspects of CF such as increasing weight gain.

“Kalydeco is the first available treatment that targets the defective CFTR protein, which is the underlying cause of cystic fibrosis,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This is a breakthrough therapy for the cystic fibrosis community because current therapies only treat the symptoms of this genetic disease.”

Two 48-week, placebo-controlled clinical studies involving 213 patients, one in patients ages 12 years and older and another in patients ages 6 years to 11 years, were used to evaluate the safety and efficacy of Kalydeco in CF patients with the G551D mutation. In both studies, treatment with Kalydeco resulted in significant and sustained improvement in lung function.

Kalydeco is effective only in patients with CF who have the G551D mutation. It is not effective in CF patients with two copies of the F508 mutation in the CFTR gene, which is the most common mutation that results in CF. If a patient’s mutation status is not known, an FDA-cleared CF mutation test should be used to determine whether the G551D mutation is present.

The most common side effects of Kalydeco include upper respiratory tract infection, headache, stomach ache, rash, diarrhea, and dizziness.

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The long-term use of bisphosphonate medications and the connection to atypical fractures of the upper thigh bone are being examined in recent studies and reports conducted by the American Academy of Orthopaedic Surgeons (AAOS), the U.S. Food and Drug Administration (FDA), The European Society on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the International Osteoporosis Foundation (IOF).

Bisphosphonate medications, including Fosamax, Actonel, Boniva and Reclast, are designed to help strengthen bones in patients with osteoporosis and reduce the rate of osteoporotic fractures which can result in hospitalization or surgery.  Bisphosphonates, used to stop the loss of bone mass, may be increasing the risk of rare, but serious, atypical femur fractures.  The thigh bone fracture is primarily seen in patients taking bisphosphonates for longer than five years.

According to the Journal of the American Medical Association, women 68-years-old and older who have been on bisphosphonates for more than five years are 2.7 times more likely to be hospitalized for fractures.

Researchers assert that the risks of osteoporosis medications is far outweighed by the benefits.  A Position Paper written by the ESCEO and the IOF concluded that there is approximately one per 1,000 patients per year with atypical fractures related to bisphosphonate use.  The Los Angeles Times “Booster Shots” blog reported that a study showed that out of 205,466 women over the age of 68 with osteoporosis who took bisphosphonates for multiple years, 716 had an atypical fracture.

In a study conducted by Melvin Rosenwasser, MD, a surgeon and director of the orthopedic hand and trauma service at New York-Presbyterian Hospital, it was determined that long-term use of bisphosphonate treatments showed noticeable changes to the structure of bones.  The study that Rosenwasser and his colleagues performed included 112 postmenopausal women with osteoporosis.  Of the participants, 62 were on bisphosphonate medications for at least four years.

Through the use of X-ray scans, Rosenwasser was able to conclude that the longer the bisphosphonate treatment, the more the structural integrity of bones declined.  There was a 3.8 to 1.3 percent decline after at least four years on medication.  “We think something is happening over time that may be changing the character of the bone,” Dr. Rosenwasser said.

It was recommended by a published study in the Journal of the American Medical Association that patients might consider taking a “drug holiday” after five years of taking bisphosphonate medication.  These medications are nonetheless a valuable help to osteoporosis patients.

The American Society of Bone Mineral Research Task Force reported that the FDA should include additional product labeling, better identification and tracking of patients experiencing these breaks, along with further research.  The FDA has reviewed all of these recommendations and all available data on bisphosphonate usage.

Professor Rene Rizzoli of the Division of Bone Diseases at the University of Geneva and the primary author of the ESCEO and IOF Position Paper said, “While we urge patients to discuss their concerns with their doctors, it is important that they do not stop taking their prescribed bisphosphonate therapy and so leave themselves open to the higher risk of osteoporotic fracture.”

Osteoporosis patients taking bisphosphonate medication should be handled on a personal case-to-case basis.  Conclusions should not be made based on what happened with other patients.

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