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Juvisync Approved for Combined Treatment of Diabetes and High Cholesterol

October 7, 2011 By Leave a Comment

First combination drug to treat type 2 diabetes and high cholesterol in one tablet.

The U.S. Food and Drug Administration (FDA) today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions, particularly if left untreated or poorly treated.

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body’s own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of “bad cholesterol” (low-density lipoprotein cholesterol or LDL-C) in the blood.

“This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet,” said Mary H. Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients. Dose selection should factor in what other drugs the patient is taking.”

This FDC is based on substantial experience with both sitagliptin and simvastatin, and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately. Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs.

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The company has committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop FDCs with the sitagliptin 25 mg dose as use of this dose is quite low.

Simvastatin is currently marketed in dosage strengths of 5, 10, 20, 40, and 80 mg. Due to recent restrictions placed on the use of the 80 mg dose because of a higher risk of muscle toxicity, there will not be a FDC using this dose. There is also no plan to develop FDCs with the simvastatin 5 mg dose as use of this dose is quite low as well.

The FDA has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes. This risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes. However, the prescribing information for Juvisync will inform doctors of this possible side effect. The company will also be required to conduct a post-marketing clinical trial comparing the glucose lowering ability of sitagliptin alone compared to sitagliptin given with simvastatin.

Juvisync is approved with a Medication Guide that provides important information to patients. The most common side effects of Juvisync include upper respiratory infection; stuffy or runny nose and sore throat; headache; muscle and stomach pain; constipation; and nausea.

Juvisync is manufactured by MSD International GmbH Clonmel, Co. in Tipperary, Ireland.

Source: FDA

Filed Under: Cholesterol, Diabetes Tagged With: , , , , , , , , , ,

FDA Awards Grants to Encourage Pediatrics Medical Device Development

October 3, 2011 By Leave a Comment

The U.S. Food and Drug Administration today announced the awards of three grants to boost the development and availability of medical devices for children.

A panel of five experts with experience in medicine, business, and device development reviewed 10 applications for the grants, which will be administered by the FDA’s Office of Orphan Products Development. The recipients and grant amounts include:

• James Geiger, M.D. and Andre Muelenaer, M.D. of the University of Michigan Pediatric Device Consortium and the Pediatric Medical Device Institute Pediatric Medical Device Consortium, $1.1 million a year for two years.
• Michael Harrison, M.D. and the University of California, San Francisco Pediatric Device Consortium, $500,000 a year for two years.
• Barbara Boyan, Ph.D. and the Atlanta Pediatric Consortium, $900,000 a year for two years.

“Congress provides FDA with this funding so that we can help connect innovators and their ideas to experienced professionals who can assist them through development,” said Debra Lewis, O.D., acting director of the FDA’s Office of Orphan Product Development. “Development of medical devices for children lags up to a decade behind similar devices used in adults.”

Children differ in terms of size, growth, and body chemistry and present unique challenges to device designers. In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children. While this program is administered by the Office of Orphan Products Development, it is intended to encompass devices used in all pediatric diseases, not just rare diseases.

Legislation passed by Congress in 2007 established funding for grants to nonprofit groups to help stimulate projects to promote the development and availability of pediatric medical devices. These grants are meant to encourage the development of multiple pediatric device projects. While a small portion of the grants fund specific projects, the real spirit of this grant program is to provide information clearinghouses to promote multiple projects.

This is the second round of this type of biennial grants to be awarded. Those receiving these grants will:

  • encourage innovation and connect qualified individuals with good pediatric device ideas to potential manufacturers
  • mentor and manage pediatric device projects through their development, including prototype design and marketing
  • connect innovators and physicians to existing federal and non-federal resources
  • assess the scientific and medical merit of proposed pediatric projects and provide assistance and advice on business development, training, prototype development and post-marketing needs.

As part of the legislation, each of the grant recipients will coordinate among the FDA, device companies, and the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate research and any necessary applications for device approval or clearance.

Past grant awardees have assisted in the development of devices to treat scoliosis, pediatric valvular heart disease, and projectile vomiting in newborns, among other diseases.

 

Source: FDA

Filed Under: Pediatrics & Parenting Tagged With: , , , , , , , , , , ,

Rotavirus Vaccine Leads to Lower Doctor Visits and Health Care Costs

September 30, 2011 By Leave a Comment

Vaccinating infants against rotavirus has resulted in dramatic decreases in health care use and treatment costs for diarrhea–related illness in U.S. infants and young children, according to a new study by the Centers for Disease Control and Prevention. The study is published in the current issue of the New England Journal of Medicine.

“This is good news for parents and our health system overall,” said Dr. Umesh Parashar, medical epidemiologist and team leader for the Viral Gastroenteritis Team in CDC′s Division of Viral Diseases. “Rotavirus vaccine is one of the most effective ways to prevent severe diarrhea–related illness in young children and keep them healthy.”

Rotavirus is a major cause of severe diarrhea in infants and young children in the United States. Before vaccines were introduced in 2006, rotavirus was responsible for about 400,000 visits to doctor′s offices, 200,000 emergency room visits, 55,000 to 70,000 hospitalizations, and 20 to 60 deaths each year in children under 5 years old.

RotaTeq and Rotarix, the two U.S. licensed rotavirus vaccines, were 85 to 98 percent effective at preventing severe rotavirus disease in clinical trials in middle and high income countries, including the United States.

This new study used data from a large U.S. insurance database for 2001 to 2009 to assess rotavirus vaccine coverage and its impact on health care use and treatment costs for diarrhea–related illness in children under 5 years old. The study examined direct benefits to vaccinated children and indirect protective benefits to unvaccinated children. National declines in health care use and treatment costs were estimated by applying the declines seen in this study to children under 5 years old in the U.S population.

By the end of 2008, 73 percent of children under 1 year of age, 64 percent of 1–year–olds, and 8 percent of 2– to–4–year–olds had received at least one dose of rotavirus vaccine. Rotavirus–related hospitalizations decreased substantially compared with pre–vaccine levels in children under 5 years old—75 percent decline for 2007–2008 and 60 percent decline for 2008–2009.

Vaccinated children had 44 to 58 percent fewer diarrhea–related hospitalizations and 37 to 48 percent fewer emergency room visits for diarrhea than unvaccinated children during the 2008 and 2009 rotavirus seasons (January to June). Even in unvaccinated children, there were substantial declines in health care use during the 2008 rotavirus season compared with pre–vaccine levels—showing indirect protective benefits.

The study estimated that about 65,000 hospitalizations of children under 5 years old from 2007 to 2009 were averted nationally with a health care cost savings of about $278 million.

“This study provides more evidence that vaccinating against rotavirus substantially reduces suffering and health care costs for this common childhood illness,” said Dr. Mark Pallansch, director of CDC′s Division of Viral Diseases. “As more children get vaccinated against rotavirus, we expect to see even greater reductions in disease among all age groups.”

Source: CDC

Filed Under: Pediatrics & Parenting Tagged With: , , , , ,

Flu Prevention for Children and Teens – Report

September 15, 2011 By Leave a Comment

Although children and teenagers rarely die from flu–related causes, many of the deaths could have been prevented if the children had been vaccinated against the flu, according to a report by the Centers for Disease Control and Prevention.

The study reports 115 influenza–associated deaths of people younger than 18, from September 2010 through August 2011 and highlights the importance of both annual vaccination and rapid antiviral treatment.

“It′s vital that children get vaccinated,” said Dr. Lyn Finelli, chief of the CDC′s Surveillance and Outbreak Response Team. “We know the flu vaccine isn′t 100 percent effective, especially not in children with high risk medical conditions. That′s why it′s essential that these two medical tools be fully utilized. Vaccinate first; then use influenza antiviral drugs as a second line of defense against the flu. Right now we aren′t fully using the medical tools at our disposal to prevent flu illnesses and deaths in children.”

The study in CDC′s Morbidity and Mortality Weekly Report provides details on the deaths. Since 2004, states have been required to report influenza-associated deaths in children and teenagers, giving the CDC a chance to look closely at factors that can increase risk.

Among the most notable findings was the infrequent use of the most important influenza prevention measure – vaccination. Despite a recommendation for vaccination of all children 6 months of age and older having been in place since 2008, only 23 percent of the 74 children older than six months with a known vaccination history had received their flu vaccine last season.

While many people believe that healthy children can withstand a bout of flu, this is not always the case. About half of the children who died last season were previously healthy and did not have a medical condition that would put them at risk for flu complications. However, the report underscores the fact that young age in itself is a risk factor. The report identified that 46 percent of the children who died were younger than 5 years and 29 percent were younger than 2 years.

The other half of the children who died did have a medical condition that predisposed them to being at greater risk of flu complications. Of 57 children with a medical condition, 54 percent had a neurological disorder, 30 percent had pulmonary disease, 25 percent had a chromosome or genetic disorder and 19 percent had congenital heart disease or other cardiac disease.

The report also identified issues with the use of antiviral drugs, which provide effective treatment for influenza. Of the 94 children who died in a hospital or emergency department, only 50 percent were prescribed antiviral drugs. Since the 2009 H1N1 pandemic especially, CDC has recommended immediate treatment with influenza antiviral medications in severely ill patients with suspected flu.

Another report in the Sept. 16 MMWR provides a summary of influenza activity from mid–May to the beginning of September. “If trends in that report continue,” Finelli says, “we should have a vaccine that will offer good protection against the viruses we expect will circulate this season.”

This season′s influenza vaccine protects against three influenza viruses, the 2009 influenza A (H1N1) virus, an influenza A (H3N2) virus, and an influenza B virus. These are the same three flu virus strains that were circulating in 2010–2011 – just the eighth time since 1969 this phenomenon has occurred. Moreover, it is important to note that vaccine immunity wanes over time so CDC is recommending that everyone get vaccinated this season, even if they got vaccinated last season, in order to be optimally protected.

Source: CDC

Filed Under: Infectious Diseases, Pediatrics & Parenting Tagged With: , , , ,

Lung Cancer Rates on the Decline

September 15, 2011 By Leave a Comment

The rates of new lung cancer cases in the United States dropped among men in 35 states and among women in 6 states between 1999 and 2008 Among women, lung cancer incidence decreased nationwide between 2006 and 2008, after increasing steadily for decades.

The decrease in lung cancer cases corresponds closely with smoking patterns across the nation. In the West, where smoking prevalence is lower among men and women than in other regions, lung cancer incidence is decreasing faster. Studies show declines in lung cancer rates can be seen as soon as five years after smoking rates decline.

The report also noted that states that make greater investments in effective tobacco control strategies see larger reductions in smoking; and the longer they invest, the greater the savings in smoking–related health care costs. Such strategies include higher tobacco prices, hard–hitting media campaigns, 100 percent smoke-free policies, and easily accessible quitting treatments and services for those who want to quit.

“Although lung cancer among men and women has decreased over the past few years,” said CDC Director Thomas R. Frieden, M.D., M.P.H. “too many people continue to get sick and die from lung cancers, most of which are caused by smoking.  The more we invest in proven tobacco control efforts, the fewer people will die from lung cancer.”

Lung cancer is the most commonly diagnosed cancer that affects both men and women, and is the leading cause of cancer death in the United States. Cigarette smoking and exposure to secondhand smoke cause most lung cancer deaths in the United States. To further reduce lung cancer incidence, intensified efforts to reduce smoking are needed.

For this report, researchers analyzed lung cancer data from CDC′s National Program of Cancer Registries and the National Cancer Institute′s Surveillance, Epidemiology, and End Results Program. They estimated smoking behavior by state using the CDC′s Behavioral Risk Factor Surveillance System.

Study findings include:

  • Among men, lung cancer rates continued to decrease nationwide.
  • From 1999 to 2008 lung cancer rates among men decreased in 35 states and remained stable in nine states (change could not be assessed in six states and the District of Columbia).
  • States with the lowest lung cancer incidence among men were clustered in the West.
  • After increasing for years, lung cancer rates among women decreased nationwide between 2006 and 2008.
  • Lung cancer rates decreased between 1999 and 2008 among women in California, Florida, Nevada, Oregon, Texas, and Washington.
  • Lung cancer rates among women remained stable in 24 states, and increased slightly in 14 states (change could not be assessed in six states and the District of Columbia).

Source: CDC

Filed Under: Cancer, Smoking Tagged With: , , , ,

Two Doses of HPV Vaccine May Protect as Much as Standard 3-dose Course

September 9, 2011 By Leave a Comment

Two doses of the human papillomavirus (HPV) vaccine Cervarix were as effective as the current standard three-dose regimen after four years of follow-up, according to researchers from the National Cancer Institute (NCI), part of the National Institutes of Health, and their colleagues. The results of the study, based on data from a community-based clinical trial of Cervarix in Costa Rica, appeared online Sept.9, 2011, in the Journal of the National Cancer Institute.

Worldwide, approximately 500,000 new cases of cervical cancer are diagnosed every year, and about 250,000 women die from the disease. An overwhelming majority of these new cases and deaths occur in low-resource countries. Virtually all cases of cervical cancer are caused by persistent infection with HPV. Cervarix is one of two vaccines approved by the U.S. Food and Drug Administration to protect against persistent infection with two carcinogenic HPV types, 16 and 18, which together account for 70 percent of all cervical cancer cases. The vaccine is intended to be administered in three doses given over the course of six months. To date, investigators have observed up to eight years of protection from persistent HPV infection with the vaccine. Studies are ongoing to determine the maximum length of protection.

The cost of the vaccine as well as the logistical difficulties of administering three doses to an adolescent population in resource-poor countries is greater than administering two doses. Even in wealthier countries such as the United States, few adolescent females complete the entire course of three vaccinations. According the Centers for Disease Control and Prevention, although approximately 49 percent of American girls ages 13 to 17 received one dose of the vaccine in 2010, only 32 percent received all three doses. In the United States, the predominately used HPV vaccine is Gardasil, which has a different formulation than Cervarix. Gardasil also protects against up to 90 percent of genital warts because it targets HPV strains 6 and 11 as well as 16 and 18.

The NCI-sponsored Costa Rica Vaccine Trial was designed to assess the efficacy of Cervarix in a community-based setting. Women ages 18 to 25 years were randomly assigned to receive the HPV vaccine or a Hepatitis A vaccine as the control treatment. Although the investigators intended to administer all three doses of the assigned vaccine to all 7,466 women in the study, about 20 percent of the participants received only one or two doses of the HPV or control vaccine. A third of women did not complete the vaccine series because they became pregnant or were found to have possible cervical abnormalities, reasons that would not likely bias the findings.

The investigators found that, after four years of follow up, two doses of the vaccine conferred the same strong protection against persistent infection with HPV 16 and 18 as did the full three-dose regimen. From just a single dose, they also observed a high level of protection, but they are cautious about the long-term efficacy of a single dose because other vaccines of this type usually require a booster dose. Additional studies are needed to evaluate the efficacy of a single dose, as well as the duration of protection for both one and two doses.

“Our study provides evidence that an HPV vaccine program using two doses will work. It may be that vaccinating more women, with fewer doses for each, will reduce cervical cancer incidence more than a standard three-dose program that vaccinates fewer women,” said Aimée R. Kreimer, Ph.D., lead author and investigator in NCI’s Division of Cancer Epidemiology and Genetics. “The main question will be whether the duration of protection from fewer doses is adequate.”

Kreimer emphasized that findings from this study of the Cervarix vaccine in women in Costa Rica may not be relevant for all populations, such as those in which HIV infection, malnutrition, or endemic diseases may influence the immune response. In addition, it is not known whether the same results would be obtained with the other FDA-approved HPV vaccine, Gardasil, because the vaccine formulations are different.

“Further studies are needed to confirm our findings in other populations as well as to quantify the duration of protection for fewer than three doses,” said Kreimer. “If other studies confirm that fewer than three doses provide adequate protection against persistent cervical HPV 16 and 18 infection, we may be one step closer to prevention of cervical cancer, especially for women in resource-poor settings, where the need is greatest.”

It is important to note that regulatory agencies have approved the HPV vaccine based on prevention of cervical precancers, not persistent infections. From studying the natural history of HPV and cervical cancer, experts know that persistent infections are first steps toward precancer. Furthermore, vaccine recommendations take into consideration many factors and studies. In the United States, the CDC’s Advisory Committee on Immunization Practices determines federal recommendations regarding vaccination.

This study was carried out by an international team of experts from the NCI, the Costa Rica HPV Vaccine Trial, and colleagues at DDL Diagnostic Laboratory in the Netherlands.


Source: NIH

Filed Under: Sexual Health Tagged With: ,

Violence During Pregnancy Can Lead to Reduced Infant Birth Weight

September 8, 2011 By Leave a Comment

Pregnant women who are assaulted by an intimate partner are at increased risk of giving birth to infants of reduced weight, according to a population-level analysis of domestic violence supported by the National Institutes of Health.

The study analyzed medical records of more than 5 million pregnant women in California over a 10-year period. Although the results showed a pattern of low-weight births among women who experienced an assault, the study was not designed to establish cause and effect, and so could not prove that violence caused the reduced birth weights. Similarly, the study was not designed to provide a biological explanation for how violence against an expectant mother might cause her child to be of lower birth weight.

Infants born to women who were hospitalized for injuries received from an assault during their pregnancies weighed, on average, 163 grams, or one-third pound, less than did infants born to women who were not hospitalized, the study found. Assaults in the first trimester were associated with the largest decrease in birth weight.

Infants born weighing less than 2,500 grams, or 5.5 pounds, are considered low birth weight and have an increased risk of death or of developing several health and developmental disorders. Low birth weight infants also are at greater risk for sudden infant death syndrome (SIDS) as well as breathing problems, cerebral palsy, heart disorders and learning disabilities. The study found that among infants born to mothers who had experienced an assault, about 15 percent weighed less than 2,500 grams at birth. This rate was higher than the rate of low birth weight infants among pregnant women who were hospitalized after a car crash or for other injuries (8 to 10 percent) and more than double the rate among women who were not hospitalized while pregnant (6 percent).

Although women’s education level, rates of smoking, and nutritional habits are known to affect birth weight, the study concluded that the lower birth weights seen in the study could not be accounted for by these factors and were most strongly linked to the violence itself.

“These findings suggest that violence experienced by pregnant women could put their infants at increased risk for low birth weight and its subsequent health problems,” said Rosalind B. King, Ph.D., of the Demographic and Behavioral Sciences Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the NIH institute that funded the study. “It follows that programs to reduce violence against women might have the added benefit of reducing the number of low birth weight infants.”

The study was conducted by Anna Aizer, Ph.D., of Brown University, Providence, R.I. Her findings were published online in the Journal of Human Resources.

Using data collected between 1991 and 2002, Dr. Aizer compared the birth records in California to the records of pregnant women hospitalized in California as a result of injuries from assault.

She found that for every 100,000 women who gave birth in that period, 31 had been hospitalized for an injury from an assault while they were pregnant. Although these data did not distinguish between domestic violence and violence from other types of assault, previous research has shown that 87 percent of pregnant women with injuries were injured by an intimate partner.

The overall rate of assaults was 31 per 100,000 women. The study documented higher rates of assault among the poor (49.5 per 100,000), black women (157 per 100,000), and those without a high school education (39 per 100,000).

Dr. Aizer theorized that higher rates of violence among poor women might be a root cause of poor health and poverty that persists in some families from one generation to the next. A connection between violence during pregnancy, adult health, and future earnings is possible because all three factors are linked to low birth weight. Poor women are at greater risk for having low birth weight infants than are other women. In turn, when they reach adulthood, individuals born at low birth weight are at increased risk for such adult health problems as diabetes and heart disease. Also, when they reach adulthood, individuals born at low birth weight infants also earn less than their counterparts who were born at normal birth weight.

“The costs of violence against women may be borne not just by the victims but by the next generation as well,” said Dr. Aizer. “Given the importance of birth weight in determining adult education and income, these results suggest that the higher levels of violence experienced by poor women may also contribute to the intergenerational persistence of poverty.”

The American College of Obstetricians and Gynecologists has developed a slide presentation for physicians, advising them on how to screen patients for intimate partner violence, how to assess patients’ safety, and where to refer patients for additional help.

via Violence during pregnancy linked to reduced birth weight, September 8, 2011 News Release – National Institutes of Health (NIH).

Filed Under: Pediatrics & Parenting Tagged With: ,

Asthma Rates in U.S. Rising

May 3, 2011 By Leave a Comment

People diagnosed with asthma in the United States grew by 4.3 million between 2001 and 2009, with nearly 1 in 12 Americans diagnosed with asthma. In addition to increased diagnoses, asthma costs grew from about $53 billion in 2002 to about $56 billion in 2007, about a 6 percent increase. The explanation for the growth in asthma rates is unknown.

Asthma is a lifelong disease that causes wheezing, breathlessness, chest tightness, and coughing, though people with asthma can control symptoms and prevent asthma attacks by avoiding things that can set off an asthma attacks, and correctly using prescribed medicine, like inhaled corticosteroids. The report highlights the benefits of essential asthma education and services that reduce the impact of these triggers, but most often these benefits are not covered by health insurers.

“Despite the fact that outdoor air quality has improved, we’ve reduced two common asthma triggers—secondhand smoke and smoking in general—asthma is increasing,” said Paul Garbe, D.V.M., M.P.H, chief of CDC’s Air Pollution and Respiratory Health Branch. “While we don’t know the cause of the increase, our top priority is getting people to manage their symptoms better.”

Asthma triggers are usually environmental and can be found at school, work, home, outdoors, and elsewhere and can include tobacco smoke, mold, outdoor air pollution, and infections linked to influenza, cold-like symptoms, and other viruses.

Asthma diagnoses increased among all demographic groups between 2001 and 2009, though a higher percentage of children reported having asthma than adults (9.6 percent compared to 7.7 percent in 2009), Diagnoses were especially high among boys (11.3 percent). The greatest rise in asthma rates was among black children (almost a 50 percent increase) from 2001 through 2009. Seventeen percent of non-Hispanic black children had asthma in 2009, the highest rate among racial/ethnic groups.

Annual asthma costs in the United States were $3,300 per person with asthma from 2002 to 2007 in medical expenses. About 2 in 5 uninsured and 1 in 9 insured people with asthma could not afford their prescription medication.

“Asthma is a serious, lifelong disease that unfortunately kills thousands of people each year and adds billions to our nation’s health care costs,” said CDC Director Thomas R. Frieden, M.D., M.P.H. “We have to do a better job educating people about managing their symptoms and how to correctly use medicines to control asthma so they can live longer more productive lives while saving health care costs.”

This report coincides with World Asthma Day, an annual event sponsored by the Global Initiative for Asthma. This year’s theme is “You Can Control Your Asthma.” Reducing asthma attacks and the human and economic costs of asthma are key priorities for the U.S. Department of Health and Human Services and the focus of a collaborative effort involving many parts of HHS. In support of this effort CDC recommends:

  • Improving indoor air quality for people with asthma through measures such as smoke-free air laws and policies, healthy schools and workplaces.
  • Teach patients how to avoid asthma triggers such as tobacco smoke, mold, pet dander, and outdoor air pollution.
  • Encouraging clinicians to prescribe inhaled corticosteroids for all patients with persistent asthma and to use a written asthma action plan to teach patients how manage their symptoms.
  • Promoting measures that prevent asthma attacks such as increasing access to corticosteroids and other prescribed medicines.
  • Encourage home environmental assessments and educational sessions conducted by clinicians, health educators, and other health professionals both within and outside of the clinical setting.

The figures were reported in Vital Signs, released today by the Centers for Disease Control and Prevention.

Source: CDC

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Medical Costs for Youth With Diabetes 6x Higher

April 27, 2011 By 1 Comment

Young people with diabetes face substantially higher medical costs than children and teens without the disease, according to a recent article in the May issue of the journal Diabetes Care. The study found annual medical expenses for youth with diabetes are $9,061, compared to $1,468 for youth without the disease.

Much of the extra medical costs come from prescription drugs and outpatient care. Young people with the highest medical costs were treated with insulin, and included all those with type 1 diabetes and some with type 2 diabetes. People with type 1 diabetes cannot make insulin anymore and must receive insulin treatment. Some people with type 2 diabetes also are treated with insulin, because their bodies do not produce enough to control blood glucose (sugar).

Children and adolescents who received insulin treatment had annual medical costs of $9,333, compared to $5,683 for those who did not receive insulin, but did take oral medications to control blood glucose.

“Young people with diabetes face medical costs that are six times higher than their peers without diabetes,” said Ann Albright, Ph.D., R.D., director of CDC’s Division of Diabetes Translation. “Most youth with diabetes need insulin to survive and the medical costs for young people on insulin were almost 65 percent higher than for those who did not require insulin to treat their diabetes.”

The study examined medical costs for children and teens aged 19 years or younger who were covered by employer-sponsored private health insurance plans in 2007, using the MarketScan Commercial Claims and Encounters Database. The estimates were based on administrative claim data from nearly 50,000 youth, including 8,226 with diabetes.

Medical costs for people with diabetes, the vast majority of whom are adults, are 2.3 times higher than costs for those without diabetes, according to CDC’s National Diabetes Fact Sheet, 2011. Authors of the Diabetes Care study suggest that the difference in medical costs associated with diabetes may be greater for youth than for adults because of higher medication expenses, visits to specialists and medical supplies such as insulin syringes and glucose testing strips.

Among youth with diabetes, 92 percent were on insulin, compared to 26 percent of adults with diabetes. Insulin is a hormone produced by the pancreas that helps convert blood glucose into energy. Without adequate insulin, blood glucose levels rise and can eventually lead to serious health complications, including heart disease, kidney failure, blindness, nerve damage and amputation of feet and legs.

Type 1 diabetes develops when the body’s immune system destroys insulin-producing beta cells in the pancreas. Risk factors may be genetic or environmental. There is no known way to prevent type 1 diabetes.

In type 2 diabetes, the body no longer handles insulin properly and gradually loses the ability to produce it. Risk factors include obesity, older age, family history, physical inactivity, history of diabetes while pregnant, and race/ethnicity. Type 2 diabetes is extremely rare in children younger than 10 years. Although type 2 diabetes is infrequent in children and teens aged 10 to 19 years, rates are higher in this group compared to younger children, with higher rates among minorities.

Source: CDC; Diabetes Care, May 2011

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Alzheimer’s Diagnostic Guidelines Updated for First Time in 27 Years

April 19, 2011 By Leave a Comment

For the first time in 27 years, clinical diagnostic criteria for Alzheimer’s disease dementia have been revised, and research guidelines for earlier stages of the disease have been characterized to reflect a deeper understanding of the disorder.

The National Institute on Aging/Alzheimer’s Association Diagnostic Guidelines for Alzheimer’s Disease outline some new approaches for clinicians and provides scientists with more advanced guidelines for moving forward with research on diagnosis and treatments. They mark a major change in how experts think about and study Alzheimer’s disease. Development of the new guidelines was led by the National Institutes of Health and the Alzheimer’s Association.

The original criteria were the first to address the disease and described only later stages, when symptoms of dementia are already evident. The updated guidelines announced today cover the full spectrum of the disease as it gradually changes over many years. They describe the earliest preclinical stages of the disease, mild cognitive impairment, and dementia due to Alzheimer’s pathology. Importantly, the guidelines now address the use of imaging and biomarkers in blood and spinal fluid that may help determine whether changes in the brain and those in body fluids are due to Alzheimer’s disease. Biomarkers are increasingly employed in the research setting to detect onset of the disease and to track progression, but cannot yet be used routinely in clinical diagnosis without further testing and validation.

“Alzheimer’s research has greatly evolved over the past quarter of a century. Bringing the diagnostic guidelines up to speed with those advances is both a necessary and rewarding effort that will benefit patients and accelerate the pace of research,” said National Institute on Aging Director Richard J. Hodes, M.D.

“We believe that the publication of these articles is a major milestone for the field,” said William Thies, Ph.D., chief medical and scientific officer at the Alzheimer’s Association. “Our vision is that this process will result in improved diagnosis and treatment of Alzheimer’s, and will drive research that ultimately will enable us to detect and treat the disease earlier and more effectively. This would allow more people to live full, rich lives without — or with a minimum of — Alzheimer’s symptoms.”

The new guidelines appear online April 19, 2011 in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association. They were developed by expert panels convened last year by the National Institute on Aging (NIA), part of the NIH, and the Alzheimer’s Association. Preliminary recommendations were announced at the Association’s International Conference on Alzheimer’s Disease in July 2010, followed by a comment period.

Guy M. McKhann, M.D., Johns Hopkins University School of Medicine, Baltimore, and David S. Knopman, M.D., Mayo Clinic, Rochester, Minn., co-chaired the panel that revised the 1984 clinical Alzheimer’s dementia criteria. Marilyn Albert, Ph.D., Johns Hopkins University School of Medicine, headed the panel refining the MCI criteria. Reisa A. Sperling, M.D, Brigham and Women’s Hospital, Harvard Medical School, Boston, led the panel tasked with defining the preclinical stage. The journal also includes a paper by Clifford Jack, M.D., Mayo Clinic, Rochester, Minn., as senior author, on the need for and concept behind the new guidelines.

The original 1984 clinical criteria for Alzheimer’s disease, reflecting the limited knowledge of the day, defined Alzheimer’s as having a single stage, dementia, and based diagnosis solely on clinical symptoms. It assumed that people free of dementia symptoms were disease-free. Diagnosis was confirmed only at autopsy, when the hallmarks of the disease, abnormal amounts of amyloid proteins forming plaques and tau proteins forming tangles, were found in the brain.

Since then, research has determined that Alzheimer’s may cause changes in the brain a decade or more before symptoms appear and that symptoms do not always directly relate to abnormal changes in the brain caused by Alzheimer’s. For example, some older people are found to have abnormal levels of amyloid plaques in the brain at autopsy yet never showed signs of dementia during life. It also appears that amyloid deposits begin early in the disease process but that tangle formation and loss of neurons occur later and may accelerate just before clinical symptoms appear.

To reflect what has been learned, the National Institute on Aging/Alzheimer’s Association Diagnostic Guidelines for Alzheimer’s Disease cover three distinct stages of Alzheimer’s disease:

  • Preclinical — The preclinical stage, for which the guidelines only apply in a research setting, describes a phase in which brain changes, including amyloid buildup and other early nerve cell changes, may already be in process. At this point, significant clinical symptoms are not yet evident. In some people, amyloid buildup can be detected with positron emission tomography (PET) scans and cerebrospinal fluid (CSF) analysis, but it is unknown what the risk for progression to Alzheimer’s dementia is for these individuals. However, use of these imaging and biomarker tests at this stage are recommended only for research. These biomarkers are still being developed and standardized and are not ready for use by clinicians in general practice.
  • Mild Cognitive Impairment (MCI) — The guidelines for the MCI stage are also largely for research, although they clarify existing guidelines for MCI for use in a clinical setting. The MCI stage is marked by symptoms of memory problems, enough to be noticed and measured, but not compromising a person’s independence. People with MCI may or may not progress to Alzheimer’s dementia. Researchers will particularly focus on standardizing biomarkers for amyloid and for other possible signs of injury to the brain. Currently, biomarkers include elevated levels of tau or decreased levels of beta-amyloid in the CSF, reduced glucose uptake in the brain as determined by PET, and atrophy of certain areas of the brain as seen with structural magnetic resonance imaging (MRI). These tests will be used primarily by researchers, but may be applied in specialized clinical settings to supplement standard clinical tests to help determine possible causes of MCI symptoms.
  • Alzheimer’s Dementia — These criteria apply to the final stage of the disease, and are most relevant for doctors and patients. They outline ways clinicians should approach evaluating causes and progression of cognitive decline. The guidelines also expand the concept of Alzheimer’s dementia beyond memory loss as its most central characteristic. A decline in other aspects of cognition, such as word-finding, vision/spatial issues, and impaired reasoning or judgment may be the first symptom to be noticed. At this stage, biomarker test results may be used in some cases to increase or decrease the level of certainty about a diagnosis of Alzheimer’s dementia and to distinguish Alzheimer’s dementia from other dementias, even as the validity of such tests is still under study for application and value in everyday clinical practice.

The panels purposefully left the guidelines flexible to allow for changes that could come from emerging technologies and advances in understanding of biomarkers and the disease process itself.

“The guidelines discuss biomarkers currently known, and mention others that may have future applications,” said Creighton H. Phelps, Ph.D., of the NIA Alzheimer’s Disease Centers Program. “With researchers worldwide striving to develop, validate and standardize the application of biomarkers at every stage of Alzheimer’s disease, we devised a framework flexible enough to incorporate new findings.”

Source: NIH

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