Sinusitis refers to inflamed sinuses normally caused by a bacterial, fungal or viral infection, the U.S. National Library of Medicine says.

The agency says these common warning signs may indicate sinusitis:
-Cold symptoms that persist for more than five to seven days.
-Inability to smell, drainage into the back of the throat, or a sore throat.
-Headache and pressure or tenderness in the face — surrounding the eyes and sometimes affecting the teeth.
-Nasal congestion, bad breath or runny nose.
-Coughing, particularly at night.
-Fever, fatigue and general feeling of illness.

The U.S. Food and Drug Administration today approved Arzerra (ofatumumab) for patients with chronic lymphocytic leukemia (CLL), a slowly progressing cancer of the blood and bone marrow.

Arzerra is approved for patients with CLL whose cancer is no longer being controlled by other forms of chemotherapy.

CLL primarily affects people older than 50 and arises from a group of white blood cells known as B-cells that are part of the body’s immune system. Each year, about 16,000 people are diagnosed with CLL and about 4,400 people die from the disease.

Arzerra is a monoclonal antibody, a type of biotechnology product. Antibodies that occur in nature are produced by the immune system in response to invaders. Arzerra binds to a specific protein found on the surface of both normal and malignant B cells, making the cells more susceptible to immune system attack.

The product was approved under the FDA’s accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. Products may receive accelerated approval based on a surrogate endpoint, such as a reduction in the size of the tumor or decrease in the number of cancerous white cells or in an enlarged spleen or lymph nodes. These indirect measures for clinical outcomes are considered reasonably likely to predict that the drug will allow patients to live longer or with fewer side effects of a disease.

“The approval of Arzerra illustrates FDA’s commitment to using the accelerated approval process to approve drugs for patients who have limited therapeutic options,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research.

The accelerated approval process requires further study of the drug. The manufacturer is currently conducting a clinical trial in CLL patients to confirm that the addition of Arzerra to standard chemotherapy delays the progression of the disease.

Arzerra’s effectiveness was evaluated in 59 patients with CLL whose disease no longer responded to the available therapies.

The product’s safety was evaluated in 181 patients in two studies in patients with cancer. Common side effects included a decrease in normal white blood cells, pneumonia, fever, cough, diarrhea, lower red blood cell counts, fatigue, shortness of breath, rash, nausea, bronchitis and upper respiratory tract infections.

The most serious side effects of Arzerra are increased chance of infections, including progressive multifocal leukoencephalopathy (PML), a brain infection that is generally fatal. Patients at high risk for Hepatitis B should be screened before being treated with Arzerra. Patients with evidence of inactive hepatitis should be monitored for re-activation of the infection during and after completing treatment.

Adding insulin to standard diabetes drugs results in better blood sugar control for many with type 2 diabetes, British researchers report, and the dose and timing of insulin received can make a big difference.

Specifically, a once-a-day, long-acting dose of insulin may be the best approach for patients making the move to insulin therapy, the study found.

Keeping blood sugar under control reduces the risk of complications in type 2 diabetes. But diabetes is also a progressive disease, which disrupts insulin production. Consequently, for many diabetes patients, the drugs used to control blood sugar need to be increased repeatedly and most patients will eventually need to take insulin, the researchers said.

“Any treatment which keeps blood sugar under control will minimize risk of complications, but in the end insulin may be the only effective way of doing this,” explained lead researcher Dr. Rury Holman, a professor of diabetic medicine at the University of Oxford. “The vast majority will need insulin in the longer term.”

The report is published in the Oct. 22 online edition of the New England Journal of Medicine, to coincide with its presentation at the 20th World Diabetes Congress in Montreal. The study received funding from drug maker Novo Nordisk and the nonprofit group Diabetes UK.

For the study, Holman’s team compared different forms of insulin therapy for patients with type 2 diabetes. Insulin treatment can start with a “basal” dose that is long-acting, a “prandial” or mealtime dose of insulin that is short-acting or a so-called biphasic dose, a mixture of both short and long-acting insulin.

However, which of these regimens works best was not clear, Holman said. To find out, the researchers randomly assigned 708 patients to biphasic insulin injections twice a day (NovoMix30), mealtime insulin injections three times a day (NovoRapid) or basal insulin injected once a day (Levemir). All of the formulations are made by Novo Nordisk.

These patients had poor blood sugar control even though they were taking two common oral diabetes medications, metformin and sulfonylurea, the researchers noted.

Three years into the trial, the researchers found that slightly more than 43 percent of the patients taking basal insulin and about 45 percent of the patients taking insulin at mealtime achieved good blood sugar control, compared with about 32 percent of those taking biphasic insulin.

In addition, those on basal insulin had a lower incidence of low blood sugar, a serious side effect of insulin therapy, compared to those on biphasic or mealtime insulin, Holman’s team found. Moreover, patients on basal insulin gained less weight than people on the other two regimens.

“These findings provide clear evidence for people with type 2 that supports starting insulin therapy with a once-a-day basal insulin and subsequently adding a mealtime insulin if glycemic targets are not met,” Holman said.

Dr. Michael Roden, from the Institute for Clinical Diabetology at the German Diabetes Center at Heinrich Heine University Clinics in Dusseldorf, and author of an accompanying journal editorial, said that “you need to do a lot to control blood glucose in type 2 diabetic patients when they need insulin.”

Roden noted that while basal insulin is the place to start insulin therapy in type 2 diabetes, over time, mealtime insulin will need to be added to maintain blood sugar control.

Whether lowering blood sugar with insulin and other medications will prevent complications from diabetes, this study was too short to tell, Roden said. “The study was not powered to analyze the so-called hard endpoints, such as eye complications or, most importantly, cardiovascular problems,” he said.

However, there were fewer deaths among those in the study started on basal insulin, Roden said. “Which is only a hint, but is not a firm conclusion [of the benefit of basal insulin therapy].”

Genes that regulate insulin in the body also play a role in the timing of the body’s sleep-wake cycle, researchers say, and this finding that could potentially lead to treatments for disorders that arise when circadian rhythms are disrupted.

The insulin-control system, which governs how the body processes sugar, may also reset our internal clock, according to the study published online Sept. 17 in Cell.

“People knew that the clock regulates many different processes, but what they didn’t realize was that when you tweak those processes, it feeds back and alters the clock,” study co-author Steve Kay, dean of the Division of Biological Sciences at the University of California San Diego, said in a university news release.

“What came out very strongly was this close relationship between circadian regulation and insulin signaling,” Kay explained. “There’s a reciprocal relationship between circadian dysfunction and metabolic dysfunction.”

According to Kay, mice with malfunctioning internal clocks get fat and develop diabetes. Chronic jetlag may cause similar problems in people, he noted.

“Understanding this close relationship between circadian regulation and metabolic homeostasis should provide novel ways of identifying new therapies for metabolic disease,” Kay said.

While vaccination rates for adolescents in the United States are gaining ground, there is still a long way to go to meet Healthy People 2010 goals of 90 percent coverage, a new government report shows.

For the first time, the Healthy People goal was met for measles-mumps-rubella and Hepatitis B vaccinations among teens aged 13 to 15.

But vaccination rates for the three vaccines recommended for teens — which cover meningitis, cervical cancer and tetanus-diphtheria-whooping cough — hover at less than 50 percent. In fact, only three states, Arizona, New Hampshire and New York, had vaccination rates over 50 percent, according to the U.S. Centers for Disease Control and Prevention.

Vaccination rates for those three teen vaccines are increasing throughout the country, although there are substantial differences in the rates among states and local areas, according to the report in the Sept. 18 issue of the CDC’s Morbidity and Mortality Weekly Report.

“Coverage among teenagers for the three routinely recommended vaccines is increasing nicely, but we still have a long way to go to reach our national objective,” said Dr. Lance Rodewald, director of immunization services at the CDC.

Although there are racial and economic disparities in many areas of health care, vaccines for children is not one of them, Rodewald said.

“If you look across race and ethnicity, by vaccine, by coverage, there aren’t a lot of disparities in coverage, so that’s quite good to see,” Rodewald said.

“In fact, for HPV vaccine (human papillomavirus, which causes cervical cancer), the below-poverty rates are higher than the above-poverty rates,” he said.

Nationally, vaccination rates for the three most recommended adolescent vaccinations and one childhood vaccination increased from 2007 to 2008.

Specifically, coverage for the MCV4, the meningococcal conjugate vaccine for meningitis, rose from 32.4 percent to 41.8 percent, and rates for Tdap, the tetanus-diphtheria-pertussis vaccine, jumped from 30.4 percent to 40.8 percent.

The rate for one or more doses of HPV vaccine, which protects women from cervical cancer, increased (from 25.1 percent to 37.2 percent). And the number getting two doses of VAR — Varicella vaccine among those without disease history — nearly doubled (from 18.8 percent to 34.1 percent), the CDC reports.

Rodewald said that more needs to be done to get vaccine coverage where it should be. For new vaccines, such as the HPV vaccination, it can take up to 10 years for coverage to reach 90 percent.

Eating more whole-grain foods may help reduce body fat in older adults, says a new U.S. study.

The study looked at the eating habits — including the consumption of whole-grain bread, brown rice, popcorn and other whole grains as well as fruits and vegetables — of 177 men and 257 women, who averaged 68 years old.

Overall, the participants consumed relatively low amounts of whole-grain foods, averaging 1.5 servings a day, and dietary fiber, averaging 18.6 grams a day. U.S. Department of Agriculture dietary guidelines recommend that older people consume three or more servings daily of whole-grain foods and 21 to 30 grams of dietary fiber a day.

Among the study participants, bread and cold breakfast cereals were the main sources of whole grains, and women were more likely than men to consume whole grains.

After adjusting for factors such as levels of physical activity, the researchers found that a higher intake of whole grains was associated with lower amounts of total body fat and abdominal fat.

People who consumed the highest amounts of whole grains had about 2.4 percent less total body fat and 3.6 percent less abdominal fat than those who ate the least. This difference was found to be related to fiber in cereal, but not in fruits or vegetables. When only cereal fiber was taken into account, those who consumed the most had 3.2 percent less body fat and 5 percent less abdominal fat than those who ate the least amount of cereal fiber.

Eating lots of fruits and vegetables can help prevent chronic diseases, including cancer, research indicates.
Most fruits and vegetables offer great nutritional benefit while contributing little to your daily fat and calorie intake.
At the same time, they help you stay full, helping you to maintain a healthy body weight and prevent excessive weight gain.
Fruits and vegetables are rich in the minerals, vitamins and fiber your body needs.

Since childhood, lots of people have heard the parental plea to eat their fruits and vegetables.

The U.S. Centers for Disease Control and Prevention offers this insight on why eating fruits and veggies is so important:

HIV/AIDS began its deadly course in the United States mostly as a disease of young men, but today the epidemic touches people of all ages, including adults aged 50 and older. On September 18, the first National HIV/AIDS and Aging Awareness Day, we pause to recognize the importance of preventing HIV infection in this age group and understanding and addressing the unique health effects of the virus on older Americans.

Thanks to the advent of potent, multi-drug therapy against HIV in the mid-1990s, many HIV-infected Americans are living into their 50s and well beyond. Also, while the majority of new HIV infections are in younger Americans, individuals 50 years of age and older accounted for approximately 10 percent of all new HIV infections in the United States in 2006.[1]As a consequence of these trends, approximately one quarter of HIV-infected adults in the United States in 2007 were at least 50 years old.[2]

Older adults with long-term or new HIV infection experience complex interactions among HIV, antiretroviral therapy, age-related changes to the body, and, often, treatment for illnesses associated with aging. These interactions affect the health care needs and quality of life of older adults. It is imperative that we in the research community decipher the medical implications of aging with HIV and continue developing more sophisticated treatment approaches so these older adults can live longer, healthier lives.

It also is critical to prevent new HIV infections in older Americans by educating them about the importance of routine HIV testing and early diagnosis; how the virus is transmitted; behaviors that place them at risk for acquiring or transmitting the virus; and strategies, such as condom use and needle exchange, that can reduce their risk. Since early diagnosis of HIV is key to optimal treatment, the Centers for Disease Control and Prevention recommends routine HIV testing for all adults up to age 64.[3] CDC also recommends HIV testing at least annually for adults aged 64 and over who have risk factors for HIV infection, such as injection drug use.

The U.S. Department of Health and Human Services this month proposed that Medicare cover HIV screening tests for beneficiaries at increased risk for acquiring the virus, including women who are pregnant, and Medicare beneficiaries of any age who voluntarily request the service. Medicare provides health insurance coverage to people who are aged 65 and over or who meet other special criteria.

Aging is an important and expanding focus of HIV/AIDS research at the National Institutes of Health and the NIH-sponsored Centers for AIDS Research. The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, funds a range of studies to understand the biology of HIV infection in older adults with the goal of improving their medical care. Scientists are studying the interaction between HIV and aging in areas as diverse as diseases of the liver, kidney, brain, heart and lung; cancer; bone density; physical activity; mental health; balance; hearing; response to antiretroviral therapy; immune function; and adherence to medical care.

For example, researchers with the Multicenter AIDS Cohort Study have shown that HIV infection accelerates the development of frailty, a condition of the elderly that makes people more vulnerable to illness, injury and death. Scientists now want to determine which HIV-infected individuals are at highest risk for developing HIV-associated frailty with the hope of identifying factors to mitigate or prevent its development. NIAID and the National Institute on Aging (NIA), also part of NIH, are planning a workshop for late 2009 to identify current knowledge and research gaps in the areas of HIV and frailty, bone health, muscle health and vitamin D production.

Still, many gaps remain in scientific knowledge about the effects of HIV and antiretroviral therapy on aging. To that end, NIAID, NIA, the National Institute of Mental Health and the National Institute of Nursing Research, all part of NIH, are soliciting research proposals to explain and prevent a spectrum of biomedical problems faced by older adults with HIV infection. More information about these funding opportunities is available at http://grants.nih.gov/grants/guide/pa-files/PA-09-018.html, http://grants.nih.gov/grants/guide/pa-files/PA-09-019.html, and http://grants.nih.gov/grants/guide/pa-files/PA-09-017.html.

When AIDS and then its cause — HIV — were recognized in the early 1980s, no one imagined that individuals with HIV infection would eventually survive for decades. Now, with a quarter of the HIV-infected U.S. population age 50 years and older, the biomedical and public health communities face new challenges at the intersection of HIV and aging. In the absence of a cure for HIV, this first annual National HIV/AIDS and Aging Awareness Day marks an opportunity to rededicate ourselves to research aimed at preventing HIV infection in older adults and improving the health and quality of life of those who are infected.

Dr. Fauci is director of the National Institute of Allergy and Infectious Diseases;, Dr. Hodes is director of the National Institute on Aging; and Dr. Whitescarver is director of the Office of AIDS Research, all at the National Institutes of Health in Bethesda, Maryland.

Scientists are closer to understanding how a recently approved class of antibiotics may work against cancer.

The drugs, called thiazole antibiotics, appear to block a cellular protein called FoxM1, one of the most over-produced proteins in cancer cells, according to researchers at the University of Illinois at Chicago College of Medicine. FoxM1 is believed to play an important role in causing cells to become cancerous and may present a promising target for future anti-cancer treatments.

The researchers also found that thiazoles may inhibit proteasomes, a molecular complex within cells that disposes of old proteins marked for destruction. Recently, a number of proteasome inhibitors have shown promise against cancer. One of these inhibitors, bortezomib (Velcade), has proven effective against a number of cancers, including myeloma and certain forms of lymphoma.

The new research, which appears in the online journal PLoS ONE, points to the possible anti-cancer use of thiazoles in the future. In a university news release, study author Andrei Gartel, an associate professor of molecular genetics, said that by using thiazole antibiotics in combination with well-known proteasome inhibitors, “we may see a synergy that allows us to markedly reduce the dose of any one of these drugs and still effectively kill the cancer cells.”

Surgery that spares the limbs of some cancer patients may have little or no additional benefit over amputation in terms of health, cost or quality of life, researchers say.

Limb-sparing surgery can be just as effective as amputation in removing bone or soft-tissue sarcomas, but the analysis by Canadian researchers found few notable differences in psychological health and quality of life between people who had the two types of surgery. In fact, people who had their limbs saved tended to have more complications either shortly after the procedure or sometime later, the study found.

People who had limb-sparing surgery for cancers in the upper areas of the legs, including the hip, did reportedly have advantages over those who’d had amputation, but in general, saving the lower limbs did not necessarily ensure a better quality of life than amputation of all or part of the leg, the researchers found.

In terms of money, limb-sparing surgery has higher “up front” costs and rehabilitation costs, but making, maintaining and replacing artificial limbs for amputees adds to those patients’ long-term costs, the study noted.

The analysis, appearing online Aug. 10 in advance of publication in the Sept. 15 issue of Cancer, reviewed previously published studies on the cost and quality of life for people undergoing limb-sparing surgery versus amputation. Its authors, Dr. Ronald Barr of McMaster University in Ontario and Dr. Jay Wunder of Mount Sinai Hospital and the University of Toronto, called for further and more comprehensive reviews into the matter to help doctors and patients make better decisions when facing the issue.

“Future studies that include function, health-related quality of life, economics and stratification of patients by age will be useful contributions to decision-making … by patients, health-care providers and administrators,” Wunder said in a news release from the American Cancer Society.