Judicious Drinking Associated with Reduced Risk of Dementia
MAYWOOD, Ill., Dec. 30 -- Having a drink only occasionally may reduce the risk of dementia, perhaps because long exposure to low alcohol levels help brain cells survive other stresses, researchers here said.
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NEW YORK, Dec. 30 -- Lowering blood glucose levels may help lessen the cognitive decline of normal aging, even in diabetes-free patients, researchers here said.
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The U.S. Food and Drug Administration today announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. “ Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional.”

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs are required to add warnings about the risk of suicidality:
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal)
Phenytoin (marketed as Dilantin)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Rufinamide (marketed as Banzel)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Valproic Acid (marketed as Depakene, Stavzor Extended Release Tablets)
Zonisamide (marketed as Zonegran)

Some of these medications are also available as generics.

Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

-- Online : http://www.fda.gov/MedWatch/report.htm

-- Regular Mail : use postage-paid FDA form 3500 available at: http://www.fda.gov/bbs/topics/NEWS/2008/www.fda.gov/MedWatch/getforms.htmand mail to MedWatch, 5600 Fishers Lane , Rockville , MD 20852-9787

-- Fax: (800) FDA-0178

-- Phone: (800) FDA-1088

For more information
Information for Health Care Professionals and Public Health Advisory: http://www.fda.gov/cder/drug/infopage/antiepileptics/default.htm

U.S. Food and Drug Administration - FDA News

UMEA, Sweden, Dec. 16 -- Long-term mortality in locally advanced prostate cancer was improved by 50% when external-beam radiation was added to hormone therapy, found researchers here.

At 10 years, prostate specific mortality was 23.9% for those given only hormone therapy versus 11.9% for the combination therapy arm, wrote Anders Widmark, M.D., of Umea University, and colleagues in the Scandinavian Prostate Cancer Group.

The findings derived from evaluable results from 875 men, 439 who received three months of total androgen blockage followed by continuous hormone therapy using flutamide, and 436 who had the same hormone regimen combined with external beam radiation.

Yet Drs. Tan and Parker concluded that the findings represented a pivotal trial that should "change current practice, making long-term hormonal therapy plus radical radiotherapy the standard of care for men with locally advanced prostate cancer."

MedPage Today

URBANA, Ill., Dec. 11 -- Older individuals may be able to stem the age-related decline in cognitive function by playing video games, researchers here found.

Nearly two dozen hours of playing a strategic video game over several weeks led to increased performance on four out of six tests of executive function, Arthur Kramer, Ph.D., of the University of Illinois at Urbana-Champaign, and colleagues reported in the December issue of Psychology and Aging.

"Whether similar transfer effects would be observed with video-game-based training to everyday cognition in older adults is a both theoretically as well as practically important question, especially given the rapid expansion of commercial products and computer programs touted to improve the cognitive abilities of older adults," the researchers said.

Previous studies have shown that training individuals in a particular cognitive task can enhance performance on that specific task, the researchers said.

But opinions are mixed on whether training can result in improvements in an array of cognitive skills, they said.

Commercially available computer products that claim to improve cognitive function, he said, tend to "take a more piecemeal approach."

The authors acknowledged that the study was limited by the fact that the control group did not play a video game.

Future studies should evaluate whether the improvements in laboratory-based measurements of cognitive function translate into everyday activities like driving a car or working in a busy office, they said.

MedPage Today

LA JOLLA, Calif., Dec. 4 -- Alzheimer's patients with coexisting obstructive sleep apnea may derive cognitive benefits from treatment with continuous positive airway pressure (CPAP), investigators here concluded.

CPAP led to significant improvement on a neuropsychological test battery compared to baseline, Sonia Ancoli-Israel, Ph.D., of the University of California San Diego, and colleagues reported in the November issue of the Journal of the American Geriatrics Society.

"Although it is unlikely that obstructive sleep apnea causes dementia, the lowered oxygen levels and sleep fragmentation associated with obstructive sleep apnea might worsen cognitive function," said Dr. Ancoli-Israel. "This study, which showed significant improvement in patients' neurological test scores after treatment with CPAP, suggests that clinicians who treat patients with Alzheimer's disease and sleep apnea should consider implementing CPAP treatment."

Alzheimer's patients have a high prevalence of obstructive sleep apnea. Estimates range from 70% to 80% of patients having at least five episodes of apnea or hypopnea per hour to 40% to 50% having 20 or more episodes per hour.

Some evidence has suggested that more severe dementia is associated with more severe obstructive sleep apnea, they continued.

Studies of CPAP treatment for sleep apnea in patients without dementia have demonstrated improvement in neuropsychological function. Whether CPAP would lead to similar improvement in patients with Alzheimer's disease had not been examined in a randomized, placebo-controlled trial.

After the first three weeks, the two groups did not differ in changes in neuropsychological scores. However, in a paired analysis at six weeks (at which time one group had received six weeks of therapeutic CPAP and the other three weeks), both groups had significant improvement that averaged 0.077 points (P=0.01).

The study was limited by the small sample size, which did not allow for analysis of specific cognitive tests, and by the short duration of the study.

"[Obstructive sleep apnea] may aggravate cognitive dysfunction in dementia and thus may be a reversible cause of cognitive loss in patients with Alzheimer's Disease," the authors concluded. "OSA treatment seems to improve cognitive functioning."

Co-author Jody Corey-Bloom, M.D., Ph.D., also of UC San Diego, commented that "any intervention that improves cognition in patients with Alzheimer's disease is likely to result in greater independence and less burden on their caretakers."

A previous report from the same study showed that CPAP significantly reduced daytime sleepiness, a common complaint of Alzheimer's patients, Dr. Corey-Bloom added.

MedPage Today

Starting on Jan. 1, New York City ambulances will take many cardiac arrest patients only to hospitals that use a delicate cooling therapy believed to reduce the chances of brain damage and increase the chances of survival, even if it means bypassing closer emergency rooms.

The move by the city’s Fire Department and Emergency Medical Service, after a year of preparation, indicates a shift away from the prevailing view among emergency workers and the public that how fast critically ill patients reach the hospital is more important than which hospital treats them.

It amounts to an endorsement by the Bloomberg administration of a labor-intensive, often expensive and still-developing therapy that smaller community hospitals say they lack the staffing and financial wherewithal to provide.

Some hospital officials fear that the policy could be unfair to these smaller hospitals, depriving them of income from emergency-room patients and hurting their reputations with the public.

Since the Fire Department sent letters to hospital chief executives this week informing them of the impending change, about 20 of the 59 hospitals with emergency rooms have said they will have cooling operations ready by the Jan. 1 deadline.

Dr. David J. Prezant, chief medical officer of the New York Fire Department, acknowledged the culture change and the possibility that some hospitals would feel slighted. But he argued that scientific data shows the survival rate of cardiac arrest patients treated with therapeutic hypothermia, as the cooling process is called, is so much better than with conventional treatment that it would be irresponsible not to provide it.

“Theoretically every closest 911-receiving hospital will be able to provide this service,” he noted. “Whether that will be a reality or not is not for me to say.”

New York joins a handful of other American cities, including Seattle, Boston and Miami, as well as Vienna and London, in requiring transport to hospitals with cooling systems. But given New York’s large population and concentration of hospitals, the policy may provide the largest test to date of therapeutic hypothermia.

Most patients who suffer total cardiac arrest outside hospitals die because their brains have been starved of oxygen. But studies show that if the pulse of patients can be restarted and the body temperature cooled to about 8 degrees Fahrenheit below normal, brain damage can be reduced or minimized.

Only those cardiac arrest patients revived enough to show a pulse and whose heart problems are not associated with some other trauma are eligible for the cooling treatment, Dr. Prezant said. In New York City, that represents 1,500 to 2,000 of the about 7,500 out-of-hospital cardiac arrest cases reported each year.

Dr. Prezant said that in deference to hospital finances, the city has set no requirements for the kind of cooling techniques hospitals must use — some may start with inexpensive saline solutions and plastic bags filled with ice, while others employ sophisticated equipment manufactured and aggressively promoted by companies like Alsius, Innercool Therapies and Medivance.

The American Heart Association endorsed cooling for some types of cardiac arrest patients after two studies on its effectiveness were published in The New England Journal of Medicine in 2002. One study found that 55 percent of the patients who received the cooling treatment ended up with moderate or no brain damage, compared with 39 percent who received standard treatment. About 41 percent of the cooled patients died within six months, compared with 55 percent of the others.

But hospitals have been slow to adopt the treatment because it requires a precision of temperature regulation that is difficult to achieve, constant vigilance and cooperation among nursing, emergency, cardiac and neurological units.

The research has shown that cooling is effective for cardiac arrest from ventricular fibrillation, in which the heart muscle wriggles ineffectively.

If a pulse can be restarted quickly enough — within a matter of minutes — with a defibrillator, such patients can walk away relatively unscathed. But if not, they become comatose and suffer a cascading series of cellular-level injuries to the brain, which frequently lead to permanent brain damage or death.

Inducing moderate cooling of the body within 6 hours, for 24 hours, followed by gradual warming, slows cerebral metabolism and seems to reduce such injuries, studies have shown. (The technique’s effectiveness on other medical problems, including traumatic brain injury, is more controversial.)

“It was a very slow process in terms of really getting it to take hold,” Dr. Mayer said of the cooling treatment. “One reason is that cardiac arrest patients have just been surrounded by this shroud of therapeutic nihilism. They come in after cardiac arrest, they’re intubated, in a coma, everybody’s reflex thought process in terms of caregivers is ‘Oh God, there’s nothing you can do for these people.’ ”

He said that his main motivation was not financial but experiential, and that he had been converted by seeing patients who were comatose and given up for dead recover full or near-full function after hypothermia.

The New York Times

Although aging puts people at greater risk for serious eye disease and other eye problems, loss of sight need not go hand in hand with growing older. Practical, preventive measures can help protect against devastating impairment. An estimated 40% to 50% of all blindness can be avoided or treated, mainly through regular visits to a vision specialist. Regular eye exams are the cornerstone of visual health as people age. Individuals who have a family history of eye disease or other risk factors should have more frequent exams. Don’t wait until your vision deteriorates to have an eye exam. One eye can often compensate for the other while an eye condition progresses. Frequently, only an exam can detect eye disease in its earliest stages. You can take other steps on your own. First, if you smoke, stop. Smoking increases the risk of several eye disorders, including age-related macular degeneration. Next, take a look at your diet. Maintaining a nutritious diet, with lots of fruits and vegetables and minimal saturated fats and hydrogenated oils, promotes sound health and may boost your resistance to eye disease. Wearing sunglasses and hats is important for people of any age. Taking the time to learn about the aging eye and recognizing risks and symptoms can alert you to the warning signs of vision problems. Although eyestrain, spending many hours in front of a television or computer screen, or working in poor light do not cause harmful medical conditions, they can tire the eyes and, ultimately, their owner (see below). The eyes are priceless and deserve to be treated with care and respect — and that is as true for the adult of 80 as it is for the teenager of 18. 5 common eye myths dispelled Myth: Doing eye exercises will delay the need for glasses. Fact: Eye exercises will not improve or preserve vision or reduce the need for glasses. Your vision depends on many factors, including the shape of your eye and the health of the eye tissues, none of which can be significantly altered with eye exercises. Myth: Reading in dim light will worsen your vision. Fact: Although dim lighting will not adversely affect your eyesight, it will tire your eyes out more quickly. The best way to position a reading light is to have it shine directly onto the page, not over your shoulder. A desk lamp with an opaque shade pointing directly at the reading material is the best possible arrangement. A light that shines over your shoulder will cause a glare, making it more difficult to see the reading material. Myth: Eating carrots is good for the eyes. Fact: There is some truth in this one. Carrots, which contain vitamin A, are one of several vegetables that are good for the eyes. But fresh fruits and dark green leafy vegetables, which contain more antioxidant vitamins such as C and E, are even better. Antioxidant vitamins may help protect the eyes against cataract and age-related macular degeneration. But eating any vegetables or supplements containing these vitamins or substances will not prevent or correct basic vision problems such as nearsightedness or farsightedness. Myth: It’s best not to wear glasses all the time. Taking a break from glasses or contact lenses allows your eyes to rest. Fact: If you need glasses for distance or reading, use them. Attempting to read without reading glasses will simply strain your eyes and tire them out. Using your glasses won’t worsen your vision or lead to any eye disease. Myth: Staring at a computer screen all day is bad for the eyes. Fact: Although using a computer will not harm your eyes, staring at a computer screen all day will contribute to eyestrain or tired eyes. Adjust lighting so that it does not create a glare or harsh reflection on the screen. Also, when you’re working on a computer or doing other close work such as reading or needlepoint, it’s a good idea to rest your eyes briefly every hour or so to lessen eye fatigue. Finally, people who stare at a computer screen for long periods tend not to blink as often as usual, which can cause the eyes to feel dry and uncomfortable. Make a conscious effort to blink regularly so that the eyes stay well lubricated and do not dry out.

FEATURED CONTENT: How the eye works The eye examination Cataract Glaucoma Age-related macular degeneration (AMD) Diabetic retinopathy Other common eye diseases of later life Presbyopia: Ready for reading glasses? Safeguarding your sight Reprinted from The Aging Eye: Preventing and treating eye disease – A Special Health Report from Harvard Medical School, © 2008 by Harvard University. All rights reserved. Harvard Health Publications Harvard Medical School

CHICAGO, Dec. 1 -- Older adults who exercise regularly may have increased cerebral blood flow and a greater number of small blood vessels in the brain, researchers here said.

This could be the mechanism by which exercise prevents cognitive decline in the elderly, Feraz Rahman, M.S., a medical student at Jefferson Medical College in Philadelphia, told attendees at the Radiological Society of North America meeting.

"Aerobic exercise improves cognitive function … and counteracts the effects of aging on the brain," Rahman said. "That may be due to blood flow and vasculature."

Previous research has shown that exercise reverses small vessel disease elsewhere in the body, and increases brain volume and cognitive function in the elderly.

Rahman concluded that the findings of this study show that "exercise is a vital part of healthy aging and might slow the loss of small vessels."

MedPage Today

When Peter Nicholson’s mother suffered a series of strokes last winter, he did something women have done for generations: he quit his job and moved into her West Hollywood home to care for her full time.

Mr. Nicholson, 53, is part of a growing number of men who are providing primary care for their aging parents, usually their mothers.

The Alzheimer’s Association and the National Alliance for Caregiving estimate that men make up nearly 40 percent of family care providers now, up from 19 percent in a 1996 study by the Alzheimer’s Association. About 17 million men are caring for an adult.

“It used to be that when men said, ‘I’ll always take care of my mother,’ it meant, ‘My wife will always take care of my mother,’ ” said Carol Levine, director of the families and health care project at the United Hospital Fund. “But now, more and more men are doing it.”

Often they are overshadowed by their female counterparts and faced with employers, friends, support organizations and sometimes even parents who view caregiving as an essentially female role. Male caregivers are more likely to say they feel unprepared for the role and become socially isolated, and less likely to ask for help.

Women still provide the bulk of family care, especially intimate tasks like bathing and dressing. At support groups, which are predominantly made up of women, many women complain that their brothers are treated like heroes just for showing up.

But with smaller families and more women working full-time, many men have no choice but to take on roles that would have been alien to their fathers. Just as fatherhood became more hands-on in the baby boom generation, so has the role for many sons as their generation’s parents age.

And then there is the inevitable question: What happens when I have to bathe her?

“That’s where the rubber meets the road,” said Donna Wagner, the director of gerontology at Towson University and one of the few researchers who has studied sons as caregivers.

Though he is not squeamish about it, he said: “The weirdness permeates our relationship. She doesn’t know if I’m her husband or her boyfriend or her neighbor. She knows she trusts me. But there are times when it’s very difficult. I need to keep her from embarrassing herself. She’ll say things like, ‘I adore you.’ I don’t know who she’s loving, because she doesn’t know who I am. Maybe I’m embarrassed about it — it’s my mom, for Christ sakes. But it’s weird how the oldest son becomes the spouse.”

On a recent evening, Mr. Kassin visited his mother, Doris Golden, in her Manhattan apartment. Ms. Golden, 82, is in the early stages of Alzheimer’s and still lives independently, but relies on Mr. Kassin to arrange her schedule, pay her bills and make sure she remembers her daily tasks (his sister also helps).

In past generations, men might have answered this question by pointing to their accomplishments as breadwinners or fathers. Now, some men say they worry about the conflict between caring for their parents and these other roles.

In a 2003 study at three Fortune 500 companies, Dr. Wagner found that men were less likely to use employee-assistance programs for caregivers because they feared it would be held against them.

“Even though the company has endorsed the program, your supervisors may have a different opinion,” Dr. Wagner said. “I had a man who worked for a large company with very generous benefits, and he was told that if he took more time to go with his dad to chemotherapy, he was at risk of losing his job. He ended up not going with his father.”

Mr. Kassin said that although his employer had been understanding, he was reluctant to talk about his caregiving because “I think it would be looked at like, when they hire a male, they expect him to be 100-percent focused.”

“Nursing homes have a very difficult time dealing with male caregivers,” Ms. Torres said. “It’s unusual for them. The male caregiver is made to feel their interest in their relative is inappropriate. Our male callers say they’re made to feel what they’re doing is unusual, that it’s wrong.”

She gave the example of a son who was the health care agent for his mother and wanted to be in the room when the staff changed her diaper because he was concerned about her skin condition. “The staff refused to allow it,” Ms. Torres said. “They said the mother’s dignity was at risk.”

After two weeks of pressing, she said, he finally got his way. With a daughter, this would not have been an issue, Ms. Torres said.

And even when they are acknowledged, for many male caregivers, as for women, there is the lingering sense that whatever they do is not enough.

“I don’t know if this is just the musings of someone who’s on the verge of tossing everything and putting her in a home,” he said. “But this is a very revealing journey about who I am to me and my family, and what’s important to me.”

The New York Times