WEDNESDAY, Oct. 3 (HealthDay News) -- Aricept, a drug commonly used to treat the cognitive symptoms of Alzheimer's disease, is no better than a placebo when it comes to treating the agitation associated with the illness, a new study finds.

When combined with other research, the trial suggests that doctors and patients shouldn't rule out using the medication, but they shouldn't count on it either, experts said.

"This is part of a greater dialogue about how you deal with these behavioral symptoms of Alzheimer's and I think the findings are relatively consistent with what's been seen before," said William Thies, vice president of medical and scientific relations at the Alzheimer's Association.

Previous trials have shown some variation in the effectiveness of cholinesterase inhibitors -- the class of medicines to which Aricept (donepezil) belongs -- in easing agitation. However, any positive effect from the drug has typically been small.

Although memory loss and cognitive dysfunction are hallmarks of Alzheimer's disease, behavioral disturbances such as agitation can cloud other changes, experts say. The group of symptoms known as "agitation" can lead patients to pace, wander, shout and become aggressive.

"These kinds of symptoms are very difficult to deal with and, both from a care and a medical perspective, they are the most likely causes of people moving into some sort of care facility as opposed to being cared for at home," Thies noted. "Memory issues often can be dealt with but when people get aggressive and agitated, that is frequently going to go beyond what a single caregiver can manage."

"Agitation is difficult to address in the first place," added Dr. Gary J. Kennedy, director of geriatric psychiatry at Montefiore Medical Center in New York City.

Antipsychotics and tranquilizers are commonly used to treat these behavioral disturbances but the effect -- if any -- is usually small and the side effects can be severe.

Cholinesterase inhibitors like Aricept have been shown to improve cognitive outcomes but the benefits in terms of behavioral disturbances have been unclear.

This British trial was originally designed to compare the efficacy of Risperdal (risperidone), a tranquilizer, against Aricept and a placebo. During the course of the trial, however, British regulatory authorities issued guidance saying that drugs such as Risperdal should not be given to Alzheimer's patients because of an increased incidence of stroke.

The trial therefore continued as a comparison of Aricept against placebo. Researchers randomly assigned 272 patients with Alzheimer's who also had agitation to receive 10 milligrams of donepezil per day or a placebo for 12 weeks. The patients had tried, but not responded to, a brief psychosocial treatment before being given medication. Most of the participants resided in nursing homes and had severe dementia with difficult-to-manage behaviors.

At the end of the study period, there was no significant difference in agitation between patients in the Aricept group and those in the placebo group, the research team report in the Oct. 4 issue of the New England Journal of Medicine.

There was a modest improvement in cognitive function among participants taking Aricept, however.

"It is becoming increasingly clear that tranquilisers are not an adequate treatment for managing behavioural symptoms in Alzheimer's patients and their use is associated with serious potential side effects," lead researcher Dr. Robert J. Howard, a professor of old age psychiatry at the Institute of Psychiatry, King's College London, said in a statement. "Sadly, but importantly, our results show that while donepezil may improve memory and attention in some patients, it is not effective in the management of these distressing behaviours."

According to Kennedy, there may be some question of whether this study can be extrapolated to practice in the United States. "In the U.K., few people are treated with cholinesterase inhibitors," he said. In the U.S., many people are on Aricept and related drugs to deal with cognitive problems and this may have a delaying effect on agitation. Prevention is a completely separate issue from treatment, the subject of this study.

"Just because donepezil, once they're agitated, doesn't seem to have much impact doesn't mean we don't have other agents to use," Kennedy said. "The danger is people will misread this study saying donepezil has no benefit for agitation when, in reality, the family of cholinesterase inhibitors may delay the emergence of agitation. It's an important study but it lends itself to misinterpretation."

The question, now and before, is how to best manage these patients.

"One of the things we can be pretty much guaranteed of is whatever effect there is is going to be small and highly individual," Thies said. "Every one of these people is different but having an orderly approach to them would be useful, looking at non-pharmacological interventions first. If you are going to treat for cognitive symptoms, certainly using a cholinesterase inhibitor is one of the first things you're going to try. If you benefit, that's good and an individual success but don't expect it to happen all the time."

There is some hope in the form of a recent study that found that Celexa (citalopram), an antidepressant, may help control agitation and psychotic symptoms associated with Alzheimer's. That study appeared in the Sept. 10 online issue of the American Journal of Geriatric Psychiatry.

More information

For more on Alzheimer's disease, visit the Alzheimer's Association  .

WEDNESDAY, Oct. 3 (HealthDay News) -- If you're over 65, getting an annual flu shot will reduce the risk you'll be hospitalized with flu complications by 27 percent and cut your risk of flu-related death by 48 percent.

That's the conclusion of new research published in the Oct. 4 issue of the New England Journal of Medicine.

"This is a bad disease but a good vaccine," said the study's lead author, Dr. Kristin Nichol, chief of medicine at the VA Medical Center in Minneapolis. "Many people fail to appreciate the serious complications of influenza."

Not everyone is convinced, however, that the flu vaccine is quite so effective in the elderly. A study released last week in the October issue of The Lancet Infectious Diseases questioned death-rate reductions seen in many previous studies. The researchers behind last week's study pointed out that many studies fail to include those over 70 -- and thus, most at risk of flu complications -- and that the people who receive flu vaccines may actually be healthier than those who don't.

But, Nichol's study was designed to answer some of those concerns. And even after compensating for numerous factors, the researchers still found that the flu vaccine reduces hospitalizations and death rates in the elderly.

"I think this study is reassuring, and it does the best job you can do to assess the efficacy of flu vaccine in the elderly," said Dr. John Treanor, author of an accompanying editorial in the New England Journal of Medicine, and a professor of medicine at the University of Rochester Medical Center, in New York.

"The vaccine is nowhere near 100 percent effective, and it's probably true that the elderly don't respond as well as younger people do. But, that does not mean that we shouldn't use the vaccine in older people, but that we should think about other ways to prevent the disease," said Treanor, adding that he'd like to see many more health-care workers receive the vaccination, as well as more healthy children.

Each year, as many as 20 percent of the U.S. population is infected with the flu, according to the federal Centers for Disease Control and Prevention. As many as 200,000 people are hospitalized annually due to flu complications, and 36,000 people die each year because of the flu. Those most at risk of serious flu complications include the elderly and young children, the CDC says.

The new study began in 1990 and included data through the 1999-2000 flu season for people from 18 different groups of community-dwelling elderly members of one health maintenance organization. Additionally, information on members of two other HMOs was included from 1996 through 2000.

The study included almost 300,000 unvaccinated people and more than 415,000 vaccinated individuals. All were over 65 years old.

In the entire study group, there were 4,599 hospitalizations and almost 9,000 deaths from influenza during the 10-year study period. On average, hospitalization rates were 0.7 percent for unvaccinated people and 0.6 percent for those vaccinated. On average, death rates were 1.6 percent and 1.0 percent, respectively.

The researchers found that those rates varied from flu season to flu season, with more hospitalizations and deaths occurring in years when the flu vaccine wasn't a good match against the strains of circulating flu.

The researchers also looked to see if hospitalizations and death rates were lower in the summer, which would suggest that the effect wasn't from the vaccine. They didn't find such an association, suggesting that the reduction during influenza season was, in fact, due to the vaccine.

"This is the most definitive look linking outcomes to vaccination status," Treanor said.

Nichol said: "I think this study goes a long way to addressing concerns and shows what the influences of the influenza vaccine might be even after taking into account age, health conditions and previous hospitalizations."

She added that, in addition to preventing hospitalizations and deaths, the flu vaccine is "highly cost-effective and even cost-saving."

More information

To learn more about flu vaccine, visit the U.S. Centers for Disease Control and Prevention.

MONDAY, Oct. 1 (HealthDay News) -- Medicare's standard monthly premium is rising to $96.40 in 2008 -- a 3.1 percent increase from 2007 and the smallest hike in six years, U.S. health officials announced on Monday.

The increase is lower because the agency fixed an accounting error that would have raised the monthly premium even more.

"In the absence of the accounting error, we would probably have an increase in the premium to about $99," Rick Foster, the chief actuary U.S. Centers for Medicare & Medicaid Services (CMS) said during a late morning teleconference. "That's largely a onetime impact."

Medicare's Part B program covers the health care of 43 million senior and disabled people. Rising costs and increasing participation have dramatically increased the program's costs in recent years, however.

Deductibles are rising, too. The average deductible for Part B rose from $131 in 2007 to $135 in 2008, the agency said.

The deductible for Medicare Part A is also increasing in 2008, agency officials said. "The deductible paid by the beneficiary when admitted to the hospital will increase from $992 to $1,024," Kerry Weems, CMS's acting administrator said during the teleconference.

Medicare's Part A program covers hospital and hospice care as well as short stays in nursing homes. Participants covered by this program do not pay a monthly premium.

The reasons for next year's premium increase are manifold and include the rising cost of items such as home health care, physician-administered drugs, ambulatory surgical center services, medical equipment, doctor's office lab services and other services and programs, Weems said.

In addition, Medicare is hiking premiums for those making $80,000 a year or more. This increase affects 5 percent of people with Part B coverage, according to Weems.

He noted that the boost in premiums is also tied to the necessity of raising Medicare Part B's contingency trust fund, which stockpiles money to pay for unexpected costs.

Increasing the fund is needed to offset increased doctor's fees, Weems said. While doctors fees charged to Medicare were expected to fall by 10 percent in 2008, Weems said he expects Congress will block that scheduled fee reduction.

Therefore,"it is appropriate to maintain a larger Part B contingency reserve than would otherwise be necessary," Weems explained.

He believes that Medicare recipients are still getting more benefits than they have ever gotten before. "The cost of the new drug benefit has come in far lower than previously projected," he said. "Medicare recipients are paying far lower out-of-pocket costs for drugs and seeing better coordinated care," Weems said

One expert was upbeat about the announcement.

"The relatively small increases underscore what an efficient national treasure Medicare is," said Robert Hayes, the president of the the Medicare Rights Center, a New York City-based advocacy group. "The economies of Medicare cry out for its use as a model to cover people who are uninsured throughout the country," he added.

Seniors may still be in for some fiscal surprises in 2008, however. In a study released Monday, experts at Consumer's Union (the publisher of Consumer Reports) warned that most insurers bump up the prices for drugs covered by the Medicare Part D drug benefit -- after enrollees have already committed to a particular plan.

"It makes no sense to ask a senior to carefully shop around [for a plan] in October and sign up for a plan, when the plan turns around a few months later and dramatically hikes the cost of the medicines," Bill Vaughan, senior health policy analyst at Consumers Union, said in a statement.

Tracking the period from February to September 2007, the group found that 95 percent of plans offered in the regions sampled raised their drug costs. In the most extreme case, Blue Medicare RX-Standard in Illinois hiked the cost of five widely used drugs by 28 percent, or $679, the report found.

More information

For more on Medicare premiums, visit the Medicare.