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Medical Organizations Issue New Guideline on Drugs to Treat Dementia

--In 50 Years, 1 in 45 Americans Will Suffer from Some Form of Dementia
--New Research Urgently Needed as Americans Age

PHILADELPHIA, March 4, 2008 -- The American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) have issued a new guideline on current pharmacologic treatment of dementia. The guideline appears in the March 4, 2008, issue of Annals of Internal Medicine, ACPs flagship journal, and is available online at www.annals.org.

A committee representing ACP and AAFP reviewed dementia literature for outcomes such as cognition, global function, behavior/mood, and quality of life/activities of daily living -- areas of importance to physicians treating patients. The committee found that high-quality scientific evidence was limited and so developed cautious recommendations:

1. Clinicians should base the decision to try therapy with the FDA approved drugs for dementia on an individualized assessment of the patient.

2. Clinicians should base the choice of drugs on tolerability, adverse effect profile, ease of use and cost of medication.

3. Further research is urgently needed to address gaps in knowledge about the clinical effectiveness of pharmacologic management of dementia.

Currently five drugs are approved by the FDA for dementia: four acetylcholinesterase inhibitors [donepezil (Aricept®), galantamine (RazadyneT, ReminylT, Nivalin), rivastigmine (Exelon), and tacrine], and one neuropeptide-modifying agent [memantine (Namenda®)]. These drugs do not cure dementia (there is no cure at this time) or repair brain damage. They may improve symptoms or slow down the disease.

Doctors, patients, and family care-givers desperately want information on how to treat this disease, said Amir Qaseem, MD, PhD, MHA, Senior Medical Associate in the Clinical Programs and Quality of Care Department at ACP. It is disheartening to find out that all we have to work with is these five drugs, and the evidence on these is scant. Consider that in 50 years, one in 45 Americans will suffer from Alzheimers disease. This is huge problem.

The guideline outlines research that needs to be done:

  • Evaluate the effectiveness of drug therapy for dementia and assess whether treatments affect key outcomes, such as institutionalization.
  • Evaluate the appropriate duration of therapy.
  • Test drugs head-to-head.
  • Test drugs in combination therapy.
  • One reason for the urgent call for research is the deficiencies found in the existing medical literature.

The ACP-AAFP committee found that most of the existing studies focused on statistical significance of changes, but patients with dementia, caregivers, and physicians are more interested in clinically important improvement.

More research is warranted because the available evidence concerning these pharmaceuticals effects on quality of life is mixed and the clinical significance of many of the findings is questionable, said Kenneth G. Schellhase, MD, MPH, an AAFP representative on the guideline committee. In addition, the duration of existing trials was usually less than one year, providing insufficient information to determine the optimal length of treatment, and few trials compare one drug directly with another.

In summary, no convincing evidence demonstrated that one therapeutic treatment is more effective than another, the committee concluded.

The National Institutes of Health describes dementia as a group of symptoms caused by disorders that affect the brain. Dementia is not a specific disease. NIH says people with dementia may not be able to think well enough to do normal activities, such as getting dressed or eating. They may lose their ability to solve problems or control their emotions. Their personalities may change. They may become agitated or see things that are not there.

Two of the most common types of dementia, Alzheimers disease and vascular dementia, are covered by the ACP-AAFP guideline.

ACP, through its Clinical Efficacy Assessment Subcommittee, has been developing guidelines since 1981. ACP guidelines have relied on evidence or clinical documentation rather than consensus or expert opinion. The guidelines grade the evidence recommendations using the American College of Physicians clinical practice guidelines grading system. ACP cautions that its clinical practice guidelines are guides only and may not apply to all patients and all clinical situations and are not intended to override clinicians' judgment.

The AAFPs clinical practice guidelines are designed to assist the clinician and patients in making decisions about appropriate health care for specific clinical circumstances. These evidence-based guidelines are often developed collaboratively between the AAFPs Commission on Science and those of other specialty societies and the federal Agency for Healthcare Research and Quality.

The dementia guideline was passed by the ACP Board of Regents on April 16, 2007, and by the American Academy of Family Physicians Board of Directors on June 13, 2007.

Annals of Internal Medicine (www.annals.org) is one of the most widely cited peer-reviewed medical journals in the world. The journal has been published for 80 years and accepts only seven percent of the original research studies submitted for publication. Annals of Internal Medicine is published by the American College of Physicians (www.acponline.org), the largest medical specialty organization and the second-largest physician group in the United States.

ACP members include 124,000 internal medicine physicians (internists), related subspecialists, and medical students. Internists specialize in the prevention, detection, and treatment of illness in adults.

Founded in 1947, the AAFP represents nearly 94,000 physicians and medical students nationwide. It is the only medical society devoted solely to primary care. Nearly one in four of all office visits are made to general and family physicians, and family physicians provide the majority of care for Americas underserved and rural populations.

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