Practice Guidelines
Recommendations for Prescribing New Antiepileptic Drugs
Several new antiepileptic drugs (AEDs) are effective in treating selected patients with partial or mixed seizure disorders, but evidence for their efficacy in patients with generalized epilepsy syndromes is lacking, according to a meta-analysis by the American Academy of Neurology (AAN) and the American Epilepsy Society (AES). Evidence-based guidelines for the prescription of new AEDs were published in the April 27, 2004, issue of Neurology.
Before 1990, six major AEDs were available for the treatment of all forms of epilepsy: carbamazepine, phenobarbital, phenytoin, primidone, valproic acid, and ethosuximide. However, many patients "failed" all of these drugs because of inadequate seizure control or side effects of treatment. In the past 10 years, the U.S. Food and Drug Administration has approved seven new AEDs to address the needs of patients for whom the existing AEDs did not provide optimal care: gaba-pentin (Neurontin), lamotrigine (Lamictal), topiramate (Topamax), tiagabine (Gabitril), oxcarbazepine (Trileptal), levetiracetam (Keppra), and zonisamide (Zonegran).
An AAN/AES committee conducted a structured literature review to determine how the efficacy and tolerability of the new AEDs compare with that of the standard AEDs in patients with newly diagnosed epilepsy, and to evaluate the evidence that the new AEDs are effective in patients with primary or secondary generalized epilepsy.
The group found that gabapentin is effective in the treatment of newly diagnosed partial epilepsy, and that lamotrigine, topiramate, and oxcarbazepine are effective in a mixed population of newly diagnosed partial and generalized tonic-clonic seizures. There currently is insufficient evidence to determine the effectiveness of tiagabine, zonisamide, and levetiracetam in newly diagnosed patients.
Oxcarbazepine, carbamazepine, valproic acid, and phenytoin are similar in efficacy, but oxcarbazepine is superior in dose-related tolerability. In children more than six years of age and adults, topiramate at dosages of 100 and 200 mg per day was equivalent in efficacy and safety to a 600-mg fixed dose of carbamazepine and 1,250 mg of valproic acid per day.
In adults and elderly patients, lamotrigine is equivalent in efficacy to carbamazepine and phenytoin and superior in tolerability to carbamazepine. Topiramate at dosages of 100 mg and 200 mg per day is equivalent in efficacy and safety to a 600-mg fixed dosage of immediate-release carbamazepine given twice daily for partial seizures and to 1,250 mg of fixed-dose valproic acid for idiopathic generalized seizures.
Gabapentin is effective in monotherapy at 900 and 1,800 mg and is equivalent in efficacy to a 600-mg fixed dose of carbamazepine. However, a 900-mg dosage of gabapentin is better tolerated than a 600-mg fixed dosage of short-acting carbamazepine given twice daily.
There are no studies in newly diagnosed patients that assess the efficacy of oxcarbazepine, topiramate, tiagabine, levetiracetam, or zonisamide in children with exclusively idiopathic or symptomatic generalized epilepsy.
There are no studies of any new AED that assess efficacy and tolerability in adults with newly diagnosed epilepsy with exclusively idiopathic or symptomatic generalized epilepsy.
Based on these findings, the group recommends that patients with newly diagnosed epilepsy who require treatment be started on standard AEDs such as carbamazepine, phenytoin, valproic acid, or phenobarbital, or on the new AEDs such as lamotrigine, gabapentin, oxcarbazepine, or topiramate. The choice of an AED will depend on individual patient characteristics. Children with newly diagnosed absence seizures may be treated with lamotrigine.
Because the newer AEDs are much more expensive than the standard agents, further research using an economic decision analysis is needed to determine whether the potential benefits are worth the additional cost.
Practice Guideline Briefs
Influenza Vaccination Among Health Care Workers
The National Foundation for Infectious Diseases (NFID) has issued a call to action on reducing influenza infection among health care workers. The NFID and the Centers for Disease Control and Prevention, as well as other infection control and major medical and nursing groups, have long recommended yearly influenza vaccination for all health care workers. However, only 36 percent actually are immunized each year. Health care workers include all personnel in a health care setting who have contact with patients.
Unvaccinated health care workers can be a key cause of influenza outbreaks in health care settings. These employees encounter high-risk patients throughout the influenza season in medical practices, general hospitals, specialty hospitals, long-term care and rehabilitation facilities, home-care sites, and other health care settings.
While many health care organizations conduct influenza vaccination programs, the impact of these programs on immunization rates has not been optimal. The NFID is calling on health care institutions, employers, insurers, and allied professional organizations to make a comprehensive, concerted effort to improve influenza vaccination rates among health care workers.
According to the NFID, measures should be taken to ensure health care workers are provided convenient access to influenza vaccination. Employers should commit resources toward institutionalizing immunization opportunities in the workplace, and to demonstrating that immunization is critical to employee and patient safety. The NFID recommends the following:
• Professional health care organizations should develop policies to support influenza immunization of health care workers and encourage their members to educate health care workers about the benefits of vaccination and the potential health consequences of influenza illness to patients and themselves.
• Those persons in management positions should become strong advocates to ensure health care workers/employees become vaccinated to accomplish better infection control, reduced absenteeism, and cost savings/effectiveness.
• Opportunities for influenza vaccination should be convenient for health care workers, and should be paid for by the employer.
• Health care workers should be reminded that vaccination is recommended annually, and that injectable vaccine cannot cause influenza. They also should be reminded that the influenza virus is transmitted easily and they are putting patients, themselves, their families, and others at risk if they do not get vaccinated.
Updated Guideline on Jaundice in Newborns
The Subcommittee on Hyperbilirubinemia of the American Academy of Pediatrics (AAP) has updated its clinical practice guideline on identifying and managing jaundice in newborns. "Management of Hyperbilirubinemia in the Newborn Infant 35 or More Weeks of Gestation" appears in the July 2004 issue of Pediatrics and is available online at http://pediatrics.aappublications.org/cgi/content/full/114/1/297.
The AAP updated its guideline to provide physicians with specific advice about treatment and to promote greater uniformity and consistency of care for all newborns. Among the new recommendations are the following:
• Physicians should perform a systematic assessment on all infants, prior to discharge, for subsequent risk of severe jaundice.
• Physicians should instruct the infant's parents to schedule a follow-up visit at three to five days of age, when the infant's bilirubin level is highest.
• Physicians should recommend that mothers breastfeed at least eight to 12 times a day for the first few days. This will help produce enough milk and help keep the infant's bilirubin level down.
• Physicians should provide parents with written and oral information about newborn jaundice. A "Frequently Asked Questions" document is included with the guidelines and is available online at http://www.aap.org/family/jaundicefaq.htm.
The Centers for Disease Control and Prevention (CDC) supports the use of the revised guideline for eliminating kernicterus and hyperbilirubinemia. In 2001, the CDC reported an increase of kernicterus cases in the United States and encouraged systematic assessment of bilirubin levels in newborns before their discharge from the birth hospital, along with proper follow-up care, lactation support, and parent education about jaundice. Additional information about kernicterus is available at http://www.cdc.gov/ncbddd/dd/kernicterus.htm.
Treatment of Infants with HIV-1 Infection
The Committee on Pediatric AIDS (acquired immunodeficiency syndrome) of the American Academy of Pediatrics (AAP) and the Infectious Diseases and Immunization Committee of the Canadian Paediatric Society have released a revised clinical report on human immunodeficiency virus (HIV) infection in infants. "Evaluation and Treatment of the Human Immunodeficiency Virus-1-Exposed Infant" appears in the August 2004 issue of Pediatrics and is available online at http://pediatrics.aappublications.org/cgi/content/full/114/2/497.
In developed countries, care and treatment are available for pregnant women and infants that can decrease the rate of HIV infections around or at the time of birth to 2 percent or less. Whenever possible, maternal HIV-1 infection should be identified before or during pregnancy, because this allows for earlier initiation of care for the mother and for more effective interventions to prevent perinatal transmission. If the maternal HIV-1 infection status is unknown at the time of the infant's birth, then HIV-1 testing of the mother or the infant is recommended with maternal consent and with results available within 24 hours of birth. The expedited HIV-1 enzyme immunoassay and rapid HIV-1 test are screening tests that may be used in this setting. If the test result for HIV-1 is positive, prophylactic antiretroviral therapy should be started promptly in the infant and confirmatory HIV-1 testing should be performed. Among the recommendations are the following:
• HIV-1-infected mothers should not breastfeed their infants and should be educated about safe alternatives.
• Maternal health information should be reviewed to determine if the HIV-1-exposed infant may have been exposed to maternal coinfections including tuberculosis, syphilis, toxoplasmosis, hepatitis B or C, cytomegalovirus, or herpes simplex virus. Diagnostic testing and treatment of the infant are based on maternal findings.
• Physicians should provide counseling to parents and caregivers of HIV-1-exposed infants about HIV-1 infection, including anticipatory guidance on the course of illness, infection-control measures, care of the infant, diagnostic tests, and potential drug toxicity.
• All HIV-1-exposed infants should undergo virologic testing for HIV-1 at birth, at four to seven weeks of age, and again at eight to 16 weeks of age to reasonably exclude HIV-1 infection as early as possible. If any test result is positive, the test should be repeated immediately for confirmation. If all test results are negative, the infant should have serologic testing repeated at 12 months of age or older to document disappearance of the HIV-1 antibody, which definitively excludes HIV-1 infection.
• All infants exposed to antiretroviral agents in utero or as infants should be monitored for short- and long-term drug toxicity.
• Prophylaxis for Pneumocystis pneumonia (PCP) should be started at four to six weeks of age in HIV-1-exposed infants in whom infection has not been excluded. PCP prophylaxis may be discontinued when HIV-1 infection has been reasonably excluded.
• Immunizations and tuberculosis screening should be provided for HIV-1-exposed infants in accordance with national guidelines. In the United States, immunization guidelines are established by the AAP, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention, and the American Academy of Family Physicians.
• HIV-1 testing should be offered and recommended to family members.
• The physician providing care for the HIV-1-exposed or HIV-1-infected infant should consult with a pediatric HIV-1 specialist and, if the HIV-1-infected mother is an adolescent, also should consult with a physician familiar with the care of adolescents.
Behavioral Interventions to Modify Physical Activity
The Agency for Healthcare Research and Quality (AHRQ) has released a new report on programs to increase exercise among Americans. "Effectiveness of Behavioral Interventions to Modify Physical Activity Behaviors in General Populations and Cancer Patients and Survivors" is available online at http://www.ahrq.gov/clinic/epcsums/pacansum.htm.
According to the latest statistics, 70 percent of adults in the United States do not get enough physical activity, and more than one third of children do not participate regularly in vigorous exercise. A study released by the Centers for Disease Control and Prevention in March 2004 found that 400,000 deaths in the United States are linked to poor diet and lack of physical activity annually, which is an increase of 33 percent since 1990.
The AHRQ's evidence review found that no specific behavioral intervention or setting appeared to be more effective than another and that shorter, less-intensive programs were just as successful at achieving behavior change as ones that lasted longer and involved more contacts with participants.
Interventions examined included face-to-face counseling, mailings, and check-ups by telephone. Settings for the interventions included clinics, community centers, schools, workplaces, child care centers, exercise centers, churches, and participants' homes.
Some behavior-modification programs designed to increase exercise show continued effects for at least three months after they end. However, the review of existing evidence also demonstrated that it is difficult to achieve sustainable gains in increased physical activity because few studies looked at the effects of these programs for more than one year.
In addition to reviewing evidence from physical activity interventions in healthy populations, the authors examined the effects of exercise on cancer survivors. The report concluded that exercise programs can improve cancer patients' functional capacity and cardiopulmonary fitness, reduce symptoms of fatigue, and improve quality of life during and after cancer treatment. In addition, exercise can reduce cancer patients' symptoms of anxiety and depression during treatment. The report suggests that physical activity may have other positive effects among cancer patients, but at this time there are too few studies to reach any conclusions.
According to the AHRQ, the report provides good information about increasing physical activity through interventions delivered in a variety of settings, and it hopes the report will help to identify programs that can lead to sustained behavior change.
Preventive Services Selector Tool for PDAs
The Agency for Healthcare Research and Quality (AHRQ) has developed a clinical decision-support tool for personal digital assistants (PDAs) that is designed to help physicians deliver evidence-based medicine when they are with a patient. The "Interactive Preventive Services Selector" tool is available for download from the AHRQ Web site at http://pda.ahrq.gov/index.html.
The tool can help physicians quickly and easily search for which preventive services to provide or not provide to patients based on their age and gender. The tool is based on the latest recommendations from the U.S. Preventive Services Task Force, and will be updated with new recommendations each time the PDA is synchronized.
Consumer Advisory on Colloidal Silver Products
The National Center for Complementary and Alternative Medicine (NCCAM) has issued a consumer advisory of colloidal silver products. The advisory is available online at http://www.nccam.nih.gov/health/alerts/silver/index.htm.
Colloidal silver products contain tiny silver particles suspended in liquid. They are marketed as dietary supplements and claim to benefit the immune system; kill disease-causing agents such as bacteria, viruses, and fungi; offer an alternative to prescription antibiotics; and treat diseases such as cancer, human immunodeficiency virus, acquired immunodeficiency syndrome, tuberculosis, syphilis, scarlet fever, shingles, herpes, pneumonia, and prostatitis. These claims have not been proven.
According to the NCCAM, over-the-counter colloidal silver products are not considered by the U.S. Food and Drug Administration (FDA) to be generally recognized as safe and effective for diseases and conditions. The FDA has taken action against a number of companies for making drug-like claims about these products.
Colloidal silver can cause serious side effects. One is argyria, a bluish-gray discoloration of the body. Argyria is not treatable or reversible. Other side effects include neurologic problems (e.g., seizures), kidney damage, stomach distress, headaches, fatigue, and skin irritation. In addition, colloidal silver may interfere with the body's absorption of prescription medications, including penicillamine, quinolones, tetracyclines, and thyroxine.
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Copyright © 2004 by the American
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