Report on Osteoporosis in Postmenopausal Women
The Agency for Healthcare Research and Quality (AHRQ) has released an evidence report summary on the diagnosis and monitoring of osteoporosis in postmenopausal women. The report was developed by AHRQ's Oregon Health Sciences University Evidence-based Practice Center.
According to the AHRQ report, bone density measured at the hip by dual-energy radiograph absorptiometry is the best predictor of hip fracture. However, the weight of evidence does not recommend repeating bone density testing within the first year of treatment. The AHRQ also noted that there was insufficient evidence to determine whether repeating bone density testing two years after starting therapy is useful. The report showed a lack of evidence to support the use of biochemical markers for risk assessment and treatment monitoring. The authors recommend that the focus of future research should be on the application of research data in the clinical setting and on the quality of information provided to patients who undergo bone measurement testing.
The summary of the evidence report, “Osteoporosis in Postmenopausal Women: Diagnosis and Monitoring,” is available online athttp://www.ahrq.gov/clinic/osteosum.htm and from the National Guideline Clearinghouse (NGC) athttp://www.guideline.gov (select “NGC Resources”). Printed copies are available from the AHRQ Publications Clearinghouse by calling 800-358-9295. Copies of the full report should be available by late 2001.
Combination Hepatitis Vaccine Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved a combination hepatitis A inactivated and hepatitis B (recombinant) vaccine (Twinrix) for the prevention of hepatitis A and B. The antigenic components in Twinrix have been used routinely in separate single antigen vaccines in the United States since 1995 and 1989 as hepatitis A and B vaccines, respectively. The combination vaccine is indicated for use in persons 18 years of age and older.
Primary vaccination consists of three doses, given on a zero-, one-and six-month schedule. According to clinical trials of the vaccine, 99.9 percent of vaccinees demonstrated a response against hepatitis A and 98.5 percent of vaccinees showed a response against hepatitis B. The most common side effects were soreness at the injection site, headache and fatigue. These were mild and did not last more than 48 hours.
NIA Progress Report on Alzheimer's Disease
The National Institute on Aging (NIA) of the National Institutes of Health (NIH) has released a new report on Alzheimer's disease. “Progress Report on Alzheimer's Disease, 2000: Taking the Next Steps” presents important scientific advances and information about the main characteristics of Alzheimer's disease and its causes, diagnosis and treatment. The report discusses new findings and the next steps to be taken in the following areas: the etiology of the disease, improving early diagnosis, developing drug treatments, improving support for caregivers and building a research infrastructure. The NIA has also included sections on support for Alzheimer's disease research by other NIH Institutes and on the outlook for the future.
For a free copy of the “Progress Report on Alzheimer's Disease, 2000: Taking the Next Steps,” write to the Alzheimer's Disease Education and Referral (ADEAR) Center, P.O. Box 8250, Silver Spring, MD 20907-8250; call 800-438-4380; or send an e-mail request firstname.lastname@example.org. The report is also available on the ADEAR Center Web site athttp://www.alzheimers.org/pubs/prog00.htm.
FDA Approves Once-a-day Insulin Injection
The U.S. Food and Drug Administration (FDA) has approved an insulin glargine (rDNA origin) injection (Lantus) for the once daily treatment of types 1 and 2 diabetes. According to the manufacturer, the injection has no pronounced peak and is used only once daily at bedtime to treat patients six years of age and older who have type 1 diabetes or adult patients with type 2 diabetes who require long-acting insulin to control hyperglycemia.
The manufacturer stresses that Lantus must not be diluted or mixed with any other insulin or solution because the onset of action and time to peak effect may be altered in an unpredictable manner. Also, Lantus is not meant to replace short-acting insulins, which provide a “bolus” at mealtimes.
The most common side effects of Lantus include hypoglycemia, lipodystrophy, skin reactions (such as injection-site reaction, pruritus and rash) and allergic reactions. For full prescribing information, visit the manufacturer's Web site athttp://www.lantus.com/information/home.html.
HTAC Report on Intracoronary Brachytherapy
The Health Technology and Advisory Committee (HTAC) has published a report on intracoronary brachytherapy. HTAC was established in 1992 by the Minnesota state legislature. It is an independent, nonpartisan advisory body that evaluates new and emerging health care technologies based on existing scientific research and technology assessments.
Intracoronary brachytherapy involves treating coronary stenoses with a radioactive source from within the artery lumen. Either gamma or beta radiation is delivered to the affected vessel via a radioactive stent or catheter-based system. The purpose of the HTAC report is to help physicians learn how safe the procedure is, whether catheter-based gamma- or beta-radiation can effectively reduce restenosis rates after angioplasty and stenting, and whether radioactive stents reduce the rates of in-stent restenosis.
According to the HTAC report, application of brachytherapy has been proposed for the treatment and prevention of coronary artery restenosis, but research on the long-term effectiveness of intracoronary brachytherapy is lacking. The HTAC reports that the best current evidence supports the short-term safety and efficacy of catheter-based gamma-and beta-brachytherapy approved by the U.S. Food and Drug Administration. The HTAC states that a strong recommendation of such therapy would be premature. Questions about patient selection criteria, optimal radiation dose, effectiveness outside the research setting and long-term outcomes must first be answered.
Based on this information, the HTAC concludes that current evidence does not support the recommendation of either catheter- or stent-delivered intracoronary brachytherapy to prevent restenosis of primary coronary artery stenosis. However, physicians should discuss potential short-term benefits of brachytherapy with patients having secondary or repeated restenosis.
CDC Updates Health Information for International Travel
The Division of Global Migration and Quarantine (DQ), National Center for Infectious Diseases of the Centers for Disease Control and Prevention has released the 2001–2002 edition of “Health Information for International Travel” (known as The Yellow Book).
This latest edition includes updated information on vaccination; updated information on malaria risk and prophylaxis, by country; updated and revised disease-specific tables and text; updated country listings; and improved maps and indexing. There are also new sections in The Yellow Book on altitude sickness and international adoption.
To purchase The Yellow Book, contact the Public Health Foundation by calling 877-252-1200 or visithttp://www.bookstore.phf.org.