Long-term low-intensity warfarin therapy found highly effective in preventing recurrent VTE
A new study led by Paul M. Ridker, M.D. of Brigham and Women’s Hospital and Harvard Medical School, has found that long-term, low-intensity warfarin therapy is a highly effective method of preventing recurrent venous thromboembolism (VTE). The article is to be published in the April 10, 2003 issue of The New England Journal of Medicine, but details were released early due to the important therapeutic implications of the study findings.

Participants in the study included 503 men and women with documented idiopathic venous thromboembolism who had completed at least three months of oral anticoagulation therapy with full-dose warfarin. Each was randomly assigned a placebo or low intensity warfarin. Terminating the study earlier than anticipated, researchers concluded that low-intensity warfarin was associated with a net clinical benefit of 48 percent reduction in recurrent venous thromboembolism, major hemorrhage and death.

The recurrent VTE risk reduction was 64 percent (80 percent for women and 53 percent for men) over a mean of 2.1 years. Subjects were tested for factor V Leiden and the G20210A prothrombin polymorphisms, but there was no differential therapeutic response found in the group that had these genetic disorders. The study excluded patients with known antiphospholipid-antibody syndrome.

Based on studies available to this point, usual care for VTE would include a 5 to 10 day course of herapin followed by 3 to 12 months of oral anticoagulation therapy with full-dose warfarin. Cessation of therapy has involved risk of recurrent VTE, but long-term use of full-dose warfarin has been associated with high rates of major bleeding episodes. Thus, no therapeutic agent has until now demonstrated an acceptable benefit-to-risk ratio for long-term management.

Finding little evidence of any increase in the risk of major hemorrhage or stroke by administering long-term use of a low dosage of warfarin, researchers believe that this approach can be readily implemented in clinical practice.

newsFDA publishes final rule to require labeling aimed at reducing antibiotic resistance
A final rule outlining new labeling regulations designed to help reduce the development of drug-resistant bacterial strains is published in the February 6, 2003 Federal Register. This final rule is aimed at reducing the inappropriate prescription of antibiotics to children and adults for common ailments such as ear infections and chronic coughs.

The new rule applies to all systemically absorbed human antibacterial drugs and requires statements in several places in the physician labeling advising that these drugs should be used only to treat infections that are believed to be caused by bacteria. The rule also requires a statement in the labeling encouraging physicians to counsel their patients about the proper use of these drugs and the importance of taking them exactly as directed. This is part of ongoing efforts at FDA to encourage the development of new antimicrobials while preserving the usefulness of already existing ones.

Many bacterial species, including the species that cause pneumonia and other respiratory tract infections, meningitis, and sexually transmitted diseases, are becoming increasingly resistant to the antibacterial drugs used to treat them. Several bacterial species have developed strains that are resistant to every approved antibiotic.

The complete text can be seen online at [removed]http://www.fda.gov/OHRMS/DOC-ETS/98fr/00n-1463-nfr00001.pdf[/removed].  

Roche grants Dade Behring non-exclusive license for the NT-proBNP CHF marker
Roche Diagnostics, of Basel, Switzerland and Dade Behring of Deerfield, Ill. have announced that Dade Behring has been granted a non-exclusive license under patent rights of Roche Diagnostics relating to the development, manufacture and marketing of immunoassays that detect a key marker of congestive heart failure (CHF), NT-proBNP (N-terminal prohormone brain natriuretic peptide).

B-type natriuretic peptide (BNP) is secreted by the left ventricle when the heart is unable to pump blood efficiently. BNP dilates blood vessels and promotes sodium and water loss, reducing fluid load on the heart and improving cardiac performance. Synthetic BNP, marketed as Natrecor (nesiritide), is a treatment for heart failure. Thus, measuring BNP does not necessarily allow the physician to differentiate between elevated BNP levels due to drug treatment and elevated BNP due to ventricular dysfunction.

By contrast, proBNP measures N-terminal proBNP (NT-proBNP), which is released when BNP is cleaved from its precursor, proBNP. Elevated plasma NT-proBNP indicates the presence of heart failure and provides information about its severity: the higher the blood level of NT-proBNP, the more serious the condition. NT-proBNP levels have been demonstrated to be a diagnostic aid in identifying left ventricular dysfunction, allowing physicians to differentiate between heart failure and lung disorders with similar symptoms.

Dade Behring now trading on the NASDAQ stock market
Dade Behring of Deerfield, Ill. announced it will be trading its common stock on the NASDAQ National Stock Market under the ticker symbol DADE. “The listing of our common stock on NASDAQ, a goal we set upon the successful completion of our capital restructuring, will provide additional liquidity for our stock and a higher profile for the corporation. The achievement of this goal is an important milestone in the growth of Dade Behring as a public company,” said Jim Reid-Anderson, chairman, president and CEO of Dade Behring.

newsCLIA waiver granted to rapid HIV test
The OraQuick Rapid HIV-1 Antibody Test, manufactured by OraSure Technologies, Inc., of Bethlehem, Pa., and marketed exclusively by Abbott Laboratories provides results in as little as 20 minutes. It is performed on a fingerstick sample of blood. Studies show that the test has an accuracy of 99.6 percent. Unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment and can be used outside of traditional laboratory or clinical settings. As with all screening tests for HIV, if the OraQuick gives a reactive test result, that result must be confirmed with an additional specific test.

The FDA approved OraQuick last November for use in laboratories that perform moderate complexity testing. The expanded use to additional sites was granted by HHS under a Clinical Laboratory Improvement Amendments (CLIA) waiver.

“Ensuring the widespread availability of a rapid HIV test to outreach services in communities where people are at high risk of HIV is vital to the public health,” HHS Secretary Tommy G. Thompson said. “Without today’s action, this test would be limited to use in laboratory settings where many high-risk people do not go for testing.”

Widespread availability of the rapid HIV test is likely to increase overall HIV testing and decrease the number of people — an estimated 225,000 Americans — who are unaware they are infected with the HIV virus. Early testing enables infected individuals to obtain medical care earlier in the course of their infection, potentially saving lives and limiting the spread of this deadly virus.

OraSure Technologies tested the accuracy and ease of the test by having 102 untrained users administer the test at four sites in the United States, including a local AIDS foundation, a program for homeless and low income and community-based HIV organizations. These users were able to obtain results similar to those obtained in the firm’s original studies done in laboratories.

CDC and the American Heart Association publish new guidelines for CRP testing
In the January 28, 2002 issue of Circulation, the Journal of the American Heart Association (2003;107:499), the CDC and AHA published a joint statement on the application of markers of inflammation to clinical and public health practice in the prevention of cardiovascular disease (see Disease Management, page ). All currently available laboratory tests for inflammation are examined and hs-CRP is noted as the analyte of choice. Recommendations are made for how measurements should be done, as well as when and in whom the marker should measured. The full text of these recommendations is available online at http://circ.ahajournals.org/cgi/content/full/107/3/499.

newsInmates newly released from prison have high rates of untreated communicable disease including hepatitis C
The Centers for Disease Control and Prevention (CDC) made public a report that addresses the national problem of infectious diseases in jails, prisons and juvenile institutions. Former Chief Medical Officer for the New York State Department of Correctional Services, Dr. Robert Greifinger, wrote the report, which was commissioned by Congress and prepared for the Justice Department in March 2001. According to the study, at least 1.3 million inmates released from jail or prison in 1996 were infected with hepatitis C. That was 29 percent of the 4.5 million cases nationwide. The study also found that newly released inmates accounted for 35 percent of the 34,000 Americans with tuberculosis in 1996 as well as accounted for 13 to 17 percent of Americans infected with HIV or AIDS. The viruses were not said to have been contracted during incarceration, and high rates of risk behaviors among the inmate populations were also noted.

Experts say the high rate of communicable diseases among inmates is a critical issue for two reasons: inmates pose a danger of infecting others both in prison and when they are released, and the opportunity to treat them is largely being wasted. In response, CDC published recommendations designed to prevent and control viral hepatitis infections in correctional settings. Some of the key recommendations include: vaccinating all persons in correctional facilities against HBV; testing inmates with risk factors for HCV and evaluating for antiviral treatment if positive; providing substance abuse treatment for persons with viral infection; and providing prevention education.

Management team purchases Leica Microsystems’ Analytical Division
Leica Microsystems’ Analytical Division of Buffalo, N.Y. has announced that the company has changed its name to Reichert, Inc. following its purchase by the firm’s current management team and a private equity investment fund. Reichert, Inc. results from the purchase of the ophthalmic and analytical instrument businesses of Leica Microsystems AG, headquartered in Wetzlar, Germany. The new company will maintain its headquarters at facilities in Buffalo, N.Y. and will be headed by John Burgess, the current CEO of Leica Microsystems’ Buffalo operations.

The Analytical Division of Reichert, Inc. designs, manufactures, sells and services a full line of laboratory and portable refractometers.

newsComputerized physician order entry improves lab reporting times
A new study conducted at the Ohio State University Hospitals suggests that doctors may reduce the time it takes to deliver medications to patients and complete X-rays and lab tests if performed electronically, via computer. Computerized physician order entry (POE) may help lower the national percentages that suggest physician error, the new study shows. As many as 25 percent of reported medication errors arise from confusion over the similarity of drug names, according to the National Coordinating for Medication Error Reporting and Prevention. Researchers at the Ohio State University Hospitals compared turn-around times before and after the implementation of computerized POE. Medication turn-around decreased by 64 percent, from nearly five-and-a-half hours to just under two hours. Radiology procedure completions times decreased by 43 percent, from just over seven-and-a-half hours to four hours and 21 minutes. Laboratory result reporting times decreased by 25 percent, from 31 minutes to 23 minutes. While the advantages of computerized POE are many, including speedy patient care, the study showed that it had little impact on hospital costs and stays. The study appears in the January/February 2003 issue of the Journal of the American Medical Informatics Association.

Newly cleared albumin cobalt binding test helps rule out MI
The FDA has cleared a new blood test that will significantly increase the ability of doctors to rule out a heart attack when a person shows up at an emergency room with severe chest pains. The test is the first new blood test for evaluation of heart attacks since the introduction of the blood test for troponin, a protein present in the blood after a heart attack, in 1994. The test, the Albumin Cobalt Binding (ACB) Test, manufactured by Ischemia Technologies, Inc., of Arvada Colo., works by measuring how much cobalt is bound to the blood protein albumin. Changes in the structure of albumin occur in several illnesses, including heart attacks. The ACB test is not a stand-alone heart attack test but must be used together with an electrocardiogram (ECG) and a blood test for troponin. A normal ACB test with a normal ECG and normal troponin gives doctors increased confidence that patients can go home because they did not have a heart attack.

A study conducted by the manufacturer of more than 200 patients at high risk of heart attack who had severe chest pain showed that when the ACB test was used together with an ECG and a troponin test, physicians were 70 percent accurate in ruling out heart attack. With an ECG and troponin test alone, physicians were 50 percent accurate in ruling out a heart attack.

newsWomen report different pre-diagnosis symptoms and dissatisfaction with cardiac care
One of every two women will die from heart disease, according to the American Heart Association. While better diagnosis and treatment of heart disease has led to a declining number of deaths among men, the number of women who die has risen to over 500,000 a year. There are 6.4 million women in the U.S. today who have been diagnosed with heart disease.

In a survey involving 104 female heart patients, more than one-half replied that they are dissatisfied with their health care. Results from the first-ever national survey of women heart patients are published in the January/February edition of Women’s Health Issues. In response to the large number of participants who complained of physician insensitivity, rudeness, abruptness and ignorance about their heart condition, Sharonne Hayes, M.D., Director of Mayo Clinic Women’s Heart Clinic said in a press release that this is a defining moment in the need for proper cardiac diagnosis and care. “Health-care professionals need to understand how much their attitudes and communication styles influence their female patients’ willingness to ask questions, participate in medical decisions, and adhere to recommended treatment and lifestyle modification,” Hayes said. “It also underscores the need to recognize and treat anxiety and depression that so often accompany heart disease,” she added.

Women also answered questions regarding their symptoms prior to diagnosis in the survey that was funded by WomenHeart: The National Coalition for Women with Heart Disease. A significant number of women reported symptoms less commonly associated with a cardiac diagnosis, including dizziness, nausea, fatigue or back pain. “Only 35 percent of the women patients initially recognized their symptoms as heart-related and 45 percent felt their heart disease came out of the blue,” said Nancy Loving, WomenHeart’s executive director. “Women need to realize heart disease is their number one killer and seek out professionals who are well-versed in women’s cardiac risks and symptoms,” Loving added.