EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, February 14, 2005
To contact corresponding author, Henry Krum, M.B.B.S, Ph.D., e-mail: Henry.Krum{at}med.monash.edu.au.

COX-2 INHIBITORS ASSOCIATED WITH BLOOD PRESSURE ELEVATION

CHICAGO—An analysis of 19 randomized controlled trials involving COX-2 inhibitors (selective cyclooxygenase-2 inhibitors) suggests that these agents raise blood pressure more than either conventional nonsteroidal anti-inflammatory drugs (NSAIDs) or placebo, according to a study to be published in an upcoming issue of the Archives of Internal Medicine, one of the JAMA/Archives journals. The study is posted online today because of its relevance to current events surrounding this class of drugs. It will be published in a future print edition of the journal.

NSAIDs, among the most widely prescribed drugs for pain relief, are associated with gastrointestinal side effects. As a result there has been a significant preference to prescribe COX-2 inhibitors over conventional NSAIDs, even when patients do not meet specified criteria for treatment, according to background information in the article. Some COX-2 inhibitors have been associated with an increased risk of cardiovascular events.

Tai-Juan Aw, M.B.B.S., F.R.A.C.P., Monash University, Melbourne, Australia, and colleagues, analyzed data from all 19 randomized controlled trials of COX-2 inhibitors published before May 2004, with a total of 45,451 participants for whom blood pressure data were available. The meta-analysis was designed to compare the relative risk of developing hypertension and of clinically important blood pressure elevation in study participants treated with COX-2 inhibitors versus those treated with NSAIDs or placebo.

COX-2 inhibitors were associated with a blood pressure elevation compared with NSAIDs and placebos, the authors found. These blood pressure elevations may be clinically significant in relation to increased cardiovascular risk. The authors also saw differences between the COX-2 inhibitors. "Rofecoxib appears to confer a greater risk of developing hypertension and clinically important elevations in both systolic and diastolic blood pressure compared with celecoxib," they stated.

EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, February 14, 2005
Media Advisory: To contact Lone Simonsen, Ph.D., call Laurie Doepel at 301-402-1663.

FLU VACCINATION IMPACT ON ELDERLY DEATHS MAY BE OVER-ESTIMATED

CHICAGO—Observational studies which report that influenza vaccination reduces winter mortality risk among the elderly by 50 percent may substantially overestimate the vaccination benefit, according to the February 14 issue of the Archives of Internal Medicine, one of the JAMA/Archives journals.

Accurate determination of the impact of influenza on mortality is difficult because the infection is often cleared before the onset of the secondary complications that actually cause a person's death, according to the article. Although influenza vaccination of the elderly in the U.S. has increased from 15 to 20 percent before 1980 to 65 percent in 2001, the authors could find no correlation between this increasing vaccination coverage after 1980 and declining deaths rates in any age group. Observational studies may introduce a systematic bias that leads to a substantial over-estimate of the impact of influenza vaccination on mortality, the authors suggest.

Lone Simonsen, Ph.D., of the National Institute of Allergy and Infectious Diseases, and colleagues, used statistical models that estimate the winter-seasonal all-cause mortality above an estimated baseline to determine influenza-related mortality indirectly. Their model incorporated information on deaths among the elderly from pneumonia and influenza and all other causes from 33 winter seasons from 1968-2001. "Our results, based on national vital statistics, are simply not consistent with the very large mortality benefits reported in observational studies," the authors write. The authors suggest that this disconnect may be explained by a disparity in who is likely to be vaccinated. "Very ill elderly people, whose fragile health would make them highly likely to die over the coming winter months, are less likely to be vaccinated during the autumn vaccination period," they stated.

EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, February 14, 2005
Media Advisory: To contact Eelko Hak, M.Sc., Ph.D., e-mail: E.Hak{at}med.uu.nl.

FLU VACCINATION BENEFITS PEOPLE OF ANY AGE WITH HIGH-RISK MEDICAL CONDITIONS

CHICAGO—Persons younger than 65 with high-risk medical conditions such as chronic lung and heart disease can substantially benefit from annual influenza vaccination during an epidemic, according to a study in the February 14 issue of the Archives of Internal Medicine, one of the JAMA/Archives journals.

Influenza continues to be a major cause of illness and death, with an annual 140,000 hospitalizations and 36,000 deaths in the United States, according to background information in the article. Many studies have shown that influenza vaccination can reduce acute respiratory disease hospitalizations and death from all causes in the elderly. This analysis, involving 75,227 patient-observations, 30,861 of which were among high-risk patients younger than 65, is the first large-scale study to show that influenza vaccination is highly effective in reducing complications across all age groups, according to the authors.

Eelko Hak, M.Sc., Ph.D., of the University Medical Center of Utrecht, the Netherlands, and his colleagues, used data from Dutch primary care data management centers during the 1999-2000 influenza A epidemic. In the Netherlands, virtually all persons recommended for influenza vaccination receive their vaccine from a general practitioner through a standardized vaccination program.

"To our knowledge, this is the first study showing high vaccine effectiveness in reducing severe end points such as deaths (78 percent) and hospitalizations for acute respiratory and cardiovascular disease (87 percent) among high-risk persons of working age," the authors stated. According to the researchers, the study is consistent with other reports that vaccination may reduce hospital admissions for cardiovascular and cerebrovascular complications as well as death or hospitalization for influenza or pneumonia in the elderly.

EMBARGOED FOR RELEASE UNTIL 3 P.M. (CT), MONDAY, February 14, 2005
To contact Judith P. Kelly, M.S., call Kristen Perfetuo at 617-638-8491.

CHANGING TRENDS IN HERBAL SUPPLEMENT USE

CHICAGO—After a rise in the popularity of dietary supplements in the 1990s, their use seems to have plateaued, although exposure may continue to increase with the addition of herbal supplements to mainstream multivitamin products, according to an article in the February 14 issue of the Archives of Internal Medicine, one of the JAMA/Archives journals.

During the last decade the use of alternative medicines, particularly herbal products, has increased considerably, according to background information in the article. Americans spent $4.2 billion on herbs and other botanical remedies in 2001, and their benefits are being cited more and more in the media.

Judith P. Kelly, M.S., from Boston University School of Public Health, and colleagues examined data from phone interviews conducted from 1998 through 2002 in order to determine which dietary supplements Americans were using. The 8,470 study participants were asked to identify all over-the-counter and prescription drugs, along with dietary supplements taken during the preceding seven days.

The percentage of people using dietary supplements increased from 14.2 percent in 1998-1999 to 18.8 percent 2002, with a low of 12.3 percent in 2000 and a high of 19.8 percent in 2001. The percentage of people aged 45 to 64 years who took supplements increased by about half between 1998-1999 and 2001-2002. However, the use of Ginko biloba and Panax ginseng declined during the study period. Overall, supplement users were older, more likely to be female (59.9 vs. 55.5 percent) and white (80.7 vs. 75.6 percent). The use of lutein, a component of multivitamin products, increased in both men and women, with a prevalence of 0.3 percent, 0.5 percent, 6.6 percent, and 8.4 percent, respectively, in 1998-1999, 2000, 2001, and 2002.

"Our observations regarding lutein use were unexpected," the authors noted. This carotenoid antioxidant which it has been suggested may be protective against macular degeneration (an important cause of blindness in adults), was first added to many popular multivitamins in late 1999 and 2000. Another antioxidant, lycopene, was added to major multivitamins in 2003 as a cancer preventative. "The addition of these supplements to multivitamin products has signaled two subtle, but important, changes in recent years," the researchers suggest. "First, the acceptance of herbal supplements and other dietary supplements as part of the mainstream health milieu has apparently increased. Second, the marketing strategy for multivitamin products appears to have broadened from supplying recommended daily allowances of vitamins and minerals that may be lacking in the diet to preventing chronic disease, such as macular degeneration and cancer."