JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.

(Embargoed for Release: 3 p.m. CT, Tuesday, August 19, 2003)

JAMA NEW RELEASES

   MOST PATIENTS WITH CORONARY HEART DISEASE HAVE AT LEAST ONE MAJOR RISK FACTOR

   FDA INCENTIVE PROGRAM IMPROVES STUDY OF MEDICATIONS FOR CHILDREN

JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)

   CORONARY HEART DISEASE RISK FACTORS MORE PREDICTIVE THAN PREVIOUSLY THOUGHT

INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.

TV Note: This week's JAMA video news release is on the association between coronary heart disease and major risk factors. The release will be fed Tuesday, August 19, from 9:00 - 9:30 a.m. ET on Telstar 6, Transponder 11 (C-Band) and from 2:00 - 2:30 p.m. ET on Telstar 6, Transponder 11 (C-Band). For more information, call 312/464-JAMA (5262).

Please Note: Our e-mail has changed to mediarelations{at}jama-archives.org

EMBARGOED FOR RELEASE: 3 P.M. (CT) TUESDAY, AUGUST 19, 2003
Media Advisory: To contact Philip Greenland, M.D., call Liz Crown at 312/503-8928. To contact Umesh N. Khot, M.D., call Kay Johnson at 317/782-7986. To contact editorialist John G. Canto, M.D., M.S.P.H., call Joy Carter at 205/934-1676.

"These results challenge claims in the medical literature that CHD events commonly occur (as often as 50 percent of the time) in persons who have not been exposed to at least one major risk factor," they write. "These data underscore the importance of considering all major risk factors in CHD risk estimation and in attempting to prevent clinical CHD. Based on these and related findings concerning the major risk factors, we suggest that preventing development of unfavorable levels of blood cholesterol and blood pressure, cigarette smoking, diabetes, and unfavorable body weight (as a precursor of unfavorable blood lipid and blood pressure levels and diabetes) should be given even greater priority than is presently the case."
(JAMA. 2003;290:891-897. Available post-embargo at jama.com)

Editor's Note: The Chicago-based investigators acknowledge support by the American Heart Association, and its Chicago and Illinois affiliates; grants from the National Heart, Lung, and Blood Institute (NHLBI); and the Chicago Health Research Foundation. The FHS and MRFIT studies also have been supported over many years by funding, predominantly from the NHLBI.

In a related article, Umesh N. Khot, M.D., from Indiana Heart Physicians, Indianapolis, and formerly from the Cleveland Clinic Foundation, Cleveland, and colleagues determined the prevalence of the 4 conventional risk factors - cigarette smoking, diabetes, hyperlipidemia, and hypertension - in a broad population of patients with CHD.

The perception that most CHD patients lack any of the conventional risk factors implies that other factors play a significant role in CHD and has led to considerable interest in nontraditional risk factors and genetic causes of CHD, according to background information in the article.

In 2002-2003, the researchers examined data gathered on 122,458 patients enrolled in 14 international randomized clinical trials of CHD conducted during the prior decade. Patients included 76,716 who had a myocardial infarction, 35,527 with unstable angina/heart attack, and 10,215 undergoing percutaneous coronary intervention (such as angioplasty).

Among patients with CHD, at least 1 of the 4 conventional risk factors was present in 84.6 percent of women and 80.6 percent of men. "In younger patients (men 55 years or younger and women 65 years or younger) and most patients presenting with either unstable angina or for percutaneous coronary intervention, only 10 percent to 15 percent of patients lacked any of the 4 conventional risk factors. This pattern was largely independent of sex, geographic region, trial entry criteria, or prior CHD. Premature CHD was related to cigarette smoking in men and cigarette smoking and diabetes in women. Smoking decreased the age at the time of CHD event (at trial entry) by nearly 1 decade in all risk factor combinations."

"It is increasingly clear that the 4 conventional risk factors and their resulting health risks are largely preventable by a healthy lifestyle. The continued emphasis on patients lacking conventional risk factors, a situation that we have shown occurs only in a small minority of patients with CHD, fails to acknowledge the important insights that have been made in current understanding of the relationships among lifestyle, conventional risk factors, and CHD. These insights indicate that intense focus on the 4 conventional risk factors and the lifestyle behaviors causing them has great potential to decrease the worldwide epidemic of CHD," the authors conclude.
(JAMA. 2003;290:898-904. Available post-embargo at jama.com)

Editor's Note: Drs. U. Khot and M. Khot are now with Indiana Heart Physicians, Indianapolis. For information on the funding and support for the study, please see the JAMA article.

EDITORIAL: MAJOR RISK FACTORS FOR CARDIOVASCULAR DISEASE - DEBUNKING THE "ONLY 50 PERCENT" MYTH

In an accompanying editorial, John G. Canto, M.D., M.S.P.H., and Ami E. Iskandrian, M.D., of the University of Alabama at Birmingham, write that the reports in this week's JAMA "may have enormous public health implications for targeting a large segment of the population at risk of developing CHD."

They add that the articles "provide evidence that convincingly challenges the frequent claim that 'only 50 percent' of CHD is attributable to the conventional risk factors of smoking, diabetes, hypertension, and hyperlipidemia, and clearly point out that additional research is needed to establish the role of other novel CHD risk markers. Perhaps more important, these studies emphasize that to reduce the burden of cardiovascular disease, physicians should have even greater vigilance in identifying conventional CHD risk factors and must redouble efforts to control them effectively."
(JAMA. 2003;290:947-949). Available post-embargo at jama.com.

Editor's Note: Dr. Canto has received grant support from and/or consulted for the American College of Cardiology, Medicare, Pfizer, GlaxoSmithKline, Wyeth-Ayerst, Bristol-Myers Squibb, Merck, Millenium, and Sanofi. Dr. Iskandrian has received grant support from and/or consulted for CV Therapeutics, Amersham, Berlex, and Fujisawa.

For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org (please note new email address).

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EMBARGOED FOR RELEASE: 3 P.M. (CT) TUESDAY, AUGUST 19, 2003
Media Advisory: To contact Rosemary Roberts, M.D., call Laura Bradbard at 301/827-6252. To contact editorialist Peter P. Budetti, M.D., J.D., call Jennifer McDonald at 405/271-2323.

"The recent policy changes in the United States, which have resulted in increased numbers of studies of the drugs being prescribed to children, have been called for internationally by others. Drugs used in children should be studied in accordance with sound ethical and scientific principles to define differences in efficacy, age-dependent changes in pharmacokinetics and/or pharmacodynamics, and to identify unique pediatric adverse events, as well as verify adverse events that are similar to those experienced by adults," they write.
(JAMA. 2003;290:905-911. Available post-embargo at jama.com)

EDITORIAL: ENSURING SAFE AND EFFECTIVE MEDICATIONS FOR CHILDREN

In an accompanying editorial, Peter P. Budetti, M.D., J.D., of the University of Oklahoma Health Sciences Center, Oklahoma City, Okla., writes that while off-label prescribing occurs with respect to medical care of adults, it is the cornerstone of pediatric medical therapeutics. "If clinicians restricted their prescribing to medications specifically approved for children, they would have a relatively modest pharmacopoeia and children would not have access to many modern drugs."

"The article by Roberts et al demonstrates how essential it is to conduct appropriate testing of drugs for use in children. 'Highly important new information' related to dosing, safety, and (lack of) efficacy was discovered in more than one-third of the drugs for which studies in children were conducted in response to a request from the FDA and led to new labeling," he writes. "The data presented by Roberts et al demonstrate that the time has come to move forward to protect children from inadequately informed use of prescription drugs while ensuring that they have the benefits of the latest pharmaceuticals and biologicals."

"Additional tools are needed to minimize the use of medications not specifically approved for children. The pharmaceutical industry, federal government, and pediatric clinicians should strive for a system that will collect the scientific data necessary to learn what works and what does not. Legislation that recently passed the Senate by unanimous consent would give the FDA authority to require studies for claimed indications for new drugs and for existing drugs that are or might well be used for approved indications in children. Working in synergy with the exclusivity provisions, this legislation would be one more step toward the too-long deferred goal of having adequate information on pharmaceuticals for children. The era of prescribing for children by trial and error should come to an end," Dr. Budetti concludes.
(JAMA. 2003;290:950-951). Available post-embargo at jama.com.

For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org (please note new email address).

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JAMA REPORTS