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.
THIS WEEK'S CONTENT
JAMA NEWS RELEASES
(Embargoed for Release: 3 p.m. CT, Tuesday, July 20, 2004)
JAMA NEWS RELEASES
RISK OF SUICIDAL BEHAVIOR SIMILAR AMONG USERS OF DIFFERENT ANTIDEPRESSANT DRUGS
STATIN DRUG IMPROVES CHOLESTEROL LEVELS AND REDUCES ARTERIAL WALL THICKNESS AMONG CHILDREN WITH VERY HIGH CHOLESTEROL
HEART FAILURE INCIDENCE REMAINS STABLE; SURVIVAL INCREASES
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 antidepressants and the risk of suicide. The release will be fed Tuesday, July 20, from 9:00 - 9:30 a.m. ET on Intelsat America 6 (formerly Telstar 6), Transponder 11 (C-Band) and from 2:00 - 2:30 p.m. ET on Intelsat America 6 (formerly Telstar 6), Transponder 11 (C-Band). For more information, call 312/464-JAMA (5262).
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mediarelations{at}jama-archives.org
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Embargoed for Release: 3 p.m. CT, TUESDAY, July 20, 2004
Media Advisory: To contact Hershel Jick, M.D., call Julianne Lamay at 617/638-8491. To contact editorialist Simon Wessely, M.Sc., M.D., F.R.C.Psych., F.Med.Sci., email: s.wessely{at}iop.kcl.ac.uk.
RISK OF SUICIDAL BEHAVIOR SIMILAR AMONG USERS OF DIFFERENT ANTIDEPRESSANT DRUGS
CHICAGO—The risk of suicidal behavior is increased in the first month after starting antidepressants, and is similar among users of four antidepressant drugs, according to a study in the July 21 issue of the Journal of the American Medical Association (JAMA).
According to background information in the article, considerable public attention recently has focused on the relation between use of antidepressants, especially selective serotonin reuptake inhibitors (SSRIs), and suicidal ideation (having thoughts of suicide or of taking action to end one's own life) and suicidal behaviors. SSRIs are antidepressant drugs that work by making available more serotonin, a chemical in the brain that is thought to play a key role in depression and anxiety. The use of antidepressant drugs among teenagers has been of particular concern.
Hershel Jick, M.D., and colleagues with the Boston Collaborative Drug Surveillance Program, Boston University, estimated the relative risks of non-fatal suicidal behavior in patients in the United Kingdom starting treatment with the SSRIs fluoxetine and paroxetine and another antidepressant, amitriptyline-compared with patients starting treatment with a fourth drug, dothiepin, that is not available in the U.S. Amtriptyline and dothiepin belong to a class of drugs known as tricyclic antidepressants. Participants could have used only one of the antidepressants, and had to have received at least one prescription for the drug within 90 days before their index date (the date of suicidal behavior or ideation for cases, and the same date for matched controls).
"The risk of suicidal behavior after starting antidepressant treatment is similar among users of amitriptyline, fluoxetine, and paroxetine compared with the risk among users of dothiepin," the authors write. "The risk of suicidal behavior is increased in the first month after starting antidepressants, especially during the first one to nine days," they report. "We think the most likely explanation for this finding is that antidepressant treatment may not be immediately effective, so there is a higher risk of suicidal behavior in patients newly diagnosed and treated than in those who have been treated for a longer time."
"Based on limited information, we also conclude that there is no substantial difference in effect of the four drugs on people aged ten to 19 years," the authors write.
"Given the careful control of potential confounding variables, including age, sex, calendar time, and duration of treatment prior to suicidal behavior, this study provides evidence that the risk of suicidal behavior is not substantially different among patients starting treatment with amitriptyline, fluoxetine, or paroxetine than among patients starting treatment with dothiepin," they conclude. "The available information on young people aged ten through 19 years is limited, however, and some important difference in effect cannot be ruled out based on this study."
(JAMA. 2004;292:338-343. Available post-embargo at jama.com)
Editor's Note: Funding for this study was from general funds available to the Boston Collaborative Drug Surveillance Program. The authors did briefly consult on the principles of study design for a possible company study on antidepressants and suicidal behavior with representatives of GlaxoSmithKline, the manufacturer of paroxetine. The Boston Collaborative Drug Surveillance Program received funding for consultation. The company has no knowledge of the study design, results, or interpretation that the authors are reporting.
EDITORIAL: SUICIDE RISK AND THE SSRIS
In an accompanying editorial, Simon Wessely, M.D., of the Institute of Psychiatry, London, writes, "The results [from Jick et al] confirm that antidepressant prescription is indeed associated with suicidal behavior, and strongly so. This simply means that antidepressants are being prescribed for the right indication, and that they do not immediately eliminate suicide risk. That we knew."
He continues: "But the hypothesis being tested is that over and above the known association of antidepressant prescribing and suicidal behavior (in which the confounder is the presence of depressive disorder), there is also a specific link in which one class of antidepressants, the SSRIs, increases that risk further. The results do not offer much support for the hypothesis."
"However, the authors appropriately caution against overinterpreting this borderline result," Dr. Wessely writes. "Most UK general practitioners are now aware that the older tricyclic drugs are more dangerous in overdose, and it remains plausible that there is a tendency to prescribe the newer SSRIs for patients about whom the physician has more concerns about suicidal risk. Only a small such bias could cause the observed results. Moreover, there was no evidence for the alleged withdrawal phenomenon, which is another of the concerns that have been raised about the SSRIs. Stopping medication did not lead to an increased risk, as postulated by some."
"Whatever decision clinicians reach, careful monitoring of adolescents (for activation, agitation, and suicidal ideation) prescribed any antidepressant remains essential," Dr. Wessely concludes.
(JAMA. 2004;292:379-381. Available post-embargo at jama.com)
Editor's Note: Dr. Wessely has received financial support from Pierre Fabry Pharmaceuticals and from Eli Lilly and Co. to attend academic meeting and for speaking engagements.
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, July 20, 2004
Media Advisory: To contact corresponding author John J.P. Kastelein, M.D., Ph.D., email:
e.vandongen{at}amc.uva.nl.
STATIN DRUG IMPROVES CHOLESTEROL LEVELS AND REDUCES ARTERIAL WALL THICKNESS AMONG CHILDREN WITH VERY HIGH CHOLESTEROL
CHICAGO—Two years of therapy with the cholesterol-lowering drug pravastatin induced significant regression of carotid artery wall thickness, and significantly reduced "bad" cholesterol among children with an inherited type of high cholesterol, with no apparent adverse effects on growth, sexual maturation, hormone levels, or liver and muscle tissue, according to a study in the July 21 issue of the Journal of the American Medical Association (JAMA).
According to background information in the article, familial hypercholesterolemia is a disorder characterized by markedly elevated levels of low-density lipoprotein cholesterol (LDL-C) from birth onward. Children with familial hypercholesterolemia have endothelial dysfunction (impairment of the blood vessel's ability to respond to changes in blood flow by expanding or contracting) and increased carotid intima-media thickness (IMT, increased thickness of the wall of the carotid artery). Endothelial dysfunction and carotid IMT are linked with premature atherosclerotic disease later in life. Atherosclerosis is the build-up of fat and cholesterol deposits, called plaque, in the arteries. The long-term efficacy and safety of cholesterol-lowering medication have not been evaluated in children.
Albert Wiegman, M.D., Ph.D., of the University of Amsterdam, and colleagues conducted a randomized, double-blind, placebo-controlled trial to determine the two-year efficacy and safety of pravastatin therapy in children with familial hypercholesterolemia. Pravastatin belongs to the class of drugs known as statins, which lower cholesterol by blocking the enzyme in the liver that is responsible for making cholesterol. The study included 214 children, aged eight to 18, who were recruited between December 1997 and October 1999, and followed up for two years. After initiation of a fat-restricted diet and encouragement of regular physical activity, 106 children were randomly assigned to receive treatment with 20 to 40 milligrams per day of pravastatin, and 108 were assigned to receive a placebo tablet.
"Compared with baseline, carotid IMT showed a trend toward regression with pravastatin, whereas a trend toward progression was observed in the placebo group," the authors report. "The mean change in IMT compared between the two groups was significant."
Children who received pravastatin showed an average 24.1 percent reduction in LDL cholesterol levels, while those who received placebo showed an average 0.3 percent increase in LDL-C.
No differences between the two groups were observed in growth, maturation, hormone levels, or muscle and liver enzymes.
"We were able to show that statin treatment improved the lipoprotein profile toward more physiological levels and we observed regression of carotid IMT," the authors conclude. "This shows that the increased arterial wall thickness progression found in children with familial hypercholesterolemia is reversible."
"Although this trial in children with familial hypercholesterolemia has, to our knowledge, the most extensive follow-up to date, data on even longer-term safety and efficacy of statin therapy in children are needed," they write.
(JAMA. 2004;292:331-337. Available post-embargo at jama.com)
Editor's Note: The authors would like to thank Zorg Onderzoek Nederland (Prevention Fund of the Dutch Government) for initial financial support of this study. Dr. Kastelein is an established investigator of the Netherlands Heart Foundation. This work was supported in part by an unrestricted grant from Bristol-Myers Squibb Inc., Princeton, N.J. The sponsor had no role in the design and conduct of the study, in the collection, analysis, and interpretation of the data, or in the preparation, review, or approval of the manuscript.
EDITORIAL: TARGETING HIGH-RISK CHILDREN
In an accompanying editorial, Antonio M. Gotto, Jr., M.D., D.Phil., of Weill Medical College of Cornell University, New York, writes that drug therapy may be needed in the majority of children with familial hypercholesterolemia.
Gotto writes, "...physicians may classify familial hypercholesterolemia patients as being at high coronary risk and may begin preventive efforts as early as childhood, with lifestyle therapy as the foundation of any regimen."
"In conclusion, there are many issues at the heart of the debate of using pharmaceuticals in young patients. At what point does the potential risk of therapy outweigh the potential benefit? In the case of familial hypercholesterolemia, the promise of reducing future cardiovascular morbidity and mortality, as well as future demands on acute care and more expensive preventive approaches, would make aggressive treatment of high-risk young patients a worthwhile long-term initiative. Appropriate targeting of lifestyle and drug therapies will optimize primary prevention in this group at demonstrated risk for early disease."
(JAMA. 2004;292:377-378. Available post-embargo at jama.com)
Financial Disclosure: Dr. Gotto is a consultant with the following companies with interest in lipid-lowering drugs: AstraZeneca, Bristol-Myers Squibb Co., Kowa, Merck & Co. Inc., Merck-Schering Plough, Novartis, Pfizer Inc., and Reliant Pharmaceuticals.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org
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Embargoed for Release: 3 p.m. CT, TUESDAY, July 20, 2004
Media Advisory: To contact Veronique L. Roger, M.D., M.P.H., call Lee Aase at 507/266-2442
.
HEART FAILURE INCIDENCE REMAINS STABLE; SURVIVAL INCREASES
CHICAGO—The incidence of heart failure did not decline over the last two decades of the 20th Century, but survival after the onset of heart failure increased overall, with less improvement among women and the elderly, according to a study in the July 21 issue of the Journal of the American Medical Association (JAMA).
Heart failure is the inability of the heart to keep up with the demands on it - specifically, failure to pump blood with normal efficiency. According to background information in the article, approximately 4.9 million Americans have been diagnosed with heart failure, and it is the most frequent cause of hospitalization in people aged 65 and older. Despite the staggering costs to society, the epidemic of heart failure has yet to be fully investigated, and data on incidence, survival, and sex-specific trends over time in community-based populations are limited.
Veronique L. Roger, M.D., M.P.H., of the Mayo Clinic and Foundation, Rochester, Minn., and colleagues conducted a population-based cohort study to test the hypothesis that the incidence of heart failure has declined and survival after heart failure diagnosis has improved over time, but that secular trends have diverged by sex. The study used the resources of the Rochester Epidemiology Project conducted in Olmsted County, Minn. The patients included 4,537 Olmsted County residents (57 percent women; average age, 74) with a diagnosis of heart failure between 1979 and 2000.
"In this large geographically defined community, the incidence of heart failure has remained stable during the past two decades in men and women," the authors write. "The incidence of heart failure is higher among men, and survival after its onset is worse among men."
The incidence of heart failure among men was 378 per 100,000 people, and the incidence of heart failure among women was 289 per 100,000 people. This did not change over time among men or women.
After an average follow-up of 4.2 years, 3,347 deaths occurred, including 1,930 among women and 1,417 among men.
"Survival after heart failure diagnosis was worse among men than women [relative risk, 33 percent higher among men] but overall improved over time," the authors report. The five-year age-adjusted survival was 43 percent in 1979-1984, compared with 52 percent in 1996-2000.
The study findings suggest the apparent gains have not been achieved equally. "Men and younger persons experienced larger survival gains, contrasting with less or no improvement for women and elderly persons," the authors report.
"These findings highlight the increasing population burden of heart failure mediated by stagnating incidence and unequal improvement in survival within the context of an aging and growing population," they conclude.
(JAMA. 2004; 292:344-350. Available post-embargo at jama.com)
Editor's Note: This study was supported by grants from the U.S. Public Health Service and the National Institutes of Health. Dr. Roger is an Established Investigator of the American Heart Association. The funding sources for this study played no role in the design or conduct of the study; data management and analysis; or manuscript preparation, review, and authorization for submission.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org
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JAMA VIDEO NEWS REPORT
RISK OF SUICIDE THE SAME FOR PATIENTS TAKING ANY OF FOUR ANTIDEPRESSANTS - TIMING IS A MORE SIGNIFICANT RISK FACTOR
VIDEO:
B-Roll
File footage of middle-aged white woman and teen son at counter getting
her medication
Pharmacy technician counting out pills
GFX/JAMA COVER
AUDIO:
THIS WOMAN REGULARLY TAKES MEDICATION TO TREAT HER DEPRESSION. BUT IS A
PARTICULAR ANITDEPRESSANT MORE LIKELY TO INCREASE A PERSON'S SUICIDAL
TENDENCIES? A NEW STUDY IN THE JOURNAL OF THE AMERICAN MEDICAL
ASSOCIATION ANSWERS THAT QUESTION.
VIDEO:
SOT/FULL @ : 14
Super: James Kaye, M.D., Dr.P.H., Boston Collaborative Drug Surveillance
Program
Runs :14
AUDIO:
"There was no difference between the antidepressant drugs that we
studied in terms of their association with either non-fatal suicidal
behaviors or suicide itself."
VIDEO:
B-ROLL
Dr. Kaye with a colleague going over data
Generic drugs - bottle labels and pills
Paroxetine
Fluoxetine
Amitriptyline
Pharmacy technician counting pills
AUDIO:
DR. JAMES KAYE AND COLLEAGUES AT THE BOSTON COLLABORATIVE DRUG
SURVEILLANCE PROGRAM AT BOSTON UNIVERSITY SCHOOL OF MEDICINE AUTHORED
THE STUDY. THEY ANALYZED DATA FROM ENGLAND ON ABOUT 160-THOUSAND
PATIENTS, AGES 10 TO 69. BETWEEN 1993 AND 1999, ALL THE PATIENTS USED
EITHER PAROXETINE (par-OX-eh-teen), FLUOXETINE (flu-OX-eh-teen),
AMITRIPTYLINE, (am-ih-TRIP-ti-leen) OR A DIFFERENT ANTIDEPRESSANT NOT
AVAILABLE IN THE U.S. THE RISK OF SUICIDE WAS ESSENTIALLY THE SAME WITH
EACH MEDICATION. IT APPEARS THAT TIMING IS THE ISSUE MORE THAN WHICH
MEDICATION ONE TAKES.
VIDEO:
SOT/FULL
James Kaye, M.D., Dr.P.H., Boston Collaborative Drug Surveillance
Program
Runs :11
AUDIO:
"The risk of suicide itself was nearly 40 times higher during the first
nine days of treatment. That was really the most striking aspect of the
findings."
VIDEO:
B-ROLL
More pills/pharmacist video
Backtime Dr. Kaye
AUDIO:
THE RESEARCHERS ALSO FOUND THAT DURING THE FIRST MONTH OF TREATMENT, A
PATIENT ON ANY OF THE ANTIDEPRESSANTS IN THE STUDY WAS THREE TO FOUR
TIMES AS LIKELY TO MAKE A NON-FATAL SUICIDE ATTEMPT OR HAVE SERIOUS
SUICIDAL THOUGHTS, AS COMPARED TO LATER, AFTER A MONTH OF TREATMENT.
DR. KAYE PROPOSES A POSSIBLE REASON FOR THIS.
VIDEO:
SOT/FULL
James Kaye, M.D., Dr.P.H., Boston Collaborative Drug Surveillance
Program
Runs :09
AUDIO:
"Patients are started on treatment when they're at their worst, and so
they're at highest risk at that period of time."
VIDEO:
B-ROLL
Crowd shots - teens
Adults
Teens
AUDIO:
THE STUDY ALSO SHOWED THAT TEENS ON ANTIDEPRESSANTS HAD LESS RISK OF
SUICIDE THAN THE ADULTS IN THE STUDY, AND LESS RISK THAN TEENS WHO WERE
NOT ON ANTIDEPRESSANT MEDICATION.
VIDEO:
B-ROLL
File footage of middle-aged white woman leaving pharmacy with her
prescription in hand.
Pills being counted.
AUDIO:
MORE INFORMATION TO CONSIDER AS PATIENTS WEIGH THE RISKS AND BENEFITS OF
ANTIDEPRESSANTS.
THIS IS MAVIS PRALL REPORTING.
