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: 3:00 p.m. CT, Tuesday, September 11, 2007)
JAMA NEWS RELEASES
LOWERING HOMOCYSTEINE LEVELS DOES NOT IMPROVE OUTCOMES FOR PATIENTS WITH CHRONIC KIDNEY DISEASE
STUDY SUGGESTS DRUG USED FOR TREATMENT FOR HEART FAILURE IN ADULTS MAY NOT BE BENEFICIAL FOR CHILDREN AND TEENS
GLYCEMIC CONTROL MEDICATION PIOGLITAZONE APPEARS TO HAVE OVERALL FAVORABLE EFFECT REGARDING RISK OF CARDIOVASCULAR EVENTS
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
FOLIC ACID AND B VITAMINS LOWER HOMOCYSTEINE LEVELS IN KIDNEY DISEASE PATIENTS, BUT DO NOT LESSEN RISK OF DEATH FROM HEART ATTACK OR STROKE
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
TV Note: This week's JAMA Report video is on the effect of lowering homocysteine levels for patients with chronic kidney disease. The report will be fed Tuesday, September 11, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 26 (formerly Intelsat America 6) C-Band, Transponder 14, downlink frequency: 3880 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, September 11, 2007
Media Advisory: To contact Rex L. Jamison, M.D., call Kerri Childress at 650-858-3925. To contact editorial co-author Colin Baigent, B.M., B.Ch., F.R.C.P., email: colin.baigent{at}ctsu.ox.ac.uk.
LOWERING HOMOCYSTEINE LEVELS DOES NOT IMPROVE OUTCOMES FOR PATIENTS WITH CHRONIC KIDNEY DISEASE
CHICAGO—Patients with end-stage kidney disease treated with high doses of folic acid and B vitamins to lower homocysteine levels did not have improvement in survival or reductions in the incidence of vascular events, according to a study in the September 12 issue of JAMA.
Numerous studies have shown that high plasma levels of homocysteine are associated with vascular disease. Patients with chronic kidney disease or end-stage renal disease (ESRD) have extensive vascular disease, with estimates of an annual rate of death as high as 20 percent, according to background information in the article. Folic acid and B vitamins decrease homocysteine levels in these patients, but whether they lower the rate of death and vascular events is not known.
Rex L. Jamison, M.D., of the Veterans Affairs (VA) Palo Alto Health Care Systems and Stanford University School of Medicine, Stanford, Calif., and colleagues conducted a study to determine whether treatment with a combination of high-dose folic acid and B vitamins can reduce the rate of death and cardiovascular events in patients with advanced chronic kidney disease (ACKD) and ESRD. The randomized controlled trial (2001-2006), involving 36 VA medical centers, included patients with ACKD (n = 1,305) or ESRD (n = 751) and high homocysteine levels. Median (midpoint) follow-up was 3.2 years. Participants received a daily capsule containing folic acid and vitamin B6 and B12 or a placebo.
After three months, patients in the vitamin group had their homocysteine level lowered by about 26 percent, while this level decreased by 1.7 percent in the placebo group. This treatment had no significant effect on the rate of death between the two groups (448 deaths in the vitamin group vs. 436 deaths in the placebo group). Treatment also had no significant effect on other outcomes such as heart attack, stroke and amputation.
“What might account for the failure of the treatment in our study? Possibly the underlying burden of disease was too great for a measurable benefit from lowering homocysteine,” the authors write.
“Our findings do not support the administration of folic acid and B vitamin supplements to prevent vascular injury or improve survival in patients with ACKD or ESRD.”
(JAMA. 2007;298(10):1163-1170. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: B VITAMINS FOR THE PREVENTION OF VASCULAR DISEASE — INSUFFICIENT EVIDENCE TO JUSTIFY TREATMENT
In an accompanying editorial, Colin Baigent, B.M., B.Ch., F.R.C.P., and Robert Clarke, M.D., F.R.C.P., of the University of Oxford, England, speculate on why this and other trials have failed to show B vitamins as an effective treatment for this condition.
“Possible reasons for the failure of the 5 completed trials to demonstrate statistically definite effects on vascular risk include an inadequate number of recorded events or insufficient duration of treatment; an attenuation of the benefit owing to folic acid fortification in North America, where most of the trials have been conducted to date; or a true failure of treatment to reduce vascular risk.”
(JAMA. 2007;298(10):1212-1214. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
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: 3:00 p.m. CT, Tuesday, September 11, 2007
Media Advisory: To contact Robert E. Shaddy, M.D., call Joey McCool at 267-426-6070. To contact editorial author Samuel S. Gidding, M.D., call Jim Lardear at 302-651-6092.
STUDY SUGGESTS DRUG USED FOR TREATMENT FOR HEART FAILURE IN ADULTS MAY NOT BE BENEFICIAL FOR CHILDREN AND TEENS
CHICAGO—Preliminary findings indicate a heart failure medication used by adults, carvedilol, may not significantly improve heart failure outcomes for children and adolescents, according to an article in the September 12 issue of JAMA.
“Heart failure due to systemic ventricular dysfunction is a significant medical problem for children and represents the reason for at least 50 percent of pediatric referrals for heart transplantation. To date, there have been no large randomized controlled trials of any medication in children and adolescents with chronic heart failure. Treatment recommendations in children and adolescents with heart failure are extrapolated from the results of clinical trials conducted in adults, which may be problematic,” the authors write.
Robert E. Shaddy, M.D., of Children’s Hospital of Philadelphia and the University of Pennsylvania, and colleagues evaluated the effects of the beta-blocker carvedilol in 161 children and adolescents with heart failure. In addition to treatment with conventional heart failure medications, patients were randomized to receive placebo or carvedilol for eight months. The size of the dosage was determined by the weight of the child.
The researchers found no statistically significant difference between the treatment groups with regard to the percentage of patients who improved, worsened, or were unchanged during the course of the study. Among 54 patients assigned to placebo, 56 percent improved, 30 percent worsened and 15 percent were unchanged. Among 103 patients assigned to carvedilol, 56 improved, 24 percent worsened and 19 percent were unchanged.
“This study did not detect a treatment effect of carvedilol on the primary composite end point of clinical heart failure outcomes. It is possible that children and adolescents with heart failure do not receive benefit from carvedilol; this would represent the first heart failure population not to show benefit with beta-blockade and is inconsistent with the many small studies supporting the benefit of beta-blockade in this patient population to date. It is unclear why carvedilol would be beneficial in adults with heart failure but not in children and adolescents,” the authors write. “...given the lower than expected event rates, the trial may have been underpowered. There may be a differential effect of carvedilol in children and adolescents based on ventricular morphology.”
(JAMA. 2007;298(10):1171-1179. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: THE IMPORTANCE OF RANDOMIZED CONTROLLED TRIALS IN PEDIATRIC CARDIOLOGY
In an accompanying editorial, Samuel S. Gidding, M.D., of Nemours Cardiac Center, Wilmington, Del., comments on the findings of Shaddy and colleagues.
“A subtle but important difference between pediatric and adult research relates to goals. Adult cardiac trials, whether related to heart failure or prevention of recurrent myocardial infarction, are considered successful when the inevitable is delayed. For most adults, the inevitable still occurs. For children with heart disease, the goals are different: to treat pediatric patients effectively so that they can experience decades of as normal a quality of life as possible. This difference provides the ethical rationale for independent pediatric clinical research and rigorous clinical trials in pediatric patients as opposed to a reliance on adult outcomes, which often are not generalizable to children. After all, and especially in pediatric cardiology research and treatment, children are not simply little adults.”
(JAMA. 2007;298(10):1214-1216. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other affiliations, financial disclosures, funding and support, etc.
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: 3:00 p.m. CT, Tuesday, September 11, 2007
Media Advisory: To contact A. Michael Lincoff, M.D., call Erinne Dyer at 216-444-8168. To contact Sonal Singh, M.D., call Shannon Koontz at 336-716-2415. To contact editorial co-author Daniel H. Solomon, M.D., M.P.H., call Kevin Myron at 617-534-1605.
GLYCEMIC CONTROL MEDICATION PIOGLITAZONE APPEARS TO HAVE OVERALL FAVORABLE EFFECT REGARDING RISK OF CARDIOVASCULAR EVENTS
CHICAGO—A meta-analysis of previous research suggests that use of pioglitazone, a glycemic control medication for patients with type 2 diabetes, significantly reduces the risk of heart attack, stroke and death, but increases the risk for serious heart failure, according to an article in the September 12 issue of JAMA.
A. Michael Lincoff, M.D., and colleagues at the Cleveland Clinic, conducted a meta-analysis of research to evaluate the effect of pioglitazone on the incidence of ischemic cardiovascular complications for patients with type 2 diabetes. Previous evidence had been insufficient to evaluate this effect. This analysis included 19 randomized trials and 16,390 patients. Duration of pioglitazone use ranged from 4 months to 3.5 years.
The researchers found that heart attack, stroke or death occurred in 375 (4.4 percent) of 8,554 patients receiving pioglitazone and 450 (5.7 percent) of 7,836 patients treated with control therapy, an 18 percent relative reduction. These outcomes were all reduced by a similar magnitude with pioglitazone treatment. Serious heart failure was reported in 200 (2.3 percent) of pioglitazone-treated patients and 139 (1.8 percent) of control patients.
“These findings suggest that the net clinical cardiovascular benefit with pioglitazone therapy is favorable, with an important reduction in irreversible ischemic events that is not attenuated by the risk of more frequent heart failure complications,” the authors write.
(JAMA. 2007;298(10):1180-1188. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
LONG-TERM USE OF GLYCEMIC CONTROL MEDICATION ROSIGLITAZONE ASSOCIATED WITH INCREASED RISK OF HEART ATTACK AND HEART FAILURE
Patients with type 2 diabetes or impaired glucose tolerance who take the medication rosiglitazone appear to be at increased risk for a heart attack or heart failure, according to a meta-analysis article in this issue of JAMA.
Sonal Singh, M.D., of the Wake Forest University School of Medicine, Winston-Salem, N.C., and colleagues reviewed research to examine the risk of heart attack, heart failure and cardiovascular death with long-term rosiglitazone use. There have been recent reports of serious adverse events with rosiglitazone use, but information available to clinicians on the magnitude and public health impact of these events has been limited.
The researchers compiled data from four randomized trials that included 14,291 patients (n = 6,421 receiving rosiglitazone; n = 7,870 receiving control therapy). Follow-up for these studies was 1-4 years.
The pooled data from the trials indicated that rosiglitazone, compared with controls, significantly increased the risk of heart attack by 42 percent (94 of 6,421 patients who received rosiglitazone vs. 83 of 7,870 patients who received control therapy) and doubled the risk of heart failure (102 of 6,421 patients vs. 62 of 7,870 patients). Use of rosiglitazone was not associated with a significant increase in risk of cardiovascular death.
“Our findings have potential regulatory and clinical implications. These data suggest a reversal of the benefit-to-harm balance for rosiglitazone present at the time of approval. Thus, currently there appear to be much safer treatment alternatives. Regulatory agencies ought to reevaluate whether rosiglitazone should be allowed to remain on the market. Health plans and physicians should not wait for regulatory actions. They should avoid using rosiglitazone in patients with diabetes who are at risk of cardiovascular events, especially since safer treatment alternatives are available,” the authors conclude.
(JAMA. 2007;298(10):1189-1195. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: CARDIOVASCULAR RISK AND THE THIAZOLIDINEDIONES — DÉJÀ VU ALL OVER AGAIN?
In an accompanying editorial, Daniel H. Solomon, M.D., M.P.H., and Wolfgang C. Winkelmayer, M.D., Sc.D., of Brigham and Women’s Hospital, Harvard Medical School, Boston, comment on the findings in this week’s JAMA regarding glycemic control medications and drug safety.
“The previous episode with the selective COX-2 inhibitors and the current one with the thiazolidinediones are instructive for designing a better drug safety system. First, early safety concerns must prompt strong and clear regulatory action. ...Second, postmarketing adverse events not frequently observed in premarketing studies should be expected when there is incomplete understanding of the mechanism of action of a drug.”
“Third, after several drugs are available for a given indication, new drug approval should be based on improvement in clinical outcomes, not surrogate measures. ...Fourth, the decisions for initial approval of a drug and subsequent continued marketing should by symmetric. ...Finally, and perhaps most difficult, safety and efficacy must be explicitly balanced when drugs are being considered for approval or for continued marketing.”
(JAMA. 2007;298(10):1216-1218. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
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 REPORTS
VIDEO: Windows Media | Quicktime
FOLIC ACID AND B VITAMINS LOWER HOMOCYSTEINE LEVELS IN KIDNEY DISEASE PATIENTS, BUT DO NOT LESSEN RISK OF DEATH FROM HEART ATTACK OR STROKE
INTRO:
Approximately eight million Americans suffer from kidney disease. People with kidney disease are at high risk for things like heart attack and stroke. Researchers hoped that folic acid and B vitamins might help combat these heart problems. They didn’t, but the study findings still help doctors treat kidney disease patients. Mavis Prall explains in this week’s JAMA Report.
VIDEO:
B-ROLL
Dr. Chertow listening to African American male kidney patient’s heart
AUDIO:
IN PATIENTS WITH KIDNEY DISEASE, IT’S NOT JUST THE KIDNEY THAT’S IN TROUBLE. IT’S THE HEART, TOO.
VIDEO:
SOT/FULL
@ :07
Super: Rex Jamison, M.D.
Veterans Affairs researcher/Stanford University
Runs :16
AUDIO:
“Patients with advanced chronic kidney disease have a terrible burden of disease of their blood vessels that cause a lot of heart attacks, strokes and hardening of their blood vessels.”
VIDEO:
B-ROLL
Dr. Jamison working at computer
Different African American man pouring pills into hand
Man taking pills
AUDIO:
DR. REX JAMISON OF STANFORD UNIVERSITY WAS A RESEARCHER IN A LARGE STUDY FUNDED BY THE DEPARTMENT OF VETERANS AFFAIRS. THE STUDY LOOKED AT THE EFFECTS OF FOLIC ACID AND B VITAMINS IN PATIENTS WITH CHRONIC KIDNEY DISEASE AND END-STAGE RENAL DISEASE, BECAUSE THOSE VITAMINS HAVE SHOWN TO LOWER A CHEMICAL IN THE BLOOD CALLED HOMOCYSTEINE (ho-mo-SIS-teen).
VIDEO:
SOT/FULL
Rex Jamison, M.D.
Veterans Affairs researcher/Stanford University
Runs :11
AUDIO:
“The higher the homocysteine level, the more frequent heart attacks, strokes and disease of the blood vessels in general.”
VIDEO:
FULL SCREEN GRAPHIC
Title: Kidney Disease Study
2,046 Veterans with advanced chronic kidney disease or end-stage renal disease
Half got daily 40 mg folic acid/100 mg vitamin B6
Half got daily placebo
GFX/JAMA COVER
AUDIO:
IN THE THREE YEAR-STUDY OF MORE THAN TWO-THOUSAND VETERANS WITH SERIOUS KIDNEY DISEASE AND HIGH HOMOCYSTEINE LEVELS, HALF GOT DAILY TREATMENT WITH FOLIC ACID AND B VITAMIN PILLS, AND HALF GOT PLACEBO OR SUGAR PILLS. THE FINDINGS APPEAR IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
VIDEO:
SOT/FULL
Rex Jamison, M.D.
Veterans Affairs researcher/Stanford University
Runs :13
AUDIO:
“We did not reduce the number of deaths in the treatment group. We did lower their homocysteine levels significantly, but despite this, there was no benefit.”
VIDEO:
B-ROLL
Dr. Chertow examining white woman, taking her blood pressure
Dr. Chertow talking with African American male patient
Pills in hand
AUDIO:
A DISAPPOINTING FINDING, ESPECIALLY GIVEN THE TWENTY-PERCENT DEATH RATE FOR PEOPLE WITH ADVANCED KIDNEY DISEASE. BUT DR. GLEN CHERTOW, A KIDNEY EXPERT AT UNIVERSITY OF CALIFORNIA SAN FRANCISCO WHO WAS NOT ASSOCIATED WITH THE STUDY, SAYS ITS FINDINGS ARE VALUABLE, BECAUSE NOW DOCTORS KNOW THAT FOLIC ACID AND B VITAMINS ARE NOT THE ANSWER.
VIDEO:
SOT/FULL
@ 1:39
Super: Glen Chertow, M.D.,M.P.H.
University of Calif., San Francisco
Runs :10
AUDIO:
“It allows us to concentrate our efforts elsewhere, so we can focus on other aspects of care or other therapies that might improve the care of patients with chronic kidney disease.”
VIDEO:
B-ROLL
Dr. Chertow with patient
AUDIO:
THIS IS MAVIS PRALL WITH THE JAMA REPORT.
TAG:
Diabetics are most at risk for kidney problems. To help avoid type 2 diabetes and other conditions that can lead to kidney disease, get regular exercise, eat nutritious foods and maintain a healthy weight, and do not smoke. For more information, visit www.jama.com.
