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 Early Release: 10 a.m. CT, Tuesday, April 1, 2008)
JAMA EARLY NEWS RELEASE
MIXED RESULTS IN CLINICAL TRIAL OF WEIGHT LOSS DRUG RIMONABANT ON SLOWING PROGRESSION OF CORONARY DISEASE
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
WEIGHT LOSS DRUG SHOWS PROMISE FOR HELPING THOSE WITH CORONARY HEART DISEASE
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TV Note: This week's JAMA Video News Report has an early embargo of 10 a.m. CT Tuesday, April 1. The report is on the results of use of a weight loss drug for people with heart disease. The report will be fed Tuesday, April 1, 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 Early Release: 10:00 a.m. CT, Tuesday, April 1, 2008
Media Advisory: To contact Steven E. Nissen, M.D., call Brian Kolonick at 720-841-1114. To contact editorial co-author Brahmajee K. Nallamothu, M.D., M.P.H., call Kara Gavin at 734-764-2220.
MIXED RESULTS IN CLINICAL TRIAL OF WEIGHT LOSS DRUG RIMONABANT ON SLOWING PROGRESSION OF CORONARY DISEASE
CHICAGO—The anti-obesity medication rimonabant showed mixed results in slowing progression of coronary artery disease in patients with abdominal obesity and pre-existing coronary disease, according to a new study in the April 2 issue of JAMA. The study is being released early online April 1 to coincide with its presentation at the annual conference of the American College of Cardiology.
“Abdominal obesity, even in the absence of type 2 diabetes, is associated with a constellation of metabolic and physiological abnormalities that amplify the risk for atheroslcerotic cardiovascular disease,” the authors write in background information for the article. Atherosclerotic disease, often commonly known as “hardening” of the arteries, occurs when deposits of plaques accumulate in the inner lining of the arteries. The researchers write that there are few treatment options to address the underlying cause of the metabolic syndrome – abdominal obesity. One promising approach is the use of the selective cannabinoid type 1 receptor antagonist rimonabant. Rimonabant has not been approved by the U.S. Food and Drug Administration, but is available in several other countries. Metabolic syndrome includes high triglyceride levels, a low HDL (good) cholesterol level, high blood pressure, and a high level of glucose (sugar) in the blood.
In this study called STRADIVARIUS, the Strategy to Reduce Atherosclerosis Development Involving Administration of Rimonabant – The Intravascular Ultrasound Study, ultrasonographic coronary imaging was used to assess atherosclerotic progression. Steven E. Nissen, M.D., of the Cleveland Clinic and the STRADIVARIUS investigators, conducted a randomized, double-blinded clinical trial from December 2004 to December 2005 comparing rimonabant with placebo in 839 patients at 112 centers in North America, Europe and Australia. The patients were randomly assigned to receive either rimonabant (20 mg daily) or a matching placebo for 18 to 20 months. Patients were eligible to participate in the study only if they also required a coronary angiography for a medical reason. The patients returned for scheduled clinic visits at 3, 6, 12, and 18 months following randomization. The main outcome the researchers were observing was a change in the percent atheroma volume (PAV) and the secondary outcome was a change in normalized total atheroma volume (TAV). PAV and TAV are different measurements of plaque build-up in an artery.
“In the rimonabant vs. placebo groups, PAV increased 0.25 percent vs. 0.51 percent, respectively, and TAV decreased -2.2mm3 vs. an increase of 0.88mm3,” the researchers report. “Rimonabant-treated patients had a larger reduction in body weight (-4.3kg [-9.5 lbs.] vs. -0.5 kg [-1.1 lbs.]) and greater decrease in waist circumference (-4.5 cm [-1.77 inches] vs. –1.0 cm [- 0.39 inches]). In the rimonabant vs. placebo groups, high-density lipoprotein cholesterol levels increased 5.8mg/dL (22.4 percent) vs. 1.8mg/dL (6.9 percent) and median (midpoint) triglyceride levels decreased -24.8 mg/dL (20.5 percent) vs. -8.9 mg/dL (6.2 percent).” However, LDL-C (“bad” cholesterol) levels and blood pressure changes did not differ significantly between treatment groups. “Psychiatric adverse effects were more common in the rimonabant group (43.4 percent vs. 28.4 percent),” the researchers note. Anxiety and depression were the most often reported adverse effects.
“Administration of rimonabant, 20mg, daily for 18 months did not significantly reduce the rate of progression of coronary disease for the primary IVUS (intravascular ultrasound) end point, the change in PAV,” the authors write. “However, the secondary endpoint, change in TAV, showed a statistically significant treatment effect favoring rimonabant.”
In conclusion, the authors write: “Because the current study failed to achieve a statistically significant effect for the primary efficacy measure, additional studies will be required to further define the role of rimonabant in the treatment of abdominally obese patients with coronary disease and metabolic risk factors.”
(JAMA. 2008;299[13]:1547–1560. 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 HOPE AND FEAR OF RIMONABANT
The STRADIVARIUS trial, “reported by Nissen and colleagues in this issue of JAMA adds critical new information on the efficacy and safety of rimonabant,” writes John S. Rumsfeld, M.D., Ph.D., from the Denver Veterans Affairs Medical Center and the Department of Medicine at the University of Colorado, and Brahmajee K. Nallamothu, M.D., M.P.H., from the Ann Arbor Veterans Affairs Medical Center and the Department of Medicine, University of Michigan, in an accompanying editorial.
“This drug is clearly efficacious for weight loss, underscoring its promise as a therapeutic option for obesity. However, despite improvements in metabolic parameters, STRADIVARIUS demonstrated no efficacy of rimonabant for coronary artery disease progression while it simultaneously heightened concern about its safety profile.”
“The hopes for rimonabant ultimately may be realized if the drug is shown to have a favorable effect on mortality and cardiovascular events. In that case, clinicians will be grateful for a new weapon in the fight against the obesity epidemic but will have to remain vigilant for trade-offs in quality of life, an outcome of equal importance to survival and certainly more important than any surrogate measure.”
(JAMA. 2008;299[13]:1601–1602. 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.
Go back to the top.
JAMA REPORTS
VIDEO: Windows Media | Quicktime
WEIGHT LOSS DRUG SHOWS PROMISE FOR HELPING THOSE WITH CORONARY HEART DISEASE
INTRO:
Heart disease is a leading cause of death in the United States. Coronary artery disease often occurs in obese adults and is very difficult to treat. Researchers have been studying whether a drug approved outside the U.S. for weight loss could also help slow the progression of coronary heart disease and the results appear promising. Jennifer Mitchell explains in this week’s JAMA Report.
VIDEO:
B-ROLL
Patient painting
Coronary arteries
AUDIO:
JOSEPH NOVAK IS ONE OF THOUSANDS OF AMERICANS BATTLING HEART DISEASE. THE PLAQUE BUILD-UP IN HIS CORONARY ARTERIES WAS SO SEVERE HE WAS HOSPITALIZED TWO YEARS AGO FOR A STENT PROCEDURE.
VIDEO:
SOT/FULL
Super @ :12
Joseph Novak
Study Participant
Runs :06
AUDIO:
“I was in the hospital as a result of fainting during a stress test.”
VIDEO:
B-ROLL
Shots of weight loss drug
Pills on table
Pills in factory
(Pill video courtesy of drug manufacturer)
Coronary arteries
AUDIO:
NOVAK ENROLLED IN A FIRST OF ITS KIND CLINICAL TRIAL IN WHICH RESEARCHERS EXAMINED WHETHER THIS WEIGHT LOSS DRUG CALLED RIMONABANT (Ra-moan-ah-bant), CURRENTLY APPROVED FOR USE OUTSIDE OF THE UNITED STATES, COULD HELP SLOW THE PROGRESSION OF CORONARY HEART DISEASE.
VIDEO:
SOT/FULL
Steven Nissen, M.D.
Cleveland Clinic
Runs :05
AUDIO:
“We really have the first glimmer of hope here.”
VIDEO:
B-ROLL
FULL SCREEN GRAPHIC:
Heart Disease Study (title)
839 Patients
Abdominal obesity & heart disease
20mg Rimonabant daily
18 months
AUDIO:
DOCTOR STEVEN NISSEN WITH THE CLEVELAND CLINIC EXPLAINS THE STUDY INCLUDED MORE THAN EIGHT HUNDRED PATIENTS WITH ABDOMINAL OBESITY AND A HISTORY OF HEART DISEASE. HALF RECEIVED TWENTY MILLIGRAMS OF RIMONABANT A DAY FOR EIGHTEEN MONTHS. THE OTHER PATIENTS RECEIVED A PLACEBO. WHAT THEY FOUND LOOKS PROMISING.
VIDEO:
SOT/FULL
Steven Nissen, M.D.
Cleveland Clinic
Runs:10
AUDIO:
“In the coronaries we saw less build up of plaque in the patients that got the drug for one of the two measures of plaque that we performed in the study.”
VIDEO:
B-ROLL
Shots of rimonabant
AUDIO:
RESEARCHERS ALSO OBSERVED OTHER HEALTH BENEFITS.
VIDEO:
SOT/FULL
Super: 1:09
Steven Nissen, M.D.
Cleveland Clinic
Runs :12
AUDIO:
“We were able not only to get them to lose weight, improve their good cholesterol but in those that were diabetic we actually improved their diabetes control to some extent.”
VIDEO:
B-ROLL
GFX/JAMA COVER
Doctor and colleague look at screen arteries
Rimonabant pills
AUDIO:
THE STUDY APPEARS THIS WEEK IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. WHILE MANY RESULTS APPEAR POSITIVE, RESEARCHERS HAD HOPED TO SEE EVEN LESS PLAQUE BUILD-UP IN THE CORONARY ARTERIES. THEY BELIEVE THAT COULD HAVE HAPPENED IF PARTICIPANTS HAD BEEN ON THE DRUG LONGER.
VIDEO:
SOT/FULL
Steven Nissen, M.D.
Cleveland Clinic
Runs:10
AUDIO:
“Weight loss approaches look like they are going to be an effective strategy for treating patients with heart disease but we’ve got to do further studies."
VIDEO:
B-ROLL
Patient painting
AUDIO:
JOSEPH NOVAK THINKS HE DID RECEIVE THE DRUG, NOT THE PLACEBO. HOW DID HE FEEL?
VIDEO:
SOT/FULL
Joseph Novak
Study Participant
Runs: 04
AUDIO:
“More energy, I felt I just felt better.”
VIDEO:
B-ROLL
Rimonabant video
AUDIO:
HE LOST ABOUT TWENTY POUNDS DURING THE STUDY AND HIS DOCTOR TELLS HIM HIS ARTERIES LOOK BETTER. JENNIFER MITCHELL, THE JAMA REPORT.
TAG:
Researchers say in terms of side effects, those who received the weight loss drug were more likely to experience anxiety and depression. Currently additional studies are underway to test the effectiveness of Rimonabant further. For more information about this study you can log on to www.jama.com.
