The weight-loss medication Acomplia (rimonabant) produced encouraging and sustained weight loss in obese participants who stayed on the drug for two years, according to a new report on previously released study results that appears in the latest issue of the Journal of the American Medical Association.

While the report is new, there is no exciting new "news" here -- even though you would never guess this from the stories appearing in reputable publications today..

Results from the two-year study entitled, Effect of Rimonabant on Weight Reduction and Weight Maintenance: RIO-NORTH AMERICA, attracted wide public attention when they were first presented 14 months ago on Nov. 9, 2004 at the American Heart Association's 2004 Scientific Sessions.

The Acomplia Report hailed the results of this trial when they were first reported as highly encouraging (see story).

While the data in the JAMA report, which was subject to peer review, is not quite as positive as that presented orally at the AHA meeting, approximately one-sixth of patients who took a 20 mg dose of rimonabant daily for two years lost in excess of 10 percent of their initial body weight, and almost two-fifths of the trial participants lost at least five percent of their body weight.

The study also showed that most of the weight loss occured in the first year, and continuing to take rimonabant was essential to keeping the weight off. "Those patients switched to placebo for the second year of treatment regained the majority of the weight they had lost the previous year," the researchers reported.

Once again, Sanofi-Aventis -- which is hoping for FDA approval of Acomplia in a matter of weeks, if not days -- on Feb. 14th, 2006 put out a news release reporting publication of the results of the RIO-North America trial in the Journal of the American Medical Association as though it were totally new "news."

"Sanofi-Aventis announced that the results of the RIO-North America trial were published today in The Journal of the American Medical Association (JAMA)," the first sentence of the press release said. Sure sounds like hot news, doesn't it?

Only near the bottom of a lengthy news release do you find the easy-to-miss sentence: "The results of the RIO-North America trial were first released at the American Heart Association Congress in New Orleans in November 2004."

As a result, many publications which do not closely track development of Acomplia once again ran breathless stories today as though these study results were being released for the very first time.

In its news release, Sanofi-Aventis continued its effort to transition Acomplia from its initial incarnation as a weight-loss drug and present it to the world as a drug that addresses a variety of risk factors collectively known as metabolic syndrome.

"The trial evaluated two-year treatment with rimonabant in overweight or obese patients, many of whom were at increased risk for diabetes and heart disease through the presence of additional risk factors including increased waist circumference (abdominal obesity), elevated blood pressure or abnormal lipid levels," Sanofi said in its news release.

"The findings showed that patients treated with rimonabant 20 mg once daily experienced significant reduction of their waist circumference and body weight as well as improvements in multiple cardiometabolic risk factors, including HDL (good) cholesterol, triglycerides and an estimate of insulin sensitivity," the company added.

"The sustained improvements we see in several risk factors were beyond what was expected from the observed weight loss and suggests that rimonabant represents an exciting breakthrough in our quest to improve the multiple cardiometabolic risk factors contributing to increased risk for diabetes and heart disease in patients who have abdominal obesity," added lead researcher Dr. Xavier Pi-Sunyer, Professor of Medicine at Columbia University.

The freshest news in JAMA was the accompanying editorial, in which experts from the U.S. National Heart, Lung, and Blood Institute sounded a note of caution, suggesting that the researchers should have followed up on weight change not just on participants who "completed study treatment," but on the many who dropped out along the way.

The more than 40% of participants who dropped out of the trial, the NHLBI researchers said, most likely had "subsequent weight increases" that might well have affected the evaluation of results.

Dr. Denise Simons-Morton and NHLBI colleagues said there also had been a higher rate of psychiatric disorders among study participants who received rimonabant than those who got an inert placebo.

"Medications, diets, and lifestyle interventions all may have a role for high-risk patients in clinical practice but more research is needed on the effectiveness of diet and lifestyle interventions actually delivered in practice, as well as on the long-term efficacy and safety of medications," the editorial said.

"I think rimonabant should play a very minimal role," Simons-Morton concluded.