Madison NORML

Source: Milwaukee Journal Sentinel
Pubdate: April 2, 2008
Author: John Fauber

YOU'D BE THINNER, BUT POSSIBLY SAD

Pill helps weight loss, not mood, study says

Chicago - Would you take a pill that would make you lose 10 pounds, but would do nothing for your heart health and might make you anxious or depressed?

The latest saga in the endless quest to find a magic bullet for weight loss was released Tuesday.

"It is the Holy Grail of pharmacology," said Marc Shelton, an Illinois cardiologist who moderated a session at which the new research was presented.

The study involved the diet drug rimonabant, which is available in Europe but has yet to get approval in the United States, though several Web sites sell the prescription medication.

In a clinical trial of 839 obese people, the drug failed to show any improvement in the health of their coronary arteries, though over a period of 18 months, participants who took the drug lost an average of 9.5 pounds and nearly 2 inches from their waists compared with those who got a placebo. Members of the placebo group lost an average of about 1 pound and less than a half-inch from their waists.

However, 43% of those who took rimonabant had adverse psychiatric effects, mostly anxiety, depression and insomnia, compared with 28% of those who took the placebo. One patient in the rimonabant group committed suicide, and one patient in the placebo group attempted suicide.

Rimonabant is an endocannabinoid receptor antagonist, meaning it works in the brain in the opposite way that marijuana makes people hungry.

"It reverses munchies," said Anthony DeFranco, a cardiologist at Aurora St. Luke's Medical Center in Milwaukee who took part in the rimonabant study when he worked in Michigan.

Results of the trial were presented at the American College of Cardiology meeting and published online in the Journal of the American Medical Association.
Some improvements seen

The typical person in the study weighed 228 pounds and had a waistline of 46 inches at the start of the trial.

In addition to the modest trimming experienced by those on the drug, they had significant improvements in their HDL cholesterol (the good kind) and triglycerides, a type of unhealthy fat found in the blood.

Despite those improvements, when researchers used a type of ultrasound catheter to look at the arteries of their heart, they found no improvement, though a secondary measure suggested that there might be a favorable effect.

"Something was happening," said lead author Steven Nissen, a cardiologist at the Cleveland Clinic.

However, Nissen said more research is needed, and he noted that two other large clinical trials of the drug now are going on in the U.S.
Drug's future

Doctors had differing opinions of what the study's findings will mean for the drug.

DeFranco said the high rate of psychiatric side effects is a bad sign.

"It's unlikely that the (Food and Drug Administration) will ever approve it," he said.

But he said several other drugs that work in a similar manner are being tested, and eventually one of them will get approved.

"That's why all sorts of drug companies are investing billion of dollars to down-regulate appetite," he said. "It may be five, seven or 10 years down the road, but we will find something."

Russell Wilke, a physician who works in the weight loss clinic at Froedtert Hospital in Wauwatosa, said he was excited by the findings.

"It's a good drug, and it's really promising," said Wilke, an associate professor of medicine at the Medical College of Wisconsin.

Wilke said the class of cannabinoid receptor drugs has beneficial metabolic effects such as improving HDL cholesterol and lowering triglycerides.

The rimonabant study was funded by the maker of the drug, Sanofi-Aventis.
Trial for another drug

In a separate trial presented at the American College of Cardiology meeting, researchers with Merck reported unpublished results from a one-year study of its cannabinoid receptor drug, taranabant.

The trial of 2,502 obese people showed that they lost nine to 12 pounds more than those taking a placebo.

Psychiatric side effects occurred in 20% of those taking a placebo and in 28% and 40% of those taking different doses of the drug.

Those on the drug had improvements in waist size, as well as HDL cholesterol and triglycerides. Coronary artery plaque measurements were not taken.

Wilke, of Froedtert Hospital, noted that there are few drug options for treating obesity. He said more study is warranted.

James Stein, a cardiologist with the University of Wisconsin-Madison, said the rimonabant findings are "nothing but bad news. I think we need to get back to what really works - exercise and diet."

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