Anti-smoking pill may also fight fat

A new pill created to fight obesity and smoking is now being tested on humans for other benefits.

The drug, which appears to encapsulate a treadmill, rehab and self-control, is called Rimonabant, or Acomplia. Creators say Rimonabant can fight obesity, kill the urge to smoke, stop cocaine addiction and obliterate marijuana and alcohol cravings.

A dream for many, Rimonabant’s testing last week showed that people on the pill could not just lose weight but keep it off for two years - a feat no other diet pill has achieved.

Like double-action birth control pills that fight off acne and pregnancy, Rimonabant combats the country’s two leading causes of death: smoking and obesity. The drug affects the brain’s reward system, which tells the body to keep doing something.

Developed by French Drug Maker Sanofi-Synthelabo, Rimonabant has also been called anti-marijuana because it blocks hungry signals experienced by smokers of the herb.

Rimonabant can be easily pushed into the same category of unbelievable Hollywood diets that suggest two-day transformations and exercise tapes that guarantee steel everything. However, researchers doing human testing of Rimonabant say they aren’t looking to make a miracle drug.

“No drug is going to do that,” researcher Luc Van Gaal of the University Hospital in Antwerp, Belgium, told Reuters news agency.

In fact, during initial human testing, 15 percent of subjects stopped taking the allotted 20 milligram doses mainly because of nausea and dizziness. That’s one in eight patients who thought the weight loss and urge suppressions of alcohol, smoking and other drugs were not worth the side effects.

Almost two out of three Americans over the age of 20 are overweight, and many are at the point of being obese, according to Obesity Week, a news and commentary source on the obesity crisis. Obesity is a major public health burden and one of the most frequent causes of death worldwide, mainly through cardiovascular disease.

Obesity is typically measured by body mass index. However, recent findings show that visceral, or abdominal fat - simply measured by waist circumference - is a better predictor of heart attack than weight or BMI. Forty-four percent of adult Americans have a waist circumference size exceeding the at-risk level (40 inches for men and 35 inches for women).

Visceral fat is associated with the cause of metabolic risk factors such as dyslipidemia or insulin resistance that may lead to diabetes, heart attack, stroke and other cardiovascular disease. Reducing abdominal fat is a recognized priority for preventing cardiovascular diseases. Also, obesity has recently been linked to infertility in men and women.

Xavier Pi-Sunyer of the New York Obesity Nutrition Research Center and the National Institute of Health said current drugs and methods are not working to decrease obesity. He mentioned preliminary tests of the drug, which found that after 16 weeks, patients who took Rimonabant lost an average of two to four times, or five to eight pounds, more weight than the patients taking a placebo. In addition, tests found that waist circumference in the patients taking the drug decreased from more than twice as much as the placebos.

Pi-Sunyer said, “the two-year results of the RIO-North America trial confirm that Rimonabant is an innovative and promising tool for the long-term management of weight and associated cardiovascular risk factors in abdominally obese patients.”

Rimonabant works by selectively blocking some of the receptors in the endocannabinoid system, balancing the overstimulated systems of both smokers and obese people. The endocannabinoid system is a natural physiological system believed to play a role in maintaining energy balance through the regulation of food intake and energy expenditure.

Obesity is a growing problem in youth, as the percentage of children and adolescents who are overweight has more than doubled since the early 1970s.

Rimonabant has not yet been approved by any federal drug agencies. Sanofi plans to seek federal approval for the drug in the spring of 2005 so that it can be marketed in the United States and Europe. If approved, the drug will probably be on the European market a few months before receiving the green light from the Federal Drug Administration.

But because of America’s battle with obesity, Sanofi’s vice president of strategic marketing, Michael Joly, hopes Rimonabant will be given a fast-track status. This would mean the chance of approval within six months of filing and the likelihood that the drug could be covered by Medicare, even though the FDA now treats anti-obesity medications as lifestyle drugs, which typically makes them ineligible for reimbursement under health insurance policies. Joly expects Rimonabant to be legal for prescription from doctors in 2006.

In the midst of this medical breakthrough, some question the ethics of fixing lifestyles with pills.

“I think it’s great for people seriously in need, but probably most people who will be taking this drug could have easily gotten healthy just eating well and exercising,” said Leslie Hinton, a University of Hawai’i art major.

The market is full of drugs that address public needs, like Viagra (followed by Levitra and Cialis) and Phentermine, the most popular diet drug worldwide.

According to the world’s leading pharmaceutical intelligence database, Pharmaprojects, the number of drugs in clinical development to treat obesity has increased by 400 percent since 2000. Makers of Rimonabant say it will revolutionize how the world treats two significant health issues - quitting smoking and losing weight.

In the United States, more tests are pending. The FDA needs to approve the drug to fight obesity and smoking before more human testing can be done to access the drug’s ability to prevent heavy drinking and drug abuse. Animal testing done recently shows Rimonabant successful in blocking the effects of marijuana and fighting relapses in alcohol and cocaine abuse.

If human test results are similar to those experienced with animals, “it’s going to have a big impact on the treatment of addiction,” said Dr. Charles O’Brien, an addiction expert at the University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center.

In the placebo-controlled test conducted to check the drug’s ability to keep off the weight subjects had lost for two years, the group that took two fixed-dose regimens of Rimonabant daily - one 5 milligrams and another 20 milligrams - had gained less weight than the placebo group.

But according to the independent news source Acomplia Report, ectopic pregnancy may be caused by the drug’s ability to block CB1 receptors. CB1 usually makes a person feel hungry, but is partially blocked by Rimonabant. A number of such pregnancies occurred during Rimonabant testing on mice, which occurs when a fertilized egg is implanted in tissue outside the uterus, where the placenta and fetus begin to develop.

According to the Centers for Disease Control and Prevention, about 100,000 ectopic pregnancies occur in the United States each year (out of more than 6 million total pregnancies) and cause about 9 percent of all pregnancy-related deaths in the country.

Provided by ArmMed Media
Revision date: July 8, 2011
Last revised: by Sebastian Scheller, MD, ScD