The drug reduced bodyweight and improved control over blood glucose and blood fats among people with Type 2 diabetes, according to the study, published online on Friday by the British health journal The Lancet.
Type 2 diabetes is a potentially life-threatening condition and usually emerges in adulthood.The tally of people with this disease has exploded in the past two decades, spurred by the spread of obesity in developed countries. Other risk factors are high blood pressure and high levels of unhealthy cholesterol.
Belgian researcher Andre Scheen and colleagues enrolled 1,047 Type-2 diabetics in 11 countries who were obese or overweight, and assigned them to one of three groups.
They were given either rimonabant at a dose of 5mg a day, rimonabant at 20mg a day, or a harmless
lookalike pill called a placebo. All were given a diet plan that provided for slightly fewer calories than they needed and were advised to do exercise.
After a year, the 5mg group had lost 2.3 kilos (5.06 pounds) on average; the 20mg group had lost 5.3 kilos (11.66 pounds); and the placebo group had lost 1.4 kilos (3.08 pounds).
In each group, about a third of volunteers dropped out. The rimonabant was "generally well tolerated," the study says. The individuals who dropped out because of side effects were most numerous in the 20mg group, citing depression, nausea and dizziness.
Levels of HDL, the "good" cholesterol deemed to be protective for the heart, rose 17 percent among the 20mg group, more than twice that of the placebo group.The study recommends a 20mg daily dose of rimonabant, in addition to diet and exercise, for obese Type-2 diabetics.
Rimonabant is made by sanofi-aventis, the French pharmaceutical giant, which also sponsored the study.The drug is the first in a new generation of treatments called cannabinoid type 1 receptor blockers, which inhibit brain cells that demand food, alcohol, nicotine and other pleasure-giving substances.
It was licensed by the European Union (EU) in June for use as weight-loss pill, in conjunction with a diet and exercise regime, for people diagnosed as obese and at risk from diabetes. The drug is marketed in Europe as Acomplia.
In the United States, though, the Food and Drug Administration (FDA) has taken a more cautious line, asking sanofi in February for more information before making a decision on licensing. Details of this request have not been disclosed.
According to some reports, pent-up demand for rimonabant is such that sanofi can expect sales of two or three billion dollars a year in revenue for obesity and weight-loss treatment alone if it gets a global green light for the molecule.
The company has been trialling the drug for potential sales outlets, including as an aid for
stopping smoking as well as a support treatment for diabetics, and another trial is looking at
whether it can curb alcoholism.
The excitement over rimonabant has also prompted calls for caution.Critics say that not enough is known about the so-called endocannabinoid system to say confidently why rimonabant works and to be sure that there are no effects elsewhere on the metabolism.
Drugs that are hailed as blockbusters after being tested among a few thousand people are sometimes found to have unexpected physical or psychological side effects when used by millions over a period of years.
Another studied by a team of international researchers shown that a new obesity pill that helps to control blood sugar levels in patients with type 2 diabetes could provide a novel way to treat the illness.
They found that the Sanofi-Aventis drug Acomplia, which is also known as rimonabant, also reduced risk factors for heart disease in patients with Type 2 diabetes who had not responded to standard treatments.
"These findings support the use of 20 milligrams per day of rimonabant, in addition to diet and exercise, as a new approach to reduce body weight and improve blood glucose control as well as other
cardiovascular risk factors in overweight or obese patients with type 2 diabetes," said Professor Andre Scheen of the University of Liege in Belgium.
Diabetes affects about 194 million people worldwide. Most cases are type 2 diabetes, caused by an inability to regulate the glucose (sugar) in the body properly, and are linked to being overweight or obese.
Reducing weight and controlling glucose levels is important because diabetics have an increased risk
of heart disease, stroke, blindness, kidney damage and nerve disorder that can lead to foot ulceration and amputations.
"Type 2 diabetes is a difficult disease to treat because we have had no optimal drugs until now," Scheen told Reuters.
"Available drugs can improve blood glucose control but unfortunately they promote weight gain,instead of weight loss."
In a study of 1,047 overweight and obese diabetes patients in 11 countries in Europe and North and
South America, the researchers compared the impact of taking either 5 or 20 mg of the drug a day to
a placebo for a year.
Patients taking the drug lost more weight, decreased their waist circumference, or abdominal fat, more and had better appetite and blood glucose control than those in the placebo group.
Scheen said the findings, published online by The Lancet medical journal, confirm results from earlier studies of the drug in overweight or obese patients without diabetes.
The drug was generally well tolerated, although some patients developed nausea, vomiting and anxiety.
"This drug is able to target several cardiovascular and metabolic risk factors," said Scheen.
Acomplia is widely viewed as Sanofi's most important new product, with potential annual global sales of more than $3 billion. The French drugmaker has launched the product in Britain, Denmark, Germany, Norway, Ireland, Finland and Austria.
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