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Europe's second, largest drugmaker Sanofi-Aventis, needs more
tests on weight
loss diet pills Acomplia to prove the company's claim
that the medicine helps obese diabetics control blood sugar
levels
Acomplia diet
pills may offer a new approach in diabetes treatment isn't
conclusive. The improvement in blood sugar levels may have
been caused by factors other than the drug.
The drug, approved in the European Union and being reviewed
by U.S. regulators, may generate as much as $3 billion in
annual sales, Sanofi forecast in February. Convincing regulators
that Acomplia diet pills offers clinical benefits beyond those
gained by weight loss among diabetics would enable the medicine
to qualify for reimbursement from health insurers.
Patients given the highest dose of the drug lost an average
5.3 kilograms (11.7 pounds) over a one-year period compared
with a weight loss of 1.4 kilograms (3.1 pounds) among patients
given a control pill. Acomplia significantly lowered the level
of HbA1c, a measure of blood sugar, to within a safe range,
according to the study.
Andre Scheen, a professor of medicine at the University of
Liege in Belgium who led the clinical trial, said the results
indicate that the drug's effect on blood sugar was double
the effect that could be attributed to weight loss alone.
Sanofi, which obtained approval to sell the drug in Europe
in June, is amassing data on patients already using the medicine
to monitor its safety beyond clinical tests. U.S. regulators
put the drug on hold in February while Sanofi provided more
information. The company has said it expects approval in the
world's biggest drugs market by the end of the year.
The U.S. Food and Drug Administration rejected the company's
request that the drug be approved for smoking cessation. The
FDA has become more prudent in recent years after drugs it
had approved were found to be dangerous to some patients.
The U.S. is one of the countries with the highest demand for
slimming products.
Side effects observed in clinical trials include nausea, depression
and anxiety. Three patients developed multiple sclerosis,
one of whom was given a sugar pill in the tests.
Acomplia is the first diet drug to damp food cravings by blocking
signals in the brain.
Consumers spend about $30 billion a year to shed weight, according
to the American Obesity Association. The estimate includes
spending on diet foods, appetite suppressants, books and videos.
About 40 percent of women are attempting to lose weight at
any given point in time, the group said.
Almost 67 percent of U.S. adults are overweight, up from about
45 percent in the early 1960s, according to the U.S. Centers
for Disease Control. A third of Americans between the ages
of 20 and 74 are now considered obese, compared with 13 percent
in the early 1960s.
In Europe, the number of obese people has increased between
10 percent and 40 percent in most countries over the past
decade, according to the European Commission.
Source:http://www.bloomberg.com
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