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Senior Citizen Health & Medicine
Acomplia (Rimonabant) Helps Type 2 Diabetes Patients Improve Blood
Sugar, Lose Weight, Lower Heart Risks
Popular weight-loss pill in many countries; not yet approved by FDA
December 5, 2006 In the latest testing of Acomplia (rimonabant) for
treating diabetes over 50% of previously untreated patients achieved
HbA1c levels below 7%, the target for good glucose control as
recommended by the American Diabetes Association, plus reductions in
body weight of 14.8 lbs. Highly touted as a weight-loss drug, Acomplia
has been approved for weight-loss use in several countries but not the
U.S. There has been speculation that the company, Sanofi-aventis, hopes
proving the added value of diabetes treatment will help win approval of
the Food & Drug Administration.
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Read the latest news on Senior
Health & Medicine |
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Sanofi-aventis said today this new data showed that patients with type 2
diabetes, not currently treated with anti-diabetic medications,
experienced significant improvements in blood sugar control and weight
as well as other risk factors such as HDL-cholesterol (good cholesterol)
and triglycerides when compared to placebo.
The
study, called SERENADE, was presented today at the International
Diabetes Federation (IDF) World Diabetes Congress in Cape Town, South
Africa. SERENADE is the second study demonstrating that rimonabant
significantly improved blood sugar levels in people with type 2
diabetes.
Rimonabant is the company's first-in-class cannabinoid type 1 (CB1)
receptor blocker.
In
the SERENADE study, untreated type 2 diabetes patients receiving
rimonabant 20mg per day for a duration of six months significantly
lowered their HbA1c levels by 0.8% from a baseline value of 7.9 as
compared to a reduction of 0.3% in the placebo group (p=0.002).
In
addition, patients with an HbA1c level greater than or equal to 8.5% at
baseline, significantly reduced their HbA1c by 1.9% with rimonabant as
compared to 0.7% with placebo (p<0.0009).
Over
50% of patients in the rimonabant arm of the trial achieved HbA1c levels
below 7%, the target for good glucose control as recommended by the
American Diabetes Association (ADA).
Importantly, these improvements in blood glucose control were
accompanied by significant and clinically meaningful reductions in body
weight of 14.8 lbs (6.7 kg) in patients treated with rimonabant 20mg,
while those patients on placebo lost only 5.95 lbs (2.7 kg) (p<0.0001).
"The
management of type 2 diabetes should not only focus on controlling blood
sugar levels but also improve other risk factors such as weight, good
and bad cholesterol, triglycerides and blood pressure," said Julio
Rosenstock, M.D., Director of the Dallas Diabetes and Endocrine Center
at Medical City and also Clinical Professor of Medicine at the
University of Texas Southwestern Medical School, Dallas, Texas who was
an investigator in the SERENADE trial.
"This
study suggests that rimonabant can achieve improvement in blood glucose
with the added benefit of significant weight loss and improvement in
other risk factors."
Today, more than 194 million adults or 5% of adults worldwide have been
diagnosed with diabetes, with type 2 diabetes constituting 85-95% of all
diabetes in developed countries.
Approximately 90 percent of type 2 diabetes is attributed to people
being overweight or obese. Diabetes and obesity are often associated
with other risk factors for cardiovascular disease including high blood
pressure and unhealthy cholesterol.
Worldwide, diabetes is among the leading causes of blindness, renal
failure and lower limb amputation, as well as death through its effects
on cardiovascular disease (70-80 percent of people with diabetes die of
cardiovascular disease).
Accompanying the improvements in HbA1c and weight seen in the rimonabant
arm of the SERENADE trial were improvements in multiple cardiometabolic
risk factors.
Patients in the rimonabant arm decreased their waist circumference (a
measure of abdominal obesity) by 6.1 cm (2.34 in) compared to a 2.4 cm
(0.93 in) decrease for patients on placebo (p<0.0001). HDL-cholesterol
or "good" cholesterol increased by 10.1% compared to 3.2% for patients
on placebo (p<0.0001).
Triglyceride levels (bad fats in the blood) decreased by 16.3% compared
to a 4.4% increase for placebo (p=0.0031).
There
was a trend toward reduction in systolic blood pressure by 5 mmHg and
diastolic blood pressure by 1.2 mmHg in the rimonabant 20mg arm compared
to a 2.2 mmHg decrease in systolic blood pressure and an increase of 0.1
mmHg in diastolic pressure in the placebo arm (p=NS).
Fasting Plasma Glucose decreased by 0.9 mmol/L (16.2 mg/dL) in the
rimonabant 20mg arm compared to a 0.1 mmol/L (1.8 mg/dL) increase in the
placebo arm (p=0.0012).
Adiponectin, a protein associated with reduced risk of diabetes and
heart disease when present in high levels, increased by 1.6
micrograms/mL in the rimonabant 20 mg arm compared to a decrease of 0.2
micrograms/mL in the placebo arm (p=0.0001).
Approximately 57% of the improvements in HbA1c (p<0.001) were
independent of the weight loss achieved, suggesting a direct effect of
rimonabant on this parameter.
The
overactivity of the Endocannabinoid System (ECS) in the fat tissue and
muscle is found to promote fat accumulation and decrease glucose uptake,
which can lead to an increased risk of developing insulin resistance and
impaired glucose tolerance.
By
selectively blocking CB1 receptors of the ECS, which according to animal
and human studies can be found in the brain, fat tissue,
gastrointestinal tract, pancreas, liver and muscle, rimonabant results
in a decrease in food intake, a loss of body weight, and direct
improvements in blood sugars (HbA1c), HDL-cholesterol and triglycerides.
"Some
current medications for type 2 diabetes are often associated with weight
gain," said Julio Rosenstock. "The fact that blood sugar levels were
reduced along with weight loss and improvements in HDL-cholesterol
("good" cholesterol) and triglycerides may further support the novel
mechanism of action of rimonabant, which is different from the mode of
action of current oral anti-diabetic medications."
The
most common side effects with placebo and rimonabant 20mg reported in
the SERENADE trial were dizziness (2.1% vs. 10.9%), nausea (3.6% vs.
8.7%), nasopharyngitis (7.9% vs. 7.2%), upper respiratory tract
infection (2.7 % vs. 7.2%), anxiety (3.6% vs. 5.8%), depressed mood
(0.7% vs. 5.8%), and headache (6.4% vs. 3.6%). The rate of serious
adverse events was 3.6% for patients in the placebo arm versus 6.5% for
patients in the rimonabant 20 mg.
Overall, discontinuation rates due to adverse events in the trial were
2.1% in placebo-treated patients versus 9.4% for patients on rimonabant
20mg. The most common adverse events leading to discontinuation for the
placebo and rimonabant 20mg patients, respectively, were nausea (0% vs.
2.2%), depressed mood disorder (0% vs. 2.2%) and paraesthesia (0% vs.
2.2%).
Editor's Notes:
About SERENADE
SERENADE (Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic
Patients) was a multi-center, randomized, double-blind,
placebo-controlled, parallel-group study comparing rimonabant 20mg once
daily to placebo in improving blood sugar control (as indicated by
HbA1c) in treatment-naive type 2 diabetic patients not adequately
controlled by diet alone for a period of six months.
The
study was conducted on 278 patients at 56 study centers in the United
States, Germany, Argentina, Chile, Hungary, Poland and the Netherlands.
The primary endpoint of the trial was change from baseline of HbA1c
levels. Secondary endpoints included weight and waist circumference, a
key marker of intra-abdominal adiposity, fasting plasma glucose, lipid
parameters and arterial blood pressure.
To
be included in the trial patients had to have a diagnosis of type 2
diabetes for at least two months but less than three years, HbA1c levels
greater than 7% and less than 10%, and could not have been treated
previously with an anti-diabetic medication within six months prior to
screening.
SERENADE is part of an extensive worldwide Phase IIIb clinical trial
program involving over 22,000 patients in eight studies, which will
investigate the role of rimonabant in the treatment of type 2 diabetes
and cardiovascular disease.
About Rimonabant
In
Europe, rimonabant, known as ACOMPLIA(R) is approved as an adjunct to
diet and exercise for the treatment of obese patients (BMI>or equal to
30kg/m2), or overweight patients (BMI>27kg/m2) with associated risk
factors, such as type 2 diabetes or dyslipidemia. Rimonabant is
currently commercialized in the United Kingdom, Germany, Denmark,
Sweden, Finland, Norway, Ireland, Argentina and Austria.
At
the end of October 2006, sanofi-aventis submitted a complete response to
the U.S. Food and Drug Administration (FDA) approvable letter received
in February 2006.
About sanofi-aventis Sanofi-aventis is the world's third largest
pharmaceutical company, ranking number one in Europe. Backed by a
world-class R&D organization, sanofi- aventis is developing leading
positions in seven major therapeutic areas: cardiovascular, thrombosis,
oncology, metabolic diseases, central nervous system, internal medicine,
and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in
New York (NYSE:SNY)
.
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