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Acomplia (rimonabant)
Weight Loss Miracle
Drug Passes Two-Year Test
May help seniors lose
weight, increase good cholesterol
 Nov. 10, 2004 A
new report on the miracle drug Acomplia (rimonabant) says a two-year
test reduced body weight and waist circumference in subjects taking the
drug, demonstrating a significant reduction in abdominal fat, a key
marker for cardiovascular disease, a major concern for senior citizens.
Patients treated with Acomplia 20mg over the two-year period also
achieved a significant increase in HDL-cholesterol (good cholesterol), a
reduction in triglycerides and an improvement in insulin sensitivity.
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More About Acomplia |
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Updates on this story:
Acomplia (Rimonabant) Miracle Weight-Loss Drug may
not be Magic Bullet but It Works
Not approved by FDA
but long-awaited drug being sold in Europe
October
18, 2006 Hailed as the weight-loss "miracle pill," Acomplia, still
known in the U.S. by its generic name "rimonabant," while it awaits FDA
approval, has been available to Europeans for months. This has provided
a better look at what it can really accomplish. Many senior citizens are particularly interested because of
claims that it reduces abdominal fat, a key marker for cardiovascular
disease, and other health benefits, such as increased "good" cholesterol
and lower blood pressure. Read more...
Rimonabant (Acomplia) Successful Again in Reducing
Weight, Waist
European study says it also reduced factors for heart
disease in obese people
April 15, 2005 - Acomplia. which is still going by
its generic name rimonabant, while it awaits FDA approval, has again won
accolades for reducing bodyweight, waist circumference, and risk factors
for heart disease in obese people, according to results of a randomized
trial published in this weeks issue of The Lancet.
Read more...
These are liniks to Websites that
track Acomplia
Acomplia Report - News about the diet drug Acomplia
(rimonabant)
Acomplia-Info.com
"Stop smoking and lose weight at the same time!" - It sounds to
good to be true, doesn't it?. These are however a few of the
promises this new drug makes. The drug is still under testing
(This article is written in September 2004), but Acomplia is
expected to be released for prescriptions to the public during
2006.
The Acomplia Blog
The
Rimomabant (Acomplia) blog - launches at
http://rimonabant.blogspot.com . This website will keep
people up to date about the development and market launch of the
new miracle drug Rimonabant (which will be sold in the United
States under the name "Acomplia"). Ultimately, this blog will
become a place where people will be able to connect with "legal"
pharmacies where they can buy Rimonabant online or buy Acomplia
online. |
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The drug, which is expected to be marketed in the
U.S. in 2006, has also
been touted for its ability to help smokers kick the habit.
The results of a
two-year Phase III study in 3040 patients with rimonabant, which will be
marked as Acomplia in the U.S. and is the first in a new class of
therapeutic agents called selective CB1 Blockers, demonstrate that the
benefits achieved with rimonabant 20mg at the end of the first year of
the study were sustained in the second year of therapy with a good
safety and tolerability profile vs. placebo.
Analysts have said they expect Sanofi-Synthelabo
Inc. to begin filing for approvals to market Acomplia in Europe and the
United States in the second quarter of 2005, with the drug first
becoming available for doctors to prescribe to patients in 2006.
If the approval process for Acomplia runs in a
manner similar to that for a number of other recent drugs, it is likely
to be available in Europe some months before it gains final U.S. Food
and Drug Administration approval lin the United States.
But Michael Joly, vice president of strategic
marketing for Sanofi, recently expressed the hope Acomplia might be
given fast-track status -- meaning possible approvai within six months
of filing -- because of rising concern in the United States over the
need to battle obesity.
The two year results
of the RIO-North America (Rimonabant In Obesity) trial were presented
for the first time yesterday by Xavier Pi-Sunyer, M.D., Chief of the
Division of Endocrinology, Saint Luke's -- Roosevelt Hospital Center,
Columbia University, New York and principal investigator of the study to
the scientific community at the American Heart Association (AHA)
Scientific Sessions in New Orleans, Louisiana.
The RIO-North
America study is the largest of all rimonabant studies presented to
date. The results from this study data are consistent with the findings
from two previous large-scale studies on rimonabant -- RIO-Lipids and
RIO-Europe -- communicated earlier this year and add to the ever-growing
body of evidence supporting the drug's efficacy and tolerability
profile. Rimonabant is currently being developed for the management of
cardiovascular risk factors including reduction of abdominal obesity,
improving lipid and glucose metabolism, and as an aid to smoking
cessation.
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 (BMI). However, recent findings have shown
that visceral (abdominal) fat (simply measured by waist circumference)
is a better predictor for heart attack than weight or BMI.
> 44% 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
disease.
"As the
cardiovascular risk factors associated with obesity have become more
manifest, it has become increasingly apparent that current approaches
are insufficient. Excess abdominal fat in particular is increasingly
recognized as one of the most telling harbingers of future
cardiovascular complications," said Professor Pi-Sunyer. "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,"
he added.
RIO-North America
objectives and design
RIO-North America
was a Phase III, multinational multicenter, randomized, double-blind,
placebo-controlled trial comparing two fixed-dose regimens of rimonabant
(5mg and 20mg once daily) to placebo for a period of two years. The
study was conducted on 3,040 patients at 72 centers in the U.S. and
Canada.
The objectives of
the trial were to assess the effect of rimonabant on weight loss over a
period of one year and to determine the ability of rimonabant to prevent
weight regain during a second year of treatment. The study objectives
also included an assessment of improvement in risk factors associated
with abdominal obesity (as measured by waist circumference) such as
dyslipidemia, glucose metabolism, and the metabolic syndrome, and an
evaluation of the safety and tolerability of rimonabant over a period of
two years.
After a screening
period of one week, patients were prescribed a mild hypocaloric diet
(designed to reduce daily caloric intake by 600 kcal from the patients'
energy requirements) and entered a four-week single-blind placebo run-in
period. Afterward, patients were randomly allocated to one of the three
treatment groups: placebo or rimonabant 5mg or 20mg for 52 weeks of
double-blind treatment using a randomization ratio of 1:2:2.
After the first year
of treatment, patients who received rimonabant 5mg or 20mg were
re-randomized to either the same dose of rimonabant or placebo using a
randomization ratio of 1:1 for an additional 52-week treatment period
(the placebo group remained on placebo during the second year).
RIO-North America
findings
The findings show
that two-year treatment with rimonabant 20mg significantly lowered
weight, reduced abdominal fat, diminished cardiovascular risk factors
and decreased metabolic disorders in this patient population. At two
years waist circumference, a simple measure of abdominal fat, in
patients treated with rimonabant 20mg for the full two year period was
reduced by 8 cm (3.1 inches) versus 4.9 cm (1.9 inches) for rimonabant 5
mg and 3.8 cm (1.5 inches) in the placebo group (p<0.001). 62.5% of
patients who received treatment with rimonabant 20mg throughout the two
year period lost more than 5 percent of their initial body weight versus
36.7% of those on rimonabant 5mg and 33.2% of those on placebo
(p<0.001). In the same period, 32.8% of patients treated with rimonabant
20mg lost in excess of ten percent of their initial body weight, versus
20% of those on rimonabant 5mg and 16.4% of patients on placebo
(p<0.001).
Metabolic parameters
were also significantly improved in patients treated with rimonabant 20
mg throughout the two year period with HDL-cholesterol increased by
24.5% in the rimonabant 20mg group versus 15.6% and 13.8% in the
rimonabant 5 mg and placebo groups respectively (p<0.001).
Triglycerides were reduced by 9.9% in patients treated with rimonabant
20mg throughout the two year period versus 5.9% and 1.6% in the
rimonabant 5mg and placebo groups respectively (p<0.05). Although
diabetic patients were not included in the study, patients on rimonabant
20mg had significantly improved their insulin sensitivity compared to
those on rimonabant 5mg and on placebo.
The effect of
rimonabant on HDL-cholesterol, triglycerides, fasting insulin and
insulin sensitivity (as measured by HOMA) appeared to be twice that
which would be expected from the degree of weight-loss achieved (all
p<0.05)
Of particular note
is that the number of patients diagnosed with metabolic syndrome at
baseline and treated with rimonabant 20mg over the two year study period
was reduced by more than one third (p<0.001). Metabolic syndrome
encompasses a series of serious health risks or conditions that increase
a person's chance to develop heart disease, stroke and diabetes.
A good safety and
tolerability profile
Rimonabant 20mg
proved to be safe and tolerable vs. placebo throughout the two year
study period. Side effects were mainly minor and short-lived. Overall
discontinuation rates for adverse events in the first year of the study
were 7.2%, 9.4% and 12.8% in placebo, rimonabant 5mg and rimonabant 20mg
groups. The discontinuation rates for patients randomly assigned to
continue their first-year treatment for a second year were 6.7%, 8.3%
and 6.0% in placebo, rimonabant 5mg and 20mg groups. No differences
were noted in the three groups with regards to scores measured by the
Hospital Anxiety Depression scale. In this trial and in two preceding
studies, rimonabant was also shown to have no significant EKG or heart
rate changes.
Rimonabant and
the EC System
The EC System is a
newly discovered, physiological system in the body that is believed to
play a key role in the central and peripheral regulation of energy
balance, glucose and lipid metabolism as well as in the control of
tobacco dependence.
CB1 receptors are
found in the brain as well as in peripheral tissues of the body such as
adipocytes (or "fat cells") which are associated with lipid and glucose
metabolism. Excessive food intake or chronic tobacco use result in an
overactive EC System. This can trigger a cycle of increased eating and
fat storage, or, in the case of smoking, sustained tobacco dependence.
Rimonabant is the
first in a new class of drugs called cannabinoid type 1 (CB1) blockers.
By selectively blocking both centrally and peripherally the CB1
receptors, rimonabant modulates the overactive EC System. The results
have been seen in reducing cardiovascular risk factors through reduction
in abdominal fat and a corresponding improvement in metabolic parameters
that is beyond that expected through weight reduction.
The new clinical
results from the RIO-North America study further suggest that rimonabant
may become an important tool in the cardiovascular risk factor reduction
armamentarium.
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