Qnexa: the Weight Loss Pill Withheld till July
 Qnexa
which was likely to get FDA approval, by mid-April has been withheld till July
17. Qnexa once on official sale will help
dieters lose 10% of
their weight when used in combination with diet and
exercise.
Researches have shown that it helps reduce
diabetes and lowers
blood pressure and other
cardiovascular
risk factors.
The date was extended after Vivus (drug company) submitted, at the Food and Drug
Administration�s request, a risk evaluation and mitigation strategy, the company
said today in a statement. The strategy is based on discussions with the agency
after advisers voted Feb. 22 in favor of the medication, while raising concern
that the drug may potentially contribute to heart risks and birth defects.
Qnexa is made up of two other older medications: the appetite suppressant
phentermine and the anti-seizure medication topiramate, which is sold under the
brand name Topamax. The latter is used to treat epilepsy and
migraines.
Phentermine works by altering levels of brain neurotransmitters that control
appetite
and by boosting
metabolism. Topiramate works as an appetite suppressant through GABA
receptors in the brain thereby increasing feeling of satiety and fullness.
Phentermine stimulates the release of the neurotransmitter noradrenalin, which
reduces appetite. The combination of Topiramate with Phentermine appears to
increase Topiramate's window of effectiveness.
How Effective is Qnexa?
Qnexa has gone through two separate phase III clinical trials required by the
FDA and results from the trials indicated that it is an effective aid to weight
loss in obese patients.
In the EQUIP trials, lasting 56 weeks and involving 1,267 obese patients,
data showed that:
-
On average patients taking the drug at full strength lost 14.7% of their
body weight, compared
with 2.5% for those on the placebo over the 56-week period
-
84% of patients on the highest dose lost 5% or more of their total body
weight, with 59% on the
lower dose achieving the same results, compared with only 26% in the placebo
group achieving the same result
-
Average weight loss for the high-dose group was 37 pounds, 18 pounds for
the low dose group and 6 pounds for the placebo group
In the CONQUER trials, involving 2,487 patients with co-morbidities such as
high blood pressure, Type 2 Diabetes and high cholesterol, the results were as
follows over a 56 week period:
- Patients lost 13.2% of their total body weight on the high dose, 10.5%
on the lower dose and 2.4% on the placebo
- 85% of patients on the high dose and 75% on the lower dose lost 5% or
more of their body weight, compared with 26% in the placebo group
 Side Effects of Qnexa
The most common side effect were dry mouth, tingling sensations,
constipation, altered taste and insomnia. The medication did not seem to cause
problems with mood,
depression or suicidal ideation.
Qnexa can cause a
rapid
heart rate, sleep
disturbances and
anxiety. This may
limit its use in people
with heart disease or
psychiatric problems. It
may also alter the taste
of foods and lead to
digestive symptoms such
as dry mouth, nausea and
constipation. Just as
concerning is the fact
that topiramate is
linked with a greater
risk for
birth defects, most
commonly cleft lip in
women who use it during
pregnancy. On the
positive side, people
taking the medication
experience lower blood
sugar and triglyceride
levels.
According to Abraham Thomas (head of
endocrinology at Henry Ford Hospital in
Detroit.), chairman of the second advisory
committee and a member of the first
committee "Although heart rate went up
slightly in some patients, blood pressure
went down." He further added "There are
health benefits for patients losing 5% to
10% of their weight, which many people can't
do by diet and exercise alone"
NOTE: All weight loss pills are
temporary solutions. They do not condition
your body to burn unwanted
fat
forever. On the contrary, prolonged
use of these drugs can make your body
resistant to the effects of the pills making
you waste even more money and causing you
more frustration. A combo of pill,
low fat diet
and effective
exercise,
cardio plus
resistance
is the only way to melt fat
permanently.
Consult your doctor before trying out on
any diet pill, to ensure you are the right
candidate.
Support:
Dated 10 April 2012
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