Hormone Replacement Therapy
SEROSTIM
Serostim
Approved by the Food and Drug Administration as a Treatment for
HIV-Related Cachexia
Serostim
is the only Human Growth Hormone Medical Treatment approved by the
FDA for the treatment of muscle wasting associated with the HIV
Virus. Serostim has been shown in increase muscle mass and stabilize
and increase healthy weight while also reducing fatigue and
increasing endurance for physical activity.
Serostim
History
Seventeen
years ago, Serostim was fast-tracked for approval by the Food and
Drug Administration. Any drugs which offer new and unique treatment
options for patients with a severe and critical ailment can qualify
for this streamlined version of the FDA-Approval Process. After being
placed in this approval track, Serono (the creator of Serostim
Bio-Identical HGH) began a large-scale study in order to fully
evaluate the usefulness and safety profile of Serostim HGH for
HIV-Wasting.
This
medical trial was double blind in nature and controlled by placebo.
In addition to this, the large-scale trial also involved numerous
independent medical facilities. The results of this trial
corroborated with initial small-scale trials which hinted at the
beneficial usefulness of Serostim for this purpose.
FDA-Facilitated
HGH Research showed that Serostim was able to both stimulate the
production of lean muscle as well as significantly reduce fatigue in
patients suffering from HIV-Related Wasting. In addition to
quantitative benefits related to Serostim HGH, patients also felt
that the benefits provided by Serostim were significantly
qualitatively beneficial as well.
Muscle
Atrophy Among Worst Symptoms of HIV and AIDS
Lean
muscle wasting is one of the most detrimental symptoms of the HIV
virus, and Serostim has been proven to alleviate or reverse the
affects of this devastating condition. Stronger muscles and decreased
fatigue give the body more resources to fight off other symptoms
associated with the HIV Virus, increasing overall health outcomes for
those that suffer from HIV.
Although
Antiretroviral medications have the ability to alleviate many of the
debilitating symptoms of the HIV Virus, it is clear that Serostim
provides an additional benefit that Antiretroviral Drugs alone cannot
produce alone. Combining these HIV Drugs with Serostim allows
patients to live a healthier life that is closer to normal.
Pitfalls
of Cachexia Due to HIV
HIV-Related
Wasting Disease is a disorder which becomes progressively worse over
time without treatment. The negative effects of lean muscle atrophy
degrade the human body over time and rapidly increase mortality rates
over time without treatment. HIV Wasting is a Metabolism Disease
which leads the body to burn organ and muscle tissue for energy. This
process is a physiological response to negative stimuli associated
with the HIV-Virus.
Even
though the human body still has stores of usable fat, the HIV Virus
tricks the body into burning vital muscle tissue rather than fat
tissue. Because of this, patients suffering from HIV-Related Cachexia
have a viciously imbalanced body-fat percentage, as the body burns
structural muscle rather than emergency fat. Lean muscle is a blanket
term which refers to a number of types of tissue throughout the body,
including organ tissue, the muscles themselves, and blood cells
within the cardiovascular system.
Decreased
Lean Muscle Mass vastly increases the risk of extreme physiological
exhaustion, illness, and infection, which can overwhelm the weakened
immune system of an HIV patient and vastly decrease both their life
quality as well as their long term odds of survival. Serostim was
designated as an Orphan Drug Treatment for HIV-Related Muscle Wasting
by the Food and Drug Administration in 1991.
HGH-AIDS
Study Protocol
The final
seal approval for Serostim Human Growth Hormone Replacement Therapy
was granted as a result of a dose-variable, double-blind, randomized
large scale medical study which was funded directly to assess the
benefits of Serostim HGH Treatments. This clinical trial included 757
participants which all suffered from Wasting as a result of HIV or
AIDS.
Subjects
were not limited to the United States, and international medical
facilities and patients also participated. Patients were either
provided Serostim Growth Hormone Injections on a daily basis, or were
provided injections daily, half of which were Serostim, half of which
were placebo. A third group was injected with a placebo on a daily
basis, and served as a complete control.
HGH-AIDS
Research Results
All groups
received injections for an identical period of time and then were
physiologically assessed at the end of an initial treatment period.
Researchers found that patients that received daily HGH Injections
had significantly increased levels of lean muscle in comparison to
the other subset of patients which only received a half-dose.
Both of
these groups of patients benefited significantly in comparison to a
third group which simply received placebo injections. In both
experimental groups, patients could perceive the benefits of Serostim
Subcutaneous Injections in their everyday life.
All of the
patients that completed the first three months of the controlled
clinical trial maintained treatment beyond the initial phase of
clinical study. Of the 646 patients that completed the initial study,
548 remained in treatment for an extra three months. Among all of
these patients, the benefits of Serostim on muscle mass maintenance
continued to accrue.
As of
today, Serostim Recombinant HGH Therapy is the only HGH Treatment
that the Food and Drug Adminsitration has granted approval for the
treatment of HIV-Related Cachexia. The dose recommended by the FDA is
0.1 Milligram per Kilogram each day. For patients that weigh more
than fifty five kilograms, the maximum dose is six milligrams of
Serostim per day. Patients that are at increased risk of side effect
should be prescribed half of a normal dose per week provided every
other day.
HGH
Caused Relatively Few Side-Effects
For the
most part, Serostim produces very few side effects. The most reported
side-effects of treatment were edema, as well as non-severe joint and
muscle pain. Any side-effects are directly related to the size of the
dose, and side-effects eventually subsided either as treatment
continued, or with a reduction in dose size.
In a very
small minority of patients, issues related to glucose tolerance
occurred, including the exacerbation of insulin sensitivity or the
uncovering of underlying Type-Two Diabetes. In some of these latter
patients, Insulin treatments either had to be initiated or adjusted
as a result of treatment. Patients with HIV-Wasting Disease with a
history of Diabetes or insulin sensitivity should be closely
monitored during HGH Treatment.
HGH
High-Dosage AIDS Treatment
It should
be noted that the Human Growth Hormone Dosage used to treat
HIV-Related Cachexia is significantly higher than that used to
therapeutically treat Adult-Onset Human Growth Hormone Deficiency.
Generally, the dose used in order to treat HGH Deficiency is between
one and two IU per day, which is far less than the six milligrams per
day generally prescribed to patients dealing with severe Cachexia.
Human
Growth Hormone has an amazing capacity to stimulate the maintenance
and development of lean muscle tissue in at-risk patients, and in the
future, there is no doubt that Human Growth Hormone Replacement
Therapy will be found highly beneficial for a number of other medical
disorders as well.
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