�GlaxoSmithKline (NYSE:
GSK) (GSK) announced that a brushup of data from over 14,600 patients
in 54 clinical studies showed no increased risk of myocardial infarction
associated with the anti-HIV medication abacavir. GSK conducted this review
upon erudition that the analysis undertaken by the D:A:D cohort had set up an
unexpected but electric potential association between highly active antiretroviral
therapy (HAART) regimens containing abacavir and an increased risk of heart
attack. GSK's review of its clinical trial database was presented at
the International AIDS Conference in Mexico City.
The analysis was conducted from a GSK inner database including data
from 54 clinical trials. The review pooled data from 9,639 subjects on
abacavir-containing HAART and 5,044 subjects on non-abacavir HAART.
Overall, less than 30 eye attacks had been reported across the abacavir
and non-abacavir groups and no increased risk of gist attack associated
with abacavir was discovered.
"GSK took the responsibility to examine the existing body of clinical
data available to us as soon as we conditioned the results of the D:A:D
cohort," said John Pottage, M.D., Vice President Global Clinical
Development at GlaxoSmithKline. "The D:A:D findings were sure as shooting
unexpected and are inconsistent with what we have seen with our possess data.
GSK believes at this fourth dimension that the D:A:D information are inconclusive."
In the GSK psychoanalysis the frequency of coronary thrombosis artery disorders for both
groups was very low and similar to the general universe: 2.5 events per
1,000 people in the abacavir HAART and 4 events per 1,000 people in the
non-abacavir HAART. Further, the frequency of heart attacks was 1.1 per
1,000 people in the abacavir HAART and 1.4 per 1,000 hoi polloi in the
non-abacavir HAART. GSK's critical review of clinical and presymptomatic data to date
did not reveal a plausible biologic mechanism for the results seen in the
D:A:D survey.
Inflammatory biomarkers that may be associated with cardiac risk,
hs-CRP and IL-6, were evaluated from the HEAT test, a prominent, randomized,
controlled study of Epzicom and Truvada. The levels of these important
biomarkers reduced from baseline at both 48 and 96 weeks for both
abacavir and tenofovir. Additionally, there were no significant differences
between the active comparitors in the study.
NRTIs currently constitute the cornerstone of combination
antiretroviral therapy with abacavir recognized as a key component and
recommended in intervention guidelines globally. GSK could not duplicate the
findings of the D:A:D analysis. In total, the available data from the
data-based cohort and from clinical trials are inconclusive. It is clear
however, that HAART overpoweringly provides substantial survival benefits
to HIV patients. As with all medications, physicians and patients must
weigh the risks of HIV disease against the overall benefits and risks of
the antiretroviral medicines useable. As a precaution, the underlying
risk of exposure of coronary heart disorder should be considered when prescribing
antiretroviral therapies, including abacavir, and action taken to minimise
all modifiable risk factors (e.g., hypertension, lipemia, diabetes
mellitus, and smoking).
About Abacavir
Abacavir sulfate is a nucleoside reverse rNA polymerase inhibitor with a
proven safety and efficacy profile as parting of an HIV discourse regimen.
Abacavir is a key factor in Ziagen(R), Trizivir(R) and Epzicom(R). The
most significant treatment-limiting event known to occur with abacavir is a
hypersensitivity reaction, which occurs in approximately octonary percent of
patients and emerges within the first six weeks of therapy.
Important Safety Information about ZIAGEN
ZIAGEN, in combination with other antiretroviral agents, is indicated
for the treatment of HIV-1 infection in adults.
ZIAGEN is one of 3 medicines containing abacavir. Before starting
ZIAGEN, your health care professional will review your medical story in
order to avoid the usance of abacavir if you have experient an allergic
reaction to abacavir in the past.
In one study, more patients had a wicked hypersensitivity reaction in
the abacavir once-daily group than in the abacavir twice-daily group.
ZIAGEN does not cure HIV infection/AIDS or prevent passing HIV to
others.
Important Safety Information
ZIAGEN(R) contains abacavir sulfate, which is likewise contained in EPZICOM
(abacavir sulfate and lamivudine) and TRIZIVIR(R) (abacavir sulfate,
3TC, and zidovudine). Patients taking ZIAGEN english hawthorn have a serious
hypersensitive reaction (hypersensitivity reaction) that can reason death. Your
risk of having this allergic reaction is much higher if you feature a factor
variation called HLA*B5701 than if you do not. Your doctor can check
with a blood try if you have this gene variation.
If you have a symptom from 2 or more of the following groups while
pickings ZIAGEN, plosive consonant taking ZIAGEN and call your doctor right away:
1. Fever
2. Rash
3. Nausea, vomit, diarrhea, or abdominal (breadbasket area) pain
4. Generally ill feel, extreme fatigue, or achiness
5. Shortness of breathing time, cough, or sore throat
Carefully take the Warning Card that your pharmacist gives you and
carry it with you at all times.
If you stop ZIAGEN because of an allergic reaction, NEVER take ZIAGEN
or whatsoever other abacavir-containing medicine (EPZICOM, TRIZIVIR) over again. If you
take ZIAGEN or whatsoever other abacavir-containing medicine once more after you have
had an allergic reaction, WITHIN HOURS you may get life-threatening
symptoms that may include very low blood pressure or death.
If you stop ZIAGEN for any former reason, even for a few years, and you
are not allergic to ZIAGEN, babble with your healthcare professional before
taking it over again. Taking ZIAGEN again tin cause a serious or
life-threatening reaction, even if you never had an allergic reaction
before. If your health care professional tells you that you tin can take ZIAGEN
again, get going taking it when you are around medical avail or people who tush
call a doctor if you need one.
A build up of lactic acid in the line of descent and an enlarged liver, including
fatal cases, have been reported.
Do not take ZIAGEN if your liver does not function normally.
Worsening of liver disease (sometimes resulting in death) has occurred
in patients infected with both HIV and hepatitis C virus wHO are pickings
anti-HIV medicines and are also organism treated for hepatitis C with
interferon with or without virazole. If you are taking ZIAGEN as well as
interferon with or without ribavirin and you live side effects, be
sure to tell your mD.
When you start taking HIV medicines, your immune system english hawthorn get
stronger and could begin to fight infections that have been hidden in your
body, such as pneumonia, herpes virus, or t.B.. If you have newfangled
symptoms afterwards starting your HIV medicines, be certain to say your doctor.
Changes in body fat may occur in some patients taking antiretroviral
therapy. These changes may admit an increased amount of fat in the upper
back and neck ("buffalo hump"), breast, and close to the luggage compartment. Loss of fat
from the legs, arms, and face may also occur. The case and semipermanent
health effects of these conditions ar not known at this time.
Some HIV s including ZIAGEN may increase your risk of heart
onrush. If you have heart problems, fume, or suffer from diseases that
step-up your endangerment of affection disease such as high gear blood pressure, high
cholesterol, or diabetes, tell your doctor.
The most common side personal effects of ZIAGEN include nausea, vomiting,
weariness, headache, looseness of the bowels, trouble sleeping, fever and chills, and loss
of appetite. Most of these side personal effects did not cause people to stop taking
ZIAGEN.
For extra important information about ZIAGEN please visit
http://www.treatHIV.com.
About GlaxoSmithKline>
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and an industry leader in HIV
research and therapies. The company is engaged in basic research programs
intentional to look into new targets to handle HIV. For full info on
GSK's HIV medications, please visit http://www.treatHIV.com.
Cautionary affirmation regarding advanced statements
Under the safe shield provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that whatever
forward-looking statements or projections made by GSK, including those made
in this announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those protruding. Factors that may
impact GSK's operations are described under 'Risk Factors' in the 'Business
Review' in the company's Annual Report on Form 20-F for 2007.
GlaxoSmithKline
http://www.gsk.com
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