FDA Says No Change in
Cardio Risks for Prilosec and Nexium
Earlier this year,
AstraZeneca, the manufacturer of Prilosec (omeprazole) and Nexium
(esomeprazole), sent the FDA results of studies being conducted by the
pharmaceutical company on the long-term use of the two drugs. The studies
revealed that the drugs, which are used to treat gastroesophageal reflux
disease (GERD), could increase the risk of heart attacks, heart failure, and
heart-related sudden death in patients taking either one of them, compared
with patients who received surgical treatment for their GERD.
While a follow-up FDA review
some months later determined that there was no increased risk of heart
problems associated with long-term use of these drugs, the FDA asked
AstraZeneca to submit additional information so that they could undertake yet
another comprehensive study to determine the drugs' safety profiles.
The FDA's latest analysis was
released last month. It said: "Based on everything now known at the agency,
the reported difference in the frequency of heart attacks and other
heart-related problems seen in the earlier analysesÖdoes not indicate the
presence of a true effect. Therefore, FDA continues to conclude that long-term
use of these drugs is not likely to be associated with an increased risk of
Tamoxifen Not Limited to
Five-Year Treatment Regimen
Results of a large
international trial suggest that the National Cancer Institute's (NCI) belief
that tamoxifen has a therapeutic life of only five years may be incorrect. In
fact, according to the trial investigators, longer treatment with the drug may
provide better results.
The NCI's five-year evaluation
of tamoxifen's effectiveness over time was based on early results from the
2002 Adjuvant Tamoxifen, Longer Against Shorter (ATLAS) trial. According to
Richard Peto, PhD, of the University of Oxford, U.K., the ATLAS study compared
five years of tamoxifen against 10 years in women diagnosed with early breast
cancer. Dr. Peto asserts that continuing on tamoxifen for another five years
resulted in about a 12% reduction in the risk of breast cancer recurrence,
compared with stopping. He concluded that, "on the whole, it seems to be safe,
except for the known side effect of endometrial
Treating Sepsis to a Tea
A new laboratory
study conducted by researchers at The Feinstein Institute for Medical
Research, headquartered in Manhasset, NY, revealed that an ingredient in green
tea rescued mice from lethal sepsis. According to investigator Haichao Wang,
PhD, this finding could lead to clinical trials in humans.
Dr. Wang had previously
discovered a late mediator of sepsis called HMGB1, a substance expressed in
the late stages of lethal sepsis. Dr. Wang's theorized that if this substance
could be blocked, it might prevent the often-lethal sepsis process from moving
forward. Dr. Wang's research group gave mice in the throes of severe sepsis
EGCG, a substance found in green tea. The dose was equivalent to 10 cups of
tea given to a human. Survival jumped from 53% in mice who did not receive the
green tea substance to 82% in those who did.
Dr. Wang said that the results
were dramatic. "Clinically, even if we could save 5% of patients, that would
be huge," he said. "In this study, we saved 25% more animals with the green
tea." Dr. Wang theorized that EGCG, which he claims is readily available,
prevents HMGB1 from being released by immune cells and "also prevents it from
activating immune cells to produce more cytokines." Cytokines, which are
produced by immune cells, act as weapons to defend the body against invaders.
Addition of Antibiotic May
Slow Progression of MS
A small pilot study
conducted at Louisiana State University Health Sciences Center in Shreveport
uncovered the fact that adding doxycycline to the interferon used to treat
multiple sclerosis (MS) may slow the progression of the debilitating disease.
While the study consisted of
only 15 patients, researcher Alireza Minagar, MD, and colleagues are very
encouraged by the results, which showed that the combination of drugs
significantly improved the scores of patients with relapsing-remitting MS. The
study results are recorded online in the Archives of Neurology. The
investigators pointed out that doxycycline is a potent inhibitor of matrix
metalloproteinase, which has been implicated in the progression of
relapsing-remitting MS. They added that the combination of drugs was safe.
Most of the adverse events were mild, resolving spontaneously.
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