US Pharm. 2008;33(1):11.

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 heart problems."

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
cancer."

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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