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Vascepa

Vascepa received initial FDA approval to decrease blood levels of a fat known as triglyceride when the circulating level surpassed an unhealthy 500 mg. This marked elevation of triglycerides places an individual at heightened risk for pancreatitis as well as cardiovascular disease or death. The FDA mandated the drug’s label warned that Vascepa had unknown effects on these risks. Actually with therapy the triglycerides fell from 680 but remained about 500 mg at the study’s conclusion. A more recent trial screened over 19,000 potential participants to wind up with a study population of slightly less than 8000. Less than 40% of these patients were studied in the United States with many from India, Romania, Poland, Russia and South Africa. In this investigation the baseline triglycerides averaged 216 mg and fell modestly to 170 mg on Vascepa and 202 mg with placebo. While the outcome suggested a statistically significant reduction in cardiovascular outcomes, this was limited to those studied in the United States. The results were not statistically significant in Eastern European countries or nations in the Asia Pacific region. Additionally no statistically significant benefit occurred in women. While the company highlights a 20% relative reduction in cardiovascular death on closer observation this translates to an actual decrease limited to 1% or less. Total death rate known as all cause mortality was not statistically different between the Vascepa group and those receiving placebo. The study did not reveal any significant improvement in the rate of new onset heart failure, new heart failure requiring hospitalization, transient ischemic attacks or TIAs also referred to as mini-strokes, surgery to clear the arteries leading to the brain or heart beat abnormalities requiring hospitalization for more than 24 hours. The risk of atrial fibrillation requiring hospitalization rose by a relative rate of nearly 50% among those treated with Vascepa compared to the placebo group. Perhaps one explanation for the outcome involved the placebo group where the high sensitivity C-Reactive Protein or hsCRP actually rose significantly. This compared to the Vascepa arm of the study where the hsCRP fell by a tiny amount not considered statistically significant. The cause for this difference remains unexplained. Rather than an inactive placebo, the group not receiving Vascepa was treated with mineral oil. A study funded by the United States government independent of any drug company involvement evaluated another fish oil supplement. Investigating more than 3 times as many patients, it failed to find any benefits of fish oil in prevention of heart disease or cancer.