Atherosclerosis Essay

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Atherosclerosis is the culprit behind coronary heart disease (CHD) and stroke, which is the most common cause of death worldwide and in the United States10. Among the modifiable risk factors of CHD and stroke is the serum low density lipoprotein level (LDL)8, 11. Several randomized clinical trials have established that reducing the serum LDL level results in a reduction in the future risk of CHD and stroke in a linear relationship, in one study it was estimated that reducing the LDL by 1 % would reduce the risk by 1.7 %.1-4, 7, 9, 13 Lipid altering drugs include several classes of medications each of which have their own mechanism of action. Statins inhibit HMG CoA reductase (hydroxymethylglutaryl CoA reductase), which is the rate-limiting enzyme for the production of cholesterol in the liver. Statins competitively inhibit this enzyme and induce an increased expression of LDL receptors in the liver. Which in turn increases the uptake catabolism of serum LDL into the liver resulting in decreased serum cholesterol level. This reduction in serum LDL and cholesterol levels has resulted in reduction of 10-year CHD and stroke risk. Pitavastatin was approved in Japan since 2003 and was granted FDA approval in 2009 and is marketed under the name of Livalo. Several phase III and IV trials have shown that Pitavastatin is both safe and efficacious in lowering both serum LDL and Triglycerides (TG) by 29.1% and 22.7% respectively from baseline levels which was significant. These studies showed that only 10% of Pitavastatin treated patients had adverse events (AE) in which 84% of these events were mild and about 1% were serious adverse events (SAE)6, 12, 14, 16-26, 28-31. Atorvastatin is the most commonly used statin in clinical practice; the F... ... middle of paper ... ...iovascular and cerebrovascular events and related deaths, which this study is going to test. 3.3 DESCRIPTION OF YOUR PRIMARY OUTCOME MEASURE The primary outcome measure that is chosen for our study is the serum LDL level change from baseline. We believe it will serve as an objective measure of our intervention and comparator effects. 3.4 DISCUSSION OF IMPLICATIONS Up to our knowledge, there are no randomized clinical trials that compared Pitavastatin with Atorvastatin with the same endpoints that we set for this trial. We believe that establishing a clinical evidence to support the use of Pitavastatin as an alternative to the most commonly used statin in a clinical setting is of great importance. Moreover, there is no evidence that Pitavastatin can reduce both cardiovascular and cerebrovascular events and related deaths, which this study is going to test.

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