2013年7月23日星期二

Something about Simvastatin

Simvastatin is a hypolipidemic drug used with exercise, diet, and weight-loss to control elevated cholesterol, or hypercholesterolemia. It is a member of the statin class of pharmaceuticals. Simvastatin is a synthetic derivative of a fermentation product of Aspergillus terreus. The drug is marketed generically following patent expiry, and under the trade name Zocor.The cas no is 79902-63-9.

The primary uses of simvastatin are for the treatment of dyslipidemia and the prevention of cardiovascular disease. It is recommended to be used only after other measures such as diet, exercise, and weight reduction have not improved cholesterol levels sufficiently. As an important medicine, Simvastatin may have some adverse effects for our body.Here are these adverse effects.

Common side effects (>1% incidence) may include abdominal pain, diarrhea, indigestion, and a general feeling of weakness. Rare side effects include joint pain, memory loss, and muscle cramps. Cholestatic hepatitis, hepatic cirrhosis, rhabdomyolysis (destruction of muscles and blockade of renal system) and myositis have been reported in patients receiving the drug chronically. Serious allergic reactions to simvastatin are rare. If the following signs of a serious allergic reaction occur seek medical attention immediately: rash, hoarsness itching/swelling, dizziness, difficulty swallowing/breathing.

A type of DNA variant known as a single nucleotide polymorphism (SNP) may help predict individuals prone to developing myopathy when taking simvastatin; a study ultimately including 32,000 patients concluded the carriers of one or two risk alleles of particular SNPs were at a five-fold or 16-fold increased risk, respectively.

On June 8, 2011, the U.S. Food and Drug Administration (FDA) announced new safety recommendations for high-dose simvastatin (80 mg) due to muscle injury risk.

In March 2012, the FDA updated its guidance for statin users to address reports of memory loss, liver damage, increased blood sugar, development of type 2 diabetes, and muscle injury. The new guidance indicates: 

1.FDA has found that liver injury associated with statin use is rare but can occur.
2.The reports about memory loss, forgetfulness and confusion span all statin products and all age groups. Egan says these experiences are rare but that those affected often report feeling “fuzzy” or unfocused in their thinking.
3.A small increased risk of raised blood sugar levels and the development of type 2 diabetes have been reported with the use of statins.
4.Some drugs interact with statins in a way that increases the risk of muscle injury called myopathy, characterized by unexplained muscle weakness or pain.

This advice has caused some controversy, and claims have been made that it is too conservative in its guidance regarding diabetes. In March 2012, Eric J. Topol, the Chief Academic Officer for Scripps Health and Director, Scripps Translational Science Institute, published an op-ed piece in the New York Times entitled 'The Diabetes Dilemma for Statin Users' claiming the trial data had been misunderstood and the risk of diabetes amongst users of simvistatin, atorvastatin, and rosuvastatin was much higher.

Since its introduction, the price of lipid-lowering drugs and their benefits in atherosclerosis has been much debated. Although this has affected the other statins, simvastatin was the first statin drug to be used extensively in clinical practice. A number of large epidemiological studies were conducted to discover which patients would benefit most from statin drugs; most studies involve simvastatin as the study drug. The most influential studies were the Scandinavian Simvastatin Survival Study (4S) and the Heart protection study.

It has been suggested that patients with one or more risk factors for cardiovascular disease (such as diabetes mellitus, hypertension, or a positive family history) can benefit from statins, even if they do not have substantially elevated cholesterol levels.This is the hypothetical concept of "total risk", by combining particular risk factors. Simvastatin was introduced in the late 1980s, and since 2006 in many countries, it is available as a generic preparation. This has led to a decrease of the price of most statin drugs, and a reappraisal of the health economics of preventive statin treatment. In the UK in 2008, the typical per patient cost to the NHS of simvastatin was about £1.50 per month.

We just talking about these things about Simvastatin, last time I will give more information about Simvastatin.


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