statin answers

Simvastatin

Simvastatin (brand name Zocor) is one of the two most widely used statins (second to atorvastatin). It has a shorter half-life in the body than atorvastatin and hence patients are told to take it in the evening or at bedtime, before the liver's most active cholesterol synthesis period.

Simvastatin was developed in 1981 and patented by Merck & Co. Simvastatin was first approved for use in Sweden in 1988; it did not receive United States FDA approval until December of 1991. Merck & Co. and Schering-Plough partnered to create Vytorin, a combination of simvastatin and ezetimibe (Zetia), a non-statin cholesterol-lowering drug. Vytorin was approved by the FDA in 2004.

Simvastatin is available in 5, 10, 20, 40, and 80 mg tablets. The daily dosing range is 5-80 mg with a recommended starting dose of 20 to 40 mgs daily, taken with meals. The patent for simvastatin expired in June 2006. As a result, total sales of Zocor in 2006 fell by 36% to $2.8 billion. However, sales of Vytorin for 2006 totaled $1.9 billion, a 90% increase from 2005. Recent clinical studies have failed to show that the Zetia has any signigicant effect in lowering cholesterol over simvastatin alone. There have also been suggestions of a link between Vytorin and an increased risk of cancer, but the FDA is still investigating that possibility.

In March 2010, the Food and Drug Administration issued an advisory on high risk of side effects from the highest dosage (80 mg/day) of simvastatin. In June 2011 the agency said that dosage should not be given to new patients because of reports of myopathy.

Simvastatin in the Body

Most of the medicine is absorbed in the instestine. About 15% typically exits through the feces. Once in the bloodstream, most is metabolized. A little is removed by the kidneys. After ingestion, peak bloodstream concentration is in 80 to 160 minutes.

Researchers have found the drug starts to work several days after the patient starts taking it and peaks in about 2 weeks, leveling off if a constant dosaging is maintained.

This drug is not approved for pregnant women, and there is some indication that cholesterol synthesis may be important in fetal development, so statin drugs should definitely not be given. If pregnancy occurs during treatment, alert your doctor, who will almost certainly discontinue simvastatin.

Patients who drink large amounts of alcohol or have a history of liver disease are sometimes not prescribed simvastatin because of concerns about the drug's effect on the liver.

Like other statins, simvastatin can be taken with meals. Generally the drug should be taken in the evening or night to increase efficacy.

Brand Names for Simvastatin

Simvastatin was under patent for years and sold in the United States under the brand name Zocor. That brand is still pretty strong, and many medical professionals commonly refer to simvastatin as "generic Zocor". Other names the medicine has been sold under around the world include Zorced; Zimstat, Sinvacor, Sivastin, Simvatin, and Lodales .

Other Sites

Medline

MayoClinic

Research

Simvastatin as a treatment for pulmonary hypertension trial.

Simvastatin in the treatment of asthma: lack of steroid-sparing effect.

FDA; Simvastatin Used With Amiodarone Safety

High-Dose Atorvastatin vs Usual-Dose Simvastatin for Secondary Prevention After Myocardial Infarction


Atorvastatin, the most prescribed statin
Rosuvastatin
simavastatin Simvastatin (Zocor)
Pravastatin
Fluvastatin