Is High-Dose Simvastatin Helpful?

A new trial of simvastatin (Tablet Zocor, Merck) has raised a caution flag for patients taking high doses of statins. In a large study, simvastatin failed to show a benefit for very high-risk heart patients; however, it did increase the chances of rhabdomyolysis, a rare but dangerous side effect.

The study is likely to steer some doctors to try other drugs. In particular, atorvastatin (generic Lipitor, Pfizer) might benefit. However, this new trial did not reveal any problems with the safety or effectiveness of simvastatin for most patients, and it did not evaluate the most common use of simvastatin in patients with elevated risk of heart attacks or other cardiovascular problems who take 20 to 40 mg/day.

The trial, which included 4,500 patients, tested an aggressive cholesterol-lowering strategy compared with a moderate approach for patients with severe unstable chest pain. The aggressive treatment was 40 mg of simvastatin for one month, followed by 80 mg for the next 23 months. The moderate approach was four months of a placebo, followed by 20 mg of simvastatin.

In a similar study reported in March 2004, 80 mg of medication atorvastatin, the highest recommended dose, was more effective in reducing low-density lipoprotein-cholesterol (LDL-C) and the risk of serious heart problems than 40 mg of drug pravastatin (Pravachol generic, Bristol-Myers Squibb).

Cardiologists expected aggressive treatment with simvastatin canadian to reflect the atorvastatin findings, especially because the control group was treated with a placebo during the first four months of the two-year trial. But even though their LDL-C levels fell to 62, patients treated aggressively with simvastatin showed no difference in heart attacks, in deaths from heart attacks, in strokes, or in hospital readmissions for heart problems at the end of four months than patients taking placebo whose LDL-C levels were twice as high.

After two years, 14.4% of patients receiving aggressive therapy with simva-statin had suffered negative outcomes compared with 16.7% on the moderate regimen, but the difference was not considered statistically significant.

High-risk patients taking simvastatin 80 mg experienced no heart health benefit after four months, no significant benefit after two years, more cases of muscle pain, and three cases of rhabdomyolysis.