Magazine article Drug Topics

Cholesterol Buster

Magazine article Drug Topics

Cholesterol Buster

Article excerpt

New statin

offers another



The Parke-Davis division of Warner-Lambert is introducing Lipitor (atorvastatin), a cholesterol-lowering agent recently approved by the Food & Drug Administration. The new drug is particularly effective against low-density lipoprotein (LDL) and triglycerides, the company said.

Clinical trials involving 6,000 patients showed that atorvastatin produced significantly greater reductions in total cholesterol, LDL ("bad cholesterol"), triglycerides, and apolipoprotein B (apo B), compared to similar drugs (lovastatin, pravastatin, simvastatin), according to data provided by Parke-Davis. Atorvastatin also raises the level of high-density lipoprotein (HDL, or "good cholesterol") by 6%-10%, a rate similar to that of competing drugs.

"Patients with both high LDL and high triglycerides are at greater risk for atherosclerosis than patients with high LDL and normal triglycerides," said Donald Hunninghake, M.D., director of the Heart Disease Prevention Clinic at the University of Minnesota Hospital, speaking at a news conference announcing approval of the drug. "Lipitor is extremely and uniquely effective in reducing LDL by 40%-60% and triglycerides by 30%-40%."

The basic dosage is 10 mg, reported Hunninghake, and a much higher percentage of patients reach their target levels of LDL on the starting dose of atorvastatin than with similar drugs. Thus, there is less need for up-titrating patients.

Hunninghake said he sees a widespread need to treat high cholesterol. "Our ability to detect and treat patients is very poor," he said. "Only one-third of those who could use it are receiving treatment. That means there are eight million people who are untreated or who haven't responded to existing medications."

In the body, atorvastatin inhibits an enzyme (HMG-CoA reductase) that acts as a catalyst in an early stage of cholesterol biosynthesis.

Atorvastatin is indicated along with diet modification for use in patients who have forms of hypercholesterolemia and mixed dyslipidemia. It is strongly contraindicated for women who are pregnant (or likely to become so) or for nursing mothers or patients with active liver disease or "unexplained persistent elevations of serum transaminases." Patients with renal failure should be monitored closely.

Atorvastatin exhibits dose-to-dose similarities with other statin drugs, said Donald Black, M.D., director of clinical investigation for Parke-Davis' research division in Ann Arbor, Mich. The most common side effects, occurring in 2%3% of patients, were gastrointestinal: constipation, flatulence, or indigestion.

Lipid-lowering drugs have been associated with biochemical abnormalities of liver function. …

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