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Study Compares Extended-Release Lovastatin and Atorvastatin: Presented at ASHP

By Maury M. Breecher, PhD, MPH

SAN DIEGO, CA -- June 10, 2003 -- Extended-release lovastatin and atorvastatin have equivalent efficacy and safety for reduction of low-density lipoprotein cholesterol (LDL-C). However, lovastatin was more effective for increasing high-density lipoprotein cholesterol (HDL-C), according to a 4-week, multicenter, assessor-blind study.

Results of the study were presented June 3^rd in a poster session here at the American Society of Health-System Pharmacists (ASHP) annual summer meeting.

The researchers enrolled 279 patients with hypercholesterolaemia who were treated with either 60 mg/day extended-release lovastatin or 10 mg/day atorvastatin.

"The effects on HDL-C may be clinically relevant in primary and secondary presentation and in treatment of dyslipidaemia associated with obesity, the metabolic syndrome, and type 2 diabetes," according to the researchers.

The study was conducted by Robert Niecestro, PhD, Arnold Sterman, MD, MBA, and colleagues affiliated with Andrx Laboratories, of Hackensack, New Jersey, the developer of extended release lovastatin.

Vincent Brett, MS., RPh, Director of Professional Services for Andrx Labs Inc., said in an interview, "Early studies of lovastatin given in a twice-a-day regimen showed a very, very potent lipid-lowering effect. The new extended-release dosage form is mimicking that BID regimen."

Previous studies demonstrated that twice-a-day lovastatin results in about 40% lowering of LDL (J Intern Med. 1991 Oct;230(4):341-50. Am J Med. 1991 Jul 31;91(1B):18S-24S), said Brett. The current study showed a 36% change from baseline LDL in patients taking the 60 mg/dL once-a-day ERL dose.

The study enrolled patients with coronary heart disease (CHD) and LDL levels between 100 and 130 mg/dL. Patients without CHD were included if their LDL-levels were between 130 and 190 mg/dL. All patients had fasting triglyceride (TG) levels below 350 mg/dL.

After a 4-week washout period for patients not taking lipid modifying drugs and an 8-week washout for patients taking lipid-modifying drugs, 185 patients were randomised on a 2 to 1 basis to either 60 mg extended release lovastatin and 94 patients received 10 mg atorvastatin.

Efficacy end point evaluations were changes in LDL-C, TG, and high-density lipoprotein from baseline.

Mean baseline LDL-C level was 159 for extended-release lovastatin and 157 mg/dL for atorvastatin. Mean baseline TG levels were 167 and 166 mg/dL, respectively. Mean baseline HDL-C levels were 52 and 51 mg/dL, respectively.

Median percent change in LDL-C was -36% and -35% with ERL and A, respectively. Median percentage change in TG was -19% for both drugs. Median percent change in HDL-C was +7% and +4% with ERL and A, respectively.

One finding of the study, Brett said, is that although both drugs were clinically equivalent at lowering LDL, ERL was found to be more cost-effective than A in both lowering LDL-C and increasing HDL-C. Median daily cost of therapy was $1.64 for ERL and $1.85 for A.


[Study title: Comparison Of The Lipid Modifying Effects and Cost Of Extended-Release Lovastatin Versus Atorvastatin.]

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