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Pravastatin Multicenter Study Group II

Arch Intern Med. 1993;153(11):1321-1329.

Abstract
Background
Treatment of severe hypercholesterolemia often requires high-dose therapy with a hydroxymethylglutaryl—coenzyme A reductase inhibitor alone or in combination with bile acid—binding resin. We evaluated the efficacy and safety of pravastatin, a new hydroxymethylglutaryl—coenzyme A reductase inhibitor with hydrophilic selectivity, alone and in combination with cholestyramine.

Methods
Pravastatin was studied at doses of 20 or 40 mg twice daily alone or 20 mg twice daily with cholestyramine, 12 g twice daily, vs placebo in a randomized, double-blind multicenter study of 311 patients for 8 weeks and in continued therapy through 24 weeks.

Results
After 8 weeks of therapy, pravastatin in a dosage of 20 mg twice daily reduced low-density lipoprotein cholesterol levels by 31%, whereas a dosage of 40 mg twice daily reduced low-density lipoprotein cholesterol levels by 38%. Cholestyramine, 24 g daily alone, reduced low-density lipoprotein cholesterol levels by 32%. Cholestyramine combined with 40 mg of pravastatin reduced the level by 51%. Pravastatin, 40 or 80 mg daily, reduced the triglyceride level by 13% to 19%, resin alone increased the triglyceride level by 21%, and no change was seen with combined therapy. High-density lipoprotein cholesterol levels increased by about 5% regardless of regimen. Similar effects were seen at 24 weeks. Symptoms reported were indistinguishable among placebo and pravastatin users and were less than with cholestyramine alone or cholestyramine in combination with pravastatin. Elevations of liver enzyme levels were small in all groups, indistinguishable between resin and pravastatin, and were highest when the two drugs were combined. Plasma creatine kinase levels did not increase in any treatment group.

Conclusions
Pravastatin treatment of hypercholesterolemia is highly effective and well tolerated alone and in combination with bile acid—binding resin and shows no tendency to increase muscle enzyme levels.

(Arch Intern Med. 1993;153:1321-1329)

Author Affiliations
From the Pravastatin Multicenter Study Group II.

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