Extended clinical safety profile of lovastatin.

摘要: Abstract Lovastatin has been available for prescription use in the United States about 20 months (as of June 1989). Over 1 million patients have received drug, and approximately 14,000 participated clinical trials. It is estimated that 500,000 lovastatin continuously at least year. This report reviews extended safety experience from all trials use. At 645 more than 3 years. There are new data a recently completed year, placebo-controlled trial 8,245 (Expanded Clinical Evaluation study) health professionals' reports on spontaneous adverse events associated with large usage. Data recent suggest risk myopathy asymptomatic sustained liver transaminase elevations less reported prior studies. The early enrolled very high receiving usual dose 80 mg/day often concomitant hypolipidemic agents including gemfibrozil niacin. After 42 months' long-term experience, not established effects human lens. Possible types rare drug-related observed include hypersensitivity reactions such as arthralgia, thrombocytopenia, symptomatic hepatitis interaction warfarin. No new, unique adverse-event profile emerged use, few who therapy 5 generally well-tolerated drug.