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| |  Study Finds Fluvastatin Most Effective Treatment For High Cholesterol ROSELAND, N.J., June 30, 1997 -- A study published today in the June issue of Clinical Therapeutics has determined that the cholesterol-lowering drug, fluvastatin (Lescol(R)), is the most effective treatment for patients with high blood cholesterol based on an examination of the drug’s safety, efficacy, outcomes and cost. The study, conducted by Prudential HealthCare(SM) with 300 patients, also found that simvastatin (Zocor(R)) is the next closest choice in effectiveness. "This study represents the first evaluation of the effectiveness of four currently available statins or cholesterol-lowering medications done in a primary care setting," said Marshall E. Spearman, Ph.D., study co-author and currently director of pharmaceutical contracting with Prudential HealthCare Pharmacy Services. "We found that fluvastatin is just as safe and effective in producing the desired patient outcome to treat and manage high blood cholesterol as other more costly drugs. This study reinforces our philosophy of basing formulary decisions on valid and scientific data." The study population consisted of 300 participating members of Prudential HealthCare’s health benefits plan in North Texas during 1994 and 1995. Patients were randomly selected including those who were diagnosed with hypercholesterolemia, and for whom pharmacotherapy with an HMG-CoA reductase inhibitor ("statin") was prescribed. Statins studied were fluvastatin (Lescol), lovastatin (Mevacor(R)), pravastatin (Pravachol(R)), and simvastatin (Zocor). All costs (including direct medical costs and indirect costs) were based on approximately the first six months of initial therapy. The purpose of the study was to provide information on the effectiveness of each drug to assist in making formulary product selection decisions by managed care organizations, that uses actual experience in the primary care environment. As stated in the Journal’s report, an objective of an effective formulary is the maximization of safety and effectiveness (regardless of drug costs). Key findings related to patient outcomes included: --A smaller percentage of patients (16%) taking fluvastatin experienced any side-effects from treatment, compared to the percentage of patients taking lovastatin (36%), pravastatin (27%), and simvastatin (33%). --There was a lower incidence, for patients who were receiving fluvastatin, of reported drug side-effects as a part of their reason for visiting the physician’s office. --Patients taking fluvastatin averaged fewer blood tests to resolve questions of safety and efficacy whereas patients taking pravastatin averaged the most blood tests. --While not statistically significant, patients taking fluvastatin, on average, experienced less loss of work as a result of side-effects, compared to those taking lovastatin, pravastatin, or simvastatin. In measuring the effectiveness of these drugs, relevant costs were determined by direct and indirect medical and pharmacy costs from the health plan’s and patient’s perspective. Direct medical costs included physician and laboratory costs. Hospital costs were not included nor were physician visits for laboratory services associated with routine monitoring. Pharmacy costs included charges for the statin drugs dispensed less discounts, rebates and patient co-pay amounts, plus dispensing flees. For the patient perspective, indirect costs, such as lost wages (represented by the days missed from work related to the effects of drug therapy) were also included in the analysis. In every instance, the cost-effectiveness ratio of fluvastatin was less than that of the other three products. “The health care industry spends a great deal of money on testing blood cholesterol drugs and on the consequences of poorly treated high blood cholesterol that can result in heart attacks or surgery. Thus, understanding the outcomes which are produced, the effectiveness of therapy, and how a managed health plan may influence these outcomes is critically important,” said Dr. Spearman. “It’s also essential to integrate pharmacy and medical care to understand the best therapies.” High blood cholesterol is one of the two most important risk factors in heart disease, the leading cause of death in the U.S. According to the National Cholesterol Education Program and based on data from the National Health and Nutrition Education Survey, only one in five Americans, who have high blood cholesterol are adequately diagnosed and treated today. This first phase of the project assessed the initial outcomes and the most cost-effective ways for treating high blood cholesterol. The next phase which is currently underway consists of a study of 1,000 patients that will address interventions implemented by a managed health plan to help produce better outcomes. Preliminary findings from this second phase are expected to be available in late 1997. Clinical Therapeutics provides rapid publication of original reports of recent developments in drug therapy. The journal serves an international audience of research clinicians in academia and industry by quickly disseminating their findings through major biomedical databases. All manuscripts are peer reviewed for clinical relevance, technical accuracy, clarity and objectivity. Headquartered in Roseland, NJ, Prudential HealthCare is a business unit of The Prudential Insurance Company of America. It administers managed health care benefits plans in more than 40 major metropolitan areas nationwide, serving approximately 4.7 million members. More information on: fluvastatin, Lescol, Zocor, Mevacor, Pravachol
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