After Baycol, Now What

Posted by James

The withdrawal of cerivastatin (Baycol, Bayer) from the market for safety reasons posed a huge problem for P&T committees and all members of the health care team who uphold the safety of patients. It came in the face of a worldwide evolution to modern lifestyles that in the aggregate involve decreased exercise levels with a consequential rise in lipid levels. This rise in lipid levels puts into sharp focus the continued need to balance aggressive treatment for high lipid levels against the increased need to monitor the sometimes dire medical consequences of using this powerful class of medications. The purpose of this article is to address the proper balance between these two divergent foci.

The negative publicity surrounding cerivastatin has placed into question the safety of all 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, also known as statins. The first duty of all members of the health care team is to overcome our patients’ fears about taking statins. This effort should exist across the continuum from personnel in clinical offices (nurses, nurse practitioners, physician assistants, and physicians) to pharmacists and PharmDs. This has never been more important, as the incidence of hyperlipidemia is increasing at epidemic proportions among our patients. Under the new National Cholesterol Education Program (NCEP) guidelines, it is estimated that in excess of one-third of all American adults should be placed on pharmaceutical intervention. With clinical research underway to determine secondary long-terms benefits from the use of statins in Alzheimer’s disease and in osteoporosis prevention, this percentage could increase even more.
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The great fear is that the type of patient who tends to overestimate the medical risk from taking lipid-lowering medications is the same type of patient who tends to underestimate the risk of hyperlipidemia, which is often aggravated by the patient’s lifestyle.

The challenge facing our P&T committee was that there was no precedent for our committee to readdress the safety of cerivastatin after the higher dosage was approved by the Food and Drug Administration (FDA). This problem extends even further, as there is no precedent for readdressing the safety of a medication after a new dosage has been approved. Nor is there any protocol to review new indications for previously approved medications. This is a concern for all the members of the health care team who are responsible for the safety of patients. The concern for those who manage formularies is even greater, as providers often prescribe medications for non-FDA-approved indications and dosages after a new drug enters the marketplace.

We, as health care providers, must empower our patients. The patient is in a better position than the physician to control the risk of deleterious side effects of taking a statin. The well-informed patient, for example, is more inclined to alert the provider to the presence of myalgias. This early notification allows the provider to begin a diagnostic evaluation and to alter the therapy sooner. The hope is that the earlier the change in therapy, the less likely the patient is to have long-term negative effects from the therapy.

All patients should be educated that even a moderate change in lifestyle can have a positive effect on LDL levels, obviating the need to increase the dose and decreasing the chance for side effects. The problem with most physicians is that after they make the decision to place a patient on a statin, they have a tendency to de-emphase non-pharmacologic cholesterol reduction. During the year or so that it takes to titrate to the proper dose, the degree of change in the patient’s lifestyle will ultimately determine the maximum dose required. antibiotics online pharmacy

The focus should be on identifying patients with multiple risk factors for coronary artery disease (CAD). The new ATP III guidelines raise persons with diabetes without coronary heart disease (CHD) to a CHD risk equivalent. Type 2 diabetes is a fast-growing epidemic. These new guidelines use projections based on the Framingham data of 10-year absolute risk to identify patients with multiple risk factors for more intensive treatment.³ The guidelines also identify patients with the dys-metabolic profile (those with abdominal obesity, low HDL, hypertriglyceridemia, hypertension, and impaired glucose tolerance) who are candidates for therapeutic lifestyle modification.