Managed Care - June 2008 - (Page 21)

MEDICATION MANAGEMENT Statins Continue to Be Ubiquitous, But Increasingly Controversial Recent reports question whether statins are being overprescribed By Martin Sipkoff tatins are the best-selling drugs in the world, with more than 25 million people, including 13 million Americans, spending $27.8 billion on the cholesterol drugs in 2006, according to IMS Health. About half of that was for Pfizer’s Lipitor, which last year had $18.4 billion in sales in the United States alone. But recent events have invigorated a longrunning controversy about value of the blockbuster drug, questioning whether it is overprescribed and inappropriately advertised. The drugs are manufactured by several large pharmacy companies in addition to Pfizer, the leaders being Merck’s Mevacor and Zocor, AstraZeneca’s Crestor, and Bristol-Myers Squibb’s Pravachol. “There is no question that for people who know they have coronary disease, statins have a significant beneficial impact,” says Howard Brody, MD, professor of family medicine at the University of Texas Medical Branch at Galveston. “But now it is being prescribed for a much broader range of patients, bringing into question the cost of treatment versus benefit.” Statin proponents are vocal in support of the use of the drug as a prophylaxis. “The efficacy and effectiveness of statins has been established by decades of research,” says David Nash, MD, chairman of the Department of Health Policy at Jefferson Medical College of Thomas Jefferson University in Philadelphia. “Controversy over use of the drug is somewhat perplexing in that there is plenty of evidence that the science is solid.” Nash is certainly correct in that the effectiveness of statins in reducing cholesterol is well established. The government’s National Cholesterol Education Program (NCEP) guidelines say that as many as 40 million Americans should S Controversy arises when statins are used “as a prophylaxis,” says Howard Brody, MD, professor of medicine at the University of Texas. be taking statins to fight heart disease, especially patients with diabetes or a family history of heart disease. But recent research questions the so-called “lipid hypothesis” of the causality of cardiovascular diseases (CVD). Dyslipidemia is defined as elevated blood cholesterol, elevated concentrations of low-density lipoprotein cholesterol (LDL-C), or abnormal proportions of LDL-C and high-density lipoprotein cholesterol (HDL-C). For decades, dyslipidemia has been identified as a causal factor in atherosclerosis and other CVDs. In the past 50 years, dozens of studies have led most medical scientists and clinicians to accept the lipid hypothesis, and the primary focus of CVD health care guidelines has been to lower LDL- C. A small, vocal group of clinicians says, however, that there has been significant bias in the studies and that the hypothesis has never been truly substantiated. They say that it is also well-established that other medical conditions can contribute to causing CVD. Overuse of statins It is the supposed overuse of statins to lower LDL-C that is generating much of the current cholesterol controversy, however. In January two manufacturers, Merck and ScheringPlough, reported results of a trial of the effectiveness of the combination of two cholesterol drugs — Merck’s statin Zocor (simvastatin) and Schering-Plough’s Zetia (ezetimibe, an antihyperlipidemic drug but not a statin), marketed as single-dose Vytorin. The combination drug was found to lower cholesterol better than the statin alone, but this demonstrated no enhanced heath benefit. In other words, combining the drugs did not reduce heart attacks or strokes better than statins alone. The results were a financial blow to the companies, which had seen sales of Vytorin grow as- Contributing Editor Martin Sipkoff is a long-time health care journalist. JUNE 2008 / MANAGED CARE 21

Table of Contents Feed for the Digital Edition of Managed Care - June 2008

Managed Care - June 2008 Editor’s Memo Contents Viewpoint Letters News and Commentary Legislation & Regulation Medication Management Compensation Monitor Plans Chart Course in Rough Waters A Conversation With Barbara Starfield, MD Smoke Signals from Payers Slow Going for Clinical Decision Support Back Pain and Physical Therapy Formulary Files PlanWatch Outlook

Managed Care - June 2008

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.