High-dose statins not cost-effective for all patients

Research suggests that patients at lower risk of cardiovascular events might not get their money's worth from taking more of these medications.

By Victoria Stagg Elliott — Posted May 14, 2007

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Questions about the cost and benefit of high-dose statin regimens for patients with coronary disease have become a hot topic. A study published in the May 8 issue of Circulation takes on the issue, finding different answers depending on the severity of their illness.

"High doses in acute coronary syndrome patients should be the standard of care. It's not only effective. It's cost-effective. The use of high-dose statins in stable coronary artery disease patients is less clear," said Paul S. Chan, MD, lead author and a cardiovascular fellow at the University of Michigan Medical School in Ann Arbor.

Researchers created several computer simulations comparing the impact of high and conventional dosages of statins over the life of a hypothetical group of 60-year-olds. Those with acute disease gained an average of 0.35 quality-adjusted life years by using the more-intensive regimen. Even when the price differential was great between the two options, the expense was less than $30,000 per year of quality life gained. Patients with stable disease gained an average of only 0.10 years -- and at great cost.

"We may want to think twice in the stable population with regard to price and in terms of incremental gains for high-dose statins," said Dr. Chan, who also is a member of the VA Health Services Research and Development Center of Excellence, also in Ann Arbor.

Several studies have found that higher doses improve outcomes by reducing the total number of negative endpoints, including deaths, cardiovascular events, hospitalizations and revascularizations. Researchers felt that there was a need to further parse out which patients get which benefits because some are more important than others. For example, in this study, higher-dose statins reduced mortality in acute patients but not in those with stable disease, although these patients did have fewer strokes and myocardial infarctions.

The authors are particularly concerned about this conclusion's implications. First, the higher doses might not be worth the cost for stable patients. Also, the dosage increases the risk of adverse side effects. In turn, these problems could lead patients to discontinue the medication altogether.

"Higher-dose treatments are less well-tolerated, and my clinical experience is that once patients decide the drugs are hard to tolerate, they often won't even take the lower-dose drugs, which are enormously beneficial," said Sandeep Vijan, MD, senior author and an associate professor of general internal medicine at the University of Michigan Medical School, Ann Arbor.

Some experts welcomed the data, finding it useful in this time when more patients are being shifted to higher doses of these drugs. Stable patients are at lower risk for cardiac events and death than acute ones, so it is not surprising that, although the relative risk reduction may be notable, the actual decline in risk is not.

"The benefit really flattens out. You get quite a bang for your buck in treating high-risk people, but people with stable coronary disease, their risk is not that high. Lowering LDL even more is not going to be as beneficial," said Jennifer G. Robinson, MD, MPH, associate professor of epidemiology and director of the lipid clinic at the University of Iowa, Iowa City.

Some physicians also suggested that, although this analysis only included people who already had cardiovascular disease, it brings to the fore the question of the role that high doses should have in primary prevention.

"It's very likely that, if high-dose statins are not cost-effective in patients with known disease, they're not going to be cost-effective in lower-risk patients," said Mark Chelmowski, MD, an internist at the multispecialty clinic Advanced Healthcare in Milwaukee.

A new round of questions

But while there was praise for the paper's underlying concepts and the overall effort to quantify the benefits of high-dose in relation to lower-dose statins, physicians questioned how valid this cost analysis would be over the long term.

Because of the nature of the clinical trials available, this study compared 20 mg of simvastatin with 80 mg of atorvastatin using 2005's prices. But with several statin drugs going off patent, becoming available as generics and, therefore, getting less expensive, many suspect that the cost-effectiveness comparisons could shift dramatically.

Doctors also questioned the merits of looking at drug dosages rather than cholesterol levels, the goal of most cardioprotective efforts and treatment guidelines on the subject. These targets, which keep going lower, sometimes can be achieved without large amounts of statins.

"The real question is what the LDL goal is supposed to be," said Robert O. Bonow, MD, chief of cardiology at Northwestern Memorial Hospital in Chicago. "The question is not high dose versus low dose, and we can often get a much lower LDL even with a low-dose statin in some patients."

Also, while stable patients did not experience reductions in death, they did have lower rates of stroke and revascularization, and some suggested that this could improve quality of life and make the higher doses worth it.

"When doctors are dealing with individual patients, you want to be as aggressive as you can," said Dr. Bonow, who is also a former president of the American Heart Assn. "What's the quality of life here? The benefit may not be in lives saved but in how many patients don't have heart attacks, fewer hospitalizations and fewer revascularizations."

Concerns also were raised about the broad groupings used by this study. Another analysis co-authored by Dr. Robinson and published in the May 1 Journal of the American College of Cardiology, advocated that continuous risk curves could be used to identify patients most in need of aggressive therapy by taking into account their heart health as well as other risk factors and potential for adverse events. This paper suggested, for instance, that diabetics with stable coronary artery disease could need higher doses than acute patients without these comorbidities.

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