The Cost of Giving Statins to Almost All of Us
Hi. I am Dr. Henry Black, Clinical Professor of Internal Medicine at New York University School of Medicine, a member of the Center for the Prevention of Cardiovascular Disease, and Immediate Past President of the American Society of Hypertension.

The American Society of Hypertension is interested, as are all cardiovascular-oriented societies, in more than just blood pressure; they are interested in lipids, diabetes, and antiplatelet agents. One of the most remarkable events that has happened in American and worldwide medicine over past decades is the advent of statin therapy and the resulting reduction in coronary events. Statins have been around now for more than 20 years, and the overall finding of the many trials that have been conducted is that these drugs reduce coronary events (and probably other events) by 25%-30%, depending on how much the low-density lipoprotein (LDL) cholesterol is lowered.

Most of the trials have been conducted in people who have an indication for statins (with some exceptions, such as the patient with an elevated high sensitivity C-reactive protein level) and have been prescribed a statin. The question is, who should we treat? Should every patient receive a statin? The old idea that we should "put statins in the water" is not appropriate, because these drugs are clearly associated with adverse reactions such as myopathy, hepatitis, and a whole series of other potentially serious issues.

These days, we have to deal with cost-effectiveness. Should we give statins to everybody? Should we give statins only to high-risk patients? What are the benefits or risks of that approach? Lee Goldman's group from Columbia University School of Physicians and Surgeons, the Cleveland Clinic, and University of California - San Francisco have been looking at the US population to try to get some idea of the cost-effectiveness of giving statins. Things have changed a bit now that we have generic statins, and the estimate is that we could give statins to people for about $4 per month. A simulation of the US population including everybody over the age of 35, with a cost-effectiveness strategy, was conducted. People with certain levels of LDL were treated with statins to see whether it would save money, cost money, or cause trouble.

To summarize this very complex study, there was no question that in high-risk individuals (people who had other risk factors or whose LDLs were higher than 160 mg/dL or 190 mg/dL), whatever we did would save money. This extended in all high-risk individuals to almost every LDL level. What about medium-risk individuals? We don't know much about this group. We know about the high-risk individuals from our trials. For the medium-risk individuals, people with a Framingham heart score from 10% to 20% per 10 years who had 1-2 risk factors, it turns out that statin therapy -- and this is low-dose statin therapy without any particular goal in mind -- also reduced events, saved millions of lives as they calculated it, and clearly was cost-effective. Very few things that we do actually save money for society. Maximum statin therapy saved more money, but then you have to think that if we are going to be treating people with different LDL levels who are very low-risk individuals, aren't we going to cause more problems? They also modeled these in a so-called Markov model using a Monte Carlo simulation -- complex statistics that would have been very hard to do prior to the current abilities of our computers to handle this.

It turns out for the low- or medium-risk individual that statin therapy was also cost-effective and actually saved money when you looked at the incremental risk and adjusted it by quality-adjusted life-year, which is one way to understand this. It didn't matter much exactly what dose you achieved or how much you reduced cholesterol. This seemed to be a very useful cost-effective strategy over a 10-year period.

One of the questions, of course, is, what about long-range issues? We only know what happens for the 10-20 years that we have had statins available. Could issues arise down the road? They made some estimates of the likelihood of cancer or diabetes, and it turns out that however they modeled this or whatever assumptions they made, statin therapy, at its worst, was very similar to smoking for lung cancer. So right now, as we are thinking about cost-effectiveness and reducing morbidity and mortality, saving lives, and saving the cost of hospitalizations, a study like this (which is not a clinical trial) is giving very important information to policymakers, doctors, and patients that perhaps we should do something like put statins in the water or give them to almost everybody. They didn't look at younger women or at men under the age of 35, but this kind of assumption means that if we intervene even in people who don't seem to need therapy at the time, we are probably going to not only save lives but also save money. That is a very important thing as we go forward. Thank you very much.