January 23rd, 2012

Rita Redberg and Roger Blumenthal Clash Over Statins for Primary Prevention in the Wall Street Journal

The debate over whether statins should be used for primary prevention moved to the Wall Street Journal with opposing perspectives from cardiologists Roger Blumenthal and Rita Redberg.

Blumenthal argues that “there is a mountain of high-quality scientific evidence” to support the use of statins in people without known heart disease but “demonstrated to be at high risk for heart disease.”

Redberg argues that “for most healthy people, data show that statins do not prevent heart disease, nor extend life or improve quality of life. And they come with considerable side effects. That’s why I don’t recommend giving statins to healthy people, even those with higher cholesterol.”

Both authors cite the West of Scotland Study and JUPITER in support of their position. Blumenthal concedes that long-term studies looking at mortality have not been performed, noting that such a study “would be enormously expensive and unwieldy, and take decades to complete.” Instead, Blumenthal cites evidence from meta-analyses, and the example of the wide acceptance of primary prevention for the treatment of high blood pressure, despite a similar lack of evidence.

Redberg says that the blood pressure data are more convincing than the statin data. No evidence supports a mortality benefit, she writes. The most “optimistic projections,” she writes, suggest that “for every 100 healthy people who take statins for five years, one or two will avoid a heart attack. One will develop diabetes.”

Both authors agree that diet and exercise are important. Blumenthal writes that “treatment doesn’t have to be all or none — all statin or all lifestyle. The two can be effectively combined to help our patients.” Blumenthal rejects the idea that statins are a moral hazard:

Think of it this way. If your doctor recommended a statin to you because of high risk of heart disease, would you eat more hamburgers because of this safety net or would you try to exercise a little more?

Redberg believes statins take resources away from lifestyle changes:

If we were to spend a small fraction of the annual cost of statins on making fruits and vegetables and physical activity more accessible, the effect on heart disease, as well as high blood pressure, diabetes, cancer and overall life span, would be far greater than any benefit statins can produce.

9 Responses to “Rita Redberg and Roger Blumenthal Clash Over Statins for Primary Prevention in the Wall Street Journal”

  1. Tina Dobsevage, MD says:

    I have to say I agree with Dr. Redberg. Statins were originally prescribed for secondary prevention, like aspirin and beta blockers. Once PHARMA recognized the huge market in primary prevention of cardiovascular events, these drugs have been prescribed with abandon.

    I have quite a few patients in my practice who have clear risk factors but cannot tolerate any statin drug. These are most often women who have NOT had a heart attack but have bad lipid profiles and strong family histories of heart disease. I counsel healthy diet e.g. Michael Pollan’s “Eat real food, mostly vegetables and don’t eat too much” as well as daily exercise of some sort: bike, treadmill, walking, etc.

    An epidemiologist friend of mine once said: Statins help one live 4-18months longer at the wrong end of life. HOWEVER, it is hard to buck trends when these drugs are so heavily advertised and promoted to patients. I do my best to restrict statins to patients at highest risk for heart disease, either status post MI or angioplasty and patients with angina.

    Competing interests pertaining specifically to this post, comment, or both:
    I have no conflicts of interest.

  2. Stephen Hansen, md says:

    “No” to “primary” statin Rx–
    “No” to TV ads for drugs–
    Yes to sensible prevention

  3. Just want to link this to my comment the other day that suggested that we think about treating based on risk. The distinction between primary and secondary prevention is artificial – they were convenient designations but are only crude indicators of risk. Particularly among the primary prevention group, those without an event, there is great heterogeneity in risk. We should move to calculating risk based on the patient’s profile – and then, I argue, make decisions about statin therapy based on that information – rather than reflexively basing the decision on lipid targets.

  4. They should be offered.

  5. Regina Druz, MD says:

    Agree…with both! There is no question that the so-called “healthy” group is heterogenous. As much as we can try to ascertain a given individual’s risk based on population-derived risk estimates (as proposed by Harlan Keumholz), there is a need to go beyond that as well as beyond numerical targets. For example, lipid particle analysis and coronary calcium score as well as carotid intima-media thickness have added prognostic value, and allow for some individualization of the risk equation. Clearly, the really healthy group, I.e. those without any evidence of sub clinical or early atherosclerosis and at low short-term risk ( we do not routinely know or quantify lifetime risk) do not need statins. However, a person similarly at risk by population measurements but with evidence of sub clinical disease may benefit. The magnitude of this benefit is difficult to quantify as there are probably subgroups within that sub clinical disease population, just as there are different risk subgroups within those with known or established coronary or vascular disease. The real question is to how to define the subgroups, and measure the benefit of a single class of drugs while accounting for multi-factorial and genetic influences in decades-long process of atherosclerosis!

  6. Rahul Bhardwaj, MD says:

    Agree with Dr. Blumenthal and Dr. Krumholz. Use of statins and lifestyle modification are not mutually exclusive options, and proper risk assessment must be performed. Legitimate studies demonstrate the benefit of statins in patients at increased risk for cardiovascular events. Why would you wait to treat higher risk patients until they’ve had a potentially life altering (or ending) cardiovascular event?

    If a patient is unwilling to exercise and diet despite education and instruction, is it moral to punish them by withholding medications that could save their life?

  7. Improvements in lifestyle and statin drugs are the two major weapons in CV prevention. Since the vast majority of patients will not succeed in changing their diets and exercise, offering statins within the discussion of the evidence is a practical obligation. Protection provided by statin drugs may not as complete as that afforded by lifestyle change and ideal CV health, especially when it is achieved early in life. However, the extent of reduction in LDL-C associated with lifestyle change, even when substantial, may not lower LDL-C sufficiently to reach “targets.” Yet, as Dr Krumholz reminds us, it is not possible to accurately assess the benefit of reaching such targets on hard end-points, and treatment intensity should be based upon total risk burden. LDL-P, in addition to CAC, may offer additional assistance during the decision-making discussion with patients.

    Patients with high risk should understand both lifestyle change and statin drugs are a necessity, and it is not merely a choice between the two.
    Richard Kones MD

  8. Neville Wilson, M.B., Ch.B., D.Fam. Med., M.Sc., D.Obs (COG) SA., B.A. says:

    The carefully selected participants in WOSCOPS and JUPITER are not representatives of the wider population and their results cannot be legitimately extrapolated to populations of healthy persons.
    Furthermore, the exaggerated claims of benefit reported are not supported by the actual data.
    The absolute risk reductions, in these and other statin trials, are invariably much smaller than the inflated figures derived from relative risk calculations, and where they exist, have no relation to the degree of LDL lowering.
    The evidence is now so overwhelming that any further attempts to justify LDL lowering must be regarded as futile and unnecessarily expensive.
    Apart from the growing recognition of under-reporting and under-estimations of statin adverse effects in LDL lowering trials, the compounded harm imposed on diabetic patients by adding a statin to their treatment regimen demands a reappraisal of conventional practice.
    Against a backdrop of escalating diabetes can we truly justify adding more numbers to that high risk population by our misguided good intentions ?

    Competing interests pertaining specifically to this post, comment, or both:
    No conflict of interest.

  9. Isaac Vilayil Mammen, M.D., D.M. says:

    Statins are not likely to make us live for 500 years. We all have to die. Be reasonable. Stop all unnecessary drugs.