Last year, the American Heart Association and American College of Cardiology released new guidelines for the treatment of an increase in the risk of heart disease with statin lowering drugs like Lipitor. The previous guidelines (Adult Treatment Panel Guidelines (ATP III)) were based upon the levels of blood cholesterol.  The new ACA/AHA Guidelines expanded on the input data to include lifestyle issues like smoking and obesity. The old ATP III Guidelines used a point system; the AHA/ACA guidelines were sufficiently complex to the point where they required a spreadsheet.

 

When the spreadsheet was analyzed, many concluded that even if one had zero increased risk based on ATP III Guidelines, every male over 63 years of age and every female over 71 years of age would receive a recommendation for Lipitor and its ilk.  Many, including Steve Nissen, MD of the Cleveland Clinic, thought this was too aggressive. The authors of the ACA/AHA Guidelines have resisted all calls for revision, expounding doctrine rather than engaging in a scientific debate. Case studies are being published so that practicing physicians can have a “nuts and bolts” comparison of the application of the new and old guidelines and, at least initially, the American Academy of Family Medicine, has not endorsed the ACA/AHA Guidelines.

 

The real conundrum with any new guideline is that one can only judge its effectiveness after it has been in effect for several years. If followed religiously, the new AHA/ACC Guidelines would place between 12 and 20 million more patients on statins.  Since statins are not risk free, that may not be a good idea. (Even if statins were risk free, are they the “best” intervention; does the opportunity cost of statins inhibit the use of something more effective, like exercise and diet?)

 

The ATP III Guidelines were based on the original data of the Framingham Study. However, the Framingham study which started in 1954 did not include the effects of exercise.

 

 

In 1968, the books; Aerobics by Ken Cooper and The Joy of Running by Jim Fixx were published, and the Exercise Era began.  There were no new medications introduced in 1968 (the first major study on niacin was released in 1979, pravastatin (Pravachol), the first statin, wasn’t released until 1988).  The American diet actually got considerably worse starting in 1968 with increasing distribution of trans-fats throughout the food chain (with labeling and restrictions only starting in the late 1990’s), as well as High Fructose Corn Syrup being introduced in 1975. Guidelines that fail to recognize the contribution of exercise will overestimate the population at risk. (People who exercise have a lower risk and lower need for additional medication.)

 

However recalcitrant the AHA and ACC might be (and how they may not fund studies that differ from their points of view, we still have Denmark, a beautiful little nation with windmills, dikes, longstanding computerization of medical records of the entire population, and a highly disciplined medical community that insists on entering accurate diagnosis.) The utility of Denmark’s data is limited only by the size of the population and the size of research budgets.

 

When studies were published in Greece declaring the risk of bleeding ulcers negated the cardiac benefits of aspirin, it was Denmark that had data demonstrating the true baseline risk of GI Bleed was ten times lower than the Greek estimate. This reversed the conclusions about aspirin. Similarly, there was a hypothesis about mercury in vaccines causing autism (which still has proponents). However, one must consider that Denmark had eliminated all mercury from its vaccine supplies 20 years earlier, maintained consistent definitions of autism, and had the same rate of autism as their mercury using neighbors.

 

In reference to the ACA/AHA Guidelines, Maryam Kavousi, M.D., Ph.D., of Erasmus MC-University Medical Center, identified 4,854 Dutch participants from the Rotterdam Study which started in 1990, and which included all the risk factors used by the new ACA/AHA Guidelines. She found that application of the ACC/AHA guidelines recommended treatment for 96.4 percent of men and 65.8 percent of women.

 

With the ACC/AHA approach, predicted risk for heart attack and stroke events was 21.5 percent vs 12.7 percent actual events for men, and 11.6 percent predicted events vs 7.9 percent actual events (for women). In other words, in a real population, statin use would have been excessive.

 

However, to be fair, one must consider the differences between the US population and Denmark. For example, in the US, 30% of the adult population is obese (Body Mass Index over 30) as opposed to only 10% of Danes. In the US, 48% people are aerobically active, in Denmark 60%.  No guideline will produce the identical outcomes in differing populations. However, for a guideline to miss reality by 40% among men and 30% among women is an error much greater than variations between two populations. A Danish researcher commented that the ACA/AHA Guidelines were essentially an age based recommendation for a drug. And this particular drug was observed by the British to have a 10% one year discontinuation rate due to side effects.

 

So the AHA/ACC should have their moment of reflection and revise their guidelines. Statins are beneficial drugs – they lower the risk of colon cancer. While niacin, diet, and exercise are much more effective cardiovascular preventatives.

James Katz MD

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