HIGH-DOSE LIPITOR FOR HEART ATTACKS:
HOW EFFECTIVE, HOW SAFE?
A New Study Shows the Maximum-Dose Lipitor Reduces Heart Attacks, but Other Findings Raise Serious Safety Concerns. Dr. Cohen Explains Who Should Use High-Dose Lipitor -- and Who Should Not.

Positive Results
     Lipitor, the top-selling drug in America, is one of the popular cholesterol-lowering drugs known as the "statins" (others: Zocor, Pravachol, Mevacor, Lescol, Crestor).  In March 2005, a new study in the New England Journal of Medicine made headlines that high-dose Lipitor reduced cardiovascular incidents (such as heart attacks or strokes) better than standard-dose Lipitor.  In this study, which was funded by Lipitor's manufacturer, Pfizer, 5,000 people with coronary heart disease received the maximum 80-mg dose of Lipitor daily, and another 5,000 received 10 mg of Lipitor daily.¹

    High-dose Lipitor reduced LDL-C (low density lipoprotein cholesterol) levels to an average of 77 mg/dl; 10-mg Lipitor reduced LDL-C levels to an average of 101 mg/dl.  Over the 5-years of the study, 8.7% (434) in the 80-mg group experienced another cardiovascular incident (such as heart attack or stroke) vs. 10.9% (548 patients) in the 10-mg group.  This was an improvement of 2.2%, which meant 104 fewer incidents with high-dose Lipitor.  This was a very positive result.

A Big Negative
     High-dose Lipitor also reduced the number of deaths from cardiovascular causes: 126 with 80-mg Lipitor vs. 155 with 10-mg Lipitor.  Twenty-nine fewer cardiovascular deaths was also a very positive result, but it was completely offset when 31 more people died from other causes while taking high-dose Lipitor.  Overall, the risk of death was the same with high-dose and lower-dose Lipitor.  In other words, high-dose Lipitor offered no advantage in the study's most important category: preventing deaths.

    Indeed, was there a reason that people taking high-dose Lipitor died more often from non-cardiovascular causes?  The study couldn't answer this question.  Dr. Bertram Pitt, an expert who wrote an accompanying editorial in the New England Journal, advised caution: "we need further reassurance as to the safety of this approach" before advocating high-dose Lipitor as a safe therapy.²  Dr. Pitt suggested that if doctors want to achieve very low LDL-C levels with their cardiac patients, they should find other means than high-dose Lipitor for accomplishing this.  Indeed, there are several ways to achieve very low LDL-C levels with statins in combination with other drugs or with natural therapies or diet (all of which I discuss in my new book, What You Must Know About Statin Drugs and Their Natural Alternatives.)

Other Negative Findings
     Side effects occurred more commonly with high-dose Lipitor: 406 people (8.1%) on high-dose Lipitor got side effects vs. 289 (5.8%) on lower-dose Lipitor.

    More people discontinued treatment (7.2%) because of side effects with high-dose Lipitor than with lower-dose Lipitor (5.3%).

    The number of people developing liver enzyme elevations, which indicates liver irritation, increased more than 500%.  Sixty people developed liver enzyme elevations with high-dose Lipitor vs. nine with lower-dose Lipitor.

    Neither dosage of Lipitor substantially increased HDL-C, the good, high-density lipoprotein-cholesterol.  For many people, a low HDL-C is a much greater risk factor for heart attacks than a high LDL-C, so for these people it is more important to increase HDL-C levels than reduce LDL-C.  Statins are not particularly effective for raising HDL-C (several drugs and natural supplements are much better at raising HDL-C, as I describe in my new book).

Additional Considerations
     The increased numbers of side effects with high-dose Lipitor are not surprising.  Strong drug doses always bring extra risks.  As I have written many times in medical journal articles and books, the higher the drug doses, the greater the risks of side effects -- and the greater the number of people discontinuing treatment.  This is regrettable, because many people need treatment. 

    Statin side effects can be prevented.  The best and safest way to get the right dose of a statin drug is to use the "start-low go-slow" approach that I describe in my book.  By starting low and, if necessary, increasing the dose gradually, each person arrives at the exact statin dose he or she needs -- and not a milligram more.  Safe treatment means individualized treatment.  Throwing high-dose Lipitor at everyone will cause more side effects and more treatment discontinuations -- and it will not even reduce overall mortality.  My experience is that many people are glad to take a little extra time to start with a lower, safer dose in order to avoid over-medication and unnecessary side effects.  In my book, I list ten principles of safe medication use.  Here is the first:

"Principle #1: The best dose of any medication is the least amount that works.  More is not necessarily better with medications."

    But what about people who need high-dose Lipitor or other high-dose statins?  Some people do require high-dose therapy.  But rather than starting everyone with 80 mg of Lipitor, many people can get the LDL-C reduction they need with 40 mg or 20 mg or, sometimes, 10 mg of Lipitor.  Even 5 mg and 2.5 mg, which Pfizer doesn't make, are highly effective for some people with moderate cholesterol elevations.

    What about people who don't want to take the time to start-low go-slow?  No problem.  Some people just want to start the drug and then forget about it.  Some people know they are generally tolerant of medications and have no concerns about side effects.  Some people have severe coronary disease and cannot afford the time to start low.  High-dose therapy is appropriate for all of these people.  But they and everyone else have a right to know about the "start-low go-slow" approach.  People have a right to know they have options.  This right is called informed consent.  There are many people who are concerned about avoiding side effects or who do not like taking medication and want to use as little as possible.  These people have a right to know about the "start-low go-slow" method that emphasizes precision, individualized treatment that I describe in my book.  Informed consent means having the right to choose among various treatment strategies.

    Why is the manufacturer researching and marketing high-dose Lipitor so strongly?  Here is one possibility: 80-mg Lipitor costs about $35 a month more than 10-mg Lipitor.  That is $420 dollars per year per patient.  Multiply this by about 5 million people (25 million already take statins), and the company nets an additional $2.1 billion dollars each year.  It appears that the manufacturer would not only like to get more people on Lipitor, but also more Lipitor users on high-dose Lipitor.  Yet, there are many ways to obtain proper treatment with statins and still minimize costs.  One way is with the low-dose approach.  (Chapter 11 of my book, "How to Reduce Statin Costs by Fifty Percent or More," lists six ways to save substantially with statin therapy.)

    The high-dose Lipitor study raises another concern.  Doctors are already prescribing statins at unnecessarily high doses to many people who do not need such intensive, risky treatment.  High-dose statin studies and the intense media coverage are producing an environment of excessive statin use.  Intensive therapy may be necessary for people with serious coronary disease, but there is no place for high-dose statin therapy for the much greater number of people with moderate cholesterol elevations.  Most people with elevated cholesterol can reach their treatment goals with a proper diet (Chapter 10 in my book) and natural therapies (Chapters 8 and 9).  Statins should be reserved for people who require drug therapy, and even then a "start-low go-slow" is less costly and safer.

    For more information on who needs statins, how to use statins safety, how to prevent or handle statin side effects, and how to select the best diet and most effective natural supplements for reducing cholesterol (and other risk factors such as elevated C-reactive protein, homocysteine, etc.) and for promoting cardiovascular health -- and how not to get overmedicated with high-dose Lipitor or other super-strong statins -- click here for more information on my new book: What You Must Know About Statin Drugs and Their Natural Alternatives (Square One Publishers 2005).

References
1.  LaRosa, JC, Grundy, SM, Waters, DD, et al.  Intensive lipid lowering with atorvastatin in patients with stable coronary disease.  New England Journal of Medicine 2005;352(14):1425-1435.
2.  Pitt, B.  Low-density lipoprotein cholesterol in patients with stable coronary heart disease -- is it time to shift our goals?  New England Journal of Medicine 2005;352(14):1483-1484.

Copyright 2008, Jay S. Cohen, M.D. All rights reserved. Readers have permission to copy and disseminate all or part of these articles if it is clearly identified as the work of: Jay S. Cohen, M.D., the MedicationSense E-Newsletter, www.MedicationSense.com. You may not use this work for commercial purposes.

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