The Truth About Statins
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The Truth About Statins is a consumer book (though, all physicians should read it as well!) on statin-type cholesterol-lowering drugs. Cardiologist Barbara H. Roberts, MD, critiques the research that is used to justify the clinical use of these drugs in the management of elevated cholesterol and heart disease. In addition, she reviews the growing list of side effects and toxicities of these drugs.
• Recommended for: anyone taking a statin-type cholesterol-lowering drug, or, anyone who wishes to avoid coronary artery disease.
ABOUT THE AUTHOR
Barbara H. Roberts, MD, is a practicing cardiologist. At the time this book was published, she was the Director of the Women's Cardiac Center at the Miriam Hospital in Rhode Island and an associate clinical professor of medicine at Brown University. Earlier in her career, she was a researcher at the NIH.
The 288-page book is organized as follows:
PART I: Are Statins for Me?
- Chapter 1: My Doctor Wants Me to Take a Statin -- What Questions Do I Need to Ask?
- Chapter 2: When Statins Help Most, and When They May Not Help At All
- Chapter 3: Common Side Effects of Statins: Cautionary Tales
- Chapter 4: Why Can't a Woman Be More Like a Man? Gender Differences and Statin Use
- Chapter 5: So What Am I To Do? Practical Lifestyle Approaches to Heart Health
PART II: Whys and Wherefores of the Statin Era
- Chapter 6: The Chinese Got There First: Red Rice Yeast and the Dawn of the Statin Era
- Chapter 7: Big Pharma, the FDA, and the Medical Profession: An Unholy, Very Lucrative Alliance
PART III: A Closer Look at the Science
- Chapter 8: The Heart and Its Discontents: What Happens in Sickness and in Health
- Chapter 9: Clinical Research and the "Science" Being Used to Support Statin Use
PART IV: The Safe, Delicious Statin Alternative
- Chapter 10: Heart-Healthy Foods and Recipes, and Two Weeks of Mediterranean Diet Menus
As the title suggests, this book doesn't pull any punches! The author doesn't hold back in her criticism of major research studies that justify the use of statins, the influence of Big Pharma on clinical research, and even the American Heart Association doesn't escape unscathed!
Although it is pure speculation on my part, it's plausible that what triggered Dr. Roberts to write this book was the publication of the controversial rosuvastatin "JUPITER" study (Ridker P, et al. New Engl J Med, November 20, 2008), and, the subsequent decision by the FDA to expand the recommendations for the use of statins to a wider cross-section of the population based largely on this study. The author thoroughly explains the flaws in the JUPITER study at various places in the book.
But, it's not just the JUPITER study that concerns Dr. Roberts. She reviews the many potentially serious side effects and toxicities of this group of drugs: not only effects on skeletal muscle (muscle pain, muscle cramps, myopathy, rhabdomyolysis), but, also, effects on the pancreas (increased risk of diabetes), the brain (depression, impairment of memory and cognition), and even connective tissue pathologies (tendon injuries). Throughout the book, the author provides descriptions of patients she has cared for who have experienced serious side effects from statins. These summaries are powerful.
• Chapter 1: This chapter gives the reader a perspective on how physicians approach the treatment of elevated cholesterol and heart disease and makes suggestions on how a patient can best engage his/her physician in the discussion. This chapter is well done.
• Chapter 2: This chapter provides a chronological history of how statin-type cholesterol-lowering drugs came to be the most frequently prescribed drugs in the world. The author discusses the major research papers that have been published since the first statin -- lovastatin (Mevacor®) -- was approved in 1987. She also summarizes what happened with cerivastatin (Baycol® by Bayer Pharmaceuticals) and why it was removed from the market in 2001. This chapter is excellent.
• Chapter 3: Chapter 3 discusses side effects of statins. It begins with summaries of 3 patients: one is an attorney and another is a cardiovascular surgeon. Both of these patients experienced very serious side effects attributed to the statins they were taking. These cases are powerful. Then, Dr. Roberts discusses the major side effects of statins, explaining concepts such as the importance of co-enzyme Q-10, and, that the myelin sheath of nerves is critically dependent on cholesterol. This chapter is superb.
• Chapter 4: In this chapter, the author points out that research findings conducted in male subjects cannot always be translated unequivocally to female subjects, something that has been overlooked in heart disease research until recently. Here is where she skewers the controversial rosuvastatin JUPITER study vigorously.
• Chapter 5: This chapter begins with a letter the author received from a university professor. He explains that he developed incapacitating depression and mental "fog" while taking a statin drug, and that these symptoms resolved after he stopped taking it. Then, Dr. Roberts discusses nutritional approaches to reversing elevated cholesterol/atherosclerosis/heart disease, with particular emphasis placed on the Mediterranean Diet. Along the way, the author explains why the well known Seven Countries Study is badly flawed. The chapter concludes with 2 paragraphs on the benefits of exercise, which, I feel is far, far too little on this topic.
• Chapter 6: Chapter 6 is a short discussion of the "herbal statin" better known as red rice yeast. This Chinese herb was the basis of the development of the first statin drug to be marketed in the US: lovastatin (Mevacor®) by Merck in 1987.
• Chapter 7: In chapter 7, the author (who worked at the NIH in her early career) mercilessly criticizes the influence that pharmaceutical and medical device manufacturers have on clinical research of the effectiveness of their products, and, further, the publication of those same research findings. She cites example after example, and even includes the American Heart Association in this "unholy lucrative alliance." What Dr. Roberts reports here is absolutely shocking.
• Chapter 8: This chapter provides a brief look at the anatomy and physiology of the cardiovascular system. Here, the author also explains the pathology that occurs in atherosclerosis. This chapter seems like it should be the introductory chapter.
• Chapter 9: In the first half, the author explains the scientific principles that should be followed when conducting research studies. In the 2nd half, she summarizes more studies of lipid-lowering drugs. This content seems like it should be included in chapter 2 which also discusses research design and reviews clinical studies.
• Chapter 10: In the final chapter, the author presents recipes and a suggested diet plan. It appears she models a lot of this after the Mediterranean Diet.
• Photos & Illustrations: The book does not contain any photos. There are only 2 illustrations. The anatomical diagram of the heart is difficult to use.
• Tables & Graphs: There are several tables in this book; they are all easy to use. There are no graphs.
• Documentation / Accuracy: This is not a scientific book, however the author does cite published research throughout. This is one of the strengths of this book. Not only does Dr. Roberts cite these references to support her statements, but she reviews the pros and cons of many of these research studies. The Bibliography at the end lists nearly 100 citations.
What I Liked About This Book:
The fact that Dr. Roberts is a practicing cardiologist adds a great deal of credibility and validity to the views expressed in this book. The first 6 chapters begin with descriptions of patients the author has seen in her own clinical practice. These summaries magnify the significance of her criticisms of the research studies on statins.
What Could Be Better:
In general, I was highly impressed by this book. But, 2 concepts could have been explained in greater detail:
1) Calculating Heart Disease Risk: the Framingham Risk Score: The Framingham Risk Score (FRS) is the foundation for the heart disease treatment guidelines that are developed in the US. The author discusses risk factors on pp. 10-13. But, unlike her careful examination of the flaws of published research on statins, a similar critique of the weaknesses of the FRS is missing. Here is my perspective on this:
First, it should be pointed out that other heart disease risk-scoring equations exist and that, while they all consider many of the same clinical parameters (eg., age, cholesterol levels, smoking, etc.), they can vary greatly in their predictive ability (Kavousi M, et al. 2014) (Wierzbicki AS, et al. 2000). Second, a review of 5 of these risk-scoring equations (Greenland P, et al. 2010) reveals that none of them include what is turning out to be THE most important physiologic variable: a person's level of aerobic fitness! (Blair SN. 2009) If the risk calculation equation is flawed, then, the risk score is inaccurate. And, if the risk score is inaccurate, then firm treatment recommendations are highly suspect. Several groups have compared cholesterol treatment guidelines in the US against treatment guidelines from other countries. These evaluations reveal that US treatment guidelines recommend drug therapy for a higher percentage of patients than other guidelines do (Kavousi M, et al. 2014) (Manuel DG, et al. 2006). Risk calculations could be substantially improved by including an objective assessment of a person's aerobic fitness level. And numerous studies have shown that: (Balady GJ, et al. 2004) (Barlow CE, et al. 2012) (Gulati M, et al. 2003) (Gupta S, et al. 2011) (Laukkanen JA, et al. 2007) (Mora S, et al. 2003) (Mora S, et al. 2005). Further, aerobic fitness level is a powerful independent risk indicator irrespective of the other "traditional" risk factors that these risk-scoring equations evaluate (Brown WJ, et al. 2014) (Kodama S, et al. 2009) (Kokkinos P, et al. 2008) (Laukkanen JA, et al. 2004) (Laukkanen JA, et al. 2010) (Sui X, et al. 2007) (Vigen R, et al. 2012). Recently, the American Heart Association published a statement in Circulation calling for the establishment of a national registry of cardiorespiratory fitness levels for adults in the US. Though this report was published February 5, 2013, ie., after The Truth About Statins was released, as indicated above a plethora of clinical research papers were available prior to the release of this book (2012) documenting that (a) aerobic fitness level is an independent risk indicator for heart disease and (b) incorporating an assessment of aerobic fitness level into traditional risk calculation equations improves the accuracy of these predictions.
2) Exercise is the best medicine: The author devotes 24 pages in chapter 5 and all of chapter 10 -- a total of 56 pages -- to discussing nutritional strategies for reversing heart disease. However, only a mere 2 paragraphs address exercise. This is disappointing. In my opinion, aerobic exercise (ie., aerobic fitness) provides even greater benefits than a healthy diet. I summarized much of the research on exercise in my own review: "Exercise and Coronary Artery Disease." Normally, AthleteInMe.com® only reviews books where exercise is the primary focus. While The Truth About Statins is not an "exercise-is-good-for-you" book, because it is in sync with our belief that regular exercise and smart nutrition are better strategies for lifestyle-related health problems than drugs are, I felt it was worthwhile to provide a review. Indeed, chapter 5 is titled "Practical Lifestyle Approaches to Heart Health."
In summary, The Truth About Statins is very well done, and, is an important tome on statin drugs. The absence of a thorough discussion of the benefits of exercise should not dissuade you from reading this book, especially those who are currently taking a statin-type cholesterol-lowering drug. Anyone currently taking a statin drug -- whether they are having side effects or not! -- should read this book.
Balady GJ, Larson MG, Vasan RS, et al. Usefulness of exercise testing in the prediction of coronary disease risk among asymptomatic persons as a function of the Framingham Risk Score. Circulation 2004;110:1920-1925.
Barlow CE, DeFina LF, Radford NB, et al. Cardiorespiratory fitness and long-term survival in "low-risk" adults. J Am Heart Assoc 2012;1(4):e001354.
Blair SN. Physical inactivity: the biggest public health problem of the 21st century? Br J Sports Med 2009;43:1-2.
Brown WJ, Pavey T, Bauman AE. Comparing population attributable risks for heart disease across the adult lifespan in women. Br J Sports Med May 8, 2014.
Greenland P, Alpert JS, Beller GA, et al. 2010 ACCF/AHA guideline for assessment of cardiovascular risk in asymptomatic adults. J Am Coll Cardiol 2010;56:e50-e103.
Gulati M, Pandey DK, Arnsdorf MF, et al. Exercise capacity and the risk of death in women. The St. James Women Take Heart Project. Circulation 2003;108:1554-1559.
Gupta S, Rohatgi A, Ayers CR, et al. Cardiorespiratory fitness and classification of risk of cardiovascular disease mortality. Circulation 2011;123:1377-1383.
Kavousi M, Leening MJG, Nanchen D, et al. Comparison of application of the ACC/AHA guidelines, Adult Treatment Panel III guidelines, and European Society of Cardiology guidelines for cardiovascular disease prevention in a European cohort. JAMA 2014;311:1416-1423.
Kodama S, Saito K, Tanaka S, et al. Cardiorespiratory fitness as a quantitative predictor of all-cause mortality and cardiovascular events in healthy men and women: a meta-analysis. JAMA 2009;301:2024-2035.
Kokkinos P, Myers J, Kokkinos JP, et al. Exercise capacity and mortality in black and white men. Circulation 2008;117:614-622.
Laukkanen JA, Kurl S, Salonen R, et al. The predictive value of cardiorespiratory fitness for cardiovascular events in men with various risk profiles: a prospective population-based cohort study. Eur Heart J 2004;25:1428-1437.
Laukkanen JA, Lakka TA, Rauramaa R, et al. Cardiovascular fitness as a predictor of mortality in men. Arch Intern Med 2001;161:825-831.
Laukkanen JA, Makikallio TH, Rauramaa R, et al. Cardiorespiratory fitness is related to the risk of sudden cardiac death: a population-based follow-up study. J Am Coll Cardiol 2010;56:1476-1483.
Laukkanen JA, Rauramaa R, Salonen JT, et al. The predictive value of cardiorespiratory fitness combined with coronary risk evaluation and the risk of cardiovascular and all-cause death. J Intern Med 2007;262:263-272.
Manuel DG, Kwong K, Tanuseputro P, et al. Effectiveness and efficiency of different guidelines on statin treatment for preventing deaths from coronary heart disease: modelling study. Br Med J 2006;332(7555):1419.
Mora S, Redberg RF, Cui Y, et al. Ability of exercise testing to predict cardiovascular and all-cause death in asymptomatic women. A 20-year follow-up of the Lipid Research Clinics Prevalence Study. JAMA 2003;290:1600-1607.
Mora S, Redberg RF, Sharrett AR, et al. Enhanced risk assessment in asymptomatic individuals with exercise testing and Framingham Risk Scores. Circulation 2005;112:1566-1572.
Sui X, LaMonte MJ, Blair SN. Cardiorespiratory fitness as a predictor of nonfatal cardiovascular events in asymptomatic women and men. Am J Epidemiol 2007;165:1413-1423.
Vigen R, Ayers C, Willis B, et al. Association of cardiorespiratory fitness with total, cardiovascular, and noncardiovascular mortality across 3 decades of follow-up in men and women. Circ Cardiovasc Qual Outcomes 2012;5:358-364.
Wierzbicki AS, Reynolds TM, Gill K, et al. A comparison of algorithms for initiation of lipid lowering therapy in primary prevention of coronary heart disease. J Cardiovasc Risk 2000;7:63-71.
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|Reviewed by: Stan Reents, PharmD
||10/30/2014 1:02:00 PM