Efficacy of Statins Generates Controversy Due to Biased Analysis of Clinical Trials

Efficacy of Statins Generates Controversy Due to Biased Analysis of Clinical Trials

87117_webDavid Diamond from Tampa’s Veterans Hospital and Uffe Ravnskov, an independent Swedish researcher, presented their criticisms about the efficacy of statins in cardiovascular diseases in a review entitled “How statistical deception created the appearance that statins are safe and effective in primary and secondary prevention of cardiovascular disease” published on February 20, 2015 in Expert Review of Clinical Pharmacology.

The principle that high cholesterol is a risk factor in coronary heart disease (CHD) led to the commercial success of statins, which lower cholesterol levels. Satins reduce the enzymatic activity of HMG-CoA reductase required for cholesterol production. Millions of people are currently on statins following the American College of Cardiology’s and the American Heart Association’s guidelines.

In this review, the authors criticized overstatements about the protective effect of statins in strokes, heart attacks and heart disease-related deaths. They agree that statins dramatically reduce cholesterol levels without improving cardiovascular outcomes. By reanalyzing the data of three different clinical trials: Jupiter Trial (Crestor), the Anglo-Scandinavian Cardiac Outcomes Trial Lipid Lowering Arm (ASCOT-LLA), and the British Heart Protection Study, they concluded that beneficial effects on cardiovascular disease are actually small whereas their adverse effects in cancer, myopathy and disorders of the Central Nervous System are considerably high. According to the authors, results were presented to create the illusion of major benefits (“statistical deception”) of statins while adverse side effects were neglected.

Presenting the results as “relative risk” instead as “absolute risk” clearly biased the clinical trials’ interpretation. In fact, if an hypothetical trial shows that 2% of the placebo-treated men and 1% of the statin-treated men suffered a myocardial infarction the absolute benefit of statins would correspond to only one out of 100 individuals. Nonetheless, narrowing the analysis to a comparison of the relative risk of patients developing heart disease produces a relative benefit of 50% (from 2% to 1%).

The authors also considered that trials end before any conclusion on cancer risk can be drawn. However, several studies showed a greater incidence of cancer, including breast cancer, in people who are under long-term statin treatment.

The authors proposed that clinicians have better alternatives, including providing people with information on benefits of cessation of smoking, weight control, exercise and stress reduction. They also think that people, in particular those who are obese and diabetic, should be educated on the great value of a low carbohydrate diet for normalizing all biomarkers of cardiovascular risk with excellent outcomes.

“There is a great appeal to the public to take a pill that offers the promise of a longer life and to live heart attack free. The reality, however, is that statins actually produce only small beneficial effects on cardiovascular outcomes, and their adverse effects are far more substantial than is generally known,” concluded the authors.

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