Statins for Primary Prevention of Heart Disease

This week from Dr. Cerami and Utah Sports and Wellness

From: Journal of the American Medical Association Internal Medicine, January 2017

Quick Summary:

In the November 15, 2016 issue of the JAMA, the latest US Preventive Services Task Force recommendation statement on statins for prevention of cardiovascular disease in adults was published. The authors point out methodological flaws in the Task Force’s analysis of the evidence for taking statins for primary prevention of cardiovascular disease, as well as shortcomings, bias, errors, etc., that “inflate” the benefits of statin drugs. This editorial is a careful analysis and essentially a rebuttal to the recommendation of the Task Force. The evidence report summarized data from 19 trials including a total of 71 344 patients and concluded that statin therapy was associated with reduced risk of all-cause and cardiovascular mortality and cardiovascular disease (CVD) events. Thus, the task force recommended “initiating use of low- to moderate-dose statins in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 10% or greater (B recommendation)” or “7.5% to 10% (C recommendation).” Although the task force did their usual careful job of reviewing the evidence, the evidence for treating asymptomatic persons with statins does not appear to merit a grade B (high certainty that the net benefit is moderate) or even a grade C (moderate certainty that the net benefit is small) recommendation. With statins, persons at low risk of heart disease have little chance of benefit and are more likely to have net harm. Using current data, “of 100 people who take a statin for 5 years, only 2 of 100 will avoid a myocardial infarction, and 98 of the 100 will not experience any benefit.” While there will be no mortality benefit for any of the 100 people taking the medicine every day for 5 years. 5 to 20 of the 100 will experience muscle aches, weakness, fatigue, cognitive dysfunction, and increased risk of diabetes. The task force evidence report estimated that to prevent 1 death from any cause over a 5 year period, 244 patients would need to take a statin daily. Given the serious concerns about the harms of the reliance on statins for primary prevention, it is in the interest of public health and the medical community to refocus efforts on promoting a heart healthy diet, regular physical activity and not smoking.

These authors also note:

• Sadly, “exacerbating the potential bias, all of the trials included in the task force evidence report were industry-sponsored except 1 trial.”
• “Industry-sponsored studies have been shown to report greater benefit and lesser adverse effects than non-commercially sponsored trials of the same drugs.”
• With statins, persons at low risk of heart disease have little chance of benefit and are more likely to have a net harm.
• Amazingly, many of the trials used by the Task Force did not ask about commonly reported statin effects, such as muscle pains and weakness.
• Using creatine kinase levels to diagnose myopathy in statin-consuming patients “leads to a significant underestimate of muscle problems” because “most muscle problems do not involve an increase in creatine kinase levels.”
• Studies estimate that about 20% of statin users have muscle problems.
• With statins, the actual trial data are held by the Cholesterol Treatment Trialists’ Collaboration on behalf of the drug industry sponsor and have “not been made available to other researchers, despite multiple requests over many years.”
• “Although reported rates of adverse events in clinical trials are low, this does not reflect the experience of clinicians who see patients who are taking statins.”
• An NPR reporter with a calculated 2.9% risk of heart disease over 10 years was prescribed a statin, and she reported that “going for a walk was like slogging through mud” until “I ditched the statin. The weakness evaporated. I could run again.”
• Studies show an association between the use of statins and cognitive dysfunction, and most studies show an increased risk of diabetes with statin use.
• In 2012, the US Food and Drug Administration issued safety label changes for statin drug labels, including:
  • The potential for cognitive side effects such as memory loss, confusion, etc.
  • Increased blood sugar
  • Increased glycosylated hemoglobin (HbA1c) levels
• The rate of statin use for primary heart disease prevention among those older than 79 years increased from 8.8% in 2000 to 34.1% in 2012.
• “There are unintended consequences of the widespread statin use in healthy persons.”
• “People taking statins are more likely to become obese and more sedentary over time than non-statin users, likely because these people mistakenly think they do not need to eat a healthy diet and exercise as they can just take a pill to give them the same benefit.”
• “Although the estimates of the benefits of statins for primary prevention used by the task force may be inflated, even if these estimates are accurate, this is still a relatively weak intervention.”
• At best, the benefits from taking statins as primary prevention is “relatively
  small.”
• “The global market for statins has been estimated to be a staggering $20 billion annually;” this market would boom if statins were used routinely for primary heart disease prevention.
• “It is incumbent on clinicians to be sure that before recommending that a patient take a daily pill [statins] that has multiple adverse effects, there is evidence that the medication will lead to a better quality of life, longer life, or both. Such evidence is lacking for statins in primary prevention.”
• “Given the serious concerns about the harms of the reliance on statins for primary prevention, it is in the interest of public health and the medical community to refocus efforts on promoting a heart-healthy diet, regular physical activity, and not smoking.”