Statin Guidelines Flawed


The American College of Cardiology (ACC), the American Heart Association (AHA) and the National Heart, Lung and Blood Institute (NHLBI) formulated guidelines for prescribing statin drugs to prevent heart attacks (J Am Coll Cardiol, Nov 2013;62(16):e147-e239). The old rule was to prescribe statins whenever a person's bad LDL cholesterol is greater than 100 mg/dL. If the person is at high risk for a heart attack, then doctors are supposed to treat any LDL greater than 70 mg/dL. The expert panel that issued the new guidelines stated that there is no evidence from controlled clinical trials to support treatment at any specific LDL cholesterol level. They provide an online calculator to help doctors and patients understand their risk for suffering a heart attack in the next ten years.

The guidelines state that doctors should prescribe statin drugs for four groups of people:
1) Those with atherosclerotic heart disease;
2) Those with LDL cholesterol levels over 190 mg/dL, such as those with very high cholesterol that runs in families;
3) Those with diabetes, ages 40-75 and with LDL-cholesterol levels between 70 and 189 mg/dL, even if there is no evidence of atherosclerotic heart disease; and
4) Those without evidence of heart disease or diabetes but who have LDL-cholesterol levels between 70 and 189 mg/dL and a 10-year risk of atherosclerotic cardiovascular disease greater than 7.5 percent.

The Flaw in the Fourth Guideline
The first three criteria are reasonable, but the fourth is under heavy debate. This guideline states that all people whose risk of having a heart attack in 10 years is greater than 7.5 percent should take statins. However, the data the authors used to calculate risk for a heart attack doubled these people’s real chances of getting a heart attack. They used data from the 1990s, when people were more likely to suffer strokes and heart attacks at an earlier age than they are now. People smoked more and were less knowledgeable of the lifestyle factors that cause heart attacks and strokes. Thus a woman whose risk for a heart attack was calculated to be eight percent was really four percent, and the new guideline would have her take statins even though there is little reason for her to do so.

Researchers who are criticizing the guideline applied the data to three large studies that followed thousands of people for more than 10 years. They then used blood pressure, cholesterol, smoking, age and other factors to predict the number of heart attacks over 10 years. They also note that the guidelines exaggerate the chances of suffering a heart attack because the Risk Score does not include:
• family history of young heart attacks,
• triglycerides,
• waist circumference,
• body-mass index (obesity), or
• lifestyle habits.
The authors of the new guidelines defend their very high estimation of the chances of suffering heart attacks by claiming that the newer studies had a lower risk because they had identified the highest-risk patients and started them on statins. This lowered their chances of suffering heart attacks. My response is shame on them. If the new, more-recent data show reduced incidence of heart attacks, then the authors should use the new data.

What Will Happen If Doctors Follow the Guidelines Despite this Flaw?
The calculator doubles the chances of people in the fourth group getting a heart attack in the next 10 years. This means that about one-third of North Americans between ages 40 and 75 (approximately 30 million) would be advised to take statins.

Try the Calculator Yourself
You can use this calculator to see how your doctor will rank your chances of suffering a heart attack in the next 10 years. If you try it, remember that the calculator uses the exaggerated risk guidelines.
Try the ASCVD Heart Attack Risk Calculator
* Enter your data: Gender, age, race, total cholesterol, HDL (good) cholesterol, systolic blood pressure
* Answer the questions: Are you a smoker? Do you have diabetes? Are you being treated for high blood pressure?
* When you  have answered all of the questions your estimated risk will appear.

Treatment Recommendations from the Guidelines
* (Group 1) For those with atherosclerotic heart disease: the panel recommends treatment with high-intensity statin therapy such as rosuvastatin (Crestor, AstraZeneca) 20 to 40 mg/day or atorvastatin 80 mg—to achieve at least a 50 percent reduction in LDL cholesterol, unless otherwise contraindicated or when statin-associated adverse events are present. In that case, doctors should use a moderate-intensity statin.

* (Group 2) Those with LDL cholesterol levels >190 mg/dL, a high-intensity statin should be used with the goal of achieving at least a 50 percent reduction in LDL cholesterol levels.

* (Group 3) Those with diabetes aged 40 to 75 years of age, a moderate-intensity statin (to lower LDL cholesterol 30-40 percent).

* (Group 4)Those aged 40 to 75 years without cardiovascular disease or diabetes but who have a 10-year risk greater than 7.5 percent and an LDL-cholesterol level between 70 to 189 mg/dL, a moderate- or high-intensity statin.

If These Recommendations Confuse You
Don’t feel bad. The committee is also confused. Doctors really do not know who needs statins and who doesn’t. They just take a group of numbers and try to do the best they can with the information that they have. Here they have used data that is too old to be dependable. This is an honest effort that is defective, and that should be abandoned or revised soon.

Statins Are Not Completely Safe
Statins do help to prevent heart attacks, but they can cause muscle pain and damage and the people who are most likely to suffer muscle damage from statins are those who exercise the most. Other known side effects include: headache, difficulty sleeping, flushing of the skin, drowsiness, dizziness, nausea or vomiting, abdominal cramping and pain, bloating and gas, diarrhea, constipation, skin rash, memory loss, mental confusion, high blood sugar, cataracts and type 2 diabetes. More on Statin Side Effects

What Should You Believe and Do?
First of all, realize that lifestyle changes are likely to be far more important in preventing heart attacks than any drug. These guidelines may give many people the wrong impression that the best way to prevent heart attacks is to take drugs. It is far more important to make lifestyle changes.

• Exercise is at least as effective as drugs in preventing diabetes and second heart attacks, and is more effective in preventing death from strokes (British Medical Journal, published online October 2013).

• Following a plant-based diet and exercising can reduce heart disease more than the drugs and standard medical care prescribed by North American physicians (J. Amer. Med. Assoc, 1998;280: 2001; Amer. J. Cardiol, 1998;82: 72T).

Some people have an inherited susceptibility for suffering a heart attack and therefore need to take statin drugs to help prevent heart attacks. However, if people concentrated on changing their lifestyles, there would be very few heart attacks.  Recommended lifestyle changes include:
• Exercising
• Not smoking; avoiding excessive alcohol
• Restricting red meat, fried foods, sugar-added foods and sugared drinks
• Eating plenty of fruits and vegetables
• Avoiding overweight and vitamin D deficiency

Checked 4/2/17