Statins, Like All Medicines, Are Neither Good Nor Bad

We have to talk about drugs.

No, not illicit drugs, but medications used by doctors and patients.

Plaintiff attorneys run ads on TV that fool people into thinking certain meds are bad. The current one I deal with is the clot-blocking drug rivaroxaban (Xarelto.) Before that, it was dabigatran (Pradaxa). If, or when, the makers of rivaroxaban settle a class action suit, you can bet apixaban (Eliquis) will be next.

These ads are a problem because they use fear persuasion (see Scott Adams’ blog), and because they can induce patients to stop taking or not start a beneficial medicine.

Lots of other medications suffer from a “bad” or “toxic” branding. Some people think statins are bad; many people think amiodarone is toxic. Warfarin (Coumadin) still suffers from the branding of rat poison.

I want to be clear: medications are neither bad nor good. Medications are chemicals that act on cells in the body in an attempt to create benefit. All medications can be toxic.

Toxicity turns mostly on dose. (Chance can also play a role in toxicity.)

Warfarin kills rats because the rodents keep eating the pellets and the drug builds up to high doses. In humans, we adjust the dose.

When patients tell me certain medications are toxic, I remind them that too much water, taken by endurance athletes, can cause dangerously low sodium levels that may lead to seizures. Oxygen given at high doses for too long in patients on ventilators can damage the lungs. Life saving-antibiotics can cause life-threatening colon infections.

I would urge doctors and patients to frame medications with the big four questions:

As an exercise, let’s apply the four questions to the statin drugs (we exclude from this discussion people with familial hypercholesterolemia):

What are the benefits of taking statins?

There is only one benefit of statins: to reduce the future probability of a heart attack, stroke or death. Do not make the mistake of thinking statins are for cholesterol lowering. The drugs do lower cholesterol levels, but that’s a mere blood test. There are plenty of drugs that lower cholesterol but do not reduce the risk of heart attack or stroke.

The benefit of statins, therefore, is a probabilistic one. It’s like a lottery. You take the pill every day in hopes it will prevent a serious cardiac event in the future.

Numerous randomized controlled clinical trials (the highest level medical evidence) confirm that statins do reduce the probability of a cardiac event.

In absolute terms, the degree of statin benefit depends on whether a person has had a cardiac event.

For those without a previous heart attack, stent, bypass or stroke, statin benefits are small—no mortality benefit and about a 1% reduction of nonfatal cardiac events over the next 5 years. Doctors call this primary prevention.

For people with a history of a cardiac event or stroke due to a blockage of some sort, statin benefits are greater—about a 1.2% lower risk of dying and 2.5-3% lower risk of a non-fatal heart attack over the next 5 years. Doctors call this secondary prevention.

What are the harms of statins?

The best known harm of statins are muscle issues. I use the word issues rather than damage because true muscle damage is rare—about 5 in 10,000.

The actual frequency of muscle symptoms is hotly debated. Randomized controlled trials (in which patients don’t know whether they are taking the statin or placebo) report very small increases in muscle complaints—about a 1-2% increase. Observational studies, however, reveal higher rates of statin muscle complaints—in the range of 10-20%.

The second potential harm of statins is a small increase in diabetes. One of the smartest doctors on the Internet, Dr. Richard Lehman, says “the issue of [statin] induced type 2 diabetes is just an artifact of the way we define the threshold for T2DM. Statins often cause a small rise in blood sugar, which would only be of significance if it was associated with an increase in macrovascular or microvascular disease. On the contrary, statins reduce macrovascular disease end-points, and there is no evidence to suggest that they increase eye or kidney microvascular disease (which are very rare in the glucose range we are talking about).”

A third potential harm of statins is the burden of taking a pill every day. Scientists call this pill “disutility” and its measured in how much extension of life one would trade for taking a pill every day. People have different feelings about pill burden.

Another possible (emphasis here on possible) harm of statins is that the drugs may interact in a negative way with lifestyle. In a 2014 theheart.org | Medscape Cardiology column that went a bit viral (647 comments), I cited two observational studies, one that reported a higher calorie intake of statin users and the other less physical activity in male statin users.

Are there simpler safer options?

Opinion alert here: I strongly suspect that a healthy lifestyle delivers similar benefits.

Eating modest amounts of real food, not processed food in packages, doing regular exercise and managing stress would likely deliver lots of probabilistic benefits for reducing the odds of having heart disease.

This “intervention” however, has not been compared to statins in randomized controlled trials. Cardiologists Aseem Malhotra, Rita Redberg and Pascal Meier, writing in the British Journal of Sports Medicine, point to the obvious reason for this: “There is no business model or market to help spread this simple yet powerful intervention.”

What happens if I do nothing?

The most likely outcome of not taking statins is the same as if you take one—nothing. In the best case, that of secondary prevention, the risk reduction for nonfatal cardiac events is about 2.5-3%. That means one has to treat about 39 patients for five years to prevent one event. The odds are you would be in the 38 of 39 category, but you don’t know.

Doctors think this is a good trade. If these stats are applied to populations, many heart attacks can be prevented.

The ultimate decision is up to you. You are not a population.

JMM

You can do this exercise for any medical intervention or medication. Why we don’t do it more often is hard for me to understand.