Why I think it’s time to make statins available over-the-counter

by Allen J. Taylor, MD, Chief of Cardiology, MedStar Heart & Vascular Institute
July 10, 2017

Heart disease and stroke are the leading cause and fifth-leading cause of death of adults in the United States, respectively. Studies show that statins – cholesterol-lowering drugs – can reduce the risk of heart attack, stroke and death from heart disease by 25 to 30 percent.

Yet of the more than 78 million adults who are eligible to take statins, 45 percent don’t. There are plenty of reasons for this: some don’t realize they’re at risk for these conditions; others don’t want to take medication or have been scared off by misinformation about statins.

But people who could benefit from a statin also face an additional barrier: it requires a prescription.

A May 2016 study estimated that giving statins over-the-counter (OTC) status would result in more than 250,000 fewer major coronary events such as heart attack, more than 41,000 fewer strokes, and reduce heart disease- and stroke-related deaths by nearly 69,000 over 10 years.

We’ve been using statins for 30 years, and they’ve proven to be some of the safest and most effective drugs for heart disease prevention. I think it’s time we remove the prescription barrier and allow people to buy them over-the-counter.

Statins as OTC medication: Why now?

Selling statins over-the-counter isn’t a new concept. It’s been discussed for years. In fact, one pharmaceutical company even began the process for developing an OTC statin before abandoning it due to sky-high requirements. But evidence found in a 2016 study really drove home for me that this is a valid idea.

“The Heart Outcomes Prevention Evaluation” (HOPE-3) study, published in May 2016 in The New England Journal of Medicine, followed more than 12,000 participants age 55-65 with at least one heart disease risk factor, such as high blood pressure or tobacco use. Half of the participants were given 10 mg of rosuvastatin, more commonly known as Crestor, and half were given a placebo. After five years, those who took a statin had a 24 percent lower risk for cardiovascular events. And, importantly, there were few if any important differences in side effects between the statin and placebo.

One interesting aspect of this study is that cholesterol levels were not used to select patients or to guide the treatment. The requirement was simply age and one heart disease risk factor. And to me, that’s the formula for an OTC medication: you don’t need a lot of fancy measurements to figure out if you could benefit from a statin. The HOPE-3 study showed statins were safe and effective in a broad population of people who didn’t already have heart disease, which I think is justification for conversion to OTC status.

A few years ago, Pfizer sought Food and Drug Administration (FDA) approval to convert its statin Lipitor to an OTC medication. The FDA set a pretty high bar for Pfizer’s study, requiring patients to measure their own cholesterol and take appropriate action based on the test results – actions no other OTC drug requires. Basically, the FDA wanted patients to act as a doctor, and it proved too complicated for most study participants. Pfizer ended the trial early.

The HOPE-3 study showed people don’t need to measure the effect of a statin on cholesterol for it to work. And by working, I mean it saves lives. So how do we narrow the gap between people who could benefit most from statins and those who take them?

Options for how to make statins available over-the-counter

There’s no question that giving a drug OTC status increases its use. One study showed an average 27 percent increase in utilization in several therapeutic drug classes, such as antihistamines and analgesics (a form of painkiller) after becoming available over-the-counter.

There are a few ways to go about expanding the availability of statins.

1. No longer require people to renew prescriptions

This is sort of a step up to true OTC status. Currently, if you have a prescription for a statin, you need to return to your doctor every year to renew the prescription. What if instead, that initial prescription was a lifetime prescription? It would be noted in your electronic medical records and you could walk up to any pharmacy window and refill it on an ongoing basis, without visiting the doctor to get a new prescription.

2.  Make statins available without a prescription

There are some people who just don’t want to see a doctor, but realize they’re at risk for heart disease or stroke. They’d take a statin if it was available like an antacid for heartburn or Tylenol for headache.

This would make statins available to anyone who stands to benefit from taking one: middle-aged individuals with one additional heart risk factor like in the HOPE-3 study. Given the poor job we do right now in getting statins to everyone who can benefit from them, it is time we begin to “think differently.”

Suggesting these options doesn’t mean I never want you to see a doctor, but it does remove a barrier to taking a potentially life-saving drug. Plus, instead of needing to discuss your statin during every visit, we can take a little extra time to focus on other topics, such as lifestyle modifications or answering questions.

How to keep people safe with OTC statins

Every medication has potential side effects. Statins are no different, although I think some concerns have been exaggerated on the internet. The most common side effect of statins is muscle pain, although it’s usually mild. Other side effects include a slightly increased risk to develop diabetes, seen as an earlier time to the diagnosis among patients likely to develop diabetes.

Have you ever bought aspirin or ibuprofen over the counter? Sure you have. In my view, statins are, in fact, safer than these drugs, and provide more benefit. Nonsteroidal anti-inflammatory drugs such as these are incredibly effective when needed, but they do have potentially serious side effects, including increased risk of bleeding in the brain and gastrointestinal bleeding. However, like statins, the benefits of these drugs greatly outweigh the potential harm.

Labels for OTC statins should carry warnings and recommended uses just like any other drug. And not every variation of statins should be available over-the-counter. For example, if you needed a dose higher than 10 mg, your doctor should have to write a prescription, just as you would for high doses of other OTC drugs.

There are still questions to be answered before statins become available over-the-counter, such as who will pay for them. Most OTC drugs aren’t covered by insurance. But statins prevent health events that insurance companies ultimately would have to pay for, so I think they should be a reimbursable expense. How that happens needs to be worked out.

Statins have a solid 30-year track record of preventing heart attacks, stroke and death from heart disease. They’re ready for prime-time. We’re entering a new era of empowering people to take charge of their health. It is time to give the public more control of their cardiovascular destiny by making statins available over-the-counter.

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Category: Healthy Living     Tags: Allen TaylorMedStar Heart & Vascular Instituteotcover-the-counter-medicationside-effects-of-statinsstatins