New statin guidelines: Thoughts from a physician on the front lines
Part 2 of a 2-part series on last year's controversial new statin guidelines
According to the controversial 2013 AHA/ACC guidelines, the four groups most likely to benefit from statin therapy include the following:
- Patients with any form of atherosclerotic cardiovascular disease (ASCVD), including acute coronary syndrome (ACS), a history of heart attack, stable or unstable angina, a history of undergoing an arterial or any other type of revascularization process, stroke, transient ischemic attack, or peripheral arterial disease
- Patients whose primary low-density lipoprotein cholesterol (LDL-C) levels are 190 mg/dL or higher
- Patients between the ages of 40 and 75 who are diabetic and have LDL-C levels between 70 mg/dL and 189 mg/dL
- Patients aged 40 to 75 who do not have diabetes or ASCVD, but have an estimated 10-year risk of 7.5% of higher
The net effect of the new guidance is a lower threshold for treatment. But how does that sit with actual physicians on the front lines of patient care?
Dr. Barry Mennen (pictured above) is one such physician. After spending more than 30 years in the pharmaceutical industry specializing in CVD, diabetes, and obesity-related medications, he is now back in private practice and has a long-term perspective on treatment trends.
“There’s not much controversy about statin treatment for people who have already had a CVD event; those with very high LDL-C; and those with diabetes, who are over the age of 40 and have modestly elevated LDL-C levels," said Dr. Mennen in an interview with BioPharma Dive. "However, when you look at the AHA/ACCC risk calculator for people without CV disease, diabetes, and/or high LDL-C -- and consider their recommendations for statin treatment -- that’s where the controversy happens."
"And that’s putting it mildly.”
Reactions from the front lines
Dr. Mennen is referring to the fact that, although the AHA/ACC guidelines have been accepted by some physicians and medical organizations, others like the American Association of Clinical Endocrinology (AACE) have been far more skeptical. AACE claims that the calculator used by the AHA/ACC working group was based on outmoded data, and that the calculator itself was never validated. On the other hand, the guidelines have been endorsed by heavyweights like the New England Journal of Medicine (NEJM), the British Medical Journal (BMJ), and the Journal of the American Medical Association (JAMA).
For his part, Dr. Mennen is skeptical that such a low treatment threshold makes sense. “As a practitioner, I believe that the new guidelines are casting too wide a net for primary prevention in otherwise healthy people. It seems that just about everyone over the age of 65 needs to be on a statin based on the new guidelines.”
But what about the evidence from NHANES that was used to create the latest risk calculator? That data makes a pretty compelling case for the new guidance, Mennen notes -- but not necessarily compelling enough. “According to the Cochrane database in the primary prevention studies they reviewed, you would need to treat 1,000 men for 5 years to prevent 18 events," said Dr. Mennen. "I think I would need to see some real risk before I would commit a patient to lifelong therapy."
A growing trend
The US is not alone in its quest to decrease CV-related mortality by lowering the threshold for statin intervention. Recently, the UK’s National Institute for Health and Care Excellence (NICE) released draft guidance that would cut the risk threshold for prescribing statin therapy in half. The current threshold is when a patient has a 20% or higher risk for a CV event within 10 years. NICE's draft guidance drops that down to a 10% or higher 10-year risk.
The reaction from UK health providers has mirrored that in the U.S. While most physicians are willing to adopt the new guidelines -- after all, a third of all deaths in the UK are CV-related -- others have warned that side effects, such as muscle pain and memory loss, as well as an increased risk of type 2 diabetes, cannot be discounted. In its guidance, NICE addresses the need to use different tactics to reduce CVD risk, including starting statin therapy earlier and making the appropriate lifestyle modifications. The agency also points out that statin therapy is cheaper than ever before and broadly accessible.
It’s been 10 months since the latest guidelines were released, and it's still too early to assess their impact statin prescriptions and sales. But one thing is clear: the new guidelines have upped the ante for physicians treating CVD.
The message being sent by the updated guidance is that physicians have the power to prevent certain CV risk factors. There will be a lot more data outlining prescription trends by early 2015. But while those trends are important, truly understanding how to balance patients' risk and aggressively applying statin therapy isn't in the cards for several years, until the long-term impact of the new guidance can be properly assessed.
You can read Part 1 of this series, The statin stumper: Are new cholesterol guidelines prudent or overzealous?, here.