The New Prevention Guidelines a Year Later
Straight Talk | In November, 2013, The American College of Cardiology Foundation (ACCF), American Heart Association (AHA), and the National Cholesterol Education Program (NCEP) published new cholesterol guidelines (ACCF/AHA/NCEP IV) for risk assessment, treatment, therapeutic lifestyle changes, and obesity,1 and, in December, the Joint National Committee (JNC-8) published new guidelines for the management of hypertension (HTN).2 There is no question that the guidelines, particularly for cholesterol and HTN, have generated considerable discussion and controversy.
For most of the HTN guidelines, I believe that the cardiovascular community has agreed with the majority of the principles, including not using ACE inhibitors and ARBs as first-line therapy in African American patients, removing beta blockers as first-line therapy for those without coronary heart disease and heart failure, and avoiding the combined use of ACE inhibitors and ARBs for almost all patients with HTN. However, the major concern that the guidelines produced involve not routinely treating systolic blood pressure (BP) levels of 140-149 mm Hg in those patients over the age of 60 years. Although many of my colleagues recognize the risk of overzealous treatment of BP in the very elderly (e.g. ≥ 80 years old)—particularly considering the orthostatic BP changes in the very elderly and their high risk of falls and other complications—I believe that most of my colleagues disagree with not treating the “younger” older patients ages 60-70 years as well as many in their 70s. In fact, soon after the publication of these guidelines, a JACC paper by Sripal Bangalore and colleagues from the INVEST Trial showed optimal CVD protection with BP levels <140 mm Hg, raising concern with this aspect of the guidelines.3
The cholesterol guidelines have been even more controversial. I believe that most of my colleagues applaud the primary prevention portion of these guidelines with the call for greater use of statins, as well as the strong emphasis on evidence-based therapy with recommendations only for treatment absolutely proven in randomized controlled trials. However, many of my colleagues have expressed concern that not only are there no goals for non-HDL cholesterol and other lipid values, there are also no goals for LDL-cholesterol. Although therapy for high-risk patients is based on treatments expected to lower LDL-cholesterol by >50%, there are no suggestions to intensify therapy in patients who do not reach this level of LDL-cholesterol reduction. For example, if a 40-year-old man with an LDL-cholesterol of 220 mg/dL has an MI treated with stents, recommended treatment for his lipids would be atorvastatin 40 mg or 80 mg or rosuvastatin 20-40 mg. In the past, guidelines would have suggested an LDL-cholesterol of at least <100 mg/dL, and most would have strived for the “optional” LDL goal of <70 mg/dL, but now even LDL-cholesterol levels of 150 mg/dL—which is <50% reduction from baseline—would not require additional treatment. Also, new guidelines do not require the elderly ages >75 years to be treated aggressively, except for those with LDL-cholesterol ≥190 mg/dL or with established CVD, and then the guidelines recommend only moderate doses of statins despite high intensity statins also having evidence for efficacy and safety in older patients.
Some will point out that most of the other organizations, including the European Society of Cardiology, European Atherosclerosis Society, The International Atherosclerosis Society, The Endocrine Society, and even the National Lipid Association have not endorsed these guidelines, and for many preventive cardiologists, the new guidelines do not “prevent” the clinicians from treating this patient population more aggressively or using lipid goals. However, for the students and new trainees, at the end of the day, these new guidelines from ACCF/AHA/NCEP IV will become the “rule of the land.”
The recent evidence from the IMPROVE-IT Trial, showing benefits of ezetimibe in addition to simvastatin even in patients with LDL-cholesterol values <70 mg/dL may stimulate greater emphasis on other non-statin lipid therapies. Some may say that the ezetimibe only produced a 2% absolute and 6.4% relative risk reduction after 7 years in over 18,000 patients, with a NNT of 350 (one event prevented for over 50 patients treated for 7 years), which would not seem to be super impressive. However, considering the negative publicity that ezetimibe received when it did not reduce carotid intima media thickness several years ago in the ENHANCE study, many were quite pleased to learn that the ezetimibe that they had been prescribing for years at least now has proven major clinical event reduction, even versus a control group with a median LDL-cholesterol of 69.9 mg/dL. Likewise, there is evidence from subgroups in the fibrate trials of patients with high triglycerides and low HDL-cholesterol that these therapies provide benefit similar to niacin therapy in subgroups from AIM-High. In fact, at the last AHA meetings, a meta-analysis of niacin therapies suggested benefit, even after including the AIM-High and HPS2-THRIVE data.
Like the HTN guidelines, soon after publication of the cholesterol guidelines, papers from Dr. Matthijs Boekholdt and colleagues,4 and by Drs. Ori Ben-Yehuda and Anthony DeMaria,5 the long-term JACC editor, suggested that with regard to lipid values and CVD, lower appears to be better, thus providing hope for additional therapies to be added to statins, including the PCSK-9 inhibitors and possibly other agents.
In conclusion, these new prevention guidelines certainly provide the potential to improve the health of many of our patients. On the other hand, strict adherence to the “letter of the law” may lead to less aggressive treatment for many of our high-risk patients, with potentially less than ideally anticipated results.
- The Expert Panel Panel Members. J Am Coll Cardiol. 2014;25:889-934.
- James PA, Oparil S, Carter BL, et al. JAMA. 2014;311:507-20.
- Bangalore S, Gong Y, Cooper-DeHoff RM, et al. JACC 2014; 64(8):784-93.
- Boekholdt SM, Hovingh GK, Mora S, et al. J Am Coll Cardiol. 2014;64:485-94.
- Ben-Yehuda O, DeMaria N. J Am Coll Cardiol. 2014;64:495-7.
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