Clinical question Is niacin effective to reduce cardiovascular events and mortality in patients with or at risk of coronary artery disease?
Bottom line We are now flush (so to speak) with data about the effects of niacin in patients with elevated cholesterol levels. Despite its ability to raise high-density lipoprotein (HDL) serum levels, it does not add additional mortality or morbidity benefit to statin treatment. Patients with diabetes may also experience worse blood glucose control, as well as other niacin-related side effects. (LOE = 1a)(www.essentialevidenceplus.com)
Reference Garg A, Sharma A, Krishnamoorthy P, et al. Role of niacin in current clinical practice: a systematic review. Am J Med 2017;130(2):173-187.
Study design: Systematic review
Funding source: Self-funded or unfunded
Setting: Various (meta-analysis)
Synopsis Niacin (nicotinic acid, vitamin B3) has been used to increase HDL cholesterol levels since the 1970s, based on studies that showed a mortality benefit. However, these initial studies were conducted prior to the era of optimized statin therapy. The researchers conducting this meta-analysis searched for all randomized studies that compared niacin with placebo, either alone or in combination with statin treatment or other treatments that lower LDL cholesterol. The authors searched 4 databases, including Cochrane CENTRAL, and identified 13 studies that enrolled a total of 35,206 patients. The number of studies is misleading; a single study, published in 2013, provides 73% of the patients included in the analysis. The systematic review was conducted according to PRISMA standards. Several studies published since 2000 have looked at the effect of niacin added to a statin. Though niacin can increase HDL levels by an average 21.4%, it does not affect all-cause mortality rates. It also does not lower the risk of cardiovascular mortality, nonfatal myocardial infarction, stroke, or the need for revascularization. There was no significant heterogeneity among trials. Even studies that specifically enrolled patients with low HDL levels did not find benefit. In patients with pre-existing diabetes, treatment with niacin worsens blood glucose control (odds ratio 1.44; 95% CI 1.31 - 1.59). Flushing and gastrointestinal and musculoskeletal side effects were also significantly more likely with niacin.
Allen F. Shaughnessy, PharmD, MMedEd Professor of Family Medicine Tufts University Boston, MA
Clinical question In patients older than 65 years with elevated low-density lipoprotein levels but no cardiovascular disease, is cholesterol lowering effective in decreasing mortality or morbidity?
Bottom line If a patient makes it to 65 years old without developing cardiovascular disease, lowering his or her cholesterol level at this point is not effective, and might even be harmful if treatment is started at age 75. Given the lack of benefit also shown in other studies, it might be time to stop checking—and treating—high cholesterol in these age groups. (LOE = 1b-)(www.essentialevidenceplus.com)
Reference Han BH, Sutin D, Williamson JD, et al, for the ALLHAT Collaborative Research Group. Effect of statin treatment vs usual care on primary cardiovascular prevention among older adults. The ALLHAT-LLT randomized clinical trial. JAMA Intern Med 2017; doi:10.1001/jamainternmed.2017.1442.
Study design: Randomized controlled trial (nonblinded)
Funding source: Government
Allocation: Concealed
Setting: Outpatient (any)
Synopsis This report is an analysis of a trial that evaluated the primary prevention of cardiovascular disease using cholesterol lowering. It focused on patients who were at least 65 years old and had an elevated fasting low-density lipoprotein cholesterol (LDL-C) level (120 - 189 mg/dL [3.1 - 4.9 millimoles/L]). The Lipid-Lowering Trial (LLT) component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT) study enrolled 2867 adults 65 years or older with hypertension but without baseline atherosclerotic cardiovascular disease. The patients were randomized, using concealed allocation, to receive usual care or pravastatin 40 mg daily. Most of the patients in the usual care group were not treated with a statin. Over the 6 years of follow-up, all-cause mortality was not different between the 2 treatment groups for patients 65 to 74 years of age (hazard ratio for pravastatin vs usual care = 1.08 (95% CI, 0.85-1.37; P = .55) and was almost statistically higher for patients at least 75 years of age (hazard ratio of pravastatin vs usual care = 1.34 (0.98-1.84; P = .07). Rates of coronary heart disease events were not different between the groups in either age group. Analysis was by intention to treat. Given that this is a post-hoc analysis, the researchers did not provide a power calculation and there might be a small difference in rates that was not see in this study.
POEMs are provided by Essential Evidence Plus, a point-of-care clinical decision support system published by Wiley-Blackwell. For more information, please see http://www.essentialevidenceplus.com(www.essentialevidenceplus.com).
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