Omega-3 Polyunsaturated Fatty Acid (Fish Oil) Supplementation and the Prevention of Clinical Cardiovascular Disease: A Science Advisory From the American Heart Association.

Multiple randomized controlled trials (RCTs) have assessed the effects of supplementation with eicosapentaenoic acid plus docosahexaenoic acid (omega-3 polyunsaturated fatty acids, commonly called fish oils) on the occurrence of clinical cardiovascular diseases. Although the effects of supplementation for the primary prevention of clinical cardiovascular events in the general population have not been examined, RCTs have assessed the role of supplementation in secondary prevention among patients with diabetes mellitus and prediabetes, patients at high risk of cardiovascular disease, and those with prevalent coronary heart disease. In this scientific advisory, we take a clinical approach and focus on common indications for omega-3 polyunsaturated fatty acid supplements related to the prevention of clinical cardiovascular events. We limited the scope of our review to large RCTs of supplementation with major clinical cardiovascular disease end points; meta-analyses were considered secondarily. We discuss the features of available RCTs and provide the rationale for our recommendations. We then use existing American Heart Association criteria to assess the strength of the recommendation and the level of evidence. On the basis of our review of the cumulative evidence from RCTs designed to assess the effect of omega-3 polyunsaturated fatty acid supplementation on clinical cardiovascular events, we update prior recommendations for patients with prevalent coronary heart disease, and we offer recommendations, when data are available, for patients with other clinical indications, including patients with diabetes mellitus and prediabetes and those with high risk of cardiovascular disease, stroke, heart failure, and atrial fibrillation.

A thermal stress treadmill walk for clinic evaluation of candidates for hazardous materials (HazMat) duty.

UNLABELLED: U.S. guidance for examining hazmat workers recommends stress testing be considered when heat stress is expected. However, the most common stress test-Bruce protocol treadmill electrocardiography (BPTE) wearing gym clothes-creates little thermal stress. OBJECTIVE: Evaluate a novel thermal stress treadmill walk (TSTW). METHODS: Body temperatures and heart rates during BPTE in 93 current and potential hazmat workers wearing gym clothes were compared with later values in 35 of these subjects while they were wearing thermally-restrictive "sauna suits" during a 45-min TSTW. Physiological strain index (PSI) was calculated from temperature and heart rate changes and compared with PSI values from hazmat simulations and climatic chamber exercises. RESULTS: Tympanic temperature (TT) rose 0.5°C (SD 0.5) during BPTE lasting 12.4 min (SD 2.9). PSI reached 6.0 (SD 1.3). TT rose 1.0°C (SD 0.5) during TSTW, p < .01. PSI averaged 6.6 (SD 1.9) in 29 subjects who completed TSTW, versus 5.7 (SD 5.7) in the 6 subjects who did not. Ingested thermistor temperatures increased more than did TT during TSTW, yielding PSI of 7.0 (SD 1.5), equal to PSI values from climatic chamber exercises, i.e., 7.0 (SD 1.0). CONCLUSION: TSTW increased body temperature and PSI in 29 of the 35 subjects who completed it to levels matching those of operational simulations in climatic chambers and during hazmat exercises. This TSTW may be useful for evaluating candidates for hazmat duty.

Adherence with the National Cholesterol Education Program guidelines in men with chronic spinal cord injury.

OBJECTIVE: Describe the management of dyslipidemia and adherence to the National Cholesterol Educational Program (NCEP) guidelines in men with Spinal Cord Injury (SCI). RESEARCH: Cross-sectional study of a consecutive sample of men with SCI presenting to a single site for coronary heart disease (CHD) risk assessment. PARTICIPANTS/METHODS: Men age 45 to 70 with traumatic SCI (ASIA A, B, and C) at least 10 years prior to participation in the study with no prior history of clinical CHD. Medical history, blood-pressure, and fasting lipid panel were used to calculate risk for CHD using NCEP guidelines and the Framingham Risk Score (FRS). Adherence to treatment recommendations and adequacy of control were assessed based on the NCEP guidelines. RESULTS: 38 men were assessed; 15/38 (39.5%, 95% CI: 24.0-56.6%) had dyslipidemia, defined as an LDL-C above their LDL-C treatment threshold (n=6) or being on treatment for dyslipidemia (n=9, for a 60% treatment rate (9/15, 95% CI: 32.3-83.7%)). Of the 9 individuals on treatment, 6 (66.7%) met their treatment goals (for a 40% overall control rate (6/15, 95% CI: 16.3-67.7%)). Dyslipidemia was well controlled in low risk individuals, but control was less common in higher risk individuals. CONCLUSIONS: Dyslipidemia is common in men age 45-70 with chronic SCI and no evidence of clinical cardiovascular disease. Rates of treatment and control of dyslipidemia in this population are far from optimal, especially among the intermediate- and high-risk groups.

Comparison of coronary artery calcification scores and National Cholesterol Education program guidelines for coronary heart disease risk assessment and treatment paradigms in individuals with chronic traumatic spinal cord injury.

OBJECTIVE: To investigate the risk of coronary heart disease (CHD) in individuals with spinal cord injury (SCI) according to the National Cholesterol Educational Program (NCEP) guidelines and CT coronary artery calcium scores (CCS). RESEARCH: Cross-sectional study of consecutive sample of males with SCI presenting to a single site for CHD risk assessment. PARTICIPANTS/METHODS: Males age 45-70 with traumatic SCI (American Spinal Injury Association (ASIA) A, B, and C) injured for at least 10 years with no prior history of clinical CHD. Medical history, blood-pressure, and fasting lipid panel were used to calculate risk for CHD with the use of the Framingham risk score (FRS). Risk and treatment eligibility status was assessed based on NCEP/FRS recommendations and by presence and amount of CCS. Percent agreement (PA) and kappa were calculated between the two algorithms. Spearman correlations were calculated between CCS and FRS and individual risk factors. RESULTS: A total of 38 men were assessed; 18 (47.4%) had CCS > 0. The PA between NCEP/FRS assessment and CCS was 18% with a kappa of -0.03. 11 (28.9%) had CCS > 100 or >75th percentile for their age, sex, and race, which might qualify them for lipid-lowering treatment. Only 26 were placed into the same treatment category by NCEP/FRS and CCS, for a PA of 68% with a kappa of 0.35. In all, 20 (52.6%) were eligible for lipid-lowering treatment by either NCEP/FRS (n=9) or CCS (n = 11). Seven subjects were above the treatment threshold based on CCS, but not NCEP/FRS and five subjects were above the NCEP/FRS threshold, but not CCS. Just four subjects were eligible by both algorithms. CCS only correlated with FRS (r = 0.508, P = 0.001) and age (r = 0.679, P < 0.001).

Association of Carotid Artery Plaque With Cardiovascular Events and Incident Coronary Artery Calcium in Individuals With Absent Coronary Calcification: The MESA.

BACKGROUND: Absence of coronary artery calcium (CAC) identifies asymptomatic individuals at low cardiovascular disease risk. Carotid artery plaque is a marker of increased risk, but its association with cardiovascular risk and incident CAC in people without CAC is unclear. METHODS: Multi-Ethnic Study of Atherosclerosis participants with CAC score of 0 at enrollment who also underwent carotid plaque measurement using B-mode ultrasonography were prospectively followed for incident coronary heart disease, stroke, and cardiovascular disease events, and CAC (score >0 on up to 3 serial computed tomography scans). The association of carotid plaque presence and plaque score (Ln[score+1]) at baseline with cardiovascular events and incident CAC was evaluated with Cox proportional hazards regression models adjusted for demographics, risk factors, and statin use. RESULTS: Among these 2673 participants (58 years, 64% women, 34% White, 30% Black, 24% Hispanic, and 12% Chinese), carotid plaque at baseline was observed in 973 (36%) and the median plaque score (range, 1-12) among those with plaque was 1. A total of 79 coronary heart disease, 80 stroke, and 151 cardiovascular disease events were observed during 16.1 years of follow-up. Carotid plaque presence and plaque score were independently associated with coronary heart disease risk (HRs, 1.66 [95% CI, 1.04-2.66]; and 1.48 [95% CI, 1.01-2.17], respectively) but not with stroke and cardiovascular disease risk. A total of 973 (36.4%) participants developed CAC over the evaluation period (median 9.3 years). Carotid plaque presence and plaque score were independently associated with incident CAC (HRs, 1.34 [95% CI, 1.18-1.54]; and 1.37 [95% CI, 1.21-1.54]), respectively. CONCLUSIONS: The presence and extent of carotid plaque are associated with long-term coronary heart disease risk and incident CAC among middle-aged asymptomatic individuals with an initial CAC score of 0.

Low-density lipoprotein and apolipoprotein B: clinical use in patients with coronary heart disease.

Managing low-density lipoprotein (LDL) is an integral part of clinical practice. What remains controversial is whether we are using the best measure of LDL quantity for this purpose. Historically, the cholesterol content of LDL particles (LDLC) has been used to express LDL quantity. However, because of variability in the cholesterol carried in LDL particles, frequent disagreement occurs between LDLC and particle measures of LDL quantity, including apolipoprotein B-100 (apo B) or nuclear magnetic resonance (NMR) LDL particle number (LDL-P). Studies consistently demonstrate apo B and LDL-P are superior predictors of coronary heart disease (CHD) risk and superior indicators of low CHD risk on lipid-lowering therapy. Recent recommendations advocate that, in addition to LDLC and non-high-density lipoprotein cholesterol, apo B (or NMR LDL-P) be used as a target of therapy. This article reviews the rationale supporting these recommendations and provides a model for integrating LDL particle measures in clinical practice.

Policosanol is ineffective in the treatment of hypercholesterolemia: a randomized controlled trial.

BACKGROUND: Policosanol is one of the fastest growing over-the-counter supplements sold in the United States. The use of policosanol to treat elevated cholesterol is based on clinical trials conducted in Cuba, which showed sugar cane-derived policosanol to be similar in efficacy to statins. Recent studies have challenged these findings, but there have been no trials conducted in North America that have examined the ability of sugar cane-derived policosanol to lower cholesterol. OBJECTIVES: This study investigated the efficacy of sugar cane-derived policosanol in healthy adults with mild hypercholesterolemia. The primary outcome was the percentage change in LDL cholesterol after 8 wk of therapy. Secondary outcome measures included changes in total cholesterol, HDL cholesterol, triacylglycerols, C-reactive protein, and nuclear magnetic resonance-determined lipoprotein profile. Dietary habits, weight, and blood pressure were also monitored. DESIGN: Ambulatory, community-dwelling healthy adults with mild hypercholesterolemia (n = 40) were assigned to receive oral policosanol (20 mg) or placebo once daily for 8 wk. This was a double-blind, randomized controlled trial conducted from January through August 2005. RESULTS: No significant differences in the change in LDL cholesterol were observed between the placebo (n = 20) and policosanol (n = 20) groups. Also, no significant changes in secondary outcome measures, including total cholesterol, HDL cholesterol, triacylglycerol, C-reactive protein, and nuclear magnetic resonance spectroscopy-determined profiles were observed. Policosanol was well tolerated, and no significant adverse events were noted. CONCLUSION: Policosanol does not alter the serum lipid profile over an 8-wk period in adults with mild hypercholesterolemia.

Stress testing in the medical evaluation for hazardous materials duty: results and consequences in three groups of candidates.

OBJECTIVE: The objective of this study was to determine the yield of exercise stress testing (GXT) and other methods for evaluating candidates for HAZMAT duty. METHODS: The authors conducted an analysis of prior and current records of GXTs, medical examinations, blood tests, chest radiographs, spirometry, and audiometry in 190 candidates. The authors also conducted scrutiny of GXT results, using Duke Treadmill Score (DTS), Chronotropic Index (CI), and Heart Rate Recovery (HRR). RESULTS: Seven candidates were disapproved by history and/or physical examination. Twenty-one others were deferred for GXT-induced, marked hypertension, and/or ST depression >/=2 mm. The latter appeared to be false-positive indications of ischemia, low risks confirmed by DTS, CI, and HRR. Heat stress was not induced in 26 subjects so evaluated. CONCLUSIONS: GXT identified marked hypertension in 12 HAZMAT candidates and ischemic ST changes in 10, the latter appearing to be false-positives. Other testing yielded useful baselines, rarely disqualifying.

Effect of a multivitamin and mineral supplement on infection and quality of life. A randomized, double-blind, placebo-controlled trial.

BACKGROUND: Use of multivitamin and mineral supplements is common among U.S. adults, yet few well-designed trials have assessed the reputed benefits. OBJECTIVE: To determine the effect of a daily multivitamin and mineral supplement on infection and well-being. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Primary care clinics at two medical centers in North Carolina. PARTICIPANTS: 130 community-dwelling adults stratified by age (45 to 64 years or >or=65 years) and presence of type 2 diabetes mellitus. INTERVENTION: Multivitamin and mineral supplement or placebo taken daily for 1 year. MEASUREMENTS: Incidence of participant-reported symptoms of infection, incidence of infection-associated absenteeism, and scores on the physical and mental health subscales of the Medical Outcomes Study 12-Item Short Form. RESULTS: More participants receiving placebo reported an infectious illness over the study year than did participants receiving multivitamin and mineral supplements (73% vs. 43%; P < 0.001). Infection-related absenteeism was also higher in the placebo group than in the treatment group (57% vs. 21%; P < 0.001). Participants with type 2 diabetes mellitus (n = 51) accounted for this finding. Among diabetic participants receiving placebo, 93% reported an infection compared with 17% of those receiving supplements (P < 0.001). Medical Outcomes Study 12-Item Short Form scores did not differ between the treatment and placebo groups. CONCLUSIONS: A multivitamin and mineral supplement reduced the incidence of participant-reported infection and related absenteeism in a sample of participants with type 2 diabetes mellitus and a high prevalence of subclinical micronutrient deficiency. A larger clinical trial is needed to determine whether these findings can be replicated not only in diabetic persons but also in any population with a high rate of suboptimal nutrition or potential underlying disease impairment.

A Randomized, Placebo-Controlled Trial of Omega-3 Fatty Acids for Inhibition of Supraventricular Arrhythmias After Cardiac Surgery: The FISH Trial.

BACKGROUND: Omega-3 polyunsaturated fatty acids (n3-PUFAs) might have antiarrhythmic properties, but data conflict on whether n3-PUFAs reduce rates of atrial fibrillation (AF) after coronary artery bypass graft surgery (CABG). We hypothesized that n3-PUFAs would reduce post-CABG AF, and we tested this hypothesis in a well-powered, randomized, double-blind, placebo-controlled, multicenter clinical trial. METHODS AND RESULTS: Patients undergoing CABG were randomized to pharmaceutical-grade n3-PUFAs 2 g orally twice daily (minimum of 6 g) or a matched placebo ≥24 hours before surgery. Gas chromatography was used to assess plasma fatty acid composition of samples collected on the day of screening, day of surgery, and postoperative day 4. Treatment continued either until the primary end point, clinically significant AF requiring treatment, occurred or for a maximum of 2 weeks after surgery. Two hundred sixty patients were enrolled and randomized. Before surgery, n3-PUFA dosing increased plasma n3-PUFA levels from 2.9% to 4% and reduced the n6:n3-PUFA ratio from 9.1 to 6.4 (both P<0.001). Similar changes were noted on postoperative day 4. There were no lipid changes in the placebo group. The rate of post-CABG AF was similar in both groups (30% n3-PUFAs versus 33% placebo, P=0.67). The post-CABG AF odds ratio for n3-PUFAs relative to placebo was 0.89 (95% confidence interval 0.52-1.53). There were no differences in any secondary end points. CONCLUSIONS: Oral n3-PUFA supplementation begun 2 days before CABG did not reduce AF or other complications after surgery. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov Unique identifier: NCT00446966. (J Am Heart Assoc. 2012;1:e000547 doi: 10.1161/JAHA.111.000547.).