Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER) 2

Abstract

Background— Niacin reduces coronary heart disease morbidity and mortality when taken either alone or in combination with statins; however, the incremental impact of adding niacin to background statin therapy is unknown. Methods and Results— This was a double-blind randomized placebo-controlled study of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease and low levels of high-density lipoprotein cholesterol (HDL-C; <45 mg/dL). The primary end point was the change in common carotid intima-media thickness (CIMT) after 1 year. Baseline CIMT (0.884±0.234 mm), low-density lipoprotein cholesterol (89±20 mg/dL), and HDL-C (40±7 mg/dL) were comparable in the placebo and niacin groups. Adherence to niacin exceeded 90%, and 149 patients (89.2%) completed the study. HDL-C increased 21% (39 to 47 mg/dL) in the niacin group. After 12 months, mean CIMT increased significantly in the placebo group (0.044±0.100 mm; P <0.001) and was unchanged in the niacin group (0.014±0.104 mm; P =0.23). Although the overall difference in IMT progression between the niacin and placebo groups was not statistically significant ( P =0.08), niacin significantly reduced the rate of IMT progression in subjects without insulin resistance ( P =0.026). Clinical cardiovascular events occurred in 3 patients treated with niacin (3.8%) and 7 patients treated with placebo (9.6%; P =0.20). Conclusions— The addition of extended-release niacin to statin therapy slowed the progression of atherosclerosis among individuals with known coronary heart disease and moderately low HDL-C.

Validation of a Carotid Intima-Media Thickness Border Detection Program for Use in an Office Setting

“…Of note, far-wall CIMT and its changes have been associated with cardiovascular risk and used to measure response to therapy in clinical trials. 3,16 Because there were fewer participants at the high end of the CIMT range, greater differences between the techniques for high or extreme CIMT values cannot be excluded. Incorporation of a BDP into an inexpensive lightweight or portable ultrasound system, validation of an abbreviated scanning protocol for officebased cardiovascular risk assessment, and studies demonstrating improved cardiovascular outcomes using CIMT measurements are needed to continue to facilitate clinical use of CIMT measurements.…”

Manual or semi‐automated edge detection of the maximal far wall common carotid intima–media thickness: a direct comparison

“…Alternatively, for offline readings, images are acquired and stored on videotape or a digital medium and read at a later moment in time [7]. This offline reading approach is most often used in clinical trials, using either semi-automated edge detection programs [8][9][10] or manual edge detection of the ultrasound interfaces [11][12][13][14]. Semi-automated edge detection is more often applied in settings in which only the common carotid artery is examined, whereas manual edge detection is usually applied in those settings in which the maximum CIMT of multiple carotid segments is measured.…”

“…A number of studies have provided data on the reproducibility, risk factor relations and rates of change in common CIMT using automated or manual edge detection [8][9][10][11][12][13][14]. However, comparison of results from these studies to compare reading methods is useless, because differences could be explained by many other factors such as differences in study population or scanning procedures rather than by differences in reading method alone.…”

Effect of niacin on endothelial function: A systematic review and meta-analysis of randomized controlled trials

“…58 Despite the negative findings of recent large-scale trials, several earlier studies -though at smaller scales -have reported an opposite finding. 18,33,[59][60][61][62][63][64] A recent meta-analysis also favored the benefits of niacin either as monotherapy or as an adjunct to statins in reducing CVD events. 64 It is also worth noting that both AIM-HIGH and HPS2-THRIVE studies were secondary prevention trials in subjects receiving optimal statin therapy.…”