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The role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol: baseline characteristics of study participants. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: impact on Global Health outcomes (AIM-HIGH) trial.
Am Heart J 2011; 161(3):538-43AH

Abstract

OBJECTIVES

The study aims to report the baseline characteristics of the fully randomized AIM-HIGH study population.

BACKGROUND

Residual risk persists despite aggressive low-density lipoprotein cholesterol (LDL-C) reduction in patients with atherosclerotic cardiovascular (CV) disease, many of whom have atherogenic dyslipidemia (low levels of high-density lipoprotein cholesterol (HDL-C), elevated triglycerides, and small dense LDL particles).

METHODS

All study participants had established CV disease and atherogenic dyslipidemia. Participants received simvastatin (or simvastatin plus ezetimibe) at a dose sufficient to maintain LDL-C at 40 - 80 mg/dL (1.03-2.07 mmol/L) and were randomized to receive extended-release niacin or matching placebo. The primary end point is time to the first occurrence of coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization with average follow-up of 4.1 years.

RESULTS

Between 2006 and 2010, 8,162 individuals signed consent to be screened, 4,275 began study drug run-in, and 3,414 were randomized to treatment. Mean age at entry was 64 ± 9 years, 85% were men, and 92% were white. As expected, risk factors were prevalent with 34% having diabetes; 71%, hypertension; and 81%, metabolic syndrome. Most participants had coronary artery disease (92%), whereas 11% had peripheral arterial disease; and 12%, cerebrovascular disease. Previous coronary revascularization occurred in 82%, and 54% reported a prior myocardial infarction. Among participants on a statin at entry (94%), mean baseline LDL-C was 71 mg/dL (1.84 mmol/L); mean HDL-C, 34.9 mg/dL (0.90 mmol/L); and median triglycerides, 161 mg/dL (1.82 mmol/L).

SUMMARY

AIM-HIGH enrolled a high-risk group of patients with established atherosclerotic CV disease and atherogenic dyslipidemia. This study should determine whether there is incremental clinical benefit of niacin in reducing cardiovascular events in patients who have attained optimal on-treatment levels of LDL-C with a statin.

Authors+Show Affiliations

Axio Research, LLC, Seattle, WA, USA. ruthm@axioresearch.com

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21392609

Citation

AIM-HIGH Investigators. "The Role of Niacin in Raising High-density Lipoprotein Cholesterol to Reduce Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease and Optimally Treated Low-density Lipoprotein Cholesterol: Baseline Characteristics of Study Participants. the Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/high Triglycerides: Impact On Global Health Outcomes (AIM-HIGH) Trial." American Heart Journal, vol. 161, no. 3, 2011, pp. 538-43.
AIM-HIGH Investigators. The role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol: baseline characteristics of study participants. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: impact on Global Health outcomes (AIM-HIGH) trial. Am Heart J. 2011;161(3):538-43.
AIM-HIGH Investigators. (2011). The role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol: baseline characteristics of study participants. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: impact on Global Health outcomes (AIM-HIGH) trial. American Heart Journal, 161(3), pp. 538-43. doi:10.1016/j.ahj.2010.12.007.
AIM-HIGH Investigators. The Role of Niacin in Raising High-density Lipoprotein Cholesterol to Reduce Cardiovascular Events in Patients With Atherosclerotic Cardiovascular Disease and Optimally Treated Low-density Lipoprotein Cholesterol: Baseline Characteristics of Study Participants. the Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/high Triglycerides: Impact On Global Health Outcomes (AIM-HIGH) Trial. Am Heart J. 2011;161(3):538-43. PubMed PMID: 21392609.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The role of niacin in raising high-density lipoprotein cholesterol to reduce cardiovascular events in patients with atherosclerotic cardiovascular disease and optimally treated low-density lipoprotein cholesterol: baseline characteristics of study participants. The Atherothrombosis Intervention in Metabolic syndrome with low HDL/high triglycerides: impact on Global Health outcomes (AIM-HIGH) trial. A1 - ,, Y1 - 2011/02/02/ PY - 2010/12/02/received PY - 2010/12/06/accepted PY - 2011/3/12/entrez PY - 2011/3/12/pubmed PY - 2011/5/27/medline SP - 538 EP - 43 JF - American heart journal JO - Am. Heart J. VL - 161 IS - 3 N2 - OBJECTIVES: The study aims to report the baseline characteristics of the fully randomized AIM-HIGH study population. BACKGROUND: Residual risk persists despite aggressive low-density lipoprotein cholesterol (LDL-C) reduction in patients with atherosclerotic cardiovascular (CV) disease, many of whom have atherogenic dyslipidemia (low levels of high-density lipoprotein cholesterol (HDL-C), elevated triglycerides, and small dense LDL particles). METHODS: All study participants had established CV disease and atherogenic dyslipidemia. Participants received simvastatin (or simvastatin plus ezetimibe) at a dose sufficient to maintain LDL-C at 40 - 80 mg/dL (1.03-2.07 mmol/L) and were randomized to receive extended-release niacin or matching placebo. The primary end point is time to the first occurrence of coronary heart disease death, nonfatal myocardial infarction, ischemic stroke, hospitalization for acute coronary syndrome or symptom-driven coronary or cerebral revascularization with average follow-up of 4.1 years. RESULTS: Between 2006 and 2010, 8,162 individuals signed consent to be screened, 4,275 began study drug run-in, and 3,414 were randomized to treatment. Mean age at entry was 64 ± 9 years, 85% were men, and 92% were white. As expected, risk factors were prevalent with 34% having diabetes; 71%, hypertension; and 81%, metabolic syndrome. Most participants had coronary artery disease (92%), whereas 11% had peripheral arterial disease; and 12%, cerebrovascular disease. Previous coronary revascularization occurred in 82%, and 54% reported a prior myocardial infarction. Among participants on a statin at entry (94%), mean baseline LDL-C was 71 mg/dL (1.84 mmol/L); mean HDL-C, 34.9 mg/dL (0.90 mmol/L); and median triglycerides, 161 mg/dL (1.82 mmol/L). SUMMARY: AIM-HIGH enrolled a high-risk group of patients with established atherosclerotic CV disease and atherogenic dyslipidemia. This study should determine whether there is incremental clinical benefit of niacin in reducing cardiovascular events in patients who have attained optimal on-treatment levels of LDL-C with a statin. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/21392609/The_role_of_niacin_in_raising_high_density_lipoprotein_cholesterol_to_reduce_cardiovascular_events_in_patients_with_atherosclerotic_cardiovascular_disease_and_optimally_treated_low_density_lipoprotein_cholesterol:_baseline_characteristics_of_study_participants__The_Atherothrombosis_Intervention_in_Metabolic_syndrome_with_low_HDL/high_triglycerides:_impact_on_Global_Health_outcomes__AIM_HIGH__trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(10)01165-8 DB - PRIME DP - Unbound Medicine ER -