Financiado en parte por Abbott Laboratories, Eli Lilly and Company, Pfizer, Sanofi, Genentech
Niacin in patients with low HDL cholesterol levels receiving intensive statin therapy
AIM-HIGH Investigators, Boden WE, Probstfield JL, Anderson T, Chaitman BR, Desvignes-Nickens P, Koprowicz K, McBride R, Teo K, Weintraub W
The New England journal of medicine · 2,097 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Abbott Laboratories
- Empresa
- Eli Lilly and Company
- Empresa
- Pfizer
- Empresa
- Sanofi
- Empresa
- Genentech
- Gobierno
- National Heart, Lung, and Blood Institute
Según 6 financiadores declarados.
Publicación
- Publicado
- 2011-11-16 · N Engl J Med · vol. 365 · número 24 · págs. 2255–2267
- Editorial
- Massachusetts Medical Society
- Citado
- 2,929 citas · más que el 100% de estudios similares · 257.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 19 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Cholesterol and Lipid Metabolism · Diabetes, Cardiovascular Risks, and Lipoproteins
- Palabras clave
- nicotinic acid, simvastatin, HDL cholesterol, low HDL cholesterol, residual cardiovascular risk, atherosclerotic cardiovascular disease, extended-release niacin, ezetimibe, LDL cholesterol, triglycerides, major adverse cardiovascular events, cardiovascular risk reduction, statin therapy, coronary artery disease, myocardial infarction, ischemic stroke, acute coronary syndrome, revascularization
- MeSH
- humans, muscular diseases, brain ischemia, cardiovascular diseases, niacin, simvastatin, triglycerides, hydroxymethylglutaryl-coa reductase inhibitors, treatment failure, drug therapy, combination, proportional hazards models, aged, middle aged, female, male, atherosclerosis, cholesterol, ldl, cholesterol, hdl, medication adherence, hypolipidemic agents, kaplan-meier estimate
1 autor
- The AIM-HIGH Investigators · autor de correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
In patients with established cardiovascular disease, residual cardiovascular risk persists despite the achievement of target low-density lipoprotein (LDL) cholesterol levels with statin therapy. It is unclear whether extended-release niacin added to simvastatin to raise low levels of high-density lipoprotein (HDL) cholesterol is superior to simvastatin alone in reducing such residual risk.
Methods
We randomly assigned eligible patients to receive extended-release niacin, 1500 to 2000 mg per day, or matching placebo. All patients received simvastatin, 40 to 80 mg per day, plus ezetimibe, 10 mg per day, if needed, to maintain an LDL cholesterol level of 40 to 80 mg per deciliter (1.03 to 2.07 mmol per liter). The primary end point was the first event of the composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
Results
A total of 3414 patients were randomly assigned to receive niacin (1718) or placebo (1696). The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. At 2 years, niacin therapy had significantly increased the median HDL cholesterol level from 35 mg per deciliter (0.91 mmol per liter) to 42 mg per deciliter (1.08 mmol per liter), lowered the triglyceride level from 164 mg per deciliter (1.85 mmol per liter) to 122 mg per deciliter (1.38 mmol per liter), and lowered the LDL cholesterol level from 74 mg per deciliter (1.91 mmol per liter) to 62 mg per deciliter (1.60 mmol per liter). The primary end point occurred in 282 patients in the niacin group (16.4%) and in 274 patients in the placebo group (16.2%) (hazard ratio, 1.02; 95% confidence interval, 0.87 to 1.21; P=0.79 by the log-rank test).
Conclusions
Among patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of less than 70 mg per deciliter (1.81 mmol per liter), there was no incremental clinical benefit from the addition of niacin to statin therapy during a 36-month follow-up period, despite significant improvements in HDL cholesterol and triglyceride levels. (Funded by the National Heart, Lung, and Blood Institute and Abbott Laboratories; AIM-HIGH ClinicalTrials.gov number, NCT00120289.).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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