Effects of extended-release niacin with laropiprant in high-risk patients
HPS2-THRIVE Collaborative Group, Landray MJ, Haynes R, Hopewell JC, Parish S, Aung T, Tomson J, Wallendszus K, Craig M, Jiang L, Collins R, Armitage J
The New England journal of medicine · 1,189 citas
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
- Financiación independiente
- Universidad u hospital
- Harbin Medical University
- Universidad u hospital
- Second Affiliated Hospital of Harbin Medical University
- Organización sin fines de lucro
- Cancer Research UK
- Gobierno
- National Institute for Health and Care Research
- Organización sin fines de lucro
- British Heart Foundation
- Universidad u hospital
- Tongji University
- Universidad u hospital
- Zhengzhou University
- Universidad u hospital
- Qingdao University
- Universidad u hospital
- First Affiliated Hospital of Zhengzhou University
- Gobierno
- National Institute for Health Research (NIHR)
- Gobierno
- Medical Research Council
- Subvenciones
- British Heart Foundation (RE/08/004); National Institute for Health and Care Research (CDF-2013-06-012)
Según 11 financiadores declarados.
Publicación
- Publicado
- 2014-07-11 · N Engl J Med · vol. 371 · número 3 · págs. 203–212
- Editorial
- Massachusetts Medical Society
- Citado
- 1,673 citas · más que el 100% de estudios similares · 190.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 33 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Antiplatelet Therapy and Cardiovascular Diseases · Cholesterol and Lipid Metabolism
- Palabras clave
- extended-release niacin, laropiprant, LDL cholesterol lowering, HDL cholesterol, major vascular events, secondary prevention, vascular disease, statin therapy, diabetes management, adverse events, cardiovascular risk reduction, lipid-lowering therapy, coronary artery disease, stroke, myocardial infarction, arterial revascularization, infection risk
- MeSH
- humans, musculoskeletal diseases, diabetes mellitus, hypercholesterolemia, hemorrhage, niacin, indoles, delayed-action preparations, drug combinations, hydroxymethylglutaryl-coa reductase inhibitors, treatment failure, risk factors, follow-up studies, double-blind method, aged, middle aged, female, male, atherosclerosis, cholesterol, ldl, hypolipidemic agents, infections
1 autor
- The HPS2-THRIVE Collaborative Group · autor de correspondencia
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Patients with evidence of vascular disease are at increased risk for subsequent vascular events despite effective use of statins to lower the low-density lipoprotein (LDL) cholesterol level. Niacin lowers the LDL cholesterol level and raises the high-density lipoprotein (HDL) cholesterol level, but its clinical efficacy and safety are uncertain.
Methods
After a prerandomization run-in phase to standardize the background statin-based LDL cholesterol-lowering therapy and to establish participants' ability to take extended-release niacin without clinically significant adverse effects, we randomly assigned 25,673 adults with vascular disease to receive 2 g of extended-release niacin and 40 mg of laropiprant or a matching placebo daily. The primary outcome was the first major vascular event (nonfatal myocardial infarction, death from coronary causes, stroke, or arterial revascularization).
Results
During a median follow-up period of 3.9 years, participants who were assigned to extended-release niacin-laropiprant had an LDL cholesterol level that was an average of 10 mg per deciliter (0.25 mmol per liter as measured in the central laboratory) lower and an HDL cholesterol level that was an average of 6 mg per deciliter (0.16 mmol per liter) higher than the levels in those assigned to placebo. Assignment to niacin-laropiprant, as compared with assignment to placebo, had no significant effect on the incidence of major vascular events (13.2% and 13.7% of participants with an event, respectively; rate ratio, 0.96; 95% confidence interval [CI], 0.90 to 1.03; P=0.29). Niacin-laropiprant was associated with an increased incidence of disturbances in diabetes control that were considered to be serious (absolute excess as compared with placebo, 3.7 percentage points; P<0.001) and with an increased incidence of diabetes diagnoses (absolute excess, 1.3 percentage points; P<0.001), as well as increases in serious adverse events associated with the gastrointestinal system (absolute excess, 1.0 percentage point; P<0.001), musculoskeletal system (absolute excess, 0.7 percentage points; P<0.001), skin (absolute excess, 0.3 percentage points; P=0.003), and unexpectedly, infection (absolute excess, 1.4 percentage points; P<0.001) and bleeding (absolute excess, 0.7 percentage points; P<0.001).
Conclusions
Among participants with atherosclerotic vascular disease, the addition of extended-release niacin-laropiprant to statin-based LDL cholesterol-lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events. (Funded by Merck and others; HPS2-THRIVE ClinicalTrials.gov number, NCT00461630.).
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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