Financiado en parte por Abbott Laboratories, Amgen, Bristol-Myers Squibb, Pfizer, AstraZeneca, GlaxoSmithKline, Gilead Sciences, Alnylam Pharmaceuticals, Intarcia Therapeutics, Amarin Corporation, MyoKardia, Daiichi-Sankyo, Eisai, Esperion Therapeutics, Janssen Research and Development, Daiichi Sankyo Europe
Efficacy and Safety of Further Lowering of Low-Density Lipoprotein Cholesterol in Patients Starting With Very Low Levels: A Meta-analysis
Sabatine MS, Wiviott SD, Im K, Murphy SA, Giugliano RP
JAMA cardiology · 161 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Metaanálisis (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
- Amgen
- Empresa
- Bristol-Myers Squibb
- Empresa
- Pfizer
- Empresa
- AstraZeneca
- Empresa
- GlaxoSmithKline
- Empresa
- Gilead Sciences
- Empresa
- Alnylam Pharmaceuticals
- Empresa
- Intarcia Therapeutics
- Empresa
- Amarin Corporation
- Empresa
- MyoKardia
- Empresa
- Daiichi-Sankyo
- Empresa
- Eisai
- Empresa
- Esperion Therapeutics
- Empresa
- Janssen Research and Development
- Empresa
- Daiichi Sankyo Europe
Según 16 financiadores declarados.
Publicación
- Publicado
- 2018-08-01 · JAMA Cardiol · vol. 3 · número 9 · pág. 823
- Editorial
- American Medical Association
- Citado
- 204 citas · más que el 100% de estudios similares · 22.9× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 18 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Diabetes, Cardiovascular Risks, and Lipoproteins · Acute Myocardial Infarction Research
- Palabras clave
- LDL cholesterol lowering, very low LDL-C, major vascular events, statins, non-statin lipid-lowering therapy, cardiovascular risk, coronary artery disease, ischemic stroke, myocardial infarction, coronary revascularization, hypercholesterolemia
- MeSH
- humans, cardiovascular diseases, anticholesteremic agents, hydroxymethylglutaryl-coa reductase inhibitors, treatment outcome, drug therapy, combination, double-blind method, cholesterol, ldl, randomized controlled trials as topic, hypolipidemic agents
5 autores
- Marc Steven Sabatine🇺🇸 · autor de correspondenciaBrigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Stephen D. Wiviott🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- KyungAh Im🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Sabina A. Murphy🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
- Robert Patrick Giugliano🇺🇸Brigham and Women's Hospital; Harvard University; Thrombolysis in Myocardial Infarction Study Group
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
In the Cholesterol Treatment Trialists Collaboration (CTTC), in patients starting with low-density lipoprotein cholesterol (LDL-C) levels of approximately 3.4 mmol/L (131.5 mg/dL), there was a 22% reduction in major vascular events per 1-mmol/L (38.7-mg/dL) lowering of LDL-C. The magnitude of clinical benefit of further LDL-C lowering in patients already with very low LDL-C levels remains debated.
Objective
To evaluate efficacy and safety of further lowering LDL-C levels in patient populations presenting with median LDL-C levels of 1.8 mmol/L (70 mg/dL) or less.
Data sources and study selection
The CTTC was used for statin data. For nonstatin therapy, Medline database was searched (2015-April 2018). Key inclusion criteria were a randomized, double-blind, controlled cardiovascular outcome trial of LDL-C lowering with data in populations starting with LDL-C levels averaging 1.8 mmol/L (70 mg/dL) or less.
Data extraction and synthesis
Two authors independently extracted data into standardized data sheets, and data were analyzed using meta-analysis.
Main outcomes and measures
The risk ratio (RR) of major vascular events (a composite of coronary heart death, myocardial infarction, ischemic stroke, or coronary revascularization) per 1-mmol/L (38.7-mg/dL) reduction in LDL-C level.
Results
In the subgroup of patients from the CTTC meta-analysis of statins with a mean LDL-C in the control arm of 1.7 mmol/L (65.7 mg/dL), 1922 major vascular events occurred and the RR for major vascular events per 1-mmol/L (38.7-mg/dL) reduction in LDL-C was 0.78 (95% CI, 0.65-0.94). For 3 trials of nonstatin LDL-C-lowering therapies added to statins, there were 50 627 patients, the median LDL-C in the control arms ranged from 1.6 mmol/L to 1.8 mmol/L (63 mg/dL to 70 mg/dL), and 9570 major vascular events occurred. Nonstatin therapy lowered LDL-C by 0.3 to 1.2 mmol/L (11 mg/dL to 45 mg/dL), and the RR for major vascular events per 1-mmol/L (38.7-mg/dL) reduction in LDL-C was 0.79 (95% CI, 0.70-0.88). For statins and nonstatins combined, the RR was 0.79 (95% CI, 0.71-0.87; P < .001). Low-density lipoprotein cholesterol lowering was not associated with an increased risk of serious adverse events, myalgias and/or myositis, elevation in the level of aminotransferases, new-onset diabetes, hemorrhagic stroke, or cancer.
Conclusions and relevance
There is a consistent relative risk reduction in major vascular events per change in LDL-C in patient populations starting as low as a median of 1.6 mmol/L (63 mg/dL) and achieving levels as low as a median of 0.5 mmol/L (21 mg/dL), with no observed offsetting adverse effects. These data suggest further lowering of LDL-C beyond the lowest current targets would further reduce cardiovascular risk.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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