Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, double-blind, placebo-controlled study
Davidson MH, Stein EA, Bays HE, Maki KC, Doyle RT, Shalwitz RA, Ballantyne CM, Ginsberg HN, COMBination of prescription Omega-3 with Simvastatin (COMBOS) Investigators
Clinical therapeutics · 263 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2007-07-01 · Clin Ther · vol. 29 · número 7 · págs. 1354–1367
- Editorial
- Elsevier BV
- Citado
- 385 citas · más que el 100% de estudios similares · 37.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 37 trabajos
- Acceso
- De pago
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Fatty Acid Research and Health · Lipid metabolism and disorders
- Palabras clave
- hypertriglyceridemia, omega-3 fatty acids, simvastatin, combination therapy, non-HDL cholesterol, triglycerides, VLDL cholesterol, LDL cholesterol, statin therapy, NCEP ATP III criteria, tolerability, efficacy, nutrition counseling, dyslipidemia
- MeSH
- humans, hypertriglyceridemia, simvastatin, docosahexaenoic acids, eicosapentaenoic acid, drug combinations, hydroxymethylglutaryl-coa reductase inhibitors, drug therapy, combination, double-blind method, middle aged, female, male
8 autores
- Michael H. Davidson🇺🇸 · autor de correspondenciaRadiant Research (United States)
- Evan A. Stein
- Harold Edward Bays🇺🇸Louisville Metabolic and Atherosclerosis Research Center
- Kevin Carl Maki🇺🇸Indiana University
- Ralph T. Doyle
- Robert A. Shalwitz
- Christie Mitchell Ballantyne🇺🇸Baylor College of Medicine
- Henry N. Ginsberg🇺🇸Columbia University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Patients with elevated serum triglyceride (TG) levels often have elevations in non-high-density lipoprotein cholesterol (non-HDL-C) levels as well. The National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) has identified non-HDL-C as a secondary therapeutic target in these patients, but treatment goals may not be reached with statin monotherapy alone.
Objective
This study evaluated the effects on non-HDL-C and other variables of adding prescription omega-3-acid ethyl esters (P-OM3; Lovaza, formerly Omacor [Reliant Pharmaceuticals, Inc., Liberty Corner, New Jersey]) to stable statin therapy in patients with persistent hypertriglyceridemia.
Methods
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study in adults who had received > or = 8 weeks of stable statin therapy and had mean fasting TG levels > or = 200 and < 500 mg/dL and mean low-density lipoprotein cholesterol levels < or = 10% above their NCEP ATP III goal. The study regimen consisted of an initial 8 weeks of open-label simvastatin 40 mg/d and dietary counseling, followed by 8 weeks of randomized treatment with double-blind P-OM3 4 g/d plus simvastatin 40 mg/d or placebo plus simvastatin 40 mg/d. The main outcome measure was the percent change in non-HDL-C from baseline to the end of treatment.
Results
The evaluable population included 254 patients, of whom 57.5% (146) were male and 95.7% (243) were white. The mean (SD) age of the population was 59.8 (10.4) years, and the mean weight was 92.0 (19.6) kg. At the end of treatment, the median percent change in non-HDL-C was significantly greater with P-OM3 plus simvastatin compared with placebo plus simvastatin (-9.0% vs -2.2%, respectively; P or= 1% of patients in the P-OM3 group that occurred with a higher frequency than in the group that received simvastatin alone were nasopharyngitis (4 [3.3%]), upper respiratory tract infection (4 [3.3%]), diarrhea (3 [2.5%]), and dyspepsia (3 [2.5%]). There was no significant difference in the frequency of AEs between groups. No serious AEs were considered treatment related.
Conclusion
In these adult, mainly white patients with persistent hypertriglyceridemia, P-OM3 plus simvastatin and dietary counseling improved non-HDL-C and other lipid and lipoprotein parameters to a greater extent than simvastatin alone.
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