Randomized study of the safety and efficacy of fish oil (omega-3 fatty acid) supplementation with dietary and exercise counseling for the treatment of antiretroviral therapy-associated hypertriglyceridemia
Wohl DA, Tien HC, Busby M, Cunningham C, Macintosh B, Napravnik S, Danan E, Donovan K, Hossenipour M, Simpson RJ
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 73 citas
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 independiente
- Organización sin fines de lucro
- American Heart Association
- Gobierno
- National Institutes of Health
- Gobierno
- National Institute of Allergy and Infectious Diseases
- Gobierno
- National Center for Research Resources
- Universidad u hospital
- School of Medicine, University of North Carolina at Chapel Hill
- Gobierno
- NIAID NIH HHS
- Gobierno
- NCRR NIH HHS
- Subvenciones
- National Center for Research Resources (RR00046); National Institute of Allergy and Infectious Diseases (5 U01 AI25868-17); National Institute of Allergy and Infectious Diseases (AI50410-04)
Según 7 financiadores declarados.
Publicación
- Publicado
- 2005-10-19 · Clin Infect Dis · vol. 41 · número 10 · págs. 1498–1504
- Editorial
- Oxford University Press
- Citado
- 118 citas · más que el 98% de estudios similares · 8.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 34 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Fatty Acid Research and Health · HIV-related health complications and treatments · Lipoproteins and Cardiovascular Health
- Palabras clave
- omega-3 fatty acids, fish oil supplementation, hypertriglyceridemia, antiretroviral therapy, HIV, nutrition counseling, physical activity counseling, fasting triglycerides, LDL cholesterol, lipid-lowering therapy, drug-induced dyslipidemia, safety and tolerability, cardiovascular risk reduction, dyslipidemia management
- MeSH
- humans, hiv infections, insulin resistance, hypertriglyceridemia, blood glucose, fatty acids, omega-3, fish oils, anti-hiv agents, body mass index, exercise, diet, patient compliance, adult, middle aged, female, male, hypolipidemic agents
10 autores
- David Alain Wohl🇺🇸 · autor de correspondenciaUniversity of North Carolina at Chapel Hill
- H.-C. Tien🇺🇸University of North Carolina at Chapel Hill
- Marjorie G. Busby🇺🇸University of North Carolina at Chapel Hill
- C. Cunningham
- Beth MacIntosh🇺🇸University of North Carolina at Chapel Hill
- Sonia Napravnik
- Elisheva R. Danan
- K Donovan🇺🇸University of North Carolina at Chapel Hill
- M. Hossenipour
- Ross J. Simpson🇺🇸University of North Carolina at Chapel Hill
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Omega-3 fatty acids (fish oils) reduce fasting serum triglyceride levels and cardiovascular disease risk in individuals without HIV infection. Whether omega-3 fatty acid supplementation can reduce hypertriglyceridemia associated with antiretroviral therapy is not known.
Methods
We conducted an open-label, randomized trial that enrolled 52 patients receiving > or =3 active antiretrovirals who had fasting triglyceride levels of >200 mg/dL and were randomized to receive nutritionist-administered dietary and exercise counseling with or without fish oil supplementation for 16 weeks.
Results
Patients assigned to receive fish oil experienced a 25% mean decline in fasting triglyceride levels at week 4 (95% CI, -34.6% to -15.7% change), compared with a 2.8% mean increase among patients assigned to receive counseling alone (95% CI, -17.5% to +23.1% change) (P=.007). By week 16, the mean reduction in triglyceride levels in the fish oil arm remained significant, at 19.5% (95% CI, -34.9% to -4.0% change), whereas the mean decrease in the diet and exercise only arm was 5.7% (95% CI, -24.6% to +13.2% change); however, the difference between study arms was no longer statistically significant (P=.12). Low-density lipoprotein cholesterol levels had increased by 15.6% (95% CI, +4.8% to +26.4% change) at week 4 and by 22.4% (95% CI, +7.91% to +36.8% change) at week 16 in the fish oil arm but did not change in the diet and exercise only group. Fish oil was well tolerated; only 1 patient experienced treatment-limiting toxicity. Patients assigned to receive fish oil experienced a 25% mean decline in fasting triglyceride levels at week 4 (95% CI, -34.6% to -15.7% change), compared with a 2.8% mean increase in patients assigned to receive counseling alone (95% CI, -17.5% to 23.1% change) (P=.007). By week 16, the mean reduction in triglyceride levels in the fish oil arm remained significant, at 19.5% (95% CI, -34.9% to -4.0% change), whereas the mean decrease in the diet and exercise only arm was 5.7% (95% CI, -24.6% to 13.2% change); however, the difference between study arms was no longer statistically significant (P=.12). Low-density lipoprotein cholesterol levels had increased by 15.6% (95% CI, 4.8%-26.4% change) at week 4 and by 22.4% (95% CI, 7.91%-36.8% change) at week 16 in the fish oil arm but did not change in the diet and exercise only group. Fish oil was well tolerated; only 1 patient experienced treatment-limiting toxicity.
Conclusions
Supplementation with omega-3 fatty acids in combination with dietary and exercise counseling was well tolerated and reduced fasting triglyceride levels in patients receiving antiretrovirals. To what extent the increase in low-density lipoprotein cholesterol levels observed in patients assigned this intervention is attributable to omega-3 fatty acid supplementation and whether this increase attenuates any benefit in lowering triglyceride levels is unclear. Given these results, further investigation of omega-3 fatty acid supplementation for the treatment of hypertriglyceridemia in HIV-infected patients is warranted.
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