Estudios primarios incluidos en esta revisión sistemática

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Estudio primario

No clasificado

Effect of metformin and rosiglitazone on lipid metabolism in HIV infected patients receiving protease inhibitor containing HAART.

Revista Acta dermatovenerologica Alpina, Pannonica, et Adriatica
Año 2005
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AIMS: Insulin resistance may be the primary event in the protease inhibitor-associated metabolic syndrome. Treatment with insulin sensitizers (metformin, rosiglitazone) can ameliorate insulin resistance. So far, the effects of these agents on blood lipids have not been well determined. The aim of the present study was to evaluate the effects of metformin and rosiglitazone treatment on lipid metabolism in HIV infected patients receiving protease inhibitors containing HAART. DESIGN AND METHODS: HIV infected male patients (>18 years) were eligible for the study if they had impaired glucose tolerance with insulin resistance, characterized by fasting insulin concentration greater then 20 mIU/L and if they were on stable antiretroviral therapy regimen including a protease inhibitor for at least 12 months prior to the study enrolment. The patients were randomly assigned to receive either 1g/day metformin (metformin group, n=30) or 4 mg/day rosiglitazone maleate (rosiglitazone group, n=30) or no treatment (control group, n=30). The primary efficacy parameters were fasting plasma lipids, glucose levels and fasting insulin levels compared between baseline and week 48, by treatment groups. RESULTS: The total cholesterol concentration in rosiglitazone group increased from 5.76 -/+1.2 to 7.1-/+1.6 mmol/l (23% increase, p<0.05), HDL levels increased from 0.91-/+0.44 to 1.3-/+0.2 (38% increase, p<0.01) and LDL levels increased from 3.5-/+0.98 to 4.5-/+1.0 (28% increase, p<0.05). Treatment with metformin had no significant effect on total, HDL and LDL cholesterol. After 48 weeks of treatment, the fasting triglycerides concentration in the metformin group declined from 4.1-/+1.6 to 3.2-/+1.3 mmol/l (22% decrease,p<0.05) but in the rosiglitazone group no statistically significant effect on plasma triglycerides was noted. Furthermore, after 48 weeks of treatment the fasting insulin concentration in the rosiglitazone group declined by 49% and in the metformin group by 28%. This improvement in insulin secretion could be clearly demonstrated when the sums of insulin concentrations after oral glucose tolerance test were compared: 548-/+13 to 345-/+11.8 mIU/l in the rosiglitazone group (37% decrease, p<0.01) and from 552-/+15 to 420-/+12 mIU/l in the metformin group (24% decrease, p<0.01). CONCLUSIONS: The study demonstrates that both therapies improve insulin resistance. However, treatment with metformin has no effect on total, HDL and LDL cholesterol, but significantly reduces triglycerides, which has beneficial effect on the lipid status in these patients. Rosiglitazone causes significant increases in total cholesterol, HDL and LDL, but has no effect on triglycerides concentrations.

Estudio primario

No clasificado

Sustituyendo abacavir para los inhibidores de la proteasa hiperlipidemia asociada en regímenes TARGA mejora el perfil lipídico en ayunas, mantiene la supresión virológica, y simplifica el tratamiento.

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Revista BMC infectious diseases
Año 2005
Enlaces Pubmed DOI PubMed Central

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ANTECEDENTES: La hiperlipidemia secundaria a inhibidores de la proteasa (PI) puede disminuir por el cambio a medicamentos contra el VIH sin efectos sobre los lípidos. MÉTODO: un ensayo abierto, estudio piloto cambios en comparación al azar en ayunas lípidos y ARN VIH-1 en 104 adultos infectados por el VIH con hiperlipidemia PI-asociado (suero de colesterol total en ayunas> 200 mg / dl) que fueron asignados al azar ya sea a un régimen de que su PI fue reemplazado por abacavir 300 mg dos veces al día (n = 52) o un régimen en el que se continuó su PI (n = 52) durante 28 semanas. Todos los pacientes tenían cargas virales indetectables (VIH-1 ARN <50 copias / ml) al inicio del estudio y eran ingenuos al abacavir y los inhibidores no nucleósidos de la transcriptasa inversa. RESULTADOS: Al inicio del estudio, el colesterol total media fue de 243 mg / dL, la lipoproteína de baja densidad (LDL) -Colesterol 149 mg / dL, la lipoproteína de alta densidad (HDL) 41 mg / dl y los triglicéridos 310 mg / dL. La media de los recuentos de células CD4 + fueron 551 y 531 células / mm3 en los brazos abacavir-switch y PI-continuación, respectivamente. En la semana 28, el brazo de abacavir-switch tuvo significativamente mayor reducción media de mínimos cuadrados desde el inicio en el colesterol total (-42 vs -10 mg / dl, p <0,001), colesterol LDL (-14 vs 5 mg / dl, P = 0,016), y los triglicéridos (-134 vs -36 mg / dl, p = 0,019) que el brazo de PI de continuación, sin diferencias en el colesterol HDL (0,2 vs 1,3 mg / dl, p = 0,583). Una mayor proporción de pacientes en el grupo de abacavir-switch tenido disminuciones en el total de grados de colesterol y triglicéridos de toxicidad de protocolos definidos, mientras que una proporción menor tuvo aumentos en estos grados de toxicidad. En la semana 28, la intención de tratar: falta = análisis de fallos mostró que los brazos abacavir-switch y PI-de continuación no difirieron significativamente con respecto a la proporción de pacientes mantener ARN VIH-1 <400 o <50 copias / ml o ajustado el cambio medio desde la basal en el recuento de células CD4 +. Se registraron dos posibles reacciones de hipersensibilidad relacionadas con abacavir. No se observaron cambios significativos en la glucosa, insulina, resistencia a la insulina, péptido C, o las proporciones de cintura a cadera en cualquiera de los brazos de tratamiento, ni diferencias en estos parámetros entre los tratamientos indicados. CONCLUSIÓN: En pacientes con hiperlipidemia, antirretroviral experimentados con niveles de ARN VIH-1 <50 copias / recuentos de células ml y CD4 +> 500 células / mm3, sustituyendo abacavir para IPs hiperlipidemia asociada en combinación regímenes antirretrovirales mejora los perfiles lipídicos y mantiene la supresión virológica durante un período de 28 semanas, y se simplifica el tratamiento.

Estudio primario

No clasificado

Metabólico beneficia 24 meses después de la sustitución de un inhibidor de la proteasa con abacavir, efavirenz o nevirapina.

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Revista AIDS (London, England)
Año 2005
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OBJETIVO: Evaluar el metabolismo de 24 meses y los beneficios morfológicos obtenidos a partir de la sustitución del inhibidor de la proteasa (IP) en un régimen con nevirapina, efavirenz o abacavir. DISEÑO Y MÉTODOS: NEFA fue un estudio aleatorio diseñado para comparar la eficacia de la nevirapina, efavirenz o abacavir como sustitutos de los PI. Un subconjunto de 90 pacientes [abacavir (n = 29), efavirenz (n = 32), nevirapina (n = 29)] formado el estudio metabólico. El ayuno de colesterol total (CT), colesterol de lipoproteínas de alta densidad (HDL-c) y los niveles de triglicéridos se determinaron. También se recogieron parámetros homeostasis de la glucosa. La lipodistrofia se evaluó mediante el examen clínico y las mediciones morfológicas. RESULTADOS: la simplificación tratamiento dado lugar a mejoras generales del perfil lipídico. A los 24 meses, los dos inhibidores no nucleósidos de la transcriptasa inversa producen beneficios lípidos similares: los niveles de c-HDL aumentó [efavirenz, el 15% (p = 0,001); nevirapina, el 21% (p <0.001)] y TC a las relaciones de HDL-C Bajó [efavirenz, el 14% (p <0,001); nevirapina, 19% (P <0,01)], un efecto no observado en el brazo de abacavir. Niveles de no HDL-c se redujeron en un 10% tanto en el abacavir (p = 0,001) y efavirenz (P <0.05) de armas. Disminuciones significativas en los niveles de triglicéridos se produjeron durante el primer año en todos los tratamientos; sin embargo, a los 24 meses la mayor parte de la pérdida inicial había sido recuperado. Los pacientes con lipodistrofia moderada o grave obtenidos beneficios de lípidos menos pronunciadas de línea de base. Varios marcadores de resistencia a la insulina mostraron una tendencia hacia la mejora. Por el contrario, no se observaron mejoras en anomalías morfológicas. CONCLUSIONES: Sustitución de PI con efavirenz, nevirapina o abacavir mejoraron el perfil lipídico, con más marcados los resultados en los pacientes no lipodystrophic. En contraste, esta estrategia no parece ser eficaz para revertir las anomalías de grasa corporal.

Estudio primario

No clasificado

Substitution of nevirapine or efavirenz for protease inhibitor versus lipid-lowering therapy for the management of dyslipidaemia.

Revista AIDS (London, England)
Año 2005
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OBJECTIVES: To evaluate simplified protease inhibitor (PI)-sparing antiretroviral treatment versus lipid-lowering therapy for the management of highly active antiretroviral therapy (HAART)-induced hyperlipidaemia. DESIGN: Randomized, open-label clinical trial assessing the efficacy on hyperlipidaemia of a switching therapy from PI to non-nucleoside reverse transcriptase inhibitor (NNRTI) nevirapine or efavirenz versus a hypolipidaemic treatment (with pravastatin or bezafibrate) added to current, unchanged antiretroviral combination. METHODS: All HIV-infected patients on their first HAART regimen, with stable immuno-virological features, naive to all NNRTIs, and with mixed hyperlipidaemia, were randomized to replace PI with nevirapine (arm A) or efavirenz (arm B), or to receive pravastatin (arm C) or bezafibrate (arm D) with unchanged HAART regimen, and were followed-up for 12 months. RESULTS: One hundred and thirty patients were evaluated: 29 patients were randomized to arm A, 34 to arm B, 36 to arm C, and 31 to arm D. At the end of the 12-month follow-up, a reduction of 25.2, 9.4, 41.2 and 46.6% in mean triglyceridaemia versus respective baseline values was reported in groups A, B, C and D, respectively, with statistically significant difference between arms A-B and C-D (P < 0.01). Similar results were reported for total and low-density lipoprotein cholesterol levels. Viro-immunological efficacy and tolerability profile were comparable in all considered arms. CONCLUSION: Pravastatin and bezafibrate proved significantly more effective in the management of HAART-related hyperlipidaemia than the switching therapy from PI to nevirapine or efavirenz.

Estudio primario

No clasificado

Fenofibrate improves the atherogenic lipid profile and enhances LDL resistance to oxidation in HIV-positive adults.

Revista Atherosclerosis
Año 2004
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BACKGROUND: Low HDL-cholesterol, hypertriglyceridemia (HTG) and occurrence of small dense LDL could be involved in increased cardiovascular risk in HIV-infected patients. This study evaluates the effects of fenofibrate and/or Vitamin E on lipoprotein profile. DESIGN: Thirty-six HIV-positive adults with fasting triglycerides (TGs) > or =2 mmol/l and stable antiretroviral therapy (ART) were randomly assigned to receive either micronised fenofibrate (200 mg/day) or Vitamin E (500 mg/day) for a first period of 3 months and the association of both for an additional 3-month period. METHODS AND RESULTS: Total cholesterol, HDL-C, LDL-C, triglycerides, apoA1, apoB, apoCIII, lipoprotein composition, LDL size and LDL resistance to copper-induced oxidation were determined before initiation of fenofibrate or Vitamin E, and 3 and 6 months thereafter. Three months of fenofibrate treatment results in a significant decrease in triglycerides (-40%), apoCIII (-21%), total cholesterol (-14%), apoB (-17%) levels, non-HDL-C (-17%), TG/apoA1 ratio in HDL (-27%) associated with an increase in HDL-C (+15%) and apoA1 (+11%) levels. Moreover, fenofibrate increases LDL size and enhances LDL resistance to oxidation. Three months of Vitamin E supplementation only improves LDL resistance to oxidation and addition to fenofibrate results in a slightly greater effect. CONCLUSION: Fenofibrate therapy improves the atherogenic lipid profile in HIV-positive adults with hypertriglyceridemia.

Estudio primario

No clasificado

A 48-week, randomized, open-label comparison of three abacavir-based substitution approaches in the management of dyslipidemia and peripheral lipoatrophy.

Revista Journal of acquired immune deficiency syndromes (1999)
Año 2003
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BACKGROUND: The mechanisms by which dyslipidemia and lipoatrophy develop during antiretroviral therapy are not clear. No treatment of lipoatrophy is currently established. METHODS: This was an open-label randomized study of HIV-positive individuals on a first-line therapy containing stavudine (d4T) with either a protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) and with hypercholesterolemia (defined as total cholesterol >5.2 mmol/L or >180 mg/dL) and/or lipoatrophy and with a viral load of <50 copies/mL. Patients switched d4T to abacavir (ABC) (group 1), a PI or NNRTI to ABC (group 2), or d4T and PI or NNRTI to ABC plus AZT (group 3). Patients were followed-up with fasting blood levels, dual-energy X-ray absorptiometry (DXA), and computed tomography (CT) scans for 48 weeks. RESULTS: Thirty patients were included, with 27 completing 48 weeks of therapy. One ABC hypersensitivity reaction was the only serious adverse event. All patients' viral loads remained at <50 copies/mL. CD4 cell counts rose in groups 2 and 3 but fell modestly in group 1. Total and low-density lipoprotein cholesterol improved significantly in groups 2 and 3. Triglycerides fell significantly in group 2. In contrast, total, arm, and leg fat mass (by DXA) rose significantly in group 1 but fell modestly in groups 2 and 3. Visceral adiposity (by CT scan) was unaffected in all groups. CONCLUSIONS: Abacavir represents a virologically effective replacement for d4T, PI, or NNRTI in persons on successful first-line therapy. Replacement of a PI or NNRTI with ABC leads to modest improvement in both cholesterol and triglycerides. Replacement of d4T with ABC leads to modest improvements in fat mass.

Estudio primario

No clasificado

Statins and fibrates for the treatment of hyperlipidaemia in HIV-infected patients receiving HAART.

Autores Calza L , Manfredi R , Chiodo F
Revista AIDS (London, England)
Año 2003
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OBJECTIVES: The aim of our work is to evaluate the role of statins and fibrates in the management of hyperlipidaemia in HIV-infected patients receiving highly active antiretroviral therapy. DESIGN: Open-label, randomized, prospective study of the efficacy and safety of bezafibrate, gemfibrozil, fenofibrate, pravastatin and fluvastatin as pharmacologic treatment for protease inhibitor-related dyslipidaemia. METHODS: Plasma lipid levels of 656 HIV-infected patients who referred to our tertiary care centre and were on protease inhibitor-based antiretroviral therapy for at least 12 months have been evaluated. All patients had HIV viral load < 50 copies/ml and presented with hypertriglyceridaemia of at least 6 months duration that was unresponsive to a hypolipidaemic diet; all have been treated with bezafibrate, gemfibrozil, fenofibrate, pravastatin, or fluvastatin for 12 months. RESULTS: Of the 656 patients observed 113 (17.2%) received pharmacological therapy, while seven patients were excluded from evaluation due to early drop-out. Of the 106 evaluable subjects, bezafibrate was used in 25 cases, gemfibrozil in 22, fenofibrate in 22, pravastatin in 19, and fluvastatin in 18. At the close of 1-year follow-up, fibrates led to a reduction of 40.7% and 21.9% versus baseline triglyceridaemia and cholesterolaemia, respectively (P < 0.001), and statins led to a reduction of 34.8% and 25.2% versus baseline triglyceride and total cholesterol levels, respectively (P < 0.001), without significant differences according to each different administered hypolipidaemic drug. CONCLUSIONS: All administered statins and fibrates revealed a similar, significant efficacy in the treatment of diet-resistant hyperlipidaemia, and showed a favourable tolerability profile.

Estudio primario

No clasificado

A randomized, double-blind study of gemfibrozil for the treatment of protease inhibitor-associated hypertriglyceridaemia.

Revista AIDS (London, England)
Año 2002
Enlaces Pubmed DOI www.cochranelibrary.com

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BACKGROUND: Hypertriglyceridaemia is common in patients with HIV, especially those taking protease inhibitors or with lipodystrophy, frequently observed at levels associated with accelerated cardiac disease. This study aimed to explore the efficacy and safety of gemfibrozil for hypertriglyceridemia in patients with HIV infection. METHODS: A 16-week, randomized, double-blind, comparative study of low saturated fat diet versus low saturated fat diet with gemfibrozil 600 mg twice daily in patients with triglycerides > or = 3mmol/l receiving protease inhibitor therapy. Following a 4-week period of dietary intervention alone, patients were randomized to gemfibrozil or matching placebo. The primary outcome was the difference in mean change in fasting triglycerides at week 16 between the two groups. RESULTS: 37 men were randomized (17 gemfibrozil, 20 placebo) with median fasting triglycerides 5.6 mmol/l. Mean changes in triglycerides from week 4 to week 16 were -1.22 mmol/l and +0.35 mmol/l for the gemfibrozil and placebo groups respectively (between-group mean difference of 1.57 mmol/l; 95% confidence interval, -6.7 to 3.5; = 0.08). Only one patient treated had triglycerides return to a desirable range (< or = 2.00 mmol/l). No significant changes in the other metabolic parameters were observed. Gemfibrozil was well tolerated, did not appear to induce additional protease inhibitor toxicity, and did not induce changes in CD4 lymphocyte counts or HIV RNA load. CONCLUSIONS: Gemfibrozil is safe and demonstrated at most, modest efficacy for hypertriglyceridemia in HIV-infected patients receiving protease inhibitors. Given the level of response, however, it is unclear whether these reductions will confer clinical benefit, at least in the presence of continued protease inhibitor use.

Estudio primario

No clasificado

Un estudio piloto de la seguridad y eficacia de Cholestin en el tratamiento de la dislipidemia relacionada con el VIH.

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Revista Nutrition (Burbank, Los Angeles County, Calif.)
Año 2002
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OBJETIVO: Se recogieron los datos de seguridad y eficacia preliminares sobre los efectos de Cholestin, un suplemento dietético que contiene estatina, en individuos con dsylipidemia relacionados con el virus de la inmunodeficiencia humana. Métodos: Catorce adultos con dsylipidemia relacionadas con el virus de inmunodeficiencia humana que se caracteriza por hipercolesterolemia, hipertriacilglicerolemia, o ambos participaron en un estudio doble ciego, estudio piloto aleatorizado controlado con placebo en una clínica de la enfermedad infecciosa con sede en un centro médico académico. Los participantes fueron asignados aleatoriamente para recibir 1,2 g de Cholestin dos veces al día (n = 7) o placebo (n = 7) durante 8 semanas. Las principales medidas de resultado fueron la seguridad (pruebas de la función hepática, virus de inmunodeficiencia humana 1 en los niveles plasmáticos de ARN, las células CD4 (+) el recuento de células, efectos adversos) y eficacia (ayuno de colesterol en suero: en total, lipoproteínas de alta y baja densidad, y el ayuno de suero triacilgliceroles). Los resultados de seguridad y eficacia se evaluó a intervalos de 2 y 8 semanas. RESULTADOS: Doce participantes (n = 6 por grupo) completaron el protocolo de tratamiento de 8 semanas. Después de 8 semanas de tratamiento con Cholestin, hubo descensos significativos de referencia en la media (+/- error estándar de la media) en ayunas de colesterol total (-30,8 +/- 8,8 frente a 7,7 +/- 5,6; p = 0,01) y baja colesterol de lipoproteínas de densidad (-32,2 +/- 7,2 frente a 26,3 +/- 14,2; P = 0,01) en comparación con placebo. Por otra parte, la disminución de colesterol total en ayunas fue significativa (-40,2 +/- 4,8 frente a 2,8 +/- 11,9; p = 0,006) después de 2 semanas de la terapia, en cuyo momento el colesterol de las lipoproteínas de baja densidad acercó a la significación (-30,2 + / - 7,4 frente al 4,4 +/- 15,2; p = 0,068). los niveles de colesterol de lipoproteínas de alta densidad y de triglicéridos no cambiaron en cada punto de tiempo. No se observaron efectos adversos con Cholestin. CONCLUSIONES: Cholestin puede con seguridad más baja total y colesterol de lipoproteínas de baja densidad en pacientes con dsylipidemia relacionados con el virus de la inmunodeficiencia humana. Se necesitan ensayos más grandes y de más largo plazo de este enfoque.

Estudio primario

No clasificado

Reversal of atherogenic lipoprotein profile in HIV-1 infected patients with lipodystrophy after replacing protease inhibitors by nevirapine.

Revista AIDS (London, England)
Año 2002
Enlaces Pubmed DOI www.cochranelibrary.com

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BACKGROUND: The widespread use of protease inhibitors (PI) has been associated with abnormalities in the lipid profile of HIV-1-infected patients. Treatment simplification approaches in which PI are replaced by nevirapine (NVP) have been shown to improve PI-related toxicity. OBJECTIVE: To assess the impact on plasma lipids of replacing the PI by NVP in HIV-1 infected patients with lipodystrophy. METHODS: We studied 34 patients with lipodystrophy who had been the first to be enrolled in a prospective, randomized trial of continuing current treatment, or replacing PI with NVP. Sixteen patients replaced their PI with NVP and 18 continued their current PI-containing treatment. Total, low density lipoprotein (LDL), very low density lipoprotein (VLDL), intermediate density lipoprotein and high density lipoprotein (HDL) cholesterol and triglyceride levels, the size and particle number of LDL were determined at baseline and after 24 weeks, by nucleic magnetic resonance spectroscopy. FINDINGS: After 24 weeks of replacing the PI with NVP, we observed a reduction of total cholesterol (P = 0.028), LDL-cholesterol (P = 0.001), the number of circulating LDL particles (P = 0.003) and the VLDL-1 triglyceride level (P = 0.032). A concomitant significant increase was observed in both HDL-cholesterol level (P = 0.002) and HDL particle size (P < 0.001). No significant changes were observed in the group that continued taking the PI. CONCLUSIONS: The replacement of PI by NVP improved the lipid profile both by reducing the number and lipid content of atherogenic LDL particles, and increasing the protective HDL fraction. Although total triglyceride levels remained unchanged, a reduction in the VLDL-1 fraction contributes to the reduction of LDL particles. These changes are expected to reduce the risk of cardiovascular disease in HIV-1-infected patients on highly active antiretroviral therapy.