Effects of treatment with monacolin K, berberine and coenzyme Q10 on lipid metabolism in patients with moderate cardiovascular risk / Efectos del tratamiento con un suplemento nutricional a base de monacolina K, berberina y coenzima Q10 (lipoK®) sobre el metabolismo lipídico en pacientes con hipercolesterolemia y riesgo cardiovascular moderado

Objective The use of nutritional supplements to treat hypercholesterolemia is gradually increasing, however further studies on their efficacy and safety are required. Patients and methods The present clinical trial included patients with moderate hypercholesterolemia and cardiovascular risk who were treated either with a nutraceutical preparation containing 3.75mg of monacolin K, 515mg of berberine and 50mg of coenzyme Q10 per tablet (Lipok®) or with a placebo. The clinical and laboratory variables were analyzed at baseline and at three and six months. None of the patients was diabetic, and none was being treated with lipid-lowering drugs or with any other nutritional supplements affecting lipid metabolism. Results In patients of the intervention group and of the placebo group, baseline LDL-C was 134.7mg/dL (14.4) and 138.7mg/dL (15.2), respectively. At three months after treatment start, LDL-C had decreased by 26.1mg/dL (−32.4 to 19.7) and increased by 4.5mg/dL (−1.5 to 10.5) in the respective groups. In the intervention group, a similar decrease in non-HDL-C and total cholesterol was observed, while no significant changes were observed in either group for HDL-C, triglycerides and lipoprotein(a). A good tolerance and safety profile was observed. Conclusion In conclusion, this study demonstrates that the combination of monacolin K, berberine and coenzyme Q10 is effective and safe for treating hypercholesterolemia in patients with a moderate degree of excess LDL-C and cardiovascular risk (AU)

Objetivo El uso de suplementos nutricionales para tratar la hipercolesterolemia está aumentando de forma progresiva; sin embargo son necesarios más estudios sobre su eficacia y seguridad. Pacientes y métodos En el presente ensayo clínico fueron incluidos pacientes con hipercolesterolemia y riesgo cardiovascular moderados que fueron tratados con un preparado nutracéutico que contenía 3,75mg de monacolina K, 515mg de berberina y 50mg de coenzima Q10 por comprimido (Lipok®) o con placebo. Se analizaron las variables clínicas y de laboratorio en situación basal y a los 3 y 6 meses. Ningún paciente era diabético y ninguno seguía tratamiento con fármacos hipolipidemiantes u otros suplementos nutricionales con efectos sobre el metabolismo lipídico. Resultados En los pacientes del grupo de intervención y del grupo placebo, el c-LDL basal era de 134,7mg/dL (14,4) y 138,7mg/dL (15,2), respectivamente. A los 3 meses de tratamiento el c-LDL había disminuido 26,1mg/dL (de –32,4 a 19,7) y aumentado 4,5mg/dL (de –1,5 a 10,5) en ambos grupos, respectivamente. En el grupo de intervención se observó un descenso similar del c-no HDL y del colesterol total, mientras que no ocurrieron cambios significativos en ninguno de los 2 grupos en el c-HDL, los triglicéridos y la lipoproteína (a). Se observó un buen perfil de tolerancia y seguridad. Conclusión Este estudio demuestra que la combinación de monacolina K, berberina y coenzima Q10 es eficaz y segura para tratar la hipercolesterolemia en los pacientes con un grado de exceso de c-LDL y de riesgo cardiovascular moderados (AU)

Effects of treatment with monacolin K, berberine and coenzyme Q10 on lipid metabolism in patients with moderate cardiovascular risk.

OBJECTIVE: The use of nutritional supplements to treat hypercholesterolemia is gradually increasing, however further studies on their efficacy and safety are required. PATIENTS AND METHODS: The present clinical trial included patients with moderate hypercholesterolemia and cardiovascular risk who were treated either with a nutraceutical preparation containing 3.75mg of monacolin K, 515mg of berberine and 50mg of coenzyme Q10 per tablet (Lipok®) or with a placebo. The clinical and laboratory variables were analyzed at baseline and at three and six months. None of the patients was diabetic, and none was being treated with lipid-lowering drugs or with any other nutritional supplements affecting lipid metabolism. RESULTS: In patients of the intervention group and of the placebo group, baseline LDL-C was 134.7mg/dL (14.4) and 138.7mg/dL (15.2), respectively. At three months after treatment start, LDL-C had decreased by 26.1mg/dL (-32.4 to 19.7) and increased by 4.5mg/dL (-1.5 to 10.5) in the respective groups. In the intervention group, a similar decrease in non-HDL-C and total cholesterol was observed, while no significant changes were observed in either group for HDL-C, triglycerides and lipoprotein(a). A good tolerance and safety profile was observed. CONCLUSION: In conclusion, this study demonstrates that the combination of monacolin K, berberine and coenzyme Q10 is effective and safe for treating hypercholesterolemia in patients with a moderate degree of excess LDL-C and cardiovascular risk.

Advances of the contemporary treatment of hypertension and hypercholesterolemia by a new fixed combination.

Parallel occurrence of high blood pressure and high plasma cholesterol level is very frequent, in our population in 30 %, and brings multiplicative higher risk for atherosclerotic cardiovascular diseases. On the other hand the contemporary treatment of them reduces that risk synergically. New fixed combination pill of rosuvastatin and ramipril (Kastel) is very felicitous choice for patients with hypercholesterolemia and mild hypertension, in which two antihypertensive drugs are not required immediatelly.

[New agents for hypercholesterolemia]. / Nuevos tratamientos para la hipercolesterolemia.

An elevated proportion of high cardiovascular risk patients do not achieve the therapeutic c-LDL goals. This owes to physicians' inappropriate or insufficient use of cholesterol lowering medications or to patients' bad tolerance or therapeutic compliance. Another cause is an insufficient efficacy of current cholesterol lowering drugs including statins and ezetimibe. In addition, proprotein convertase subtilisin kexin type 9 inhibitors are a new cholesterol lowering medications showing safety and high efficacy to reduce c-LDL in numerous already performed or underway clinical trials, potentially allowing an optimal control of hypercholesterolemia in most patients. Agents inhibiting apolipoprotein B synthesis and microsomal transfer protein are also providing a new potential to decrease cholesterol in patients with severe hypercholesterolemia and in particular in homozygote familial hypercholesterolemia. Last, cholesteryl ester transfer protein inhibitors have shown powerful effects on c-HDL and c-LDL, although their efficacy in cardiovascular prevention and safety has not been demonstrated yet. We provide in this article an overview of the main characteristics of therapeutic agents for hypercholesterolemia, which have been recently approved or in an advanced research stage.

Pravastatina: eficácia e segurança em hipercolesterolêmicos primários idosos: estudo multicêntrico aberto / Pravastatin: Efficacy and Sofety in Hypercholesterolemic Elderly Patients. Multicenter Open Study

PURPOSE--To analyze the response of hypercholesterolemic elderly patients to pravastatin. METHODS--Two hundred and sixty six primary hypercholesterolemics, 65 to 80 years of age, after ingesting a standard diet for four weeks, received 10mg of pravastatin for 12 weeks. RESULTS--Average reductions of 24 per cent or more were observed for TC and LDL-C, and more than 60 per cent of those reductions were considered good or excellent (above 20 per cent ). Increases in HDL-C (6.6 per cent ) and the reduction of TG (21.2 per cent ) were significant. Patients 65 to 70 years old compared to patients 71 to 80 years old did not show significant response differences, however, the 71 to 80 year old patients had smaller reductions in TC and LDL-C but greater increases in HDL-C. The drug was very well tolerated, with an incidence of adverse events of only 10.5 per cent , none of which resulted in the discontinuation of drug administration. There were significant increases in hepatic enzymes (SGOT and SGTP), however the variations did not have clinical significance. For CK changes were not significant. CONCLUSION--Primary hypercholesterolemic elderly seem to respond to pravastatin in a similar way as middle age patients. The effects on the lipid fractions are significant, adverse effects are rare and the drug is very well tolerated. Thus it should be considered a first line hypolipidemic drug

Avaliação da eficácia e segurança da pravastatina em portadores de hipercolesterolemia primária: estudo aberto multicêntrico brasileiro / An evaluation of the efficacy and safety of pravastatin in patients with primary hypercholesterolemia: a Brazilian open multicenter study

Objetivo - Avaliar a resposta terapêutica e a segurança da pravastatina em portadores de hipercolesterolemia primária. Casuística e Métodos - 1.850 pacientes com hipercolesterolemia primária da clínica privada ou ambulatorial foram submetidos após quatro semanas de dieta padronizada, a tratamento com 10mg de pravastatina uma vez ao dia por período de 12 semanas. Resultados - Reduções médias superiores a 25%foram observadas para colesterolemia total e para LDL-C, sendo que individualmente elas foram consideradas ótimas e boas (diminuições superiores a 20%) em aproximadamente 70% dos pacientes. Também foram observadas elevações importantes superiores a 10% de HDL-C em 51% dos pacientes. A aderência à droga foi excelente, pois somente 118 (6,4%) apresentaram distúrbios clínicos atribuíveis ao uso do medicamento, mas a sua interrupção só foi necessária em 18 (0, 9°/0), dos quais 9 por queixas musculares, 3 por sintomas digestivos, 2 por manifestações cutâneas e 4 por manifestações gerais. Não houve interferência de condições clínicas (diabetes melito, obesidade, hipertensão arterial) na resposta hipolipemiante. A resposta a pravastatina não foi estatisticamente diferente, independente de um tratamento antilipêmico prévio. Pacientes responsivos ou não a esquemas terapêuticos prévios responderam igualmente a pravastatina. Conclusão - Considerando os efeitos expressivos sobre adversos e facilidade de utilização, a pravastatina entra como droga de primeira linha no arsenal terapêutico hipolipemiante

Purpose: To evaluate the efficacy and safety of pravastatin in patients with primary hypercholesterolemia Patients and Methods: In an open-label multicenter uncontrolled study under the usual conditions of clinical practice 1,850 patients with primary hypercholesterolemia were submitted, after one month of placebo control and low fat/low cholesterol diet, to 12 weeks of treatment with pravastatin 10mg o.d. Results: Significant reductions higher than 25% were obtained in plasma levels of total cholesterol and low density lipoprotein (LDL) cholesterol associated with an increase > 10% in the HDL cholesterol plasma concentration in 51% of the patients. The individual results were classified as satisfactory (higher than 20% decrease) in 70% of the studied population. The compliance of pravastatin was excellent, since 118 patients (6.4%) developed adverse reactions, but interruption of the treatment was necessary in only 18 (0.9%); 9 patients due to muscular pain, 3 by gastrointestinal symptoms, 2 by cutaneous reactions and 4 due to general complaints.The clinical conditions of diabetes, obesity, hypertension did not modify the efficacy of the drug. Previousinsatisfactory hypolipidemic treatment did not alter the results of the efficacy. Conclusion: The satisfactory results in efficacy and safety and the facility of the pravastatin use, make this drug as afirst line agent in the hypolipidemic treatment