Efectividad de la combinación de atorvastatina 10 mg más ezetimiba en el control de la hipercolesterolemia en atención primaria / Effectiveness of the combination of atorvastatin 10 mg plus ezetimibe in controlling hypercholesterolemia in primary care

Objetivos. Analizar la efectividad de atorvastatina 10 mg combinada con ezetimiba respecto a atorvastatina en altas dosis para el tratamiento de la hipercolesterolemia en pacientes de alto riesgo cardiovascular en atención primaria. Pacientes y método. Estudio transversal retrospectivo, de intervención en condiciones de uso habitual en pacientes hipercolesterolémicos con alto riesgo cardiovascular (diabéticos tipo II o postinfarto de miocardio y cifras de colesterol de las lipoproteínas de baja densidad [cLDL] > 100 mg/dl). Se incluyó un total de 102 pacientes (el 44,8% varones) con una media ± desviación estándar de edad de 60,9 ± 9,4 años. Un 61,4% eran diabéticos, el 52,1% había tenido episodio de cardiopatía isquémica. Recibieron tratamiento con atorvastatina 10 mg + ezetimiba 49 pacientes y 53 recibieron atorvastatina 40 mg/día durante 4 meses. Resultados. El cLDL, el colesterol total y los triglicéridos se redujeron significativamente con ambos tratamientos, si bien la combinación de ambos tratamientos redujo más rápidamente los parámetros lipídicos (2 meses; p < 0,05) que atorvastatina en altas dosis; a los 4 meses hubo reducciones de cLDL del 35,42% con la combinación de la estatina con ezetimiba y del 25,69% con la estatina sola; la reducción del cLDL fue de 57,58 ± 27,83 mg/dl y 58,33 ± 14,22 mg/dl a los 2 y 4 meses, respectivamente, con la combinación, frente a 16,4 ± 22,62 mg/dl y 40,14 ± 10,8 mg/dl con atorvastatina en altas dosis. A los 4 meses alcanzaron los objetivos terapéuticos de control de cLDL de acuerdo con las recomendaciones de la Adaptación Española de la Guía Europea de Prevención Cardiovascular de 2004 un 60,4% de los tratados con la combinación de fármacos y un 51,5% de los tratados con atorvastatina. Conclusiones. Ambos tratamientos se han mostrado efectivos en reducir las cifras de colesterol. Sin embargo, la combinación de atorvastatina en dosis de 10 mg y ezetimiba ha sido más efectiva y rápida que atorvastatina sola en altas dosis (AU)

Objectives. To analyze the effectiveness of atorvastatin 10 mg plus ezetimibe versus high-dose atorvastatin in the treatment of hypercholesterolemia in patients with high cardiovascular risk in primary care. Patients and method. We performed a retrospective, cross-sectional study of an intervention performed under conditions of normal use in hypercholesterolemic patients with high cardiovascular risk (type II diabetes or postmyocardial infarction and low density lipoprotein cholesterol [LDLc] values > 100 mg/dl). A total of 102 patients (44.8% men) with a mean age ± standard deviation of 60.9 ± 9.4 years were included. Of these, 61.4% were diabetic and 52.1% had had an episode of ischemic heart disease. Forty-nine patients received treatment with atorvastatin 10 mg plus ezetimibe and 53 received atorvastatin 40 mg/day for 4 months. Results. Values of LDLc, total cholesterol (TC) and triglycerides were significantly reduced with both treatments. However, the combined treatments produced a more rapid reduction in lipid parameters (2 months; p < 0.05) than did high-dose atorvastatin. At 4 months, a reduction in LDLc of 35.42% was found for the combination of atorvastatin plus ezetimibe versus 25.69% with atorvastatin alone; at 2 and 4 months, LDLc was reduced by 57.58 ± 27.83 mg/dl and 58.33 ± 14.22 respectively with the combined treatment compared with a decrease of 16.4 ± 22.62 and 40.14 ± 10.8 mg/dl with high-dose atorvastatin. At 4 months, the therapeutic targets for LDLc control, based on the recommendations of the Spanish adaptation of the European Guidelines on Cardiovascular Disease Prevention of 2004, had been achieved by 60.4% of patients receiving the combined treatment and by 51.5% of those treated with atorvastatin. Conclusions. Both treatments were effective in reducing cholesterol values. However, atorvastatin 10 mg and ezetimibe were faster and more effective than high-dose atorvastatin alone (AU)

A pharmacoeconomic evaluation of statins in the treatment of hypercholesterolaemia in the primary care setting in Spain.

BACKGROUND: Cardiovascular disease is one of the leading causes of death and it has been shown that primary prevention with the HMG-CoA reductase inhibitor (statin) lipid-lowering drugs can reduce cardiovascular events. Acquisition costs vary between statins and this may be an important consideration in the overall cost effectiveness (CE) of different options. OBJECTIVE: To perform a CE study of the main statins used in Spain for primary prevention of cardiovascular disease in patients with high cholesterol levels [corrected] STUDY DESIGN: The CE analysis was based on an open-label, prospective, naturalistic, randomised intervention study under usual care conditions in primary care settings in patients with high cholesterol levels (total cholesterol [TC] >240 mg/dL, low-density lipoprotein cholesterol [LDL-C] >160 mg/dL) and one or more cardiovascular risk factors. The analysis was conducted from the perspective of the Spanish National Health System; the year of costing was 2001. PATIENTS: A total of 161 patients (49.7% males), mean age 65 +/- 10.3 years, without evidence of cardiovascular disease were included in the study. Of those, 82.1% were hypertensive, 37.1% had diabetes mellitus and 17.9% were smokers. INTERVENTIONS: Forty-eight patients received oral atorvastatin 10 mg/day, 32 received fluvastatin 40 mg/day, 44 received simvastatin 20 mg/day and 37 patients received pravastatin 20 mg/day for 6 months. MAIN MEASUREMENTS AND RESULTS: After 6 months, the therapeutic goals of LDL-C control, according to the recommendations of the Spanish Society of Arteriosclerosis--Consensus-2000, were reached in 62.5%, 43.8%, 45.5% and 40.5% of patients treated with atorvastatin, fluvastatin, simvastatin and pravastatin, respectively. The average CE ratio, expressed as the cost in euros (euro) per patient achieving the therapeutic goals, was euros 424.3 for atorvastatin, euros 503.5 for fluvastatin, euros 527.0 for simvastatin and euros 683.4 for pravastatin. The incremental CE ratios for atorvastatin versus fluvastatin and simvastatin were euros 238.9 and euros 149.5, respectively, per additional patient reaching therapeutic goals. Atorvastatin, fluvastatin and simvastatin all dominated pravastatin. CONCLUSIONS: All the statins studied have been shown to be effective for reducing both TC and LDL-C levels. In this study, atorvastatin was the most efficient drug, with the best CE ratio (cost per patient reaching therapeutic goals). Atorvastatin was more effective and less costly than pravastatin, and when compared with fluvastatin or simvastatin the additional cost per additional patient achieving therapeutic goals was