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Ensayo controlado aleatorizado1990

Regression of coronary artery disease as a result of intensive lipid-lowering therapy in men with high levels of apolipoprotein B

Brown G, Albers JJ, Fisher LD, Schaefer SM, Lin JT, Kaplan C, Zhao XQ, Bisson BD, Fitzpatrick VF, Dodge HT

The New England journal of medicine · 1,347 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Eventos clínicos como enfermedad o muerte

Quién lo pagó

Financiación
Financiación independiente
Gobierno
National Heart, Lung, and Blood Institute
Gobierno
National Center for Research Resources
Gobierno
NCRR NIH HHS
Gobierno
NHLBI NIH HHS
Subvenciones
National Heart, Lung, and Blood Institute (R01 HL 19451); National Center for Research Resources (RR 37); National Heart, Lung, and Blood Institute (P01 HL-30086)

Según 4 financiadores declarados.

Publicación

Publicado
1990-11-08 · N Engl J Med · vol. 323 · número 19 · págs. 1289–1298
Editorial
Massachusetts Medical Society
Citado
2,153 citas · más que el 100% de estudios similares · 184.4× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
53 trabajos
Acceso
Lectura gratuita
Áreas de investigación
Lipoproteins and Cardiovascular Health · Cholesterol and Lipid Metabolism · Atherosclerosis and Cardiovascular Diseases
Palabras clave
coronary artery disease, apolipoprotein B, intensive lipid-lowering therapy, lovastatin, nicotinic acid, colestipol, LDL cholesterol, HDL cholesterol, systolic blood pressure, cardiovascular events, revascularization, myocardial infarction, mortality, nutrition counseling
MeSH
humans, coronary disease, colestipol, niacin, lovastatin, apolipoproteins b, coronary angiography, drug therapy, combination, diet, multivariate analysis, double-blind method, adult, middle aged, male, cholesterol, ldl, cholesterol, hdl

10 autores

  • Greg Brown🇺🇸University of Washington
  • John J. Albers🇺🇸University of Washington
  • Lloyd D. Fisher🇺🇸University of Washington
  • Susan M. Schaefer
  • Jiin-Tarng Lin
  • Cheryl Kaplan🇺🇸University of Washington
  • Xue-Qiao Zhao
  • Brad Bisson
  • Virginia Fitzpatrick🇺🇸University of Washington
  • Harold T. Dodge

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background and methods

The effect of intensive lipid-lowering therapy on coronary atherosclerosis among men at high risk for cardiovascular events was assessed by quantitative arteriography. Of 146 men no more than 62 years of age who had apolipoprotein B levels greater than or equal to 125 mg per deciliter, documented coronary artery disease, and a family history of vascular disease, 120 completed the 2 1/2-year double-blind study, which included arteriography at base line and after treatment. Patients were given dietary counseling and were randomly assigned to one of three treatments: lovastatin (20 mg twice a day) and colestipol (10 g three times a day); niacin (1 g four times a day) and colestipol (10 g three times a day); or conventional therapy with placebo (or colestipol if the low-density lipoprotein [LDL] cholesterol level was elevated).

Results

The levels of LDL and high-density lipoprotein (HDL) cholesterol changed only slightly in the conventional-therapy group (mean changes, -7 and +5 percent, respectively), but more substantially among patients treated with lovastatin and colestipol (-46 and +15 percent) or niacin and colestipol (-32 and +43 percent). In the conventional-therapy group, 46 percent of the patients had definite lesion progression (and no regression) in at least one of nine proximal coronary segments; regression was the only change in 11 percent. By comparison, progression (as the only change) was less frequent among patients who received lovastatin and colestipol (21 percent) and those who received niacin and colestipol (25 percent), and regression was more frequent (lovastatin and colestipol, 32 percent; niacin and colestipol, 39 percent; P less than 0.005). Multivariate analysis indicated that a reduction in the level of apolipoprotein B (or LDL cholesterol) and in systolic blood pressure, and an increase in HDL cholesterol correlated independently with regression of coronary lesions. Clinical events (death, myocardial infarction, or revascularization for worsening symptoms) occurred in 10 of 52 patients assigned to conventional therapy, as compared with 3 of 46 assigned to receive lovastatin and colestipol and 2 of 48 assigned to receive niacin and colestipol (relative risk of an event during intensive treatment, 0.27; 95 percent confidence interval, 0.10 to 0.77).

Conclusions

In men with coronary artery disease who were at high risk for cardiovascular events, intensive lipid-lowering therapy reduced the frequency of progression of coronary lesions, increased the frequency of regression, and reduced the incidence of cardiovascular events.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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