Randomised clinical trial of an intensive intervention in the primary care setting of patients with high plasma fibrinogen in the primary prevention of cardiovascular disease

Juan José Rodríguez Cristóbal, Carlos Alonso-Villaverde Grote, Pere Travé Mercadé, José Ma Pérez Santos, Esther Peña Sendra, Anna Muñoz Lloret, Cristina Fernández Pérez, Domingo Bleda Fernández, EFAP group, Juan José Rodríguez Cristóbal, José Ma Pérez Santos, Ma José González Burguillos, Margarita Solanes Casas, MaCarmen Esparrach Casasses, Ana Ma Diez Tino, Marta Delclos Baulies, Elida Quillama Torres, Ma Del Carmen Mpa Sifuko, Carmen Morillo Godoy, Teresa Gonzalez Nogales, Montse Blanco Rodriguez, Gemma Luna Redondo, Adela Gonzalez Sierra, Trinidad Mejías Serrano, Oscar Sanchez Soro, Jorge Fernandez Ruiz, Eugenia Herrador Delso, Begoña Barnés Sánchez, Anna Comabella Cueco, Teresa Ruso Bernardo, Margarida Guino Royo, Yolanda Ginés Sánchez, Conrada Benitez Saiz, Fuensanta Mesa Aranda, Remedios Montes Velayos, Concepción Gonzalez Perez, Antonio Gomez Navarro, María Ramos Sanchez, Mònica Cano Lopez, Sandra L aborda Lopez, Isabel Gavin Blasco, Carmen Lopez Sanchez, Eva Mon López, Aurora López Galán, Ma Carmen Muñoz Duque, Fina Arroyo Blesa, Mercedes Escudero Hernandez, Irene Pardo Escudero, Marife Alvarez Rodriguez, Bartolomé Rodriguez Lozano, Antonio Aranta Diaz, Vicky Cabré Aguilar, Enric García Gomila, Roser Llort Rañe, Ana María Gil Colome, Julia Mena Sánchez, Mercedes Bielsa Alquezar, Raul Miguel Capillas Perez, Mercè Aliaga Ugarte, Rosario Fernandez Perez, Maria Isabel Muñoz Castanedo, Montserrat Peraferrer Puigpelet, Carme Llorens Martinez, Miriam Montserrat Vinals, Ma Victòria Gomez Moral, Sacri Gutierrez Mesa, Eduvigis Abril Escusa, Almudena Gonzalez Casado, Montserrat Pérez Gañan, Ma Isabel García Villaplana, Magdalena Ortilles Tejera, Ágata Sala Sastre, Ma Dolores Leon Varo, Ma Carmen Gonzalez Sanchez, Rosa Gutierrez Lengua, Neus Lopez Ojeda, Concepción Torralba Casado, Leonor Blasco Villanueva, Anna Gasol Farga, Montserrat Comelles Villalba, Carmen Contreras García, Araceli Monge Escribano, Rosa Mas de Miguel Pérez, Isabel Ortega Abarca, Sonia Martínez Carmona, Rosa Gonzalez Diaz, Anna de Mon er de Castellano, Montserrat Bonfill Gavaldà, Rosalia Santesmases Masana, Eva Beltran, Angeles Toledano Perez, Alicia Rodríguez Pérez, MaDolores Rodriguez Magallanes, Cinta Boix Cervera, Alicia Rodriguez Perez, Gloria Mercè Martorell, Manuel Baullon Rodríguez, Montserrat Sanchez, Linarejos Jurado Vergara, Elena López Pérez, Ma Isabel Plaza Vicente, Glòria Tintoré Jiménez-Fortín, Ma Engracia Valbuena, Yolanda Espinosa, Pilar Tarragó Espí, Ma Carmen Lamuedra Martínez, Juan Ramón Morón Bermejo, Amparo Bonet Bernabeu, Francisca Benavides, Cristina Martín Sierra, Antonio Botey Serrano, Mónica Castro Pérez, Vicenta Estrada, Antonia Ferre Codina, Rosana Coma, Rosa Mené, Lidia Pujol Ramírez, Ma Engracia Aliguer Masramon, Montserrat Piñeiro Casaus, Teresa Giró Molmer, Susana Morgade Gonzalez, Manuel Mendez Fernandez, Ma Rosario Madico Cerezo, Ramona Ortiz Secanell, Mercedes Liroz Navarro, Gemma Capdevila Fogués, Gemma Roig i Ribas, Ma Jesús Valderas Sanchez, Lydia Riba Bellera, Carmen Ubierna Gomez, Montse Roc Laborda, Marisol Rilova Perez, Maria José Morro Vevel, Anna Pérez Alberti, Ma Teresa Isidro Barbero, Teresa Serrano Demarco, Montserrat Medina Sacristan, Guadalupe Fernández Esteve, Elisabeth Fontoba Nadal, Luis Malvas Garcia, Marisa Torres Segura, Enric Pons Segales, Anna Manzanares Janini, Francesca Pablo Gil, Ma Jesús Freixas Pascual, Ma Rosina Crespo López, Ma José Borrell Mestre, Ma Esther Calero Molina, Silvia Gonzalez Rodríguez, Ma Concepción López Canfranc, Ma Emilia Velasco Vicente, Ma Teresa Fuertes Rodríguez, Montse Bosc, Angels Arévalo Garcia, Ma Antonia Viloca Llobet, Ana Sánchez Alvarez, Iluminada Perea Martinez, Julia T Mayta Taica, Charo Fuentes Roldan, Ma Antonia Cuesta Pipson, Gloria Paris Puigcerver, Ma Antonia Fernández, Isabel Ginés, David Garcia Bonias, Artur Daleo i Pibernat, Miriam Payan Cruz, Antoni Blasco Trabado, Maite Alvarez Castella, Esther Llauradó Sanclemente, Marga Mendez-Aguirre Guitian, Rosa Ma Yrla Figueras, Angels Ballester Adell, Manuel Campiñez Navarro, Isabel Martínez Pascual, Esperanza Palacios Teruel, Nieves Barragán Brun, Palmira Villafuerte Navarro, Rosario Jiménez Leal, Rosario Corral Antón, Oscar Rochera López, Remedios Martin Alvarez, Yolanda Gomez Escudero, Ma Mercedes Garcia Fuentes, Montserrat Alegret, Mireia Sánchez aragoza, Amparo Romera Cabezas, Lilia Villagrasa Romerales, Teresa Benítez Camacho, Montserrat Ventura Albadalejo, Dolores Marín Perales, Magda Elías Hernández, Rosa Solé Sancho, Juan José Rodríguez Cristóbal, Carlos Alonso-Villaverde Grote, Pere Travé Mercadé, José Ma Pérez Santos, Esther Peña Sendra, Anna Muñoz Lloret, Cristina Fernández Pérez, Domingo Bleda Fernández, EFAP group, Juan José Rodríguez Cristóbal, José Ma Pérez Santos, Ma José González Burguillos, Margarita Solanes Casas, MaCarmen Esparrach Casasses, Ana Ma Diez Tino, Marta Delclos Baulies, Elida Quillama Torres, Ma Del Carmen Mpa Sifuko, Carmen Morillo Godoy, Teresa Gonzalez Nogales, Montse Blanco Rodriguez, Gemma Luna Redondo, Adela Gonzalez Sierra, Trinidad Mejías Serrano, Oscar Sanchez Soro, Jorge Fernandez Ruiz, Eugenia Herrador Delso, Begoña Barnés Sánchez, Anna Comabella Cueco, Teresa Ruso Bernardo, Margarida Guino Royo, Yolanda Ginés Sánchez, Conrada Benitez Saiz, Fuensanta Mesa Aranda, Remedios Montes Velayos, Concepción Gonzalez Perez, Antonio Gomez Navarro, María Ramos Sanchez, Mònica Cano Lopez, Sandra L aborda Lopez, Isabel Gavin Blasco, Carmen Lopez Sanchez, Eva Mon López, Aurora López Galán, Ma Carmen Muñoz Duque, Fina Arroyo Blesa, Mercedes Escudero Hernandez, Irene Pardo Escudero, Marife Alvarez Rodriguez, Bartolomé Rodriguez Lozano, Antonio Aranta Diaz, Vicky Cabré Aguilar, Enric García Gomila, Roser Llort Rañe, Ana María Gil Colome, Julia Mena Sánchez, Mercedes Bielsa Alquezar, Raul Miguel Capillas Perez, Mercè Aliaga Ugarte, Rosario Fernandez Perez, Maria Isabel Muñoz Castanedo, Montserrat Peraferrer Puigpelet, Carme Llorens Martinez, Miriam Montserrat Vinals, Ma Victòria Gomez Moral, Sacri Gutierrez Mesa, Eduvigis Abril Escusa, Almudena Gonzalez Casado, Montserrat Pérez Gañan, Ma Isabel García Villaplana, Magdalena Ortilles Tejera, Ágata Sala Sastre, Ma Dolores Leon Varo, Ma Carmen Gonzalez Sanchez, Rosa Gutierrez Lengua, Neus Lopez Ojeda, Concepción Torralba Casado, Leonor Blasco Villanueva, Anna Gasol Farga, Montserrat Comelles Villalba, Carmen Contreras García, Araceli Monge Escribano, Rosa Mas de Miguel Pérez, Isabel Ortega Abarca, Sonia Martínez Carmona, Rosa Gonzalez Diaz, Anna de Mon er de Castellano, Montserrat Bonfill Gavaldà, Rosalia Santesmases Masana, Eva Beltran, Angeles Toledano Perez, Alicia Rodríguez Pérez, MaDolores Rodriguez Magallanes, Cinta Boix Cervera, Alicia Rodriguez Perez, Gloria Mercè Martorell, Manuel Baullon Rodríguez, Montserrat Sanchez, Linarejos Jurado Vergara, Elena López Pérez, Ma Isabel Plaza Vicente, Glòria Tintoré Jiménez-Fortín, Ma Engracia Valbuena, Yolanda Espinosa, Pilar Tarragó Espí, Ma Carmen Lamuedra Martínez, Juan Ramón Morón Bermejo, Amparo Bonet Bernabeu, Francisca Benavides, Cristina Martín Sierra, Antonio Botey Serrano, Mónica Castro Pérez, Vicenta Estrada, Antonia Ferre Codina, Rosana Coma, Rosa Mené, Lidia Pujol Ramírez, Ma Engracia Aliguer Masramon, Montserrat Piñeiro Casaus, Teresa Giró Molmer, Susana Morgade Gonzalez, Manuel Mendez Fernandez, Ma Rosario Madico Cerezo, Ramona Ortiz Secanell, Mercedes Liroz Navarro, Gemma Capdevila Fogués, Gemma Roig i Ribas, Ma Jesús Valderas Sanchez, Lydia Riba Bellera, Carmen Ubierna Gomez, Montse Roc Laborda, Marisol Rilova Perez, Maria José Morro Vevel, Anna Pérez Alberti, Ma Teresa Isidro Barbero, Teresa Serrano Demarco, Montserrat Medina Sacristan, Guadalupe Fernández Esteve, Elisabeth Fontoba Nadal, Luis Malvas Garcia, Marisa Torres Segura, Enric Pons Segales, Anna Manzanares Janini, Francesca Pablo Gil, Ma Jesús Freixas Pascual, Ma Rosina Crespo López, Ma José Borrell Mestre, Ma Esther Calero Molina, Silvia Gonzalez Rodríguez, Ma Concepción López Canfranc, Ma Emilia Velasco Vicente, Ma Teresa Fuertes Rodríguez, Montse Bosc, Angels Arévalo Garcia, Ma Antonia Viloca Llobet, Ana Sánchez Alvarez, Iluminada Perea Martinez, Julia T Mayta Taica, Charo Fuentes Roldan, Ma Antonia Cuesta Pipson, Gloria Paris Puigcerver, Ma Antonia Fernández, Isabel Ginés, David Garcia Bonias, Artur Daleo i Pibernat, Miriam Payan Cruz, Antoni Blasco Trabado, Maite Alvarez Castella, Esther Llauradó Sanclemente, Marga Mendez-Aguirre Guitian, Rosa Ma Yrla Figueras, Angels Ballester Adell, Manuel Campiñez Navarro, Isabel Martínez Pascual, Esperanza Palacios Teruel, Nieves Barragán Brun, Palmira Villafuerte Navarro, Rosario Jiménez Leal, Rosario Corral Antón, Oscar Rochera López, Remedios Martin Alvarez, Yolanda Gomez Escudero, Ma Mercedes Garcia Fuentes, Montserrat Alegret, Mireia Sánchez aragoza, Amparo Romera Cabezas, Lilia Villagrasa Romerales, Teresa Benítez Camacho, Montserrat Ventura Albadalejo, Dolores Marín Perales, Magda Elías Hernández, Rosa Solé Sancho

Abstract

Background: We have studied the possible effects of an intensive lifestyle change program on plasma fibrinogen levels, in patients with no cardiovascular disease, with elevated levels of fibrinogen, normal cholesterol levels, and a moderate estimated risk of coronary heart disease (CHD) and we have also analysed whether the effect on fibrinogen is independent of the effect on lipids.

Results: This clinical trial was controlled, unblinded and randomized, with parallel groups, done in 13 Basic Health Areas (BHA) in l'Hospitalet de Llobregat (Barcelona) and Barcelona city. The study included 436 patients, aged between 35 and 75 years, with no cardiovascular disease, elevated levels of fibrinogen (> 300 mg/dl), cholesterol < 250 mg/dl, 218 of whom received a more intensive intervention consisting of advice on lifestyle and treatment. The follow-up frequency of the intervention group was every 2 months. The other 218 patients followed their standard care in the BHAs. Fibrinogen, plasma cholesterol and other clinical biochemistry parameters were assessed.The evaluation of the baseline characteristics of the patients showed that both groups were homogenous. Obesity and hypertension were the most prevalent risk factors. After 24 months of the study, statistically significant changes were seen between the adjusted means of the two groups, for the following parameters: fibrinogen, plasma cholesterol, systolic and diastolic blood pressure and body mass index.

Conclusion: Intensive intervention to achieve lifestyle changes has shown to be effective in reducing some of the estimated CHD factors. However, the effect of intensive intervention on plasma fibrinogen levels did not correlate with the variations in cholesterol.

Trial registration: ClinicalTrials.gov: NCT01089530.

Trial registration: ClinicalTrials.gov NCT01006213 NCT01089530 NCT01006213.

Figures

Figure 1
Figure 1
General outline of the study.
Figure 2
Figure 2
Relationship between Fibrinogen and final cholesterol study according to the type of intervention.

References

    1. Rodríguez Cristóbal JJ, Villaverde Grote CA, Flor Serra F, Travé Mercadé P, Pérez Santos JM, Peña Sendra E. en representación del grupo EFAP. Ensayo clínico de intervención en pacientes con hiperfibrinogenemia en prevención primaria de enfermedad cardiovascular en el ámbito de la atención primaria de salud. Clin Invet Arterioscl. 2008;20:102–9.
    1. Ernst E, Resch KL. Fibrinogen as cardiovascular risk factor: a meta-analysis and review of the literature. Ann Intern Med. 1993;118:956–63.
    1. Kannel WB. Overview of hemostatic factors involved in atherosclerotic cardiovascular disease. Lipid. 2005;40:1215–20. doi: 10.1007/s11745-005-1488-8.
    1. Dotevall A, Johansson S, Wilhelmsen L. Associaton between fibrinogen and other risk factor for cardiovascular disease in men and women. Results from the Goteborg MONICA survey 1985. Ann Epidemiol. 1994;4:369–74. doi: 10.1016/1047-2797(94)90071-X.
    1. Ernst E, Resch KL. Therapeutic interventions to lower plasma fibrinogen concentration. Eur Heart J. 1995;16(Suppl A):S47–53.
    1. Danesh J, Collins R, Appleby P, Peto R. Association of fibrinogen, C-reactive protein, albumin, or leukocyte count with coronary heart disease: meta-analyses of prospective studies. JAMA. 1998;279:1477–82. doi: 10.1001/jama.279.18.1477.
    1. Masiá R, Pena A, Marrugat J, Sala J, Vila J, Pavesi M, Covas M, Aubó C, Elosua R. High prevalence of cardiovascular risk factors in Gerona, Spain, a province with low myocardial infarction incidence. REGICOR Investigators. J Epidemiol Community Health. 1998;52:707–15. doi: 10.1136/jech.52.11.707.
    1. Gil B, Avilés J, Maldonado A, Fernández M. Factores de riesgo en ancianos. Estudio de 143 cientes. An Med Intern (Madrid) 1997;14:495–9.
    1. Rodríguez JJ, Villaverde CA, Torelló L, Trocho C, Tibau N, Villaverde AA. Relationship between cholesterol and fibrinogen in primary-care areas. 15 the Wonca World Conference. 1998. p. 78.
    1. Rodríguez Cristóbal JJ, Villaverde Grote CA, Tibau Llardén N, Juan Babot O, Andrades Corrales A, Peña Sendra E. Relationship between cholesterol and fibrinogen in two populations of different geographical location of Catalonia. Rev Clin Esp. 2004;204:405–9. doi: 10.1157/13064313.
    1. Yano K, Grove J, Chen R, Rodríguez BL, Curb JD, Tracy RP. Plasma fibrinogen as a predictor of total and cause-specific mortality in elderly Japanese-American men. Arterio Throm Vascul Biol. 2001;21:1065–70. doi: 10.1161/01.ATV.21.6.1065.
    1. Wood D, De Backer G, Faergeman O, Graham I, Mancia G, Pyörälä K. Prevention of coronary heart disease in clinical practice. Summary of recommendations the second joint task force of European and other societies on coronary prevention. Blood Press. 1998;5-6:262–9.
    1. Kannel WB. Influence of fibrinogen on cardiovascular disease. Drugs. 1997;54(Suppl 3):S32–40.
    1. Rodríguez Cristóbal JJ, Benavides Márquez F, Villaverde Grote C, Peña Sendra E, Flor Serra F, Travé Mercadé P. EFAP Group. Randomised clinical trial of an intensive intervention into life-styles of patients with hyperfibrinogenaemia in primary prevention of cardiovascular pathology in primary health care. Aten Primaria. 2005;35:260–4. doi: 10.1157/13072792.
    1. Sociedad Española para el Estudio de la Obesidad (SEEDO) Consenso SEEDO'2000 para la evaluación del sobrepeso y la obesidad y el establecimiento de criterios de intervención terapéutica. Med Clin (Barc) 2000;115:587–597.
    1. Maiques A, Villar F, Brotons C, Torcal J, Orozco-Beltran D, Navarro P, Lobos-Bejarano JM, Banegas B, Ortega S, Gil G, Solana S. Recomendaciones preventivas cardiovasculares en atención primaria. Grupo de expertos del PAPPS. Aten Primaria. 2007;39(Suppl 3):15–26.
    1. Woolf S, Jonas S, Lawrence R. Health Promotion and Disease Prevention in Clinical Practice. Baltimore: Williams & Wilkins; 1996. pp. 177–223.
    1. Medrano MJ, Cerrato E, Boix R, Delgado-Rodríguez M. Factores de riesgo cardiovascular en la población española: metaanálisis de estudios transversales. Med Clin (Barc) 2005;124:606–12. doi: 10.1157/13074389.
    1. Wadden TA, Berkowitz R, Womble LG, Sarwer DB, Phelan S, Cato RK, Hesson LA, Osei SY, Kaplan R, Stunkard AJ. Randomized trial of lifestyle modification and pharmacotherapy for obesity. N Engl J Med. 2005;353:2111–20. doi: 10.1056/NEJMoa050156.
    1. Shaw K, O'Rourke P, Del Mar C, Kenardy J. Intervenciones psicológicas para el sobrepeso o la obesidad (Revisión Cochrane) The Cochrane Library. 2005.
    1. Steptoe A, Kerry S, Rink E, Hilton S. The impact of behavioral counseling on stage of change in fat intake, physical activity, and cigarette smoking in adults at increased risk of coronary heart disease. Am J Public Health. 2001;91:265–9.
    1. Sans S, Fitzgerald AP, Royo D, Conroy R, Gram I. Calibración de la tabla SCORE de riesgo cardiovascular para España. Rev Esp Cardiol. 2007;60:476–85.
    1. Marrugat J, Subirana I, Comín E, Cabezas C, Vila J, Elosua R, Nam BH, Ramos R, Sala J, Solanas P, Cordón F, Gené-Badia J, D'Agostino RB. VERIFICA Investigators. Validity of an adaptation of the Framingham cardiovascular risk function: the VERIFICA Study. J Epidemiol Community Health. 2007;61:40–7. doi: 10.1136/jech.2005.038505.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel