Efficacy of a Combined Strategy to Improve Low-density Lipoprotein Cholesterol Control Among Patients With Hypercholesterolemia: A Randomized Clinical Trial

Ignacio Párraga-Martínez^a^,

, Francisco Escobar-Rabadán^b, Joseba Rabanales-Sotos^c, Fernando Lago-Deibe^d, Juan M. Téllez-Lapeira^e, Alejandro Villena-Ferrer^f, Mariano Blasco-Valle^g, José M. Ferreras-Amez^h, Susana Morena-Rayoⁱ, José M. del Campo-del Campo^j, M. Candelaria Ayuso-Raya^b, José J. Pérez-Pascual^b

^a Centro de Salud de La Roda, Gerencia de Atención Integrada de Albacete, Servicio de Salud de Castilla-La Mancha, Facultad de Medicina de Albacete, Universidad de Castilla-La Mancha, Albacete, Spain
^b Centro de Salud Zona IV, Servicio de Salud de Castilla-La Mancha, Albacete, Spain
^c Facultad de Enfermería de Cuenca, Universidad de Castilla-La Mancha, Cuenca, Spain
^d Centro de Salud de Sárdoma, Servicio de Salud de Galicia, Vigo, Pontevedra, Spain
^e Centro de Salud Zona V-B, Servicio de Salud de Castilla-La Mancha, Albacete, Spain
^f Centro de Salud de San Clemente, Servicio de Salud de Castilla-La Mancha, San Clemente, Cuenca, Spain
^g Centro de Salud Delicias Sur, Servicio de Salud Aragón, Zaragoza, Spain
^h Servicio de Urgencias, Hospital Royo Villanova, Servicio Aragonés de Salud, Zaragoza, Spain
ⁱ Centro de Salud Hellín 2, Servicio de Salud de Castilla-La Mancha, Hellín, Albacete, Spain
^j Centro de Salud de Almansa, Servicio de Salud de Castilla-La Mancha, Almansa, Albacete, Spain

Keywords

Hypercholesterolemia. Medication adherence. Primary health care. Clinical trial.

Abstract

Introduction and objectives

Several interventions can improve low-density lipoprotein cholesterol (LDL-C) control. Our main objective was to evaluate the efficacy of a combined intervention to improve LDL-C control in patients with hypercholesterolemia. The study also assessed the efficacy of the intervention in improving adherence (pharmacological, diet, and exercise).

Methods

A multicenter, parallel group, randomized clinical trial (primary care) was conducted in 358 adults diagnosed with hypercholesterolemia, whether receiving prior drug therapy or not. We compared 178 participants who received the combined intervention (written material, self-completed registration cards, and messages to mobile telephones) with 178 controls. The main outcome variable was the proportion of participants with adequate LDL-C control (target levels of the European guidelines on dyslipidemia and cardiovascular risk) at 24 months.

Results

At 24 months, the mean reduction in LDL-C was significantly higher in the intervention group (23.8 mg/dL [95%CI, 17.5-30.1]) than in the control group (14.6 mg/dL [95%CI, 8.9-20.4]; P = .034). The mean LDL-C decrease was 13.1% ± 28.6%. At 1 year, the proportion of participants with adequate control was significantly higher in the intervention group than in the control group (43.7% vs 30.1%; P = .011; RR, 1.46). Adherence was significantly higher in the intervention group, both to drug therapy (77.2% vs 64.1%; P = .029) and exercise (64.9% vs 35.8; P < .001), but not to diet.

Conclusions

The combined intervention significantly reduced LDL-C (by more than 13% at 2 years) and improved the degree of LDL-C control in patients with hypercholesterolemia at 1 year.