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  • SCImago Journal Rank (SJR):0,11
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doi: 10.1016/S1889-1837(03)71397-X
Eficacia y tolerabilidad de irbesartán en pacientes con hipertensión arterial y diabetes mellitus tipo 2
Effectiveness and tolerability of irbesartan in patients with arterial hypertension and type 2 diabetes mellitus
R. Marín Iranzo,a, , S. Tranche Iparraguirreb, S. Armengol Bertolínc, L. Rodríguez Mañasd, J. Abellán Alemáne, P. Aranda Laraf, C. Calvo Gómezg, A. Coca Payerash, en representación del grupo pirddos (prevención de la insuficiencia renal en la diabetes tipo 2), fase ii
a Servicio de Nefrología. Unidad de Hipertensión. Hospital de Covadonga. Oviedo
b Centro de Salud de El Cristo. Oviedo.
c Departamento Médico Sanofi-Synthelabo.
d Hospital Universitario de Getafe
e Centro de Salud San Andrés. Murcia.
f Unidad de Hipertensión y Riesgo Vascular. Hospital Carlos Haya. Málaga
g Unidad de Hipertensión. Hospital General de Galicia. Universidad de Santiago.
h Unidad de Hipertensión. Hospital Clínico. Instituto de Investigaciones Biomédicas Augusto Pi Suñer (IDIBAPS). Universidad de Barcelona
Abstract
Fundamento

La coexistencia de hipertensión arterial (HTA) y diabetes tipo 2 constituye una combinación de incidencia creciente y de elevado riesgo cardiovascular. El bloqueo del sistema renina angiotensina con inhibidores de la enzima convertidora (IECA) o con antagonistas de los receptores de angiotensina confiere a los pacientes con HTA y diabetes una mayor protección frente a la enfermedad cardiovascular (ECV) y renal (ER). El presente estudio tiene como objetivo evaluar la eficacia y la tolerabilidad del antagonista de los receptores de angiotensina irbesartán en una cohorte de pacientes con HTA y diabetes mellitus tipo 2.

Diseño y métodos

Estudio prospectivo observacional en una cohorte de 1.184 pacientes diagnosticados de diabetes mellitus tipo 2, con cifras de tensión arterial (TA) ≥130 y/o 85 mmHg. El tratamiento antihipertensivo se realizó con irbesartán a dosis entre 75 y 300 mg añadiendo posteriormente hidroclorotiazida 12,5 mg/día si no se había alcanzado el objetivo de reducir la TA a un nivel inferior a 130/85 mmHg. El seguimiento clínico fue de 12 semanas. La eficacia del fármaco se evaluó mediante la disminución de la TA determinada por un sistema de medida oscilométrico semiautomático. Las variables de seguridad fueron los niveles de creatinina y de potasio séricos, así como la aparición de reacciones adversas.

Resultados

El tratamiento con irbesartán produjo un descenso significativo (p = 0,0001), tanto de la TA sistólica (TAS) (de 157,6 ± 17,1 a 141,8 ± 18,8 mmHg) como de la TA diastólica (TAD) (de 90,5 ± 10,2 a 81,0 ± 9,9 mmHg). El porcentaje de pacientes controlados a las 12 semanas fue del 70,4 % para la TAD (< 85 mmHg) y del 17 % para la TAS (< 130 mmHg). No se verificaron acambios significativos en los valores medios de creatinina (de 0,97 ± 0,19 a 0,98 ± 0,19 mg/dl) ni en las cifras de potasio sérico (de 4,34 ± 0,46 a 4,34 ± 0,48 mmol/l). Igualmente, la tasa de reacciones adversas fue mínima, pues sólo el 3,1 % de los pacientes presentaron alguna reacción adversa.

Conclusiones

El irbesartán es un fármaco eficaz, seguro y bien tolerado para el tratamiento de la HTA en pacientes con diabetes tipo 2. Produce descensos significativos de la TA con una tasa muy baja de reacciones adversas.

Abstract
Background

The coexistence of arterial hypertension (AH) and type 2 diabetes mellitus constitutes a combination of increasing incidence and high cardiovascular risk. The blockade of the renin- angiotensin system with either converting enzyme inhibitors or angiotensin receptor antagonists affords patients with AH and diabetes more protection against cardiovascular and renal disease. The present study aims to evaluate the effectiveness and tolerability of the angiotensin receptor antagonist, irbesartan, in a group of patients with AH and type 2 diabetes mellitus.

Design and methods

A prospective observational study within a group of 1,184 patients diagnosed with type 2 diabetes mellitus, having blood pressure (BP) values ≥130 and/or 85 mmHg. Antihypertensive treatment was carried out with irbesartan at doses of between 75 and 300 mg, later adding hydrochlorothiazide (12.5 mg/day) if BP reduction to a value≥130/85 mmHg had not been achieved. There was a 12-week follow up period. The drug’s effectiveness was determined by evaluating BP reduction as measured by a semi-automatic monitor incorporating oscillometric measuring techniques. Levels of creatinine and serum potassium, as well as the appearance of adverse reactions, served as margins of security.

Results

Treatment with irbesartan produced a significant reduction (p = 0.0001) in both systolic blood pressure (SBP) (from 157.6±17.1 to 141.8±18.8 mmHg) and diastolic blood pressure (DBP) (from 90.5 ± 10.2 to 81.0 ± 9.9 mmHg). The percentage of patients with controlled BP at 12 weeks was 70.4 % for DBP (< 85 mmHg) and 17% for SBP (< 130 mmHg). There were no significant changes observed in the mean values of either creatinine (from 0.97±0.19 to 0.98±0.19 mg/dl) or serum potassium (from 4.34 ± 0.46 to 4.34 ± 0.48 mmol/l). What is more, the incidence of adverse reactions was minimal, with only 3.1 % of the patients presenting any such reactions.

Palabras clave
hipertensión arterial, diabetes tipo 2, antagonistas receptores angiotensina II
keywords
arterial hypetension, diabetes type 2, angiotensin II receptor antagonists
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Correspondencia: R. Marín. Servicio de Nefrología. Hospital de Covadonga. Celestino Villamil, s/n. 33006 Oviedo.
Copyright © 2003. Sociedad Española de Hipertension-Liga Española para la Lucha de la Hipertensión Arterial (SEH-LELHA)