¿Aún no está registrado?

Cree su cuenta. Regístrese en Elsevier y obtendrá: información relevante, máxima actualización y promociones exclusivas.

Registrarme ahora
Help - - Sign up - Phone number 902 888 740

Indexed in:



  • SCImago Journal Rank (SJR):0,11
  • Source Normalized Impact per Paper (SNIP):0,189
Hipertensión 2003;20:252-8 - 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

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.


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
arterial hypetension, diabetes type 2, angiotensin II receptor antagonists
This article is only available in PDF
UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38
BMJ, 317 (1998), pp. 703-713
L. Hansson,A. Zanchetti,S.G. Carruthers,B. Dahlof,D. Elmfeldt,S. Julius
for the HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the hypertension optimal treatment (HOT) randomised trial
Lancet, 351 (1998), pp. 1755-1762
Joint National Committee on detection, evaluation, and treatment of high blood pressure (JNC VI): the Sixth Report of the Joint National Committee on Detection, Evaluation and Treatment of High Blood Pressure
Arch Intern Med, 157 (1997), pp. 2413-2446
Guidelines Subcommittee. 1999 World Health Organization- International Society of Hypertension Guidelines for the management of hypertension
J Hypertens, 17 (1999), pp. 151-183
J.D. Curb,S.L. Pressel,J.A. Cutler,P.J. Savage,W.B. Applegate,H. Black
Effect of diuretic-based antihypertensive treatment on cardiovascular disease risk in older diabetic patients with isolated systolic hypertension. Systolic Hypertension in the Elderly Program Cooperative Research Group
JAMA, 276 (1996), pp. 1886-1892
UK Prospective Diabetes Study Group. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39
BMJ, 317 (1998), pp. 713-720
J. Tuomilehto,D. Rastenyte,W.H. Birkenhäger,L. Thijs,R. Antikainen,C.J. Bulpitt
for the Systolic Hypertension in Europe Trial Investigators. Effects of calcium-channel blockade in older patients with diabetes and systolic hypertension
N Engl J Med, 340 (1999), pp. 677-684 http://dx.doi.org/10.1056/NEJM199903043400902
R. Estacio,B. Jeffers,W. Hiatt,S. Biggerstaff,N. Gifford,R.W. Schrier
The effect of nisoldipine as compared with enalapril on cardiovascular outcomes in patients with non-insulin-dependent diabetes and hypertension
N Engl J Med, 338 (1998), pp. 645-652 http://dx.doi.org/10.1056/NEJM199803053381003
Heart Outcomes Prevention Evaluation (HOPE) Study Investigators. Effects of ramipril on cardiovascular and microvascular outcomes in people with diabetes mellitus: results of the HOPE study and MICRO-HOPE substudy
Lancet, 355 (2000), pp. 253-259
E.J. Lewis,L.G. Hunsicker,R.P. Bain,R.D. Rohde
for the Collaborative Study Group. The effect of angiotensin converting enzyme inhibition on diabetic nephropathy: the Collaborative Study Group
N Engl J Med, 329 (1993), pp. 1456-1462 http://dx.doi.org/10.1056/NEJM199311113292004
The EUCLID Study Group. Randomised placebo-controlled trial of lisinopril in normotensive patients with insulindependent diabetes and normoalbuminuria or microalbuminuria
Lancet, 349 (1997), pp. 1787-1792
E.J. Lewis,L.G. Hunsicker,W.R. Clarke,T. Berl,M.A. Pohl,J.B. Lewis
Renoprotective effect of the angiotensin-receptor antagonist irbersartan in patients with nephropathy due to type 2 diabetes
N Engl J Med, 345 (2001), pp. 851-860 http://dx.doi.org/10.1056/NEJMoa011303
B.M. Brenner,M.E. Cooper,D. De Zeeuw,W.F. Keane,W.E. Mitch,H.H. Parving
for the RENAAL Study Investigators. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy
N Engl J Med, 345 (2001), pp. 861-869 http://dx.doi.org/10.1056/NEJMoa011161
H.H. Parving,H. Lehnert,J. Bröchner-Mortensen,R. Gomis,S. Andersen,P. Arner
The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes
N Engl J Med, 345 (2001), pp. 870-878 http://dx.doi.org/10.1056/NEJMoa011489
L.H. Lindholm,H. Ibsen,B. Dahlöf,R. Devereux,G. Beevers,U. Faire
for the LIFE study group. Cardiovascular morbidity and mortality in patients with diabetes in the losartan intervention for endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol
E. O’Brien,B. Waeber,G. Parati,J. Staessen,M.G. Myers
on behalf of the European Society of Hypertension Working Group on Blood Pressure Monitoring. Blood pressure measuring devices: recommendations of the European Society of Hypertension
BMJ, 322 (2001), pp. 531-536
R. Marín,A. Coca,S. Tranche,L. Rodríguez Mañas,J. Abellán,A. Moya
en representación del grupo de Estudio PIRDDOS (Prevención de la Insuficiencia Renal en la Diabetes tipo 2). Prevalencia de la afectación renal en una población de diabéticos tipo 2 seguidos en Atención Primaria
Nefrología, 22 (2002), pp. 152-161
L.D. Reardon,D.S. Macpherson
Hyperkalemia in outpatients using angiotensin-converting enzyme inhibitors
Arch Intern Med, 158 (1998), pp. 26-32
D. Ellis
Combined use of enalapril and losartan to reduce proteinuria: a question of safety
Am J Kidney Dis, 39 (2002), pp. 209-210
E. Grossman,F.H. Messerli,U. Goldbourt
High blood pressure and diabetes mellitus: are all antihypertensive drugs created equal?
Arch Intern Med, 160 (2000), pp. 2447-2452
A.I. Adler,I.M. Stratton,H.A. Neil,J.S. Yudkin,D.R. Matthews,C.A. Cull
Association of systolic blood pressure with macrovascular and microvascular complications of type 2 diabetes (UKPDS 36): prospective-observational study
BMJ, 321 (2000), pp. 412-419
American Diabetes Association. Treatment of hypertension in adults with diabetes
Diabetes Care, 25 (2002), pp. 199-201
P. Tatti,M. Pahor,R.P. Byington,P. Di Mauro,R. Guarisco,G. Strollo
Outcome results of the fosinopril versus amlodipine cardiovascular events randomized trial (FACET) in patients with hypertension and NIDDM
Diabetes Care, 21 (1998), pp. 597-603
L. Hansson,L.H. Lindholm,L. Niskanen,J. Lanke,T. Hedner,A. Niklason
Effects of angiotensin-converting enzyme inhibition compared with conventional therapy on cardiovascular morbidity and mortality in hypertension: the Captopril Prevention Project (CAPPP) randomised trial
Lancet, 353 (1999), pp. 611-616
L. Hansson,L.H. Lindholm,T. Ekbom,B. Dahlöf,J. Lanke,B. Schersten
Randomised trial of old and new antihypertensive drugs in elderly patients: cardiovascular mortality and morbidity the swedish trial in old patients with Hypertension-2 study
Lancet, 354 (1999), pp. 1751-1756
A. Mimran,L.M. Ruilope,L. Kerwin,M. Nys,D. Owens,K. Kassler-Taub
A randomized, double-blind comparison of the angiotensin II receptor antagonist, irbesartan, with the full dose range of enalapril for the treatment of mild-to-moderate hypertension
J Hum Hypertens, 12 (1998), pp. 203-208
J.L. Pool,R.M. Guthrie,T.W. Littlejohn,P. Raskin,A.M.M. Shephard,M.A. Weber
Dose-related antihypertensive effects of irbesartan in patients with mild-to-moderate hypertension
Am J Hypertens, 11 (1998), pp. 462-470
R.A. Reeves,C.S. Lin,K. Kassler-Taub,H. Pouleur
Dose-related efficacy of irbesartan for hypertension. An integrated analysis
Hypertension, 31 (1998), pp. 1311-1316
T.A. Simon,R.T. Gelarden,S.A. Freitag,K.B. Kassler-Taub,R. Davies
Safety of irbesartan in the treatment of mild-to-moderate systemic hypertension
Am J Cardiol, 82 (1998), pp. 179-182
M.R. Weir
Are drugs that block the renin-angiotensin system effective and safe in patients with renal insufficiency?
Am J Hypertens, 12 (1999), pp. 195S-203S
A. Coca Payeras
Evolución del control de la hipertensión arterial en España. Resultados del estudio Controlpres 98
Hipertensión, 15 (1998), pp. 298-307
A.V. Chobanian
Control of hypertension. An important national priority
N Engl J Med, 345 (2001), pp. 534-535 http://dx.doi.org/10.1056/NEJM200108163450709
American Diabetes Association.Diabetic nephropathy
Diabetes Care, 25 (2002), pp. 85S-91S

Ver en apéndice la lista de investigadores.

Correspondencia: R. Marín. Servicio de Nefrología. Hospital de Covadonga. Celestino Villamil, s/n. 33006 Oviedo. (R. Marín Iranzo rmarini@hca.es)
Copyright © 2003. Sociedad Española de Hipertension-Liga Española para la Lucha de la Hipertensión Arterial (SEH-LELHA)