OBJECTIVE: This study aimed to assess the blood pressure-lowering potency, renoprotective efficacy and safety of the angiotensin II type 1 (AT(1))-receptor blocker irbesartan in monotherapy or in combination with hydrochlorothiazide or other antihypertensive medications in patients with type 2 diabetes mellitus switched from various antihypertensive pretreatments. DESIGN AND METHODS: Multicentre, open, prospective, 6-month observational study in 38 016 patients at 9838 general practitioners' offices throughout Germany. Microalbuminuria in type 2 diabetics was measured with semiquantitative immunological Micral-II urine dipstick tests. MAIN OUTCOME MEASURE: Proportion of patients with albuminuria at baseline and at 3 and 6 months. Analysis of adverse events. RESULTS: The study population consisted of an equal number of males and females, mean body mass index was 28.4 kg/m(2), and mean glycosylated haemoglobin (HbA(1c)) was 7.2%. After the switch to irbesartan (in 86% of patients to the 300mg dosage in mono- or combination therapy), mean systolic/diastolic blood pressure was decreased by 23/12mm Hg. Irbesartan treatment over 6 months reduced the proportion of patients with microalbuminuria from 49.2 to 23.2% (relative reduction: 52.8%; p < 0.05) and the rate of patients with macroalbuminuria from 6.0 to 4.4% (relative reduction: 26.7%; p < 0.05). The renoprotective effect of irbesartan was consistent in various subgroups (analyses by sex, weight, diabetes duration, insulin treatment, strength of blood pressure-lowering effect, and antihypertensive pretreatment). Tolerability was excellent: 99.6% of patients remained free of any adverse events during the study. CONCLUSION: The profound blood pressure-lowering and renoprotective effect of irbesartan in type 2 diabetes documented in clinical endpoint studies was confirmed in second-line therapy in a large sample of primary-care patients. Furthermore, in patients switched from previous ACE-inhibitor therapy, the renoprotective effect of irbesartan was of the same magnitude as in the total cohort.
OBJECTIVE: This study aimed to assess the blood pressure-lowering potency, renoprotective efficacy and safety of the angiotensin II type 1 (AT(1))-receptor blocker irbesartan in monotherapy or in combination with hydrochlorothiazide or other antihypertensive medications in patients with type 2 diabetes mellitus switched from various antihypertensive pretreatments. DESIGN AND METHODS: Multicentre, open, prospective, 6-month observational study in 38 016 patients at 9838 general practitioners' offices throughout Germany. Microalbuminuria in type 2 diabetics was measured with semiquantitative immunological Micral-II urine dipstick tests. MAIN OUTCOME MEASURE: Proportion of patients with albuminuria at baseline and at 3 and 6 months. Analysis of adverse events. RESULTS: The study population consisted of an equal number of males and females, mean body mass index was 28.4 kg/m(2), and mean glycosylated haemoglobin (HbA(1c)) was 7.2%. After the switch to irbesartan (in 86% of patients to the 300mg dosage in mono- or combination therapy), mean systolic/diastolic blood pressure was decreased by 23/12mm Hg. Irbesartan treatment over 6 months reduced the proportion of patients with microalbuminuria from 49.2 to 23.2% (relative reduction: 52.8%; p < 0.05) and the rate of patients with macroalbuminuria from 6.0 to 4.4% (relative reduction: 26.7%; p < 0.05). The renoprotective effect of irbesartan was consistent in various subgroups (analyses by sex, weight, diabetes duration, insulin treatment, strength of blood pressure-lowering effect, and antihypertensive pretreatment). Tolerability was excellent: 99.6% of patients remained free of any adverse events during the study. CONCLUSION: The profound blood pressure-lowering and renoprotective effect of irbesartan in type 2 diabetes documented in clinical endpoint studies was confirmed in second-line therapy in a large sample of primary-care patients. Furthermore, in patients switched from previous ACE-inhibitor therapy, the renoprotective effect of irbesartan was of the same magnitude as in the total cohort.
Authors: H C Gerstein; J F Mann; Q Yi; B Zinman; S F Dinneen; B Hoogwerf; J P Hallé; J Young; A Rashkow; C Joyce; S Nawaz; S Yusuf Journal: JAMA Date: 2001-07-25 Impact factor: 56.272
Authors: H L Hillege; W M Janssen; A A Bak; G F Diercks; D E Grobbee; H J Crijns; W H Van Gilst; D De Zeeuw; P E De Jong Journal: J Intern Med Date: 2001-06 Impact factor: 8.989
Authors: Ulrich Tebbe; Peter Bramlage; Stephan Lüders; Alessandro Cuneo; Peter Sistig; Fokko de Haan; Roland Schmieder; Michael Böhm; W Dieter Paar; Jochen Schrader Journal: J Clin Hypertens (Greenwich) Date: 2010-08-20 Impact factor: 3.738