Objective: This study aimed to assess the blood pressure-lowering potency, renoprotective efficacy and safety of the angiotensin II type 1 (AT1)-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/m2, and mean glycosylated haemoglobin (HbA1c) 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.
Irbesartan HCTZ Renoprotective Effect Oral Antidiabetic Drug Irbesartan Treatment
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This study was supported by Sanofi-Synthelabo Berlin, Germany. We thank the investigators for their commitment to the study. The statistical analysis was performed by Dr Schauerte GmbH, Munich, Germany. PB is also an employee of Sanofi-Synthelabo Germany. The other authors have reported no conflicts of interest directly relevant to the content of this study.
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