[IRMA-pRAcs: irbesartan in the treatment of microalbuminuria and proteinuria in patients with type 2 diabetes and hypertension-prospective observational study involving 38,016 patients in the general practice setting].

BACKGROUND AND AIMS

In daily practice, nephropathy is diagnosed in a high percentage of type 2 diabetics, including those in whom blood pressure is well controlled. The aim of the present study was to reduce albuminuria in these patients by changing over antihypertensive treatment to the AT, blocker irbesartan. 9,838 general practitioners recruited a total of 38,016 type 2 diabetics aged at least 18 years to an open observational study: In the majority of cases, current antihyprertensive treatment was discontinued and patients given 300 mg (a small percentage received 150 mg or 75 mg) irbesartan, either as monotherapy or in combination with 12.5 mg hydrochlorothiazide (HCT). The primary target outcome for efficacy was the 6-months normalization rate in patients with microalbuminuria or proteinuria; secondary target parameters included the change in protein excretion (grades: negative, 20 mg, 50 mg, 100 mg), normalisation of the systolic or diastolic blood pressure, and responder and blood pressure normalization rates. The target criterion for tolerability was the number of patients with adverse events (AE).

RESULTS

46% of the patients were controlled with 300 mg irbesartan alone, and 40% with irbesartan in combination with HCT. Albumin excretion normalized in 60.5% of the patients, improved by at least one grade in 81.9%, remained unchanged in 17.5%, and increased in 0.7% of the cases. The beneficial response was found to be independent ofthe type of prior antihypertensive treatment (including ACE-inhibitors) and was also seen in normotensive patients. Only 0.4 % of the patients reported AEs.

CONCLUSION

In type 2 diabetics, treatment with 300 mg irbesartan administered alone or in combination with 12.5 mg HCT produced a pronounced nephroprotective effect.