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The aim of this post hoc analysis was primarily to evaluate the effect of irbesartan treatment on the biomarker levels and, secondarily, to investigate whether the favorable effect of irbesartan on urinary albumin excretion rate seen in the principal study was associated with changes in one or more biomarkers.
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In studies of hypertensive patients, there is no sex difference in half-life or accumulation, but somewhat higher plasma concentrations of Irbesartan are observed in females (11% to 44%).
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Secondary endpoints and subgroup analyses also suggested no benefit of irbesartan over placebo in this patient group.
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Coadministration of AVALIDE with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result hyperkalemia, sometimes severe.
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Treatment with irbesartan also reduced the occurrence of sustained doubling of serum creatinine as a separate endpoint (33%), but had no significant effect on ESRD alone and no effect on overall mortality (see Table 1).
If a patient discontinued treatment before the end of the study, the last measurement prior to removal from the trial was carried forward for analysis.
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