CHMP foreslog derfor, at indikationen skulle ændres til “ Behandling af nyresygdom hos patienter med hypertension og type II - diabetes mellitus med proteinuri > 0, 5 g/ dag som led i en antihypertensiv behandling ”, således at den ville stemme overens med inklusionskriterierne i RENAAL- undersøgelsen.
Therefore, the CHMP proposed that the indication should be re-worded to “ Treatment of renal disease in patients with hypertension and Type II diabetes mellitus with proteinuria > 0.5g/ day as part of an antihypertensive treatment” to reflect the inclusion criteria of the RENAAL study.