Tekturna (Novartis) fails ALTITUDE study in Diabetic Hypertensive patients with Renal Impairment

Tekturna/Rasilez (aliskiren) from Novartis has failed to show a benefit in target organ protection which has resulted in the early closure of the Phase III ALTITUDE study by reason of safety concerns. The 8,606-patient trial was assessing the effects of adding aliskiren to standard antihypertensive treatment in patients with Type 2 Diabetes and RenalImpairment. Researchers found a higher rate of adverse events in study arm receiving Tekturna on top of and ACE inhibitor or ARB during its seventh interim review of the data. There were higher levels of non-fatal stroke, renal complications, hyperkalaemia, and hypotension after 18-24 months with aliskiren in this patient population which is already at an increased risk of cardiovascular and renal events. Novartis said it was stopping promotion of aliskiren-based products for use in combination with an ACE inhibitor or angiotensin II receptor blockers (ARB) as a precaution.