Aliskiren trial halted due to adverse effects
MedWire News: The ALTITUDE trial has been halted due to an increase in adverse events and no apparent benefits among patients treated with the direct renin inhibitor aliskiren.
The decision to terminate the trial came after a recommendation from the independent data monitoring committee overseeing the trial, states the trial's sponsor, Novartis.
The placebo-controlled double-blind phase III ALTITUDE study included 8606 patients with Type 2 diabetes and renal impairment. Patients were randomly allocated to receive treatment with aliskiren 300mg once daily or placebo, on top of optimal cardiovascular treatment using an ACE inhibitor or angiotensin receptor blocker.
In patients who were treated with aliskiren in combination with standard treatment, there was a significantly increased incidence of nonfatal stroke, renal complications, hyperkalemia, and hypotension after 18-24 months of follow-up.
The Committee therefore concluded that patients were "unlikely to benefit" from aliskiren therapy.
The drug was approved for use in the EU and USA under the brand names Rasilez and Tekturna, respectively, for the treatment of hypertension either as monotherapy or in combination with other medications, in 2007.
At present, Novartis is participating in ongoing discussions with health authorities worldwide about the implications of the findings from the ALTITUDE trial. As a precaution, they have ceased the promotion of aliskiren-based products.
The company has also recommended that the trial investigators remove aliskiren-based medications from their patients' treatment regimens and review their antihypertensive medications.
In addition, it is reviewing the findings with data monitoring committees of other clinical studies involving aliskiren and combination therapies.
Patients taking part in the trial have been advised to contact their study site for guidance.
"Patient safety is the highest priority for Novartis, and we are in a dialogue with health authorities worldwide," commented David Epstein, Division Head of Novartis Pharmaceuticals, in a press statement.
MedWire (http://www.medwire-news.md/) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012
By Piriya Mahendra