Dec 20, 2011 Shelley Wood from heartwire
Basel, Switzerland – An increase in adverse events and no apparent benefits among patients randomized to aliskiren (Rasilez/Tekturna, Novartis) in the ALTITUDE trial has prompted the data safety and monitoring board (DSMB) for the study to recommend its termination, the sponsor announced today [Novartis press release here].
ALTITUDE was studying aliskiren on top of ACE-inhibitor or angiotensin-receptor-blocker (ARB) therapy in patients with type 2 diabetes and renal impairment compared with a placebo add-on.
In making its recommendation, the DSMB noted that the active-treatment group experienced an increased incidence of nonfatal stroke, renal complications, hyperkalemia, and hypotension over 18 to 24 months of follow-up. The committee concluded that patients were unlikely to benefit from aliskiren on top of standard antihypertensive therapy.
“Novartis is in ongoing discussions with health authorities worldwide about the implications of the findings from ALTITUDE for patients,” a press release reads. “As a precautionary measure, Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE inhibitor or ARB.”
The company is also checking in with the DSMBs of other clinical studies studying aliskiren alone or in combination.
ALTITUDE investigators are being told to remove aliskiren from their patients’ treatment regimen and review their current blood-pressure medications; patients in ALTITUDE are advised to contact their doctors.
Earlier this year, positive results of the ACCELERATE trial looking at aliskiren in combination with a calcium-channel blocker were published in the Lancet. Last year the FDA approved both a dual- and triple- combination drug including aliskiren, but neither drug included an ACE inhibitor or ARB.
Original source: Heartwire
Novartis Press Release: ALTITUDE press release