Singapore, Dec 21, 2011: Global pharma company Novartis has announced that following the seventh interim review of data from the ALTITUDE study with Rasilez/Tekturna (aliskiren), a decision to terminate the trial has been taken on the recommendation of the independent Data Monitoring Committee (DMC) overseeing the trial.
The DMC concluded that patients were unlikely to benefit from treatment added on top of standard anti-hypertensives, and identified higher adverse events in patients receiving Rasilez/Tekturna in addition to standard of care in the trial. Specifically, in the trial arm in which Rasilez/Tekturna was added to the standard of care there was an increased incidence of non-fatal stroke, renal complications, hyperkalemia and hypotension in this high-risk study population after 18-24 months.
ALTITUDE was a multinational study in 8,606 patients from 36 countries evaluating the potential benefits of Rasilez/Tekturna to reduce the risk of cardiovascular and renal events in this patient population. The first randomized. Double-blind, placebo-controlled Phase III ALTITUDE study was the first trial to investigate Rasilez/Tekturna for more than one year in a specific population of patients with type 2 diabetes and renal impairment. These patients are known to be at high risk of cardiovascular and renal events. In the study, Rasilez/Tekturna was given in addition to optimal cardiovascular treatment including an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
Novartis is in ongoing discussions with health authorities worldwide about the implications of the findings from ALTITUDE for patients. As a precautionary measure Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE-inhibitor or ARB.
"Patient safety is the highest priority for Novartis, and we are in a dialogue with health authorities worldwide," said David Epstein, division head of Novartis Pharmaceuticals.
Novartis is recommending that ALTITUDE investigators remove Rasilez/Tekturna-based products from their patients' treatment regimen and review their high blood pressure medication. Novartis is also reviewing the findings with DMCs of other clinical studies involving Rasilez/Tekturna-based products and combination therapies.
Source:BioSpectrum Bureau