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news.Novartis, a healthcare solutions provider, has discontinued the Altitude study with Rasilez/Tekturna (aliskiren), on the recommendation of the independent Data Monitoring Committee (DMC) studying the trial.
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The first randomized double-blind placebo-controlled Phase III Altitude study included patients with type 2 diabetes and renal impairment, to evaluate Rasilez/Tekturna for more than one year in a specific population of patients with type 2 diabetes and renal impairment.
In the study, patients were treated with Rasilez/Tekturna in combination with an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB).
The study demonstrated that the trial arm in which Rasilez/Tekturna was added to the standard of care showed an increased incidence after 18-24 months of non-fatal stroke, renal complications, hyperkalemia and hypotension in the high-risk study population.
The committee reported that patients receiving Rasilez/Tekturna were unlikely to benefit from treatment added on top of standard anti-hypertensives, and also observed higher adverse events over standard of care.
Novartis is in discussions with health authorities worldwide about the implications of the findings from Altitude study, and as a precautionary measure it will stop promoting Rasilez/Tekturna-based products for use in combination with an ACE-inhibitor or ARB.