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Novartis has decided to conclude the Altitude study with Rasilez/Tekturna (aliskiren), on the recommendation of the independent data monitoring committee overseeing the trial.
The committee said that patients receiving Rasilez/Tekturna were unlikely to benefit from treatment added on top of standard anti-hypertensives, and identified higher adverse events compared to the standard of care.
In the first randomised, double-blind and placebo-controlled Phase III Altitude study, patients with type 2 diabetes and renal impairment were given Rasilez/Tekturna along with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker.
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 company is in a dialogue with health authorities worldwide about the implications of the findings from Altitude for patients, and as a precautionary measure it will stop promoting Rasilez/Tekturna-based products for use in combination with an angiotensin converting enzyme inhibitor or angiotensin receptor blocker.
Study investigators have been recommended to remove Rasilez/Tekturna-based products from patients’ treatment regimens and review their high blood pressure medication by Novartis.
The company said total sales of Rasilez/Tekturna-based products for the first nine months of 2011 were $449m, and are expected to be negatively impacted by the study results.
In previous clinical studies, the efficacy and safety of Rasilez/Tekturna have been investigated in more than 57,000 patients.
Caption: Novartis terminates clinical study with Rasilez/Tekturna in diabetic patients.