Novartis to drop Rasilez/Tekturna in high-risk patients with diabetes and renal impairment

In a major disappointment for Swiss drug major Novartis (NOVN: VX), the company says that, following the seventh interim review of data from the ALTITUDE study with Rasilez/Tekturna (aliskiren), it has decided to terminate the trial in high-risk patients with diabetes and renal impairment 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 after 18-24 months of non-fatal stroke, renal complications, hyperkalemia and hypotension in this high-risk study population.

The placebo-controlled Phase III ALTITUDE study is 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).

Will stop promoting the drug for use with ACU or ARBs