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Researchers terminate trial examining aliskiren in high-risk patients
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Novartis recently announced its decision to halt a trial assessing the safety and efficacy of aliskiren for treatment of hypertension in patients with type 2 diabetes and renal impairment who are at high risk for cardiovascular and renal events, according to a press release.
After the seventh interim review of data from the placebo-controlled, phase 3 Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE), the independent Data Monitoring Committee overseeing the trial concluded that patients were unlikely to benefit from treatment added to standard antihypertensives. The committee also noted a higher adverse event rate in these high-risk patients receiving aliskiren (Rasilez/Tekturna, Novartis) combined with standard care. Specifically, the committee highlighted an increased incidence of nonfatal stroke, renal complications, hyperkalemia and hypotension among those who had received 18 to 24 months of treatment with aliskiren as well as standard therapy.
In ALTITUDE, patients with type 2 diabetes and renal impairment received treatment with aliskiren in addition to optimal CV treatment, including an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin-receptor blocker (ARB).
Novartis announced that it is in ongoing discussions with health authorities worldwide regarding findings from ALTITUDE and will cease promotion of aliskiren-based products for use in combination with ACE inhibitors or ARBs. Further, the company is reviewing findings with Data Monitoring Committees of other clinical studies involving aliskiren-based products and combination therapies.
Novartis also recommends that ALTITUDE investigators remove aliskiren-based products from their patients’ treatment regimens and review their hypertension medications. The company urges patients in ALTITUDE to contact their study site for guidance on medication and should not stop treatment until they have consulted with their physician.
“Patient safety is the highest priority for Novartis, and we are in a dialogue with health authorities worldwide,” David Epstein, division head of Novartis, said in the press release.
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