Reuters reports this morning that Novartis International AG/Novartis has announced that the
Data Monitoring Committee for it’s ALTITUDE study has recommended early
termination of the study.
The ALTITUDE
study involved patients with type 2 diabetes and renal impairment (n= 8,606) at
high risk of cardiovascular and renal events. Details of the study design are shown here.
The study was a
phase 3 randomized, double-blind, placebo-controlled, parallel group study of
either aliskiren 300 mg once daily plus conventional therapy versus placebo on
top of conventional therapy.
The DMC identified higher adverse events when aliskiren (Rasilez/Tekturna) was added to an ACE or ARB drug in this patient population. In
the trial arm in which aliskiren 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.
Novartis is recommending that ALTITUDE
investigators remove aliskiren-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 aliskiren and combination therapies.
