Risky business: Diabetic Clinical Trial Ends Abruptly
Late last year Novartis announced termination of ALTITUDE study with Rasilez®/ Tekturna® in high-risk patients with diabetes and renal impairment; 8,609 patients from 36 countries were involved.
There was an increased incidence after 18-24 months of non-fatal stroke, kidney complications, hyperkalemia (high potassium levels) and hypotension (low blood pressure) in the diabetic high-risk study population.
According to the press release put out by Novartis, following the seventh interim review of data from the ALTITUDE study with Rasilez®/Tekturna®, a decision to terminate the trial has been taken on the recommendation of the independent Data Monitoring Committee (DMC).
The DMC noted 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.
As a precautionary measure Novartis will cease promotion of Rasilez/Tekturna-based products for use in combination with an ACE-inhibitor or ARB.
Patients involved in the ALTITUDE study should have contacted their study site for guidance on medication but should not stop treatment until they have seen a doctor who can help control high blood pressure.
Michael Monheit is the managing lawyer at Monheit Law near Philadelphia, PA. He has practiced law since 1989. Monheit was the managing attorney of the law offices of Herbert Monheit, a firm founded by Herbert Monheit in 1963. He is also the managing... Michael Monheit→