Novartis announced the termination of the ALTITUDE study in high-risk patients with diabetes and renal impairment.
The study was designed to determine if aliskiren could reduce cardiovascular and renal morbidity and mortality, compared with placebo, when added to conventional treatment (including ACEi or ARB).
Based on the recommendation from the Data Monitoring committee, it was felt patients were unlikely to benefit from aliskiren added in addition to standard therapy. More importantly, the aliskiren arm had more frequent adverse events, including non-fatal stroke, renal complications, hyperkalemia and hypotension.
The peer reviewed publication has not yet been published. The full text link provides the Novartis press release.
- Cardiorenal End Points in a Trial of Aliskiren for Type 2 Diabetes
- ACLASTA (zoledronic acid 5mg/100mL) solution for intravenous infusion – Association with renal dysfunction
- Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) in CKD Patients With Type-2 Diabetes