Novartis has prematurely halted the AlTITUDE study following an interim safety review. ALTITUDE was a trial of the direct renin inhibitor aliskiren (Rasilez®) in type 2 diabetes and renal impairment patients, with a high risk of cardiovascular and renal events, taking either an angiotensin receptor blocker (ARB) or an angiotension converting enzyme (ACE) inhibitor.
What’s the harm?
The independent Data Monitoring Committee (DMC) found no additional benefit of aliskiren when added to standard therapy. In addition, it was found the aliskiren treatment arm experienced an increased incidence of non-fatal stroke, renal complications, hyperkalemia and hypotension after 18-24 months of treatment.
Prior studies of aliskiren have been of relative short-term treatment, and have focused on falls in blood pressure rather than long-term outcome data. While many those studies have shown little difference in the occurance of serious ADRs between aliskiren and placebo, one study performed in diabetics taking an ACE inhibitor found an increase in the reate of hypokalaemia. Two small observational studies put forward in support of the use of aliskiren at stage 4 of the NICE/BHS hypertension guidelines, when the drug would likely be given with an ARB or an ACE inihibitor can now be discounted. In January 2010 [pdf] tthe Scottish Medicines Consortium failed to reccomend its use with NHS Scotland.
What should you do?
Prescribers should remain aware of the current NICE/BHS and SMC guidance on the treatment of hypertension with aliskiren, and be aware of this additional risk associated with the use of aliskiren when used in combination with ACE inhibitors or ARBs. Prescribers may also wish to review any patients currently co-prescribed aliskiren with ACE inhibitors or ARBs.
As aliskiren (Rasilez®) is a black triangle drug, any suspect adverse drug reactions should be reported on a Yellow Card.