Novartis has issued new safety information for aliskiren (Rasilez™) following interim results from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE). The data suggest a higher incidence of adverse events related to non-fatal stroke, renal complications, hyperkalaemia and hypotension in this high-risk population. Analyses of these data are ongoing, however, in the meantime as a precautionary measure, the following recommendations have been advised:
 

Routine (non-urgent) review is recommended for patients taking aliskiren-containing medicines.

• Aliskiren or aliskiren-containing fixed combination products should not be used in combination with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) in patients with diabetes, therefore:

• Healthcare professionals should stop aliskiren-containing treatment in patients who are diabetic and also taking an ACE inhibitor or an ARB. Alternative antihypertensive treatment should be considered as necessary.

• Aliskiren-containing products should not be initiated in diabetic patients who are also taking either an ACE inhibitor or ARB.

• Patients should not stop any treatment before discussing with a healthcare professional.

Additional analyses from ALTITUDE are ongoing and updated advice may be issued early in 2012.