Aliskiren diabetes advice

The European Medicines Agency (EMA) has advised that the direct renin inhibitor, aliskiren (Rasilez), should not be prescribed in combination with angiotensin-converting-enzyme (ACE) inhibitors or angiotensin II antagonists in patients with diabetes.

Renin complexed with an inhibitor. | SCIENCE PHOTO LIBRARY
Renin complexed with an inhibitor. | SCIENCE PHOTO LIBRARY

Routine (non-urgent) review is recommended in patients taking aliskiren. The drug should be stopped in patients with diabetes who are taking an ACE inhibitor or angiotensin II antagonist and alternative antihypertensive treatment should be considered.

Patients in clinical trials of aliskiren should contact their study site for guidance.

ALTITUDE study

These recommendations follow the release of preliminary results from the ALTITUDE trial, which involved 8606 patients with type 2 diabetes at high risk of cardiovascular and renal events. Patients received aliskiren 300mg plus an ACE inhibitor or angiotensin II antagonist. The four-year study was terminated early because aliskiren displayed a lack of efficacy in preliminary analyses and a high incidence of adverse events was observed including non-fatal stroke, renal complications, hyperkalaemia and hypotension.

Updated 27 April 2012

MHRA issues further advice

The MHRA has issued further advice concerning the use of aliskiren in combination with angiotensin-converting-enzyme (ACE) inhibitors or angiotensin II antagonists.

This combination is now contraindicated in all patients with an estimated glomerular filtration rate (eGFR) ≤60ml/min/1.73m2, with or without diabetes.

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