New Data on Risks when Renin Inhibitor Aliskiren (Rasilez) is Used With ARBs or ACE Inhibitors

April 21, 2012

The US Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing Aliskiren (Rasilez) with angiotensin converting enzyme(ACE) inhibitors and angiotensin receptor blockers (ARBs) in patients with diabetes or renal impairment.

These drug combinations should not be used in patients with diabetes. In addition, a new warning is being added to avoid use of these drug combinations in patients with renal impairment.

In ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints) study, the risks of renal impairment, hypotension, and hyperkalemia in a group of patients taking Aliskiren plus an ARB or ACE inhibitor increased relative to a group of patients taking an ARB or ACE plus placebo.

The preliminary data from ALTITUDE also demonstrated a slight excess of cardiovascular events (death or stroke) in the Aliskiren group. However, the FDA has reached no definite conclusion regarding an actual link between these drugs and death or stroke.

The FDA will evaluate the final trial results as well as results from other Aliskiren trials and will communicate any new information when it becomes available.

The following recommendations are being added to the drug labels:
• A new contraindication against the use of Aliskiren with ARBs or ACE inhibitors in patients with diabetes because of the risk of renal impairment, hypotension, and hyperkalemia.
• A warning to avoid use of Aliskiren with ARBs or ACE inhibitors in patients with moderate to severe renal impairment (i.e., glomerular filtration rate <60 mL/min).

The purpose of ALTITUDE study was to determine whether Aliskiren plus conventional treatment reduces death and disease caused by the heart, the circulatory system, and the kidney. Patients with type 2 diabetes with renal disease were randomized to Aliskiren 300 mg daily (n = 4,283) or placebo (n = 4,296). All patients were receiving concomitant therapy with an ARB or an ACE inhibitor.

The primary efficacy outcome was the time to the first event of the primary composite endpoint, which consisted of cardiovascular death, resuscitated sudden death, non-fatal myocardial infarction, non-fatal stroke, unplanned hospitalization for heart failure, onset of end-stage renal disease, renal death, and doubling of serum creatinine concentration from baseline sustained for at least 1 month.

After a median patient follow up of about 27 months, the trial was terminated early for lack of efficacy. Greater risks of renal impairment, hypotension and hyperkalemia were observed in the Aliskiren group compared with the placebo group.



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