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* The antihypertensive drug aliskiren (Tekturna) and products containing this drug shouldn't be coadministered with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers if the patient has diabetes or renal impairment.
* Clinical trial data indicated that there were increased risks of renal impairment, hypotension, and hyperkalemia when these combinations were used in the treatment of patients with diabetes and renal insufficiency.
Aliskiren is an antihypertensive medication that inhibits the production of renin. The Food and Drug Administration (FDA) recently issued new warnings that aliskiren (Tekturna) and products containing aliskiren-Amturnide, Tekturna HCT, Tekamlo, and Valturna (Valturna has been recalled; marketing of this product will stop after July)-shouldn't be coadministered with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) if the patient has diabetes or renal impairment. ACE inhibitors and ARBs are both used in the treatment of hypertension.
The labels are being updated as a result of preliminary data from the Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE). In ALTITUDE, the risks of renal impairment, hypotension, and hyperkalemia in a group of patients taking aliskiren plus an ARB or ACE inhibitor increased, in comparison with a group of patients taking placebo with an ARB or ACE inhibitor. There was also a slightly higher rate of cardiovascular events (death or stroke) in the aliskiren group. However, the FDA hasn't reached a definitive conclusion regarding an actual link between these drugs and death or stroke. The agency says it will "evaluate the final trial results," as well as results from other aliskiren trials, and "communicate any new information when it becomes available."
These drug label revisions state that aliskiren taken in combination with an ACE inhibitor or an ARB is contraindicated if the patient has diabetes and that the drug shouldn't be used if the patient's glomerular filtration rate is less than 60 mL/min.
Nurses should be aware of these warnings. The medical and drug history of patients scheduled to start therapy with aliskiren or products containing aliskiren should be carefully assessed to determine whether the patients have diabetes or moderate-to-severe renal impairment or are already taking an ACE inhibitor or an ARB. To read the FDA Drug Safety Communication regarding these label changes, go to http://1.usa.gov/HY3VrE.
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