Aliskiren Warning for People with Diabetes   (April 26, 2012))

"Do not use with angiotensin receptor blockers (ARBs) or ACE inhibitors(ACEI) in patients with diabetes." Pretty strong words, and part of the newly-revised label for a blood-pressure drug called aliskiren.

Aliskiren is a drug in a class called renin inhibitors, and is sold for the treatment of hypertension, to lower blood pressure (BP). By itself, it's okay to use, but it could be supposed that many physicians caring for PWD with kidney disease who have been on either ARBs or ACEIs (which are standard drugs for PWD with impaired kidney function) might have been tempted to add aliskiren while continuing the previous ARB or ACEI drug. A recent study says that's not a wise idea.

In a company-sponsored study called ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints), patients with diabetes and renal disease (defined either by the presence of urine protein or reduced function as measured by GFR) were randomized to aliskiren (N=4283) or placebo (N=4296); all patients in the study were receiving background therapy with either an ARB or ACEI. The ALTITUDE trial "was terminated early for lack of efficacy and higher incidence of adverse events compared to placebo in this high risk population" according to the manufacturer.

The big concern really was the observation of a higher risk of kidney damage, and hypotension (low BP) and hyperkalemia (high potassium levels) which were seen in patients treated with aliskiren compared to those patients treated with placebo.

TEKTURNA, TEKTURNA HCT, TEKAMLO, and AMTURNIDE are brand names for aliskiren. There's also a combination pill, Valturna® (aliskiren plus the ARB valsartan), which the manufacturer will voluntarily stop selling.

If you, or someone you know, are taking several blood pressure drugs at the same time, check with your pharmacist or physician or diabetes nurse educator to find out if any of them contains aliskiren. If so, alternate BP therapy should be started as soon as reasonably possible.