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European review prompts warning against “dual blockade” of renin-angiotensin system

Patients with diabetes-related kidney disease should not be given the combination of an angiotensin-receptor blocker (ARB) and an angiotensin-converting enzyme (ACE) inhibitor, says a sub-committee of the European Medicines Agency.

Blood pressure check

Source: HywitDimyadi / Dreamstime.com

Blood pressure should be monitored when dual blockade is considered necessary

The advice is part of broader recommendations about the medicines that warn against so called “dual blockade” — the concomitant use of two classes of medicines that act on the renin-angiotensin system (RAS) at the same time. Direct renin inhibitors, such as aliskiren, are included in the advice, which has been put forward by the EMA’s Pharmacovigilance Risk Assessment Committee after a review of the evidence.

The review was triggered by the Italian medicines agency, which had concerns that combining the different classes could increase the risk of hyperkalaemia, low blood pressure and of worsening kidney function. 

The PRAC advice states that if dual blockade is absolutely necessary then it must be carried out under the supervision of a specialist with close monitoring of kidney function, fluid, salt balance and blood pressure. This includes the licensed use of candesartan and valsartan as add-on therapy to ACE-inhibitors in patients with heart failure who require such a combination.

However, it adds that the combination of aliskiren with an ARB or ACE inhibitor is “strictly” contraindicated in patients with kidney impairment or diabetes.

The recommendations from PRAC will now be considered by the Committee for Medicinal Products for Human Use, which will decide the EMA’s final opinion.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11137425

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