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European Medicines Agency recommends against combining RAS-acting drugs
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The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has issued a recommendation against the combined use of different classes of medications acting on the renin-angiotensin system.
The drug classes mentioned in the recommendation include angiotensin receptor blockers, ACE inhibitors and direct renin inhibitors, according to a press release.
The combination of drugs from any two of the three classes should be avoided, particularly among patients with diabetic nephropathy, who should not receive ACE inhibitors and angiotensin receptor blockers in combination. In the event that a combination of medications from these classes is “absolutely necessary,” administration should be performed under the supervision of a specialist, and BP, kidney function and fluid and salt balance should be monitored. According to the release, this would apply to patients with HF treated with ACE inhibitors who require add-on therapy with candesartan or valsartan.
This recommendation follows a review conducted in 2012 that determined the combination of an ACE inhibitor or angiotensin receptor blocker with aliskiren could lead to adverse events related to the heart, kidneys and circulation. Reviewers concluded in 2012 that the combination of these drugs should not be recommended for any patient, and should be contraindicated in patients with moderate-to-severe kidney impairment or diabetes, according to the release.
The recent review also included results from studies of patients with pre-existing diabetes or CVD that indicated increased risk for kidney damage, low BP and hyperkalemia from ACE inhibitors and angiotensin receptor blockers administered in combination. The reviewers also observed no benefit from the administration of these medications in combination among patients without HF, with benefits outweighing risks only in a subgroup of patients with HF who were ineligible for other treatments, according to the release.
The Pharmacovigilance Risk Assessment Committee recommendation will be forwarded to the Committee for Medicinal Products for Human Use to issue the final opinion.