Avoid aliskiren with ACE inhibitors and ARBs
People with diabetes should not be prescribed aliskiren in combination with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-II receptor blockers (ARBs), according to advice issued last month by the European Medicines Agency.
The recommendation follows early termination of the ALTITUDE study, which was designed to investigate the effect of adding aliskiren to standard care — including an ACE inhibitor or ARB — for patients with type 2 diabetes and a high risk of cardiovascular and renal events.
According to the manufacturer Novartis, the phase-III study has been halted because interim results showed that treatment with aliskiren offered no benefit, and was associated with more cases of non-fatal stroke, renal complications, hyperkalaemia and hypotension, compared with placebo.
The EMA has announced plans to review all aliskiren products and, until the results of this review are available, it has recommended that:
- Aliskiren-containing medicines should not be prescribed to diabetic patients who are also taking an ACE inhibitor or an ARB
- Prescribers should review patients taking aliskiren at a routine (non-urgent) appointment and, if patients are diabetic and are also taking ACE inhibitors or ARBs, aliskiren should be stopped and alternative treatments considered
Helen Williams, consultant pharmacist for cardiovascular disease in south London, said that the results of the ALTITUDE study are not entirely unexpected: “Previous studies of dual inhibition of the renin-angiotensin system (ACE inhibitor plus ARB) have reported increased adverse effects — specifically, hypotension and renal dysfunction — and no benefit.”
An anomaly, she told Clinical Pharmacist, is the unexplained increased risk of stroke for those patients treated with aliskiren plus an ACE inhibitor or an ARB. “There has been speculation that this may be due to excessive lowering of blood pressure in those patients receiving the combination therapy but, because the detailed results of the study have not yet been published, this is difficult to confirm,” Ms Williams added.
“Outside of the setting of heart failure, there is little evidence to support dual inhibition of the renin-angiotensin system and it should generally be avoided,” she concluded.
Citation: Clinical Pharmacist URI: 11092886
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