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Prescribing Advice for GPs

An NHS Prescribing Advisers' Blog

Review of aliskiren announced

The European Medicines Agency has announced a review of the benefits and risks of aliskiren (Rasilez®) after the ALTITUDE Study was terminated early.

ALTITUDE was terminated on the recommendation of the data monitoring committee after a higher rate of adverse events was noted among the study participants. The study recruited 8,606 patients with type 2 diabetes at high risk of adverse heart and kidney events. In most patients, blood pressure was adequately controlled before participation in the study. Aliskiren at a dose of 300mg daily or placebo was added into existing therapy with either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). The primary outcome for the study was a composite endpoint of cardiovascular death, resuscitated death, myocardial infarction, stroke, unplanned hospital admission for heart failure, onset of end-stage renal disease or doubling of baseline serum creatinine concentration.

The interim analysis found no benefit from treatment with aliskiren and a higher incidence of non-fatal stroke, kidney complications, hyperkalaemia and hypotension. Regulatory agencies have made the following interim recommendations:

  • Clinicians should not prescribe aliskiren-containing medicines to diabetic patients in combination with ACE inhibitors or ARBs
  • Clinicians should review the treatment of patients taking aliskiren at a routine appointment, and if patients are diabetic and are also taking ACE inhibitors or ARBs, aliskiren should be stopped and alternative treatments considered
  • Patients are advised to discuss their treatment with their doctor at their next scheduled appointment
  • Patients in clinical trials with aliskiren should contact their study site for guidance on their medication
  • Patients who have any questions or concerns about their treatment should speak to their doctor or pharmacist at a routine appointment

Action: Clinicians should be aware of this review and implement the interim recommendations. Further details will be published as the review progresses. Clinicians should report any adverse events related to aliskiren through the Yellow Card reporting system.

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2 Comments to “Review of aliskiren announced”

  1. [...] regarding the new contraindications and cautions added to aliskiren (Rasilez®) after a recent study found no benefit and an increased risk of harm when this drug was used in combination with either [...]

    Pingback by Prescribing Advice for GPs » Drug Safety Update – March 2012 — March 9, 2012 #

  2. [...] ALTITUDE Study was recently stopped early due to a higher rate of adverse events occurring in the treated study participants. [...]

    Pingback by Prescribing Advice for GPs » Aliskiren review completed — February 20, 2012 #

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