The European Medicines Agency is reviewing aliskiren-containing medicines, to assess the impact of data coming from the ALTITUDE study on the balance of benefits and risks of these medicines in their approved indication.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) started the review after it was informed by the company of the decision to terminate the ALTITUDE study early. This placebo-controlled phase III trial included patients with type 2 diabetes and renal impairment and/or cardiovascular disease. In most patients blood pressure was adequately controlled. The patients in the trial received aliskiren in addition to either an ACE inhibitor or an angiotensin receptor blocker (ARB). Termination of the trial was recommended by the independent Data Monitoring Committee because the results showed that there was no benefit with aliskiren and that there were more cases of stroke, renal complications, hyperkalemia and hypotension in patients who received aliskiren compared with patients who received a placebo.
The information available at present is limited. The Committee has asked the company to provide additional analyses to allow the CHMP to assess the impact of these findings on the overall benefit-risk profile of aliskiren-containing medicines and to determine the need for regulatory action. While the review is ongoing the CHMP recommends the following precautionary measures:
• 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 (non-urgent) appointment, and if patients are diabetic and are also taking ACE inhibitors or ARBs, aliskiren should be stopped and alternative treatments considered.
• Patients should not stop any of their treatment before speaking to their doctor.
• Patients in clinical trials with aliskiren should contact their study site for guidance on their medication.
Further information on the review of aliskiren-containing medicines will be provided when available.