Naar aanleiding van het vervroegd stopzetten van de ALTITUDE studie, waarin het bloeddrukverlagend middel aliskiren werd onderzocht, gaat de EMA (European Medicines Agency) de voor- en nadelen van aliskiren op een rij zetten. In de ALTITUDE studie werden patiënten met type 2 diabetes en nierinsufficiëntie en/of hart- en vaatziekten behandeld met aliskiren naast behandeling met een ACE-remmer of een AII-receptor antagonist. In de groep die aliskiren kreeg werden geen voordelen van de behandeling gezien terwijl er wel meer gevallen van beroertes, renale complicaties, hyperkaliëmie en hypotensie werden waargenomen.

Als voorzorgsmaatregel adviseert de EMA om bij type 2 diabeten tot nader orde geen aliskiren voor te schrijven indien zij ook ACE-remmers of AII-receptor antagonisten gebruiken. Voor patiënten die deze combinatie reeds gebruiken wordt geadviseerd dit met hun behandelaar te bespreken en wordt geadviseerd om alternatieven te overwegen.

Het volledige persbericht:

European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study

Interim advice while review is ongoing

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.

Aliskiren-containing medicines are approved for the treatment of essential hypertension. ‘Essential’ means that there is no obvious cause for high blood pressure.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) started the review after it was informed on 19 December 2011 by the marketing authorisation holder of the decision to terminate the ALTITUDE study early. This clinical trial included patients with type 2 diabetes and renal impairment and/or cardiovascular disease. In most patients arterial blood pressure was adequately controlled. The patients included in the trial received aliskiren in addition to either an angiotensin converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB).

Termination of the placebo-controlled phase III trial was recommended by the independent Data Monitoring Committee overseeing the study, 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 the results of the ALTITUDE trial on the overall benefit-risk profile of aliskiren-containing medicines and to determine the need for regulatory action.

Interim advice for doctors and patients

While the review is ongoing the CHMP recommends, as a precautionary measure, that doctors should not prescribe aliskiren-containing medicines to diabetic patients in combination with ACE inhibitors or ARBs.

Doctors should therefore 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, because stopping anti-hypertensive medication without medical supervision can put them at risk. They are advised to discuss their treatment with their doctor at their next scheduled (non-urgent) appointment.

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.

Bron: www.ema.europe.eu