The Danish Medicines Agency’s recommendations while the review is ongoing
Yesterday, the European Medicines Agency (EMA) started reviewing the benefits and risks of blood pressure medicines that contain aliskiren.
EMA started the review in response to new data on the benefits and risks from a major clinical study known as the ALTITUDE study.
The company behind the study (Novartis) has just informed EMA that it is terminating the placebo-controlled study earlier than planned because the study results had shown no benefit of treatment and more cases of apoplexies (strokes), renal complications, hyperkalemia (high potassium levels in the blood) and hypotension (low blood pressure) in patients treated with aliskiren.
The ALTITUDE trial studied the effect of aliskiren compared to a placebo in patients with type 2 diabetes and renal impairment and/or cardiovascular disease whose blood pressure was adequately controlled. The patients in the trial received aliskiren in addition to either an ACE inhibitor or an angiotensin II antagonist.
The presently available information on the unexpected findings is limited, and EMA has asked for further data and analyses to allow EMA to better assess the benefits and risks of aliskiren and to make a decision on any possible outcomes.
Until EMA has made a final decision, the Danish Medicines Agency recommends doctors not to prescribe aliskiren-containing medicines to patients with type 2 diabetes who are receiving an ACE inhibitor or an angiotensin II antagonist at the same time.
Furthermore, doctors are advised to review the treatment of patients with type 2 diabetes who already take aliskiren in combination with an ACE inhibitor and/or an angiotensin II antagonists at the patient’s next routine appointment.
Based on the present knowledge, the Danish Medicines Agency does not find that there is cause to review the patients’ treatment urgently.
In Denmark, there are presently about 5,000 patients who are treated with aliskiren. The Danish Medicines Agency assesses that only very few of these patients have type 2 diabetes and are treated concomitantly with an ACE inhibitor and/or an angiotensin II antagonist, like the patients participating in the ALTITUDE study. Aliskiren is contained in the medicines Rasilez® and Rasilez® HTC.
Patients treated with either of the above medicines are advised not to stop treatment without first having discussed it with their doctor.
Danish patients who have participated in the ALTITUDE study must contact the hospital department which included them in the study.
Link to EMA's press releases: European Medicines Agency starts review of aliskiren-containing medicines following termination of ALTITUDE study.