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December 23, 2011 - Re-evaluation of Aliskiren-Containing Medicines after Halting of Study
The benefit-risk balance of aliskiren-containing medicines
(Rasilamlo, Rasilez HCT, Rasitrio, Riprazo HCT and Sprimeo HCT)
will be re-evaluated. This was the conclusion by the CHMP – the
scientific committee of the European Medicines Agency (EMA) – in
which the Medicines Evaluation Board (MEB) is represented, based on
a report that a study into a new use of aliskiren in diabetes
patients (ALTITUDE) was halted after the treated patients were
found to have a significantly higher number of cardiovascular and
renal adverse effects than the placebo group.
In view of this, the CHMP will re-evaluate the benefits and
risks of aliskiren-containing medicines within the approved
indication. Whilst awaiting this ruling, interim advice will be
given to physicians and diabetes patients about treatment with
these products.
Doctors are advised not to prescribe aliskiren-containing
medicines to diabetes patients in combination with ACE inhibitors
or ARBs (blood pressure lowering medication). For diabetes patients
who are using this combination, doctors should stop the treatment
with aliskiren and consider alternative methods of treatment.
Patients are advised not to halt the treatment without consulting
the prescribing physician, due to the health risks involved. They
are advised to discuss their treatment at the next appointment with
the physician.
Aliskiren is a blood pressure lowering product that is used –
alone or in combination with other products – in the treatment of
adult patients with essential hypertension. The study that was
halted examined whether aliskiren could reduce the risk of illness
and death due to cardiac, cardiovascular or renal complications in
type II diabetes patients with decreased renal function and/or
cardiovascular conditions. The majority of the patients in the
study had normal blood pressure.
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