EMA Recommends New Contraindications and Warnings for Aliskiren-Containing Medicines | DocGuide

Source: DGNews
EMA Recommends New Contraindications and Warnings for Aliskiren-Containing Medicines

LONDON – February 17, 2012 -- The European Medicines Agency finalised a review
of aliskiren-containing medicines, recommending that these medicines should be
contraindicated in patients with diabetes or moderate to severe renal
impairment who take angiotensin converting enzyme (ACE) inhibitors or
angiotensin receptor blockers (ARBs). In addition, the Agency recommended the
inclusion of a warning that the combination of aliskiren and ACE inhibitor or
ARB is not recommended in all other patients because adverse outcomes cannot be
excluded.

Aliskiren-containing medicines are approved for the treatment of essential
hypertension.

Doctors should stop prescribing aliskiren-containing medicines to patients with
diabetes (type 1 or type 2) or with moderate to severe kidney impairment who
are also taking an ACE inhibitor or ARB, and should consider alternative
antihypertensive treatment as necessary.

For all other patients receiving aliskiren-containing medicines in combination
with an ACE inhibitor or an ARB, the balance of benefits and risks of
continuing treatment should be considered carefully.

Patients should discuss their treatment with their doctor at their next
scheduled (non-urgent) appointment. They 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.

Patients in clinical trials with aliskiren should contact their study site for
guidance on their medication.

The recommendations follow a review of all available safety data by the
Agency’s Committee for Medicinal Products for Human Use (CHMP). The review
was started in December 2011 after the Agency was informed by the marketing
authorisation holder 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, arterial
blood pressure was adequately controlled. The patients included in the trial
received aliskiren in addition to either an ACE inhibitor or an ARB.

Although the information available at the time was limited, the CHMP gave
interim recommendations in December 2011, advising doctors that they should not
prescribe aliskiren-containing medicines to diabetic patients in combination
with ACE inhibitors or ARBs.

Since then further data and analyses from the ALTITUDE study, alongside all
data from other studies and spontaneous reports of suspected adverse drug
reactions, have become available and were reviewed by the CHMP. The data
suggest a risk of adverse outcomes (hypotension, syncope, stroke, hyperkalaemia
and changes in renal function, including acute renal failure) when aliskiren is
combined with ACE inhibitors or ARBs, especially in diabetic patients and those
with impaired renal function. Although less evidence is available for other
patient groups, adverse outcomes cannot be excluded and therefore the
CHMP no longer recommends the use of this combination.

Healthcare professionals in the European Union will receive a letter shortly to
inform them of the changes to the prescribing information for
aliskiren-containing medicines.

SOURCE: European Medicine’s Agency