European Medicines Agency recommends new contraindications and warnings for aliskiren-containing medicines

 

Combination of aliskiren with ‘ACE’ inhibitors and ‘ARBs’ no longer recommended for patients; contraindications in patients with diabetes or kidney problems

 

London, UK, (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. ‘Essential’ means that there is no obvious cause for high blood pressure.

 

 

Advice for doctors and patients

 

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.

 

 

Notes

 

  • A European Commission decision on this opinion will be issued in due course.
  • Eight aliskiren-containing medicines are authorised in the European Union (EU) since 2007: Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Riprazo, Riprazo HCT, Sprimeo and Sprimeo HCT. Some of these medicines (Rasilamlo, Rasilez HCT, Rasitrio, Riprazo HCT and Sprimeo HCT) are combinations of aliskiren with other antihypertensive medicines. Aliskiren-containing medicines are available as tablets and marketed in all EU Member States, except Estonia, Latvia, Lithuania and Romania.
  • The review of aliskiren was conducted in the context of a formal review, initiated at the request of the European Commission under Article 20 of Regulation (EC) No 726/2004.

 


 

European Medicines Agency, 17.02.2012 (tB).

MEDICAL NEWS

Fitness watches generate useful information, but increase patient anxiety
A new device provides added protection against COVID-19 during endoscopic…
81 million Americans lacking space or bathrooms to follow COVID…
Front-line physicians stressed and anxious at work and home
EULAR: High-Dose Glucocorticoids and IL-6 Receptor inhibition can reduce COVID-19…

SCHMERZ PAINCARE

Morbus Fabry mittels Datenanalysen aus dem PraxisRegister Schmerz aufspüren
Neandertaler besaßen niedrigere Schmerzschwelle
Deutscher Schmerz- und Palliativtag 2020 – ONLINE
Deutsche Gesellschaft für Schmerzmedizin fordert Anerkennung von Nicht-Psychologen in der…
DBfK: Besondere Rolle für Pflegeexpert/innen Schmerz – nicht nur in…

DIABETES

“Körperstolz”: Michael Krauser managt seinen Diabetes digital
Der richtige Sensor – von Anfang an
Diabetes mellitus: Ein Risikofaktor für frühe Darmkrebserkrankungen
Fastenmonat Ramadan: Alte und neue Herausforderung für chronisch Erkrankte während…
Sanofi setzt sich für die Bedürfnisse von Menschen mit Diabetes…

ERNÄHRUNG

Corona-Erkrankung: Fehl- und Mangelernährung sind unterschätze Risikofaktoren
Gesundheitliche Auswirkungen des Salzkonsums bleiben unklar: Weder der Nutzen noch…
Fast Food, Bio-Lebensmittel, Energydrinks: neue Daten zum Ernährungsverhalten in Deutschland
Neue Daten zur Ernährungssituation in deutschen Krankenhäusern und Pflegeheimen: Mangelernährung…
Baxter: Parenterale Ernährung von Patienten mit hohem Aminosäurenbedarf

ONKOLOGIE

Darolutamid bei Prostatakarzinom: Hinweis auf beträchtlichen Zusatznutzen
Multiples Myelom: Wissenschaftler überprüfen den Stellenwert der Blutstammzelltransplantation
Neues zur onkologischen Supportiv- und Misteltherapie und aktuelle Kongress-Highlights zum…
Finanzierung der ambulanten Krebsberatung weiterhin nicht gesichert
Lungenkrebsscreening mittels Low-Dose-CT

MULTIPLE SKLEROSE

Geschützt: Multiple Sklerose: Novartis’ Siponimod verzögert Krankheitsprogression und Hirnatrophie bei…
Neurofilamente als Diagnose- und Prognosemarker für Multiple Sklerose
Bedeutung der Langzeittherapie bei Multipler Sklerose – mehr Sicherheit und…
Bristol Myers Squibb erhält Zulassung der Europäischen Kommission für Ozanimod…
Einige MS-Medikamente könnten vor SARS-CoV-2/COVID-19 schützen

PARKINSON

Neue Studie zur tiefen Hirnstimulation bei Parkinson-Erkrankung als Meilenstein der…
Putzfimmel im Gehirn
Parkinson-Patienten in der Coronakrise: Versorgungssituation und ein neuer Ratgeber
Neuer Test: Frühzeitige Differenzialdiagose der Parkinson-Erkrankung
Gegen das Zittern: Parkinson- und essentiellen Tremor mit Ultraschall behandeln…