European Medicines Agency concludes that benefit-risk balance of angiotensin II receptor antagonists remains positive

Review of evidence does not suggest any link with cancer

 

London, United Kingdom (October 20, 2011) – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reviewed the possible link between the use of angiotensin II receptor antagonists (ARBs) and the occurrence of new cancers and concluded that the evidence does not support any increased risk of cancer in patients using these medicines.

 

Angiotensin II receptor antagonists have been authorised in the European Union since the mid-1990s for the treatment of hypertension (high blood pressure). They are also used in the treatment of conditions such as heart failure and kidney disease in type 2 diabetes and for the prevention of strokes and heart disease.

 

The review was formally requested by the Italian Medicines Agency following the publication of a meta-analysis which showed a small increased risk of new cancers (particularly lung cancer) with ARBs compared with placebo and other heart medicines (7.2% versus 6%).

 

The CHMP reviewed all available data on the risk of cancer in patients taking ARBs, including the meta-analysis. It found that the evidence from the meta-analysis was weak, noting several problems with the quality of the data, specifically that patients in the trials were not followed up for long enough to clearly establish a link between ARBs and cancer, information on the risk of cancer before start of treatment was lacking, and there was a possibility of publication bias, whereby studies that showed a link with cancer were more likely to have been included in the analysis.

 

The CHMP also reviewed data from large population-based studies and more complete meta-analyses that did not have the same methodological problems as the original meta-analysis, and the results did not show an increased risk of cancer with ARBs.

 

As with all medicines, the safety of ARBs will be continuously monitored by EU regulatory authorities.

 

 

Notes

 

All other opinions and documents adopted by the CHMP at its October 2011 plenary meeting will be published on Friday, 21 October 2011 at 12.00 noon UK time on a dedicated webpage.

 

Meta-analysis by: Sipahi I, Debanne SM, Rowland DY, Simon DI, Fang JC. Angiotensin-receptor blockade and risk of cancer: meta-analysis of randomised controlled trials. Lancet Oncol. 2010 Jul;11(7):627-36.

 

Several angiotensin II receptor antagonists are authorised in the European Union: candesartan, eprosartan, irbesartan, losartan, olmesartan, valsartan and telmisartan. Of these, irbesartan, telmisartan and valsartan are authorised through the centralised authorisation procedure managed by the European Medicines Agency.

 

The review of angiotensin II receptor antagonists was conducted in the context of a formal review, initiated at the request of the Italian Medicines Agency under Article 5(3) of Regulation (EC) No 726/2004

 

 


European Medicines Agency (EMA), 20.10.2011 (tB).

MEDICAL NEWS

Inadequate sequencing of SARS-CoV-2 variants impedes global response to COVID-19
New meta-analysis finds cannabis may be linked to development of…
New guidance on how to diagnosis and manage osteoporosis in…
Starting the day off with chocolate could have unexpected benefits
Better mental health supports for nurses needed, study finds

SCHMERZ PAINCARE

Versorgung verbessern: Deutsche Gesellschaft für Schmerzmedizin fordert die Einführung des…
Pflegeexpertise im Fokus: Schmerzmanagement nach Operationen
Versorgung verbessern: Bundesweite Initiative der Deutschen Gesellschaft für Schmerzmedizin zu…
Jedes vierte Kind wünscht bessere Schmerzbehandlung
Lebensqualität von Patienten in der dauerhaften Schmerztherapie mit Opioiden verbessern

DIABETES

Bundestag berät über DMP Adipositas: DDG begrüßt dies als Teil…
Mit der Smartwatch Insulinbildung steuern
Verbände fordern bessere Ausbildung und Honorierung von Pflegekräften für Menschen…
Minimalinvasive Geräte warnen ungenügend vor Unterzuckerung
Typ-1-Diabetes und Hashimoto-Thyreoiditis treten häufig gemeinsam auf

ERNÄHRUNG

Wie eine Diät die Darmflora beeinflusst: Krankenhauskeim spielt wichtige Rolle…
DGEM plädiert für Screening und frühzeitige Aufbautherapie: Stationäre COVID-19-Patienten oft…
Führt eine vegane Ernährungsweise zu einer geringeren Knochengesundheit?
Regelmässiger Koffeinkonsum verändert Hirnstrukturen
Corona-Erkrankung: Fehl- und Mangelernährung sind unterschätze Risikofaktoren

ONKOLOGIE

Anti-Myelom-Therapie mit zusätzlich Daratumumab noch effektiver
Positive Ergebnisse beim fortgeschrittenen Prostatakarzinom: Phase-III-Studie zur Radioligandentherapie mit 177Lu-PSMA-617
Lymphom-News vom EHA2021 Virtual. Alle Berichte sind nun online verfügbar!
Deutsch-dänisches Interreg-Projekt: Grenzübergreifende Fortbildungskurse in der onkologischen Pflege
Sotorasib: Neues Medikament macht Lungenkrebs-Patienten Hoffnung

MULTIPLE SKLEROSE

NMOSD-Erkrankungen: Zulassung von Satralizumab zur Behandlung von Jugendlichen und Erwachsenen
Verzögerte Verfügbarkeit von Ofatumumab (Kesimpta®)
Neuer Biomarker bei Multipler Sklerose ermöglicht frühe Risikoeinschätzung und gezielte…
Multiple Sklerose beginnt oft lange vor der Diagnose
Goldstandard für Versorgung bei Multipler Sklerose

PARKINSON

Meilenstein in der Parkinson-Frühdiagnose
Parkinson-Erkrankte besonders stark von Covid-19 betroffen
Gangstörungen durch Kleinhirnschädigung beim atypischen Parkinson-Syndrom
Parkinson-Agenda 2030: Die kommenden 10 Jahre sind für die therapeutische…
Gemeinsam gegen Parkinson: bessere Therapie durch multidisziplinäre Versorgung