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arznei-telegramm 2012; 43: 23

 


Cancer due to liraglutide (VICTOZA)? A metastasized renal cell carcinoma was diagnosed in a 57-year-old woman after treatment of her diabetes mellitus with the incretin mimetic liraglutide (VICTOZA) for more than one year and more than one-and-a-half year's administration of the anti-oestrogen tamoxifen (NOLVADEX, generics) after resection of a breast cancer (NETZWERK Report 15.980). It is known that tamoxifen can lead to endometrial carcinomas (c.f. a-t 2000; 31: 80). However, a life-extending benefit is well documented in adjuvant breast cancer therapy and the risk-benefit balance is therefore favourable. Liraglutide is suspected of having a carcinogenic effect: in animal studies it produced C-cell adenomas and carcinomas and in clinical trials neoplasms were more common than in the comparative groups (8.9 versus 5.3 per 1000 patient-years; a-t 2009; 40: 80-2). The Federal Institute for Drugs and Medical Devices (BfArM) overviews 88 suspected reports of cancers linked to liraglutide from Germany and abroad up to 9 November 2011, including 31 of the pancreas and 19 of the thyroid (BfArM: letter dated 14 Nov. 2011). As yet no clinical benefit of the drug with respect to sequelae of diabetes has been proven. It seems that data regarding cardiovascular diseases can first be expected from the LEADER* study which is due to be completed in 2016 and which also records cancers (Novo Nordisk: letter dated 27 Jan. 2012; Novo Nordisk: LEADER study, as at 31 Oct. 2011; http://clinicaltrials.gov/ct2/show/NCT01179048). Until then we advise against its use, -Ed.

 

*

LEADER = Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results - a long term evaluation



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