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EC number: 604-045-2
CAS number: 137862-53-4
Ames test; no evidence of mutagenic activity
Gene Mutation; negative
Micronucleus test; Negative
In 2010 a meta-analysis (Sipahi et al 2010) suggested that angiotensin
receptor blockers could be associated with increased cancer risk – over
85% of the patients included in the meta-analysis received telmisartan.
In response to that publication, Novartis completed a meta-analysis with
individual patient data with valsartan that showed no increased risk of
cancer or cancer related death (approximately 44,000 patients with a
mean valsartan exposure of almost 3 years/patient from four trials:
Val-HeFT VALUE, VALIANT and NAVIGATOR). Novartis submitted these data to
the FDA and EMA and both authorities concluded that treatment with
angiotensin receptor blockers do not increase a patient’s risk of
In 2011 another meta-analysis of 70 randomized clinical trials (over
320,000 patients) concluded that, in patients receiving angiotensin
receptor blockers, there was no difference in the risk of cancer (odds
ratio 1·01, 95%CI 0.93 to ·1.09) or in the risk of cancer-related
mortality (odds ratio 1·00, 95%CI 0.87 to 1.15) (Bangalore et al 2011).
There was no evidence of mutagenicity or clastogenicity in the studies.
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