Angiotensin II receptor antagonists: evidence does not suggest any link with cancer

Evidence does not support any increased risk of cancer in patients who use these medicines.

Article date: December 2011

Angiotensin II receptor antagonists (ARBs) are an important option in the treatment of hypertension.

In 2010, a meta-analysis of randomised controlled trials by Sipahi and colleagues[footnote 1] reported a small but significant association between use of ARBs and new cancer occurrence, particularly lung cancer. This study had several methodological limitations and it sparked further investigation of the issue by several other independent investigators.

Since then, the results of three further meta-analyses have become available.[footnote 2] [footnote 3] [footnote 4] These analyses include most of the available data from randomised controlled trials and, although they were conducted differently, all have very similar findings. Importantly, none suggest an association with cancer.

The findings from the meta-analyses of randomised controlled trials are largely supported by the findings of two large observational studies.[footnote 5] [footnote 6] Although some subgroup analyses and individual trials showed a modest increase or decrease in risk, these findings were inconsistent across trials or analyses.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has reviewed a possible link between the use of ARBs and the occurrence of new cancers and concluded that the evidence does not support any increased risk of cancer in patients who use these medicines. Rather than supporting the original concerns raised for ARBs, the totality of the available evidence from well conducted analyses is reassuring and does not support any increased risk of cancer.

Further information

European Medicines Agency press release

BNF section 2.5.5 Drugs affecting the renin-angiotensin system

US Food and Drug Administration drug safety announcement

Article citation: Drug Safety Update Vol 5 Issue 5, Dec 2011: H1.

  1. Sipahi et al. Lancet Oncol 2010; 11: 627–36. 

  2. Bangalore et al. Lancet Oncol 2011; 12: 65–82. 

  3. ARB Trialists Collaboration. J Hypertens 2011; 29: 623–35. 

  4. US Food and Drug Administration. Statistical review - meta-analysis, clinical studies. 2011. Ref ID: 2940354. 

  5. Pasternak et al. Circulation 2011; 123: 1729–36. 

  6. Chang et al. J Clin Oncol 2011; 29: 3001–07. 

Updates to this page

Published 11 December 2014