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Effects of telmisartan, irbesartan, valsartan, candesartan, and losartan on cancers in 15 trials enrolling 138 769 individuals

The ARB Trialists Collaboration

doi: 10.1097/HJH.0b013e328344a7de

Background Angiotensin-converting enzyme inhibitors (ACEi) and angiotensin II receptor blockers (ARBs) reduce cardiovascular disease (CVD) events, but a recent meta-analysis of selected studies suggested that ARBs may increase cancer risks.

Objective Candesartan, irbesartan, telmisartan, valsartan, and losartan were assessed for incident cancers in 15 large parallel long-term multicenter double-blind clinical trials of these agents involving 138 769 participants.

Patients and methods Individuals at high CVD risk were randomized to telmisartan (three trials, n = 51 878), irbesartan (three trials, n = 14 859), valsartan (four trials, n = 44 264), candesartan (four trials, n = 18 566), and losartan (one trial, n = 9193) and followed for 23–60 months. Incident cancer cases were compared in patients randomized to ARBs versus controls. In five trials (n = 42 403), the ARBs were compared to ACEi and in 11 trials (n = 63 313) to controls without ACEi. In addition, in seven trials (n = 47 020), the effect of ARBs with ACEi was compared to ACEi alone and in two trials ARBs with ACEi versus ARB alone (n = 25 712).

Results Overall, there was no excess of cancer incidence with ARB therapy compared to controls in the 15 trials [4549 (6.16%) cases of 73 808 allocated to ARB versus 3856 (6.31%) of 61 106 assigned to non-ARB controls; odds ratio (OR) 1.00, 95% confidence interval (CI) 0.95–1.04] overall or when individual ARBs were examined. ORs comparing combination therapy with ARB along with ACEi versus ACEi was 1.01 (95% CI 0.94–1.10), combination versus ARB alone 1.02 (95% CI 0.91–1.13), ARB alone versus ACEi alone 1.06 (95% CI 0.97–1.16) and ARB versus placebo/control without ACEi 0.97 (95% CI 0.91–1.04). There was no excess of lung, prostate or breast cancer, or overall cancer deaths associated with ARB treatment.

Conclusion There was no significant increase in the overall or site-specific cancer risk from ARBs compared to controls.

Received 29 August, 2010

Revised 13 January, 2011

Accepted 14 January, 2011

Correspondence to Dr Koon K. Teo, Population Health Research Institute, Rm C2-106, David Braley Cardiac Vascular Stroke Research Institute, Hamilton General Hospital, 237 Barton Street East, Hamilton, ON L8L 2X2, Canada Tel: +1 905 521 2100x76222; fax: +1 905 521 5053; e-mail: or

© 2011 Lippincott Williams & Wilkins, Inc.