Treatment with angiotensin receptor blockers (ARBs) does not increase a person’s risk of developing cancer, the FDA has concluded following an evaluation of 31 randomized clinical trials comparing incidence of cancer in ARB users and nonusers (www.fda.gov/Drugs/DrugSafety/ucm257516.htm).
In July 2010, the FDA announced that the agency would perform a safety review of ARBs after a published meta-analysis of five randomized clinical trials involving about 62,000 patients found a small but statistically significant increased risk of cancer among patients taking these blood pressure medications. The FDA called its own study, which included nearly 156,000 patients, the largest meta-analysis of clinical trials exploring the association between ARBs and cancer conducted to date.
The FDA investigation uncovered no evidence of an increased risk of incident cancer or cancer-related deaths in persons taking ARBs. Among 84,461 patients randomized to ARBs and 71,355 randomized to non-ARB comparators (mean follow-up: 39 months), the rate of new cancers was 1.82 per 100 patient-years vs 1.84 per 100 patient-years, respectively. The relative risk (RR) of incident cancer in ARB users was 0.99, and for cancer-related death, 1.04.
The study also found no evidence of association between ARB use and risk of breast cancer (odds ratio 1.06), lung cancer (odds ratio 1.07), or prostate cancer (odds ratio 1.05).
Single-agent ARBs include candesartan (Atacand), irbesartan (Avapro), Olmesartan (Benicar), losartan (Cozaar), valsartan (Diovan), telmisartan (Micardis), and eprosartan (Teveten). Other ARBs combine these drugs with hydrochlorothiazide and/or amlodipine or aliskiren.