Angiotensin Receptor Blockers
June 3, 2011
FDA completed a review of angiotensin receptor blocker (ARB) agents after a recent meta-analysis suggested a possible association with a small increase in cancer risk. Angiotensin receptor blockers are used to treat high blood pressure and certain other heart-related conditions. The ARB class of drugs includes azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan). Angiotensin receptor blockers also are available in combination with other drugs, such as thiazide diuretics.
FDA conducted a meta-analysis of 31 randomized, controlled studies. The review included over 84,000 patients randomized to ARBs and over 71,000 patients randomized to non-ARB comparators. No differences in the rate of cancer events were observed between ARB-treated patients (1.82 per 100 patient years) and non-ARB comparators (1.84 per 100 patient years; relative risk 0.99: 95% CI 0.92 to 1.06).
The initial meta-analysis which prompted the FDA review included data from several long-term, randomized, controlled trials and included data from over 60,000 patients. The mean follow-up periods in these trials ranged from 1.7 to 4.8 years. In this analysis, the frequency of new cancer was 7.2% in patients taking ARBs compared to 6.0% in patients not taking an ARB (risk ratio = 1.08, 95% confidence interval: 1.01-1.15). No statistically significant difference in the number of cancer related deaths was reported. This meta-analysis must be interpreted with caution. The trials were not designed to specifically analyze the relationship between ARBs and cancer risk. In some of the trials, cancer-related adverse event reporting was not adjudicated; therefore, it is not known if the adverse events were new cancers or events related to pre-existing cancers.
FDA has determined that ARBs do not increase the risk for cancer. Patients should continue ARBs as prescribed unless instructed otherwise by their healthcare professionals. Report any adverse events to the MedWatch program.
Additional information is available at the following links:
- Drug Safety Communication (June 2, 2011):
- Drug Safety Communication (July 15, 2010):
June 3, 2011; July 19, 2010; University of Utah, Drug Information Service. Copyright 2011, Drug Information Service, University of Utah, Salt Lake City, UT.