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Aug. 29, 2011

Aug. 29, 2011

FDA comprehensive meta-analysis of clinical trials on ARBs, and ARB combination products, show no increased risk of developing cancer.

Last June, the FDA concluded that treatment with an ARB, including ARB combination products, does not increase the risk of developing cancer.

In 2010, the FDA announced it was conducting a safety review to determine a link between the use of ARBs and a small, but statistically significant increased risk of cancer. This review was based upon published meta-analysis of five randomized clinical trials in The Lancet Oncology.

To evaluate the validity of this finding, the FDA conducted a trial-level meta-analysis of clinical trials in which patients were randomly chosen for an ARB treatment or a non-ARB treatment. This analysis was comprised of 31 trials and approximately 156,000 patients in comparison to 62,000 patients in the published analysis. The FDA's comprehensive meta-analysis did not demonstrate an increased cancer risk for patients on ARBs. The analysis found the rate of incident cancer events for the ARB group was 1.82 per 100 patient-years vs. 1.84 per 100 patient-years in non-ARB comparators.

Why is this important?

ARBs have been widely used since 1995. Over 300,000 Humana members filled prescriptions for ARB-containing products in April of 2011. Humana's net paid for these medications during the same period was approximately $12 million.

Currently, seven ARBs are available, including:

  • Atacand® (candesartan)
  • Avapro® (irbesartan)
  • Benicar® (olmesartan)
  • Cozaar® (losartan)
  • Diovan® (valsartan)
  • Edarbi® (azilsartan)
  • Micardis® (telmisartan)
  • Teveten® (eprosartan)

Cozaar became generically available in April 2010.

Multiple clinical trials have shown improvements in morbidity and mortality when using an ARB for the treatment of high blood pressure or heart failure. ARBs have also been shown to be renally protective when used in the diabetic population. In addition, combination products containing ARBs are available for use in hypertension to increase medication adherence.

Members should not stop taking an ARB medication without talking to a healthcare professional. Physicians are urged to report any side effects with product to the FDA's MedWatch program.

Read more about ARBs on the Federal Drug Administration website