The Food and Drugs Administration (FDA) has announced that it is investigating data from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study that found an increased rate of cancer. The media have reported this announcement (Daily Express).
The SEAS Study recruited approximately 1,400 patients with aortic stenosis. Participants were randomised to treatment with simvastatin 40mg and ezetimibe 10mg daily or placebo. The primary outcome for the study was a composite of major cardiovascular endpoints including valve replacements, heart failure and cardiovascular death.
The study found no difference in the primary outcome despite a 61% reduction in low-density lipoprotein cholesterol (LDL-C). There were more adverse events related to cancer in the treatment arm of the study (93 [9.9%] versus 65 [7.0%], p=0.03) and more cancer related deaths (39 [4.1%] versus 23 [2.5%], p=0.05).
These findings are based on small numbers from a single study. Additionally, the FDA note that large prospective studies have not demonstrated any increase in cancer incidence in treatment arms compared to placebo. The FDA investigation is on-going and is likely to report final recommendations early in 2009, in the meantime they recommend that patients continue taking cholesterol lowering medication and consult their doctor if they have concerns.
Action: Patients should be reassured and advised to continue taking cholesterol lowering medication. Healthcare professionals should continue to report any suspected side effects.