A study linking any substance with cancer can be guaranteed to make the news, even when the news is that the link might not exist.

Interim results of a small trial of Inegy — a combination of ezetimibe with the generic statin simvastatin designed to lower cholesterol — were made public in July when a higher cancer incidence was observed in the treated group. The researchers on the Simvastin and Ezetimibe in Aortic Stenosis (SEAS) trial advised further study to assess whether this was a side-effect or merely a statistical anomaly. Now, a meta-analysis of two large ongoing clinical trials has failed to find a connection between Inegy and cancer incidence, but its concurrent publication with the final results of the SEAS trial has emphasized that uncertainty remains.

The US Food and Drug Administration has announced an investigation into the drug, and opinions are divided: “I am not sure that the efficacy is proven and I am not sure that the safety is proven. I wouldn't take the drug myself,” says Professor Heinz Drexel, spokesman for the European Society of Cardiology (http://www.telegraph.co.uk/ 3 Sep 2008). However, Dr Terje Pedersen, who conducted the SEAS trial, points out that “[t]he duration of the trial is not long enough to believe that the treatment would cause cancer” (http://www.nytimes.com/ 1 Sep 2008).

An editorial in the New England Journal of Medicine accompanying the trial results acknowledges that patients and physicians must wait for more conclusive evidence, which might not be soon in coming. In the meantime treatment is recommended to continue where indicated. Dr Mike Knapton of the British Heart Foundation provides a balanced view, stating, “People should be reassured that drug regulators will act quickly if robust evidence of risk to patient health appears” (http://www.timesonline.co.uk/ 3 Sep 2008).