Combined statin drug concern

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Combined statin drug concern

Don't stop taking cholesterol-busting medication: the apparent link with an increased risk of cancer needs further study, say scientists

Concerns have been raised about the safety of the cholesterol-lowering medication Inegy after a study in the New England Journal of Medicine linked the drug to a higher incidence of cancer. However health professionals are urging patients not to stop taking the medication as the results may simply have come about by chance and have not been replicated in other trials.

The study, carried out at Ulleval University Hospital in Oslo, Norway looked at 1873 patients over a 52-month period who suffered from mild to moderate aortic-valve stenosis - a heart condition where the aortic valve becomes narrowed, impeding blood flow. Around half of the patients were given Inegy, which is a combination of two drugs, simvastatin and ezetimibe. The rest were given a placebo. The team found that over the trial period 105 patients in the Inegy group were diagnosed with cancer compared to 70 in the placebo group.

"The finding of increased numbers of incident and fatal cancers in the simvastatin–ezetimibe group, as compared with the placebo group, was unexpected and requires further exploration in trials of simvastatin and ezetimibe," say the authors of the study.

In the past two years about 300,000 prescriptions for Inergy have been dispensed in England and Wales. The tablets contain two drugs that work together in different ways to lower cholesterol levels.

The Oslo team acknowledges that these results may have come about by chance and are keen to point out that there has been no previous evidence linking statin therapy with cancer.

"Long-term statin therapy has not been associated with an increased risk of cancer. Analysis of data from 14 statin trials involving approximately 90,000 patients showed no evidence of an increased incidence of or death from cancer," the authors report.

"Ezetimibe has been studied less extensively than statins, and the finding of a significant difference between the two study groups in the numbers of patients with new and fatal cancers is a concern."

A team of researchers from Oxford have conducted a further analysis of data from this trial as well as data from two other randomised clinical trials currently in progress to investigate whether adding ezetimibe to statin therapy might increase the incidence of cancer.

They report that "available results from these three trials do not provide credible evidence of any adverse effect of ezetimibe on rates of cancer."

"The combined evidence of all data on cancer and ezetimibe in combination with a statin shows no increased risk of developing cancer," says Dr Mike Knapton, Director of Prevention and Care at the British Heart Foundation (BHF).

"Because one study did show a cancer risk, it is crucial that others continue and are monitored closely to definitively confirm or refute any link.

"People should be reassured that drug regulators will act quickly if robust evidence of risk to patient health appears.

"If you have been prescribed ezetimibe you should continue to take it. If you have concerns about side effects of this or other medication, you should talk to your doctor to weigh up the risks and benefits."

Website: British Heart Foundation - www.bhf.org.uk

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